Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels
Phase: PHASE4
Conditions: Ulcerative Colitis
Sponsor: Guy's and St Thomas' NHS Foundation Trust

 
GO-LEVEL 
Page 1 of 25  
Version 4.1 
 
PROTOCOL FULL TITLE:  
Study of the Golimumab Exposure-Response 
Relationship using Serum Trough Levels  
 
Protocol Short Title/Acronym: GO-LEVEL 
Trial Identifiers 
EudraCT Number -  
CRN/CPMS -  
IRAS Number - 
ClinTrials.gov -  
2017-001374-42 
34486 
194917 
NCT03124121 
 
Sponsor 
Name: Helen Critchley 
Guy’s & St Thomas’ NHS Trust 
Address: F16 Tower Wing, Guy's Hospital, Great Maze Pond, SE1 9RT 
Telephone: 02071885732 
Fax: 02071888330 
Email: helen.critchley@kcl.ac.uk 
Chief Investigator  
Name: Peter Irving 
Address: Guy's and St Thomas' Hospital, Department of Gastroenterology, 
First Floor College House, North Wing, St Thomas' Hospital, Westminster 
Bridge Road, London, SE1 7EH 
Telephone: 02071882499 
Email: peter.irving@gstt.nhs.uk 
 
Protocol version 4.1, 13th June 2019 

Protocol  
GO-LEVEL 
Version 4.1, 13th June 2019 
EudraCT Number 2017-001374-42 
 
IRAS Number 194917 
 
 
 
Page 2 of 25 
 
 
 
Name and address of Co-Investigator(s) & Laboratories 
Name: Mark Samaan, Sub-investigator 
Address: Guy's and St Thomas' Hospital, Department of Gastroenterology, First 
Floor College House, North Wing, St Thomas' Hospital, Westminster Bridge 
Road, London, SE1 7EH 
Telephone: 07740637713                                  Email: mark.samaan@gstt.nhs.uk 
Name: Zehra Arkir, Co-investigator                                                               
Address: Viapath Laboratories, St Thomas' Hospital, Westminster Bridge Road, 
London, SE1 7EH                                                                                      
Telephone: 020 7188 7188 
 
 
Email: zehra.arkir@viapath.co.uk 
 
Funder 
Name: Merck Sharp & Dohme Limited 
Address: Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU 
Telephone: +44 (0) 7974 444508  
 
Email: yash.patel@merck.com 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol  
GO-LEVEL 
Version 4.1, 13th June 2019 
EudraCT Number 2017-001374-42 
 
IRAS Number 194917 
 
 
 
Page 3 of 25 
 
 
 
CONTENTS 
 
1.Protocol Synopsis……………………………………………………………………….4 
2. Glossary of Terms………………………………………………………………………7  
3.Background & Rationale ...................................................................................... 8 
4. Trial Objectives and Design.............................................................................. 11 
4.1. Trial Objectives ................................................................................................. 11 
4.1.1 Primary Endpoints…………………………………………………………………..11 
4.1.2 Secondary Endpoints……………………………………………………………….11 
4.2 Trial Design ....................................................................................................... 12 
4.3 Trial Flowchart ................................................................................................... 13 
5 Trial Medication .................................................................................................. 15 
5.1 Investigational Medicinal Product ...................................................................... 15 
5.2 Dosing Regimen ................................................................................................ 15 
5.3 IMP Risks .......................................................................................................... 15 
5.4 Drug Accountability ........................................................................................... 15 
5.5 Storage of IMP .................................................................................................. 15 
5.6 IMP Labelling..................................................................................................... 15 
5.7 Subject Compliance .......................................................................................... 15 
5.8 Concomitant Medication .................................................................................... 15 
6 Selection and Withdrawal of Subjects .............................................................. 16 
6.1 Inclusion Criteria ................................................................................................ 16 
6.2 Exclusion Criteria .............................................................................................. 16 
6.3 Selection of Participants .................................................................................... 17 
6.4 Randomisation Procedure / Code Break ........................................................... 17 
6.5 Withdrawal of Subjects ...................................................................................... 17 
6.6 Expected Duration of Trial. ................................................................................ 18 
7  Trial Procedures ................................................................................................ 18 
7.1 By Visit .............................................................................................................. 20 
7.2 Laboratory Tests ............................................................................................... 20 
8 Assessment of Efficacy ..................................................................................... 20 
8.1.1 Primary Efficacy Parameters .......................................................................... 20 
8.1.2 Secondary Efficacy Parameters ..................................................................... 20 
8.2 Procedures for Assessing Efficacy Parameters ................................................. 20 
9 Assessment of Safety ........................................................................................ 21 
9.1 Specification, Timing and Recording of Safety Parameters. .............................. 21 
9.2 Procedures for Recording and Reporting Adverse Events ................................. 21 
9.2.1 Adverse events that do not require reporting .................................................. 22 
9.3 Treatment Stopping Rules ................................................................................. 22 
10 Statistics ........................................................................................................... 22 
10.1 Sample Size .................................................................................................... 22 
10.2 Analysis ........................................................................................................... 23 
11 Direct Access to Source Data and Documents .............................................. 23 
12 Ethics & Regulatory Approvals ....................................................................... 23 
13 Quality Assurance ............................................................................................ 23 
14 Data Handling ................................................................................................... 23 
14.1 Source Data…………………………………………………………………………..24 
15 Data Management ............................................................................................. 24 
16 Publication Policy ............................................................................................ 24 

Protocol  
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EudraCT Number 2017-001374-42 
 
IRAS Number 194917 
 
 
 
Page 4 of 25 
 
 
 
17 Insurance & Indemnity ..................................................................................... 24 
18 Financial Aspects ............................................................................................. 25 
19 Signatures ......................................................................................................... 25 
19.1 CI Signature .................................................................................................... 25 
19.2 PI Signature..................................................................................................... 25 
 
1. Study Synopsis 
 
Title of clinical trial 
 
 
Study of the Golimumab Exposure-Response 
Relationship using Serum Trough Levels 
Protocol Short Title/Acronym 
 
 
GO-LEVEL 
Trial Phase if not mentioned in title 
 
 
Phase IV 
Sponsor name 
 
 
Guy’s & St Thomas’ NHS Foundation Trust 
Chief Investigator 
 
 
Peter Irving 
EudraCT number 
 
 
2017-001374-42 
IRAS number 
 
 
194917 
Medical condition or disease under 
investigation 
 
Ulcerative colitis (UC) 
Purpose of clinical trial 
 
 
To study the exposure-response relationship of 
golimumab using serum trough levels 
Primary objective 
 
 
To define a week 6 golimumab trough level 
concentration that predicts response at week 14 
Secondary objective (s) 
 
 
To define golimumab trough level concentrations at 
weeks 6, 10 and 14 that predict response at each time 
point during induction therapy, respectively.  
To define a golimumab trough threshold that is 
associated with remission during maintenance 
therapy. 
Tertiary objectives will centre on the study of the 
relationship between serum golimumab trough levels 
and 
novel 
disease 
activity 
indices 
(PRO2), 
biochemical markers of disease activity (CRP, faecal 
calprotectin) and quality of life indices. The role of 
anti-drug antibodies will also be investigated in 
relation to trough levels and disease activity.  

Protocol  
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EudraCT Number 2017-001374-42 
 
IRAS Number 194917 
 
 
 
 
 
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Trial Design 
 
 
Open-label, non-randomised, phase IV trial.  
Patients commencing induction therapy with 
golimumab (cohort 1) will be enrolled into a 
prospective study. 
 
Patients on maintenance golimumab therapy (cohort 
2) will be enrolled into a cross-sectional study. 
Endpoints 
 
 
Primary: golimumab trough levels and UC disease 
activity (SCCAI) at weeks 6 and 10 
 
Secondary: biochemical markers of UC disease 
activity (fecal calprotectin and CRP), clinical disease 
activity (PRO2), development of antibodies and 
quality of life (IBD-Control) at weeks 6, 10 and 14.  
Sample Size 
 
 
Total: 112 patients  
(cohort 1: 42 patients, cohort 2: 70 patients) 
Summary of eligibility criteria 
 
Inclusion criteria for cohort 1:  
• 
Aged 18 years or over  
• 
Written informed consent to participate 
• 
Moderate-to-severe UC, defined as: 
o SCCAI > 5 and, 
▪ 
A raised fecal calprotectin 
(> 59 μg/g) or, 
▪ 
A raised CRP (> 5 mg/L) 
or,  
▪ 
Endoscopic disease 
activity Mayo 2 or above, 
Evaluated within 4 weeks of 
screening  
• 
Commencing golimumab treatment 
• 
Sufficient English language skills to 
understand the patient information sheet 
and consent form 
 
Inclusion criteria for cohort 2: 
 
• 
Aged 18 years or over 
• 
Written informed consent to participate 
• 
Receiving golimumab treatment for UC 
over 14 weeks (have completed 6 
injections at time of screening) 
• 
Sufficient English language skills to 
understand the patient information sheet 
and consent form 

Protocol  
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IRAS Number 194917 
 
 
 
 
 
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Exclusion criteria (cohort 1 only) 
 
• 
Contra-indication to golimumab: 
tuberculosis, severe infections or 
congestive cardiac failure 
• 
Imminent need for colectomy (i.e. 
colectomy is being planned) 
• 
Previous primary non-response to anti-
TNF therapy in the opinion of the 
investigator 
• 
Previous treatment with more than one 
anti-TNF therapy (excluding golimumab) 
 
IMP, dosage and route of administration 
 
Patients will receive standard induction treatment 
with subcutaneous golimumab 200 mg at week 0 
and 100 mg at week 2. Followed by maintenance 
treatment of 50 or 100 mg (based on weight) every 
four weeks until the supervising clinician makes the 
decision to withdraw treatment (as is the standard of 
care). 
Active comparator product(s) 
 
N/A 
Maximum duration of treatment of a 
Subject 
 
Total duration of treatment will be decided by the 
supervising physician on clinical grounds (exactly as 
the standard of care) and enrolment into the study 
will have no bearing on this decision. 
Version and date of protocol 
amendments 
 
Version 4.1, 13th June 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol  
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Version 4.1, 13th June 2019 
EudraCT Number 2017-001374-42 
 
IRAS Number 194917 
 
 
 
 
 
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2. Glossary of Terms 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ADA 
Anti-drug antibodies 
CRP 
C-reactive protein  
EMA  
European Medicines Agency  
FDA  
US Food and Drug Administration  
GCP  
Good Clinical Practice  
PK  
Pharmacokinetics  
QoL  
Quality of Life  
RCT  
Randomized controlled trial  
(S)AE  
(Serious) Adverse Event  
Sponsor  
The sponsor is the party that commissions the organization or 
performance of the research, for example a pharmaceutical 
company, academic hospital, scientific organization or investigator. 
A party that provides funding for a study but does not commission 
it is not regarded as the sponsor, but referred to as a subsidizing 
party.  
SCCAI  
Simple Clinical Colitis Activity Index  
SUSAR  
Suspected Unexpected Serious Adverse Reaction  
TNF  
Tumor necrosis factor  
UC  
Ulcerative Colitis  

Protocol  
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IRAS Number 194917 
 
 
 
 
 
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3. Background & Rationale 
The advent of biologic therapies has led to significant changes in treatment strategies for 
ulcerative colitis (UC). Prior to biologic therapies, options for treatment primarily 
consisted of the stepwise use of mesalazine, corticosteroids and immunomodulators for 
disease of increasing severity. Mesalazine was used to achieve and maintain remission 
in mild-to-moderate cases with the addition of corticosteroids for those failing to respond 
or with severe disease. Patients with colitis refractory to intravenous (IV) corticosteroids 
received ciclosporin or underwent colectomy. Over the past decade, multiple clinical 
trials have shown the efficacy of anti-TNF therapies for these patients with moderate to 
severe UC. Therefore, Anti-TNF agents are key tools in current treatment algorithms for 
both chronically active and acute severe UC.  
 
The effectiveness of biologic agents has also changed treatment goals in ulcerative 
colitis. This is evident in the evolution of endpoints used for clinical trials and targets 
used in clinical practice. Conventional and established goals of treatment focused 
predominantly on achieving symptomatic remission. The cessation of corticosteroid use 
and achieving mucosal healing were secondary goals. However, in the era of anti-TNF 
agents with the ability to heal colonic mucosa when other drugs have failed, mucosal 
healing and steroid-free clinical remission have gained prominence as therapeutic 
targets. 
 
A significant proportion of UC patients fail to respond to induction therapy with anti-TNF 
agents (primary non-responders) or require dose escalation due to loss of response over 
time (secondary non-responders). Dose escalation has been demonstrated to be an 
effective strategy in patients losing response to anti-TNF therapy. Where this strategy 
fails or in the presence of significant levels of anti-drug antibodies, switching to another 
anti-TNF agent (or mechanism of action) is advocated. Therefore, an increase in the 
range of anti-TNF agents available to clinicians was desired and necessary to overcome 
the substantial rates of non-response over time. In addition, a better understanding of 
the effect-response relationship of these agents would allow a more evidence-based 
approach to dose optimization.  
 
Golimumab represents a new treatment option for patients with moderate-to-severe UC, 
failing or intolerant of conventional treatments. It is a transgenic, fully human monoclonal 
immunoglobulin G1 antibody that is synthesized from TNF-immunized transgenic mice 
expressing human immunoglobulin G. Although it was approved for use in rheumatoid 
arthritis, psoriatic arthritis, and ankylosing spondylitis in 2009, it was not until 2013 that 
the US Food and Drug Administration (FDA) and the European Medicines Agency 
(EMA) granted approval for UC.  
 
The PURSUIT (Program of Ulcerative Colitis Research Studies Utilizing an 
Investigational Treatment) trial program was a series of randomized, double-blind, 
placebo-controlled studies that led to regulatory approval for the use of golimumab in 
UC1,2. The comprehensive trial program consisted of investigation of the most 
appropriate route of administration (subcutaneous or intravenous), a phase II dose-
ranging study and a phase III trial of induction and maintenance therapy. Subcutaneous 
administration was found to result in equivalent efficacy and a preferable 
pharmacokinetic profile when compared with intravenous dosing and is therefore the 
approved route of administration. PURSUIT-SC demonstrated that induction therapy 
with golimumab resulted in a significantly greater proportion of patients achieving a 

Protocol  
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IRAS Number 194917 
 
 
 
 
 
Page 9 of 25 
clinical response, clinical remission and mucosal healing at week 6 compared with 
placebo1. All subjects from the PURSUIT-SC study were eligible for enrollment into 
PURSUIT-M, which evaluated the efficacy and safety of golimumab maintenance 
therapy over 54 weeks. On-going treatment with golimumab was shown to result in a 
significantly increased rate of sustained clinical benefit (both response and remission) 
compared with placebo2.     
 
However, despite the fact that the PURSUIT trial program yielded positive results and 
met its primary endpoints, unanswered questions remain regarding the optimal use of 
golimumab in UC. For example, how could the observed rates of primary and secondary 
non-response (approximately 50% and 40%) be minimized? In addition to significant 
rates of non-response, the majority of patients who do respond to the drug remain 
symptomatic to some degree, are on concomitant steroids, and are without a “normal or 
inactive” (Mayo 0) mucosal appearance. It’s possible that these outcomes could be 
improved upon, given a more detailed understanding of the initial exposure-response 
relationship data that emerged from PURSUIT.  
 
Patients with higher serum concentrations of golimumab were observed to have higher 
rates of response and remission as well as greater improvement in median composite 
Mayo scores. In PURSUIT-SC the change from baseline Mayo score and rates of clinical 
response and clinical remission at week 6 increased with increasing quartiles of serum 
golimumab concentration. Serum quartile analysis of the subsequent maintenance trial 
showed that more patients in the higher quartiles achieved clinical response through to 
week 54, or clinical remission at both weeks 30 and 54, when compared with those in 
the lower quartiles. 
 
In a recent publication, Adedokun and colleagues reported a rigorous and meticulously 
performed a study of the pharmacokinetics and pharmacodynamics of golimumab using 
samples taken as part of the PURSUIT trials. As part of these analyses the authors 
found serum golimumab concentrations to be dose proportional and that a positive 
correlation exists between concentrations and efficacy outcomes (clinical response, 
clinical remission and mucosal healing) during induction and maintenance therapy. They 
then went further by using receiver-operating-characteristics (ROC) curve analysis to 
define serum golimumab concentrations that may serve as potential targets for treatment 
optimization; proposing thresholds of 2.5 μg/ml at week 6 and 1.4 μg/ml during steady-
state maintenance therapy3. Prior to this, similar findings were also reported by a group 
from Leuven as part of an observational study of 21 patients being treated with 
golimumab in a clinical setting. Median golimumab concentrations were significantly 
higher in partial clinical responders than in non-responders at week 2 (10.0 vs 7.4 μg/ml, 
p = 0.035) and week 6 (5.1 vs 2.1 μg/ml, p = 0.037). Their ROC curve analysis revealed 
a cut-off of 2.6 μg/ml at week 6 (90% specificity, 56% sensitivity, Area Under the Curve 
0.79 [95% CI], p = 0.034) for the association with a partial clinical response after 14 
weeks of treatment4. The authors of both of these studies highlighted the need for further 
prospective trials to validate their findings and add further validation to commercially 
available assays for the measurement of golimumab serum concentrations. Data such 
as these could be used to optimise the use of golimumab in clinical practice and inform 
prospective therapeutic drug monitoring trials employing trough levels to drive dosing.   
 
Anti-drug antibodies were also detected in a small minority of patients (2.9%) in the 
PURSUIT trials and the majority of these (67.7%) were found to be neutralizing. Their 
occurrence was significantly less common in patients who were receiving concomitant 

Protocol  
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IRAS Number 194917 
 
 
 
 
 
Page 10 of 25 
immunomodulators (1.1%) compared with patients who were not (3.8%). However, due 
to the low observed incidence it is difficult to draw conclusions regarding their impact on 
efficacy. Nonetheless, a clearer understanding of their impact on drug exposure and 
subsequently, disease activity would be of benefit in defining the optimal use and 
monitoring of golimumab.    
 
In conclusion, golimumab is a promising new treatment of moderate-to-severe UC. 
However, several aspects regarding its optimal use remain unclear. Most important of 
these is the quantification of a minimum exposure threshold that results in a clinical 
benefit. This requires dedicated clinical trials to generate the necessary evidence to 
guide clinicians and allow patients to get the most benefit from this new agent. 
 
References: 
1. Sandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, et al. 
Subcutaneous Golimumab Induces Clinical Response and Remission in Patients 
With Moderate-to-Severe Ulcerative Colitis. Gastroenterology. 2014 
Jan;146(1):85-95. PubMed PMID: 23735746. 
2. Sandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, et al. 
Subcutaneous Golimumab Maintains Clinical Response in Patients With 
Moderate-to-Severe Ulcerative Colitis. Gastroenterology. 2014 Jan;146(1):96-
109 e1. PubMed PMID: 23770005. 
3. Adedokun OJ, Xu Z, Marano CW, Strauss R, Zhang H, Johanns J, et al. 
Pharmacokinetics and Exposure-response Relationship of Golimumab in 
Patients with Moderately-to-Severely Active Ulcerative Colitis: Results from 
Phase 2/3 PURSUIT Induction and Maintenance Studies. Journal of Crohn's & 
colitis. 2017 Jan;11(1):35-46. PubMed PMID: 27440869. Pubmed Central 
PMCID: 5175493. 
4. Detrez I, Dreesen E, Van Stappen T, de Vries A, Brouwers E, Van Assche G, et 
al. Variability in Golimumab Exposure: A 'Real-Life' Observational Study in Active 
Ulcerative Colitis. Journal of Crohn's & colitis. 2016 May;10(5):575-81. PubMed 
PMID: 26738756. Pubmed Central PMCID: 4957447. 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol  
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IRAS Number 194917 
 
 
 
 
 
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4 Trial Objectives and Design  
4.1. Trial Objectives 
 
Primary Objective 
To define a week 6 golimumab trough level concentration that predicts response at week 
14. 
Secondary Objectives 
To define golimumab trough level concentrations at weeks 6, 10 and 14 that predict 
response at each time point, respectively.  
To define a golimumab trough threshold that is associated with remission during 
maintenance therapy. 
Tertiary Objectives 
Tertiary objectives will centre on the study of the relationship between serum golimumab 
trough levels and novel disease activity indices (PRO2), biochemical markers of disease 
activity (CRP, faecal calprotectin) and quality of life indices. The role played by anti-drug 
antibodies will also be investigated in relation to trough levels and disease activity.   
The role played by anti-drug antibodies will be investigated in relation to golimumab trough 
levels and disease activity.  
This study will also generate data that can be used to validate a commercially available 
golimumab assay as well as a novel patient reported outcome (PRO) assessment of 
disease activity. 
4.1.1 Primary endpoints   
Drug exposure to golimumab will be evaluated using serum trough level 
concentrations measured using a commercially available ELISA produced by 
Theradiag (LISA TRACKER) at weeks 6 and 10. Clinical UC disease activity will be 
evaluated using SCCAI with the following definitions: 
 
 
Remission  
SCCAI ≤ 2   
       
Response  
SCCAI ≤ 5, with a decrease by ≥ 2 
 
Relapse 
SCCAI ≥ 5 (following a response) 
 
4.1.2 Secondary endpoints 
UC disease activity assessments at each time point (weeks 6, 10 and 14) using PRO2, 
development of anti-drug antibodies, acute infusion reactions (allergic), fecal 
calprotectin, serum CRP measurements, albumin and QoL assessments using IBD-
Control. 
 

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IRAS Number 194917 
 
 
 
 
 
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4.2 Trial Design  
This will be an open-label, non-randomised, phase IV trial. 
The study will involve two study groups:  
Cohort 1 (42 patients): Patients commencing golimumab induction therapy will be 
included in a prospective, observational study.  
Cohort 2 (70 patients): Patients receiving golimumab maintenance therapy will be 
included in a cross-sectional, observational study. 
The study will be initiated and primarily run at Guy’s and St Thomas’ Hospital, a tertiary 
IBD referral center. To acquire sufficient patient numbers in a timely manner, patients 
will also be recruited from Kings College Hospital using pre-existing collaborative 
research links.  
The planned inclusion period is estimated to be one and a half years; by which time the 
target of 112 patients (between the two study cohorts) will be enrolled.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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IRAS Number 194917 
 
 
 
 
 
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4.3 Trial Flowchart 
 
Patients in Cohort 1 (commencing induction treatment): 
 
 
Screen Visit        
(day -90 – day 0) 
Day 0 
 
Day 
14 
Day 
38-42 
Day 
42 
Day 
66-70 
Day 
70 
Day 
94-98 
Day 
98 
 
 
Week 
0 
Week 
2 
 
Week 
6 
 
Week 
10 
 
Week 
14 
Signed Informed consent  
X 
 
 
 
 
 
 
 
 
Collection of demographic 
and UC disease related 
data 
X 
 
 
 
 
 
 
 
 
Review 
inclusion/exclusion criteria 
X 
 
 
 
 
 
 
 
 
Golimumab administration   
(self-administered by 
patients)  
 
X 
X 
 
X 
 
X 
 
X 
Serum golimumab 
concentration and anti-
drug antibody 
measurements 
 
 
 
X 
 
X 
 
X 
 
Clinical disease activity 
scores (SCCAI and 
PRO2)  
X 
 
 
X 
 
X 
 
X 
 
Injection-site reaction and 
IBD-relevant concomitant 
medication review 
X1 
 
 
X 
 
X 
 
X 
 
Serum CRP and albumin 
measurements 
X 
 
 
X 
 
X 
 
X 
 
Faecal calprotectin (FC) 
X 
 
 
X 
 
X 
 
X 
 
Quality of life assessment    
(IBD-Control) 
X 
 
 
X 
 
X 
 
X 
 
 
1. Injection site reaction review is not applicable at this visit  
 
 
 
 
 
 

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IRAS Number 194917 
 
 
 
 
 
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Patients in Cohort 2 (on maintenance golimumab treatment): 
 
 
Day 0 
Screen Visit 
Day 21-28 
Day 28 
Signed Informed consent  
 
X 
 
 
Collection of demographic and UC disease 
related data 
 
X 
 
 
Review inclusion/exclusion criteria 
 
X 
 
 
Golimumab administration                                      
(self-administered by patients) 
X 
 
 
X 
Serum golimumab concentration and anti-drug 
antibody measurements 
 
 
X 
 
Clinical disease activity scores                               
(SCCAI and PRO2) 
 
 
X 
 
Injection-site reaction and IBD-relevant 
concomitant medication review 
 
X 
 
 
Serum CRP and albumin measurements 
 
 
X 
 
Faecal calprotectin (FC) 
 
 
X 
 
Quality of life assessment (IBD-Control) 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 

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IRAS Number 194917 
 
 
 
 
 
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5 Trial Medication 
5.1 Investigational Medicinal Product 
Golimumab (Simponi®, Janssen Biotech, Inc., Horsham, PA, USA) is a sub-cutaneously 
administered anti-TNF agent. A homecare agreement is already in place with the 
golimumab supplier (MSD) and the medicine will be delivered to the patients’ home in 
the standard manner for each site. 
5.2 Dosing Regimen 
Patients will receive standard golimumab induction treatment of 200 mg at week 0 and 
100 mg at week 2, according to standard clinical practice. From week 6 maintenance 
treatment is started at 100 mg (≥ 80 kg) or 50 mg (< 80 kg) every four weeks. Treatment 
will be continued until the supervising clinician makes the decision to withdraw treatment 
(exactly as the standard of care). Enrolment into the trial will have no bearing on this 
decision. 
5.3 IMP Risks  
In the controlled period of the pivotal trials in rheumatoid arthritis, psoriatic arthritis, 
ankylosing spondylitis, and UC, upper respiratory tract infection was the most common 
adverse drug reaction (ADR) reported in 12.6% of golimumab-treated patients compared 
with 11.0% of control patients. The most serious ADRs that have been reported for 
golimumab include serious infections (including sepsis, pneumonia, TB, invasive fungal 
and opportunistic infections), demyelinating disorders, lymphoma, HBV reactivation, CHF, 
autoimmune processes (lupus-like syndrome) and haematologic reactions. 
5.4 Drug Accountability 
No accountability as this is part of local site standard care. As patients are being treated 
as part of standard care, the IMP will be supplied by the NHS (i.e. not by MSD). 
5.5 Storage of IMP 
A homecare plan (to teach patients how to self-administer injections) is already in place 
with the golimumab supplier (MSD) and the medicine will be delivered to the patients’ 
home in the standard manner. Standard storage information will be given to patients. 
5.6 IMP labelling 
No labelling of the IMP will be required since it is a type A trial and the study drug will be 
used from commercial stock and according to its SmPC. 
5.7 Subject Compliance 
No specific compliance testing will be carried out but non-compliance could be deduced 
based on serum drug levels made as part of the trial. 
 
5.8 Concomitant Medication 
No restrictions on concomitant medications will be made. 
Data regarding IBD-relevant concomitant medications only will be collected at each visit 
and recorded on the eCRF. 

Protocol  
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IRAS Number 194917 
 
 
 
 
 
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6 Selection and Withdrawal of Subjects  
6.1 Inclusion Criteria  
Adult patients with moderate-to-severe UC with an inadequate response to, or unable to 
tolerate, one or more of the following conventional therapies: oral 5-aminosalicylates, 
oral corticosteroids, immunomodulators; or are corticosteroid dependent.  
Inclusion criteria for cohort 1:  
• 
Aged 18 years or over  
• 
Written informed consent to participate 
• 
Moderate-to-severe UC, defined as: 
- 
SCCAI > 5 and, 
i. A raised fecal calprotectin (> 59 μg/g) or, 
ii. A raised CRP (> 5 mg/L) or,  
iii. Endoscopic disease activity Mayo 2 or above, 
Evaluated within 4 weeks of screening  
• 
Commencing golimumab treatment 
• 
Sufficient English language skills to understand the patient information sheet 
and consent form 
 
Inclusion criteria for cohort 2: 
 
• 
Aged 18 years or over 
• 
Written informed consent to participate 
• 
Receiving golimumab treatment for UC over 14 weeks  (have completed 6 
injections at time of screening) 
• 
Sufficient English language skills to understand the patient information sheet 
and consent form 
6.2 Exclusion Criteria (cohort 1 only) 
 
• 
Contra-indication to golimumab: tuberculosis, severe infections or congestive 
cardiac failure 
• 
Imminent need for colectomy (i.e. colectomy is being planned) 
• 
Previous primary non-response to anti-TNF therapy in the opinion of the 
investigator 
• 
Previous treatment with more than one anti-TNF therapy (excluding 
golimumab) 
 
There are no relevant exclusion criteria for patients entering cohort 2. 

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6.3 Selection of Participants  
At Guy’s & St Thomas’ Hospital potential participants could be identified by any member 
of the multidisciplinary direct care team, including registrars, clinical research fellows, 
consultants as well as clinical nurse specialist and IBD research nurses or pharmacists. 
Potential participants could be identified during gastroenterology out patient clinics, at 
endoscopy or during our multidisciplinary meeting ("Virtual Biologics and 
Immunosuppressant Clinic, VBIC"). 
Patients in cohort 1: The decision to commence golimumab treatment will be made in 
the patients’ best interest along standardised clinical treatment algorithms that are in 
accordance with NICE guidance. Once this decision has been made potential inclusion 
in GO-LEVEL will be considered. Patients meeting the inclusion criteria will be invited to 
take part in the study.  
Patients in cohort 2: Patients already receiving golimumab treatment will be identified 
using pharmacy records and patients will be invited to take part in the study. 
 
At King’s College Hospital, a similar participant identification plan will be followed with 
the local Principle Investigator and/or multidisciplinary IBD team identifying potential 
participants. With the additional step taken that a member of the local clinical care team 
will contact the potential participant to ask whether they would agree to receive a call 
from a researcher regarding a study, to which they would be eligible.  
 
To increase recruitment, participants may also be selected using patient identification 
centres (PIC). Arrangements have been made with Consultant (Dr Leon Pee) and 
Registrar (Dr Emma Johnston) colleagues at a local secondary care Gastroenterology 
department: Lewisham University Hospital, Lewisham & Greenwich NHS Trust. A total of 
approximately 15 minutes per subject is expected to be sufficient for screening records 
and providing information to potential participants. These additional activities will not be 
funded but have been agreed with local clinicians, who will also be invited to participate 
with the publication of the final study results. They may provide a patient information 
sheet to patients and ask them that if they are interested to contact relevant persons at 
Guy’s & St Thomas’. Alternatively, they may verbally consent patients for their contact 
details to be forwarded to Guy’s & St Thomas’. Once this verbal consent is obtained they 
will email details using secure @NHS.net to @NHS.net email or by telephone. 
 
6.4 Randomisation procedure/Code-break  
 
This is not a randomised study. Patients who are commencing golimumab treatment will 
be enrolled into cohort 1. Patients who are already on golimumab maintenance therapy 
will be enrolled into cohort 2. This will be confirmed as an investigator as part of an 
eligibility review. Every patient will be appointed a sequential two-digit study number. 
 

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6.5 Withdrawal of Subjects  
Participants in both study cohorts have the right to withdraw from the study at any time 
for any reason.  The investigator also has the right to withdraw patients from the study 
drug in the event of inter-current illness, AEs, SAE’s, SUSAR’s, protocol violations, cure, 
administrative reasons or other reasons.  It is understood by all concerned that an 
excessive rate of withdrawals can render the study un-interpretable; therefore, 
unnecessary withdrawal of patients should be avoided.  Should a patient decide to 
withdraw from the study, all efforts will be made to report the reason for withdrawal as 
thoroughly as possible.   
 
Should a patient withdraw from study drug only, efforts will be made to continue to 
obtain follow-up data (including relevant safety assessments), with the permission of the 
patient. Because this is a non-interventional trial there won’t be an interim analysis or 
premature termination of the study.  
 
Participants who wish to withdraw from trial medication (IMP) will be asked to confirm 
whether they are still willing to provide the following:  
• 
Trial specific data (clinical and biochemical disease activity scores and quality 
of life evaluations)  
• 
Data collected as per routine clinical practice 
 
Patient status with regards continuation on the trial will be assessed at every visit and in 
cases of withdrawal an eCRF withdrawal form will be completed. 
6.6 Expected Duration of Trial 
The end of the trial will be defined as the date of the final database lock. Each 
individual subject will remain on the trial until they have completed standard induction 
therapy with golimumab. The visit at week 14 will be the ‘end of study visit’ and there 
will be no additional follow-up visits beyond week 14.  
 
7 Trial Procedures  
7.1 By Visit 
Cohort 1 
Screening visit 
• 
Signed Informed consent 
• 
Review inclusion/exclusion criteria 
• 
Demographic details: age, gender 
• 
IBD-relevant concomitant medication review (Injection site reaction review is not 
applicable at this visit) 
• 
Baseline clinical (SCCAI and PRO2) and biochemical assessments (CRP, 
albumin and FC)  
• 
Baseline quality of life assessment (IBD-Control) 
• 
UC disease related details: anatomic distribution (proctitis, left-sided disease or 
extensive colitis) and duration of disease 

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Day 0 (week 0), day 14 (week 2), day 42 (week 6), day 70 (weeks 10) and day 98 (week 
14) 
Patients self-administer golimumab at home.  
Any late golimumab administrations (within a week of the planned injection date) would 
not be considered to significantly impact the integrity of the trial or its results and these 
will not be considered protocol deviations. 
Day 38-42 (week 6), day 66-70 (week 10), day 94-98 (week 14) 
• 
Serum golimumab concentration measurement 
• 
Anti-golimumab antibody measurement 
• 
Injection-site reactions and IBD-relevant concomitant medication review 
• 
Clinical (SCCAI and PRO2) and biochemical assessments (CRP, albumin and 
FC)  
• 
Quality of life assessment (IBD-Control) 
In cohort 1 patients commencing induction therapy with golimumab, will receive delivery 
of the drug and self-injection training from registered nurses under the Homecare 
agreement already in place. This will be identical to the standard of care provided by the 
NHS (both at Guy’s & St Thomas’ and King’s College Hospitals). Routine clinical care 
would usually involve clinical review prior to treatment initiation and again at approximately 
10-14 weeks from treatment initiation. GO-LEVEL will include clinical and biochemical 
assessments made at weeks 6, 10 and 14, and one of these will be arranged to coincide 
with their routine clinical appointment. Taking part in the study will therefore involve an 
additional two visits for patients, above routine clinical care. Patients will be asked to self-
administer their treatment in the usual way and visits will be arranged such that trough 
concentrations will be measured within four days prior to the subsequent dose. 
Golimumab injections could be given on the same day as the trial visit but assessments 
and blood tests must be taken prior to self-administration. 
Cohort 2 
Screening visit 
• 
Signed Informed consent 
• 
Review inclusion/exclusion criteria 
• 
Demographic details: age, gender 
• 
Injection-site reaction and IBD-relevant concomitant medication review  
• 
UC disease related details: anatomic distribution (proctitis, left-sided disease or 
extensive colitis) and duration of disease 
Day 0 (week 0) 
• 
Patients self-administer golimumab at home 
Day 21-28 (week 4) 
• 
Serum golimumab concentration measurement 
• 
Anti-golimumab antibody measurement 
• 
Clinical (SCCAI and PRO2) and biochemical assessments (CRP, albumin and 
FC)  
• 
Quality of life assessment (IBD-Control) 
 

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Day 28  
• 
Patients self-administer golimumab at home 
Any late golimumab administrations (within a week of the planned injection date) would 
not be considered to significantly impact the integrity of the trial or its results and these 
will not be considered protocol deviations. 
In cohort 2 patients receiving maintenance therapy with golimumab, trough levels will be 
measured at the next available opportunity after enrollment or at the time of loss of 
response.  In cohort 2, a trough level measurement will be defined as a drug level taken 
in the final week before the patients next planned injection. Patients may be recruited to 
cohort 2 in the week leading up to their week 18 injection (i.e. from week 17 after initiation 
of golimumab onwards). 
7.2 Laboratory Tests 
For both cohorts, at each time point serum golimumab measurements will be made as 
well as measurements of antibodies to golimumab, serum CRP and albumin. Routine 
biochemical measurements (CRP and albumin) will be processed in the standard NHS 
manner. Agreement is in place with our local reference chemistry laboratory (Viapath) 
for ELISA measurements of golimumab concentrations and anti-drug antibodies using 
a commercially available assay (LISA TRACKER, produced by Theradiag). Samples 
from King’s College Hospital for golimumab serum concentrations and anti-drug 
antibody measurement will be transferred to Vipath via an established sample transfer 
route. 
Fecal calprotectin measurements will also be taken at each study time point (i.e. weeks 
6, 10 and 14 in cohort 1 and at a single point in cohort 2). The faecal calprotectin 
samples will be handled in the standard NHS manner, which involves transfer to the 
reference chemistry laboratory (via an established sample transfer route) at King’s 
College Hospital. 
8 Assessment of Efficacy  
Clinical disease activity will be evaluated at each time point (weeks 6, 10 and 14) using 
the Simple Clinical Colitis Activity Index (SCCAI) and a recently defined two-item (stool 
frequency and rectal bleeding) patient reported outcome (PRO2) score. Quality of life will 
be assessed using the IBD-Control questionnaire. 
8.1.1 Primary Efficacy Parameters 
• 
Drug exposure to golimumab using serum trough level concentrations.  
• 
Clinical UC disease activity using SCCAI using the following definitions: 
− 
Remission:  
SCCAI ≤ 2   
− 
Response:  
SCCAI ≤ 5, with a decrease by ≥ 2 
− 
Relapse: 
SCCAI ≥ 5 (following a response) 

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8.1.2 Secondary Efficacy Parameters 
UC disease activity assessments using PRO2, development of anti-drug antibodies, 
acute infusion reactions (allergic), fecal calprotectin, serum CRP measurements, 
albumin, QoL assessments using IBD-Control at each time point. 
8.2 Procedures for Assessing Efficacy Parameters 
For serum trough golimumab levels, anti-drug antibodies and CRP venepuncture will be 
carried out with 15 ml to be drawn within three days of the subsequent golimumab dose 
during induction therapy (cohort 1) or one week of subsequent dose during maintenance 
therapy (cohort 2). Clinical and biochemical disease (calprotectin) activity assessments 
and quality of life measurements will be collect at weeks 6, 10 and 14 in cohort 1 and week 
4 in cohort 2.  
9 Assessment of Safety  
9.1 Specification, Timing and Recording of Safety Parameters  
General safety assessments will be made as part of each assessment. 
9.2 Procedures for Recording and Reporting Adverse Events 
The Medicines for Human Use (Clinical Trials) Regulations 2004 and Amended 
Regulations 2006 gives the following definitions: 
Adverse Event (AE): Any untoward medical occurrence in a subject to whom a 
medicinal product has been administered including occurrences which are not 
necessarily caused by or related to that product.  
Adverse Reaction (AR): Any untoward and unintended response in a subject to an 
investigational medicinal product which is related to any dose administered to that 
subject.  
Unexpected Adverse Reaction (UAR): An adverse reaction the nature and severity of 
which is not consistent with the information about the medicinal product in question set 
out in: 
The summary of product characteristics  (SmPC) for that product (for products 
with a marketing authorisation)  
Serious adverse Event (SAE), Serious Adverse Reaction (SAR) or Unexpected 
Serious Adverse Reaction (USAR): Any adverse event, adverse  reaction or 
unexpected adverse reaction, respectively, that 
 
Results in death; 
 
Is life-threatening; 
 
Required hospitalisation/prolongation of existing hospitalisation; 
 
Results in persistent or significant disability or incapacity; 
 
Consists of a congenital anomaly or birth defect. 
Important Medical Events (IME) & Pregnancy 
Events that may not be immediately life-threatening or result in death or hospitalisation 
but may jeopardise the patient or may require intervention to prevent one of the other 
outcomes listed in the definition above should also be considered serious. 
Although not a serious adverse event, any unplanned pregnancy will also be reported 
via the SAE reporting system. 

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Reporting Responsibilities  
King’s Health Partners Clinical Trials Office (KHP-CTO) is responsible for 
Pharmacovigilance (as defined in Regulation 5 of the Medicines for Human Use (Clinical 
Trials) Regulations 2004 
All SAEs, SARs and SUSARs will be reported immediately by the Principle Investigator 
(and certainly no later than 24hrs) to the KHP-CTO in accordance with the current 
Pharmacovigilance Policy. All SAEs, SARs and SUSARs are to be reported to MSD’s 
Drug Surveillance Department (“MSD DSD”) group by the Chief Investigator, including 
but not limited to all initial and follow up information involving any study subject.   
The KHP-CTO will report SUSARs to the regulatory authorities (MHRA, competent 
authorities of other EEA (European Economic Area) states in which the trial is taking 
place. 
The Chief Investigator will report to the relevant ethics committee. Reporting timelines 
are as follows: 
− 
SUSARs which are fatal or life-threatening must be reported not later than 7 days 
after the sponsor is first aware of the reaction. Any additional relevant information 
must be reported within a further 8 days. 
− 
SUSARs that are not fatal or life-threatening must be reported within 15 days of the 
sponsor first becoming aware of the reaction.   
The Chief Investigator and KHP-CTO will submit a Development Safety Update Report 
(DSUR) relating to this trial IMP, to the MHRA and REC annually. 
9.2.1 Adverse events that do not require reporting 
AE’s will not be collected during the study period but will be managed as per the 
standard of care. Only injection-site reactions will be collected as AR’s during the trial 
period. They will be managed as per the standard of care. 
9.3 Treatment Stopping Rules 
Because this is a non-interventional trial there won’t be an interim analysis or premature 
termination of the study. The trial may be prematurely discontinued by the sponsor, chief 
investigator or regulatory authority on the basis of new safety information or for other 
reasons given by the regulatory authority or ethics committee.  
10 Statistics 
To determine a representative cut-off value for golimumab trough levels between the 
groups of patients stratified by disease activity/response a receiver-operator 
characteristics (ROC) curve will be created. A trade-off between sensitivity and specificity 
will be made to establish an adequate lower margin of the therapeutic golimumab range. 
This statistical plan was reviewed by an independent statistician at King’s College London. 
Relationships between golimumab trough levels and patient characteristics and clinical 
parameters (albumin, serum CRP, formation of ADA’s, fecal calprotectin and IBD-Control) 
will be evaluated. 
10.1 Sample Size 
To achieve a power of 80%, with two-sided significance, and to detect a mean difference 

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in serum concentration of 2 mg/L difference a minimum sample size of 42 patients in 
each cohort would be required. Increasing the sample size beyond this point would 
achieve greater power to detect smaller differences in serum concentrations between 
subgroups. 
10.2 Analysis 
Descriptive statistics will be used to analyze baseline characteristics. The primary variable 
of interest will be golimumab drug levels. Other variables will include: efficacy, gender, 
age, smoking status, concomitant medication, disease location, disease duration, 
development of anti-drug antibodies, acute infusion reactions, serum CRP, albumin, fecal 
calprotectin, SCCAI, PRO2, IBD-Control. 
Differences between responders and non-responders will be evaluated using a t-test with 
the threshold for statistical significance set at 0.05. Univariate and bi-variate analysis will 
be used to assess factors predicting response, including serum golimumab levels at each 
time point. 
11 Direct Access to Source Data and Documents 
The Investigator(s) will permit trial-related monitoring, audits, REC review, and 
regulatory inspections by providing the Sponsor(s), Regulators and REC direct access 
to source data and other documents (e.g. patients’ case sheets, blood test reports, X-
ray reports, histology reports etc.). 
12 Ethics & Regulatory Approvals 
The trial will be conducted in compliance with the principles of the Declaration of Helsinki 
(1996), the principles of GCP and in accordance with all applicable regulatory 
requirements including but not limited to the Research Governance Framework and the 
Medicines for Human Use (Clinical Trial) Regulations 2004, as amended in 2006 and 
any subsequent amendments. 
 
This protocol and related documents will be submitted for review to the Research Ethics 
Committee (REC), and to the Medicines and Healthcare products Regulatory Agency 
(MHRA) for Clinical Trial Authorisation. 
Subsequent protocol amendments will be submitted to the REC and Regulatory 
Authorities for approval, and that the Chief Investigator will comply with regulations, 
particularly specifying, Pharmacovigilance reporting and providing the REC & MHRA 
with progress reports, and a copy of the Final Study Report. 
The Chief Investigator will submit a final report at conclusion of the trial to the KHP-CTO 
(on behalf of the Sponsor), the REC and the MHRA within the timelines defined in the 
Regulations. 
13 Quality Assurance 
Monitoring of this trial will be to ensure compliance with Good Clinical Practice and 
scientific integrity will be managed and oversight retained, by the KHP-CTO Quality 
Team.  

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14 Data Handling  
The Chief Investigator will act as custodian for the trial data. The following guidelines 
will be strictly adhered to: 
 
Patient data will be anonymised 
• 
All trial data will be stored in line with the Medicines for Human Use (Clinical 
Trials) Amended Regulations 2006 and the Data Protection Act and archived in 
line with the Medicines for Human Use (Clinical Trials) Amended Regulations 
2006 as defined in the Kings Health Partners Clinical Trials Office Archiving 
SOP. 
14.1 Source Data 
Source data regarding eligibility review, demographic details, UC disease-related details, 
injection-site reactions and concomitant medication as well as clinical disease activity 
(SCCAI and PRO2) will be documented in the patients electronic notes. Data regarding 
biochemical disease activity will be printed from EPR and stored in a study specific 
folder along with quality of life questionnaires. Golimumab serum concentrations and 
anti-drug antibody measurements will also be stored in the study specific folder. 
15 Data Management 
Anonymised patient data will be recorded on a bespoke password protected electronic 
CRF created by King’s Clinical Trials Unit. All patient specific data will be recorded using 
only this number. The full name and birth date will only be recorded on the informed 
consent form. The study coordinator will monitor patient inclusion and protocol steps, 
coordinate data entry, perform data analyses and reporting. 
16 Publication Policy  
Patients are entitled to public disclosure of the results of the trial on the basis of their 
participation in it. The results of research will be submitted for publication to peer-
reviewed scientific journals. Data generated during this study would be of interest and 
appropriate for publication in the IBD section of high impact general gastroenterology 
journal (e.g. Gastroenterology, Gut or Clinical Gastroenterology & Hepatology), a 
specialist IBD journal (Inflammatory Bowel Diseases, The Journal of Crohn’s and Colitis) 
or a specialist Gastroenterology therapeutics journal (Alimentary Pharmacology & 
Therapeutics). Data in abstract form would be submitted to meetings such as ECCO, 
BSG, DDW and UEGW. 
17 Insurance / Indemnity  
No trial-specific insurance/indemnity is in place. Standard NHS insurance/indemnity will 
apply. 
 

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18 Financial Aspects 
Funding to conduct the trial is provided in the form of an initial £81,683 grant from 
Merck Sharp & Dohme (MSD) with a further £15,547 following the increase in 
recruitment target. 
19 
Signatures 
19.1 CI Signature  
 
______________________________________  
 
_________________________ 
 
Chief Investigator 
 
 
 
 
 
Date 
 
Peter M Irving 
 
19.2 PI Signature 
 
______________________________________  
 
_________________________ 
 
Principle Investigator  
 
 
 
 
Date