Clinical trial NCT01288287: Long Term Effects of an Early Response to Certolizumab Pegol (CZP, Cimzia®) in Rheumatoid Arthritis (RA) Patients
Official title: A Prospective, Multicentre, Non-interventional, Observational, Cohort Study to Evaluate the Long Term Clinical, Patient Reported and Health Care Resource Utilization Effects of an Early Response to Certolizumab Pegol (Cimzia®) in Rheumatoid Arthritis Patients in Daily Clinical Practice in the United Kingdom and Eire.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis,Rheumatoid
Keywords: Certolizumab pegol
Cimzia®
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2011-02-02
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic

Brief summary: To determine if early clinical response at 12 weeks to Certolizumab Pegol (CZP, Cimzia ®) therapy in adult Rheumatoid Arthritis (RA) patients is a predictor of better long term clinical response at 18 months compared with a lack of clinical response at 12 weeks.

Detailed description: Clinical response will be assessed by the percentage of patients achieving a reduction from Baseline in Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) \[DAS28(ESR)\] score of greater than 1.2 points, which is considered the minimum clinically important difference.

Eligibility criteria: Inclusion Criteria:

* Informed consent is signed and dated
* The patient is considered capable of and prepared to adhere to the study protocol procedures
* The patient is prescribed CZP according to the Summary of Product Characteristics (SmPC) (UK and Eire) and National Institute of Clinical Excellence (NICE) (UK only) guidelines for anti tumor necrosis factor (TNF) α therapy for Rheumatoid Arthritis (RA).
* The patient is screen-negative for tuberculosis
* The patient is 18 years of age or above

Exclusion Criteria:

* The patient has been exposed previously to biological disease modifying anti rheumatic drugs (DMARD) agents.
* Patient has previously participated in this study or the patient has previously been assigned to treatment in a study of CZP or another biological agent used to treat RA.
* Patient has participated in another study within the last 30 days
* Patient has any medical or psychiatric condition that, in the opinion of the physician, can jeopardize or would compromise the patient's ability to adequately participate in the study
* Patient has inadequate literacy to understand and complete the questionnaires.
* Contraindications stated in the SmPC
* Patient is pregnant or breast feeding

Primary outcomes:
measure: Percentage of Participants With a Disease Activity Score (DAS) Response at 78 Weeks Where DAS Response is Defined as a Reduction From Baseline in DAS 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score of Greater Than 1.2 Points
timeFrame: Baseline (Week 0), 78 weeks
Secondary outcomes:
measure: Change From Baseline in Disease Activity Score 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score at 78 Weeks
timeFrame: Baseline (Week 0), 78 weeks
measure: Percentage of Participants With a Disease Activity Score (DAS)-Based European League Against Rheumatoid Arthritis (EULAR) Response at 78 Weeks Compared to Baseline
timeFrame: Baseline (Week 0), 78 weeks
measure: Change From Baseline in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores at 78 Weeks
timeFrame: Baseline (Week 0), 78 weeks
measure: Change From Baseline in Health Assessment Questionnaire-Disease Index (HAQ-DI) Scores at 78 Weeks
timeFrame: Baseline (Week 0), 78 weeks
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: 2
city: Durham
country: United Kingdom
facility: 4
state: County Durham
city: Poole
country: United Kingdom
facility: 17
state: Dorset
city: Eastbourne
country: United Kingdom
facility: 24
state: East Sussex
city: Southend
country: United Kingdom
facility: 13
state: Essex
city: Manchester
country: United Kingdom
facility: 11
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: 12
state: Greater Manchester
city: Southampton
country: United Kingdom
facility: 6
state: Hampshire
city: Gillingham
country: United Kingdom
facility: 20
state: Kent
city: St. Helens
country: United Kingdom
facility: 15
state: Lancashire
city: Liverpool
country: United Kingdom
facility: 10
state: Merseyside
city: Ashford
country: United Kingdom
facility: 22
state: Middlesex
city: Abergavenny
country: United Kingdom
facility: 14
state: Monmouthshire
city: Bath
country: United Kingdom
facility: 5
state: Somerset
city: Burton
country: United Kingdom
facility: 19
state: Staffordshire
city: Chertsey
country: United Kingdom
facility: 3
state: Surrey
city: Birmingham
country: United Kingdom
facility: 18
state: West Midlands
city: Cannock
country: United Kingdom
facility: 16
state: West Midlands
city: Dudley
country: United Kingdom
facility: 9
state: West Midlands
city: York
country: United Kingdom
facility: 1
state: Yorkshire
city: Bridgend
country: United Kingdom
facility: 7
city: Cardiff
country: United Kingdom
facility: 25
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Kumar N, Naz S, Quinn M, Ryan J, Kumke T, Sheeran T. Treatment of Rheumatoid Arthritis with Certolizumab Pegol: Results from PROACTIVE, a Non-Interventional Study in the UK and Ireland. Adv Ther. 2018 Sep;35(9):1426-1437. doi: 10.1007/s12325-018-0758-1. Epub 2018 Aug 3.