Clinical trial NCT01235598: Magnetic Resonance Image Verified Early Response to Certolizumab Pegol in Subjects With Active Rheumatoid Arthritis (RA)
Official title: A 16-week Double-blind, Placebo-controlled (for Initial 2 Weeks) Randomized Period, Followed by a 24-week Open-label Extension to Assess Magnetic Resonance Image (MRI) - Verified Early Response to Certolizumab Pegol in Subjects With Active Rheumatoid Arthritis (RA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Cimzia®
CDP870
CZP
Certolizumab Pegol
Rheumatoid Arthritis
MRI
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2010-11-05
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase IIIb study to determine early response to Certolizumab Pegol (CZP) with Magnetic Resonance Imaging (MRI) score Outcome Measures in Rheumatoid Arthritis (RA) Clinical Trials (OMERACT) RA MRI Scoring System (RAMRIS) in subjects with RA.

Detailed description: To identify the efficacy of Certolizumab Pegol (CZP) on synovitis in dynamic MRI parameters; to make the correlation between European League Against Rheumatism (EULAR), American College of Rheumatology (ACR)p, Disease Activity Score-28 (DAS 28) responses, and Digital XRay (DXR) assessment with reduction of synovitis.

Eligibility criteria: Inclusion Criteria:

* Subjects with a diagnosis of adult-onset Rheumatoid Arthritis (RA) of at least 3 months duration but no longer than 15 years
* Subjects with an active adult Rheumatoid Arthritis disease
* Subjects who have been on Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy for at least 12 weeks

Exclusion Criteria:

* Subject must not have a secondary, non-inflammatory type of musculoskeletal condition (eg, osteoarthritis or fibromyalgia) that in the investigator's opinion is symptomatic enough to interfere with evaluation of the effect of study drug on the subject's primary diagnosis of Rheumatoid Arthritis (RA)
* Subject must not have a diagnosis of any other inflammatory arthritis (eg, psoriatic arthritis or ankylosing spondylitis)
* Subject must not have a history of an infected joint prosthesis at any time with prosthesis still in situ
* Subject must not have received more than 1 biological agent
* Subject must not have a history of lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time
* Subject with known Tuberculosis (TB) disease, high risk of acquiring TB infection or latent TB infection
* Subject must not have a known hypersensitivity to any components of the investigational medicinal product
* Subject must not have contraindications for Magnetic Resonance Image (MRI) and contrast agent
* Subject must not have any other condition which, in the investigator's judgement, would make them unsuitable for inclusion in the study

Primary outcomes:
measure: Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 16 Compared to Baseline for Certolizumab Pegol Arm
timeFrame: From Baseline to Week 16
measure: Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 8 Compared to Baseline for Certolizumab Pegol Arm
timeFrame: From Baseline to Week 8
measure: Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 4 Compared to Baseline for Certolizumab Pegol Arm
timeFrame: From Baseline to Week 4
measure: Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 2 Compared to Baseline for Certolizumab Pegol Arm
timeFrame: From Baseline to Week 2
measure: Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 1 Compared to Baseline for Certolizumab Pegol Arm
timeFrame: From Baseline to Week 1
Secondary outcomes:
measure: Change From Baseline to Week 16 in the Dynamic Magnetic Resonance Image (MRI) Parameter, Initiation Rate of Enhancement (IRE)
timeFrame: From Baseline to Week 16
measure: Change From Baseline to Week 16 in the Dynamic Magnetic Resonance Image (MRI) Parameter, Maximal Enhancement (ME)
timeFrame: From Baseline to Week 16
measure: Change From Baseline to Week 16 in the Dynamic Magnetic Resonance Image (MRI) Parameter, Number of Voxels (Nvox) With Plateau and Washout Pattern
timeFrame: From Baseline to Week 16
measure: Percentage of Subjects Achieving a Good European League Against Rheumatism (EULAR) Response at Week 16
timeFrame: From Baseline to Week 16
measure: Percentage of Subjects Meeting the American College of Rheumatology 20 % Criteria (ACR20) at Week 16
timeFrame: From Baseline to Week 16
measure: Percentage of Subjects Meeting the American College of Rheumatology 50 % Criteria (ACR50) at Week 16
timeFrame: From Baseline to Week 16
measure: Percentage of Subjects Meeting the American College of Rheumatology 70 % Criteria (ACR70) at Week 16
timeFrame: From Baseline to Week 16
measure: Change From Baseline to Week 16 in the Disease Activity Score-28 (C-Reactive Protein) (DAS28 (CRP)) Response
timeFrame: From Baseline to Week 16
measure: Percentage of Subjects Achieving Disease Activity Score 28 (DAS28 (CRP)) Remission Status (DAS28 (CRP) < 2.6) at Week 16
timeFrame: From Baseline to Week 16
measure: Change From Baseline to Week 16 in Bone Mineral Density as Measured by Digital XRay (DXR)
timeFrame: From Baseline to Week 16
measure: Change From Baseline to Week 16 in Tender Joint Count (TJC)
timeFrame: From Baseline to Week 16
measure: Change From Baseline to Week 16 in Swollen Joint Count (SJC)
timeFrame: From Baseline to Week 16
measure: Change From Baseline to Week 16 in Health Assessment Questionnaire - Disability Index (HAQ-DI)
timeFrame: From Baseline to Week 16
measure: C-Reactive Protein (CRP) Ratio to Baseline at Week 16
timeFrame: From Baseline to Week 16
measure: Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With European League Against Rheumatism (EULAR) Response at Week 16
timeFrame: From Baseline to Week 16
measure: Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With American College of Rheumatology 20 % Criteria (ACR20) at Week 16
timeFrame: From Baseline to Week 16
measure: Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With American College of Rheumatology 50 % Criteria (ACR50) at Week 16
timeFrame: From Baseline to Week 16
measure: Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With American College of Rheumatology 70 % Criteria (ACR70) at Week 16
timeFrame: From Baseline to Week 16
measure: Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With Disease Activity Score-28 (DAS28 (CRP)) Response at Week 16
timeFrame: From Baseline to Week 16
measure: Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With Changes in Hand Bone Mineral Density as Measured by Digital XRay (DXR) at Week 16
timeFrame: From Baseline to Week 16
measure: Change From Baseline for the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Synovitis Score at Week 1 Placebo (PBO) Versus Certolizumab Pegol (CZP)
timeFrame: From Baseline to Week 1
measure: Change From Baseline for the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Synovitis Score at Week 2 Placebo (PBO) Versus Certolizumab Pegol (CZP)
timeFrame: From Baseline to Week 2
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: 003
city: Hellerup
country: Denmark
facility: 002
city: Hvidovre
country: Denmark
facility: 001
city: Slagelse
country: Denmark
facility: 016
city: Nijmegen
country: Netherlands
facility: 012
city: Utrecht
country: Netherlands
facility: 010
city: Warszawa
country: Poland
facility: 018
city: Warszawa
country: Poland
facility: 019
city: Goteburg
country: Sweden
facility: 008
city: Malmoe
country: Sweden
facility: 004
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Ostergaard M, Jacobsson LT, Schaufelberger C, Hansen MS, Bijlsma JW, Dudek A, Rell-Bakalarska M, Staelens F, Haake R, Sundman-Engberg B, Bliddal H. MRI assessment of early response to certolizumab pegol in rheumatoid arthritis: a randomised, double-blind, placebo-controlled phase IIIb study applying MRI at weeks 0, 1, 2, 4, 8 and 16. Ann Rheum Dis. 2015 Jun;74(6):1156-63. doi: 10.1136/annrheumdis-2014-206359. Epub 2014 Dec 15.