Phase 3
Completed N=41
Magnetic Resonance Image Verified Early Response to Certolizumab Pegol in Subjects With Active Rheumatoid Arthritis (RA)
Source: ClinicalTrials.gov NCT01235598 ↗Enrolled (actual)
41
Serious AEs
10.0%
Results posted
Feb 2014
Primary outcomePrimary: 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 — -1.0 scores on a scale — p=0.049
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-1.0 | 0.049 sig |
| PRIMARY 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 |
-0.7 | 0.206 |
| PRIMARY 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 |
-0.4 | — |
| PRIMARY 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 |
-0.4 | — |
| PRIMARY 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 |
-0.6 | — |
| SECONDARY Change From Baseline to Week 16 in the Dynamic Magnetic Resonance Image (MRI) Parameter, Initiation Rate of Enhancement (IRE) |
-0.0044 | 0.164 |
| SECONDARY Change From Baseline to Week 16 in the Dynamic Magnetic Resonance Image (MRI) Parameter, Maximal Enhancement (ME) |
-0.0172 | 0.865 |
| SECONDARY Change From Baseline to Week 16 in the Dynamic Magnetic Resonance Image (MRI) Parameter, Number of Voxels (Nvox) With Plateau and Washout Pattern |
-813.3 | 0.015 sig |
| SECONDARY Percentage of Subjects Achieving a Good European League Against Rheumatism (EULAR) Response at Week 16 |
71.4; 66.7; 23.8; 25.0; 4.8; 8.3 | — |
| SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 20 % Criteria (ACR20) at Week 16 |
86.4; 75.0; 13.6; 25.0 | — |
| SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 50 % Criteria (ACR50) at Week 16 |
68.2; 58.3; 31.8; 41.7 | — |
| SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 70 % Criteria (ACR70) at Week 16 |
45.5; 58.3; 54.5; 41.7 | — |
| SECONDARY Change From Baseline to Week 16 in the Disease Activity Score-28 (C-Reactive Protein) (DAS28 (CRP)) Response |
-2.27; -2.50 | — |
| SECONDARY Percentage of Subjects Achieving Disease Activity Score 28 (DAS28 (CRP)) Remission Status (DAS28 (CRP) < 2.6) at Week 16 |
57.1; 58.3; 42.9; 41.7 | — |
| SECONDARY Change From Baseline to Week 16 in Bone Mineral Density as Measured by Digital XRay (DXR) |
-0.00606; -0.00630 | — |
| SECONDARY Change From Baseline to Week 16 in Tender Joint Count (TJC) |
-9.28; -9.92 | — |
| SECONDARY Change From Baseline to Week 16 in Swollen Joint Count (SJC) |
-7.06; -7.92 | — |
| SECONDARY Change From Baseline to Week 16 in Health Assessment Questionnaire - Disability Index (HAQ-DI) |
-0.54; -0.79 | — |
| SECONDARY C-Reactive Protein (CRP) Ratio to Baseline at Week 16 |
0.491; 0.219 | — |
| SECONDARY Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With European League Against Rheumatism (EULAR) Response at Week 16 |
-0.20 | 0.394 |
| SECONDARY 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 |
-0.11 | 0.625 |
| SECONDARY 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 |
-0.34 | 0.128 |
| SECONDARY 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 |
-0.08 | 0.732 |
| SECONDARY 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 |
0.19 | 0.411 |
| SECONDARY 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 |
0.32 | 0.208 |
| SECONDARY 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) |
0.1; -0.6 | 0.254 |
| SECONDARY 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) |
0.2; -0.4 | 0.472 |
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
Data sourced from ClinicalTrials.gov (NCT01235598). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.