Phase 3
Completed N=879
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01519791 ↗Enrolled (actual)
879
Serious AEs
10.3%
Results posted
Sep 2015
Primary outcomePrimary: Percentage of Subjects in Sustained Remission at Week 52 — 15.0; 28.9 percentage of subjects — p=<0.001
Summary
This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for inducing and sustaining clinical response in the treatment of Disease Modifying Antirheumatic Drug (DMARD)-naïve adults with early active Rheumatoid Arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects in Sustained Remission at Week 52 |
15.0; 28.9 | <0.001 sig |
| SECONDARY Percentage of Subjects in Sustained Low Disease Activity (LDA) at Week 52 |
28.6; 43.8 | <0.001 sig |
| SECONDARY Change From Baseline in Modified Total Sharp Score (mTSS) to Week 52 |
1.8; 0.2 | <0.001 sig |
| SECONDARY Percentage of Subjects With Radiographic Non-progression From Baseline to Week 52 |
49.7; 70.3 | — |
| SECONDARY Change From Baseline in the Joint Erosion Score to Week 52 |
1.1; 0.1 | — |
| SECONDARY Change From Baseline in the Joint Narrowing Score to Week 52 |
0.7; 0.1 | — |
| SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52 |
61.5; 69.0 | — |
| SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52 |
52.6; 61.8 | =0.023 sig |
| SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52 |
39.9; 51.3 | — |
| SECONDARY Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria at Week 52 |
20.7; 32.4 | — |
| SECONDARY Percentage of Subjects With Clinical Disease Activity Index (CDAI) ≤ 2.8 at Week 52 |
26.3; 38.9 | — |
| SECONDARY Percentage of Subjects With Simplified Disease Activity Index (SDAI) ≤ 3.3 at Week 52 |
24.9; 38.9 | — |
| SECONDARY Percentage of Subjects With Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) < 2.6 at Week 52 |
26.8; 42.6 | — |
| SECONDARY Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice at Week 52 |
24.9; 35.3 | — |
| SECONDARY Percentage of Subjects Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Week 52 |
82.2; 89.9 | — |
| SECONDARY Change From Baseline in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 52 |
-3.014; -3.615 | — |
| SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) to Week 52 |
-29.09; -33.11 | — |
| SECONDARY Change From Baseline in Simplified Disease Activity Index (SDAI) to Week 52 |
-30.24; -34.55 | — |
| SECONDARY Percentage of Subjects With a Health Assessment Questionnaire- Disability Index (HAQ-DI) ≤ 0.5 at Week 52 |
35.7; 48.1 | — |
| SECONDARY Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) to Week 52 |
-0.819; -0.997 | <0.001 sig |
| SECONDARY Change From Baseline in the Bristol Rheumatoid Arthritis Fatigue- Multidimensional Questionnaire (BRAF-MDQ) Total Score to Week 52 |
-15.6; -17.8 | — |
| SECONDARY Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 |
0.9; 0.6 | — |
| SECONDARY Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 |
1.8; 1.0 | — |
| SECONDARY Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 |
1.9; 1.4 | — |
| SECONDARY Number of Days With no Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 |
3.0; 1.9 | — |
| SECONDARY Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 |
3.0; 2.1 | — |
| SECONDARY Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 |
0.7; 0.6 | — |
| SECONDARY Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 |
0.9; 0.9 | — |
| SECONDARY Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 |
2.5; 1.9 | — |
| SECONDARY Percentage of Subjects Achieving Low Disease Activity (LDA) at Week 52 |
39.4; 54.7 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects must have a time since diagnosis of adult-onset Rheumatoid Arthritis (RA) less than 1 year as defined by the 2010 ACR/EULAR classification criteria from Screening Visit
- Positive Rheumatoid Factor (RF) and/or positive anticyclic Citrullinated Peptide Antibody (anti-CCP)
- Active RA disease
- DMARD-naïve
- Subject is naïve to RA related biologics
Exclusion Criteria
- A diagnosis of any other inflammatory Arthritis
- History of infected joint prosthesis, or other significant infection and other serious medical condition
- Known Tuberculosis (TB) disease or high risk of acquiring TB infection
Data sourced from ClinicalTrials.gov (NCT01519791). 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.