Phase 3
Completed N=319
Efficacy Confirmation Study of CDP870 in Early Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01451203 ↗Enrolled (actual)
319
Serious AEs
11.1%
Results posted
Nov 2015
Primary outcomePrimary: Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 — 1.58; 0.36 units on a scale — p=<0.001
Summary
The objective of this study is to assess the efficacy of certolizumab pegol (CZP) with methotrexate (MTX) compared with MTX-alone in patients with early-stage rheumatoid arthritis (RA) who are naive to MTX and have with poor prognostic factors, using inhibition of radiographically confirmed joint damage progression over a one-year period as a primary endpoint. Following a year of treatment with CZP plus MTX treatment, CZP will be discontinued, and the subjects will be monitored for one more year (the follow-up period) to investigate the sustainability of efficacy of CZP during the MTX monotherapy for exploratory purposes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 |
1.58; 0.36 | <0.001 sig |
| SECONDARY Change From Baseline in mTSS at Week 24 |
0.86; 0.26 | 0.003 sig |
| SECONDARY Clinical Remission Rate: Percentage of Participants Meeting the Disease Activity Score-28 Joint Count (DAS28) Erythrocyte Sedimentation Rate (ESR) (DAS28[ESR]) Remission Criteria at Weeks 24 and 52 |
30.6; 52.8; 36.9; 57.2 | <0.001 sig |
| SECONDARY Clinical Remission Rate: Percentage of Participants Meeting the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Simplified Disease Activity Index (SDAI)-Based Remission Criteria at Weeks 24 and 52 |
29.3; 48.4; 33.8; 57.9 | <0.001 sig |
| SECONDARY Percentage of Participants Meeting the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean-based Remission Criteria at Weeks 24 and 52 |
22.3; 36.5; 28.0; 45.3 | 0.002 sig |
Eligibility Criteria
Inclusion Criteria
- Subjects with RA as defined by the ACR/EULAR criteria (2010) who meet all of the following criteria:
- Subjects who developed RA within one year after onset of RA.
- Subjects who have never received MTX before (MTX naive)
- Subjects whose disease activity is moderate or higher (DAS28(ESR) ≥ 3.2）
- Subjects must satisfy at least two of the three criteria (Anti-CCP antibody positive, Rheumatoid factor positive, Presence of X-ray erosion） for poor prognostic factors. The anti-CCP antibody positive is essential for every patient.
Exclusion Criteria
- Patients who have a diagnosis of any other type of inflammatory arthritis.
- Patients who have a secondary, non-inflammatory type of arthritis.
- Patients who have used with MTX, reflunomide, or any other biologics prior to the start of study drug administration.
- Patients who have NYHA (New York Heart Association) Class III or IV congestive heart failure
- Patients who currently have, or who have a history of, tuberculosis.
- Patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease)
- Patients who currently have, or have a history of, malignant tumor
- Female patients who are breastfeeding or pregnant, who are of childbearing potential
Data sourced from ClinicalTrials.gov (NCT01451203). 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.