Phase 3
Completed N=846
A Study of the Safety and Effectiveness of Lyophilized Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00175877 ↗Enrolled (actual)
846
Serious AEs
41.6%
Results posted
Mar 2013
Primary outcomePrimary: Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years — 94.9 percentage of participants
Summary
An open ended study in which patients who completed the double-blind study CDP870-027 [NCT00152386] are given Certolizumab Pegol (CZP) and assessed for signs and symptoms of Rheumatoid Arthritis (RA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years |
94.9 | — |
| PRIMARY Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years |
41.6 | — |
| PRIMARY Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study |
16.2 | — |
| SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 48 |
87.0 | — |
| SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 96 |
88.0 | — |
| SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 144 |
87.9 | — |
| SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 192 |
89.4 | — |
| SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 240 |
82.5 | — |
| SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal |
81.3 | — |
| SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 48 |
63.0 | — |
| SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 96 |
66.0 | — |
| SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 144 |
65.4 | — |
| SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 192 |
64.8 | — |
| SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 240 |
58.5 | — |
| SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal |
57.6 | — |
| SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 48 |
37.7 | — |
| SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 96 |
40.7 | — |
| SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 144 |
41.2 | — |
| SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 192 |
42.8 | — |
| SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 240 |
34.4 | — |
| SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal |
38.2 | — |
| SECONDARY Change From Baseline of the Preceding Double-Blind Study to Week 96 in Modified Total Sharp Score (mTSS) |
0.95 | — |
| SECONDARY Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire - Disability Index (HAQ-DI) Total Score |
-0.674 | — |
| SECONDARY Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness |
-2.147 | — |
| SECONDARY Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR]) |
-3.222 | — |
| SECONDARY Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit |
42.4 | — |
| SECONDARY Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score |
8.813 | — |
| SECONDARY Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score |
4.612 | — |
Eligibility Criteria
Inclusion Criteria
Patients must have either failed to achieve American College of Rheumatology 20 % Response Criteria (ACR20) at Weeks 12 and 14 in C87027 [NCT00152386], or must have completed the entire Week 52 assessment of C87027 [NCT00152386] trial.
Exclusion Criteria
- A diagnosis of any other inflammatory Arthritis (e.g. Psoriatic Arthritis or Ankylosing Spondylitis)
- A secondary, non-inflammatory type of Arthritis (e.g. Osteoarthritis or Fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of CDP870 on the patient's primary diagnosis of Rheumatoid Arthritis
- Any concomitant biological therapy
- Any experimental therapy, within or outside a clinical trial
Data sourced from ClinicalTrials.gov (NCT00175877). 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.