Phase 3
N=194
Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00674362 ↗Enrolled (actual)
194
Serious AEs
5.9%
Results posted
Jan 2012
Primary outcome: Primary: Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24 — 18.8; 6.1 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Certolizumab pegol (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UCB Pharma
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24 |
18.8; 6.1 | — |
| SECONDARY 28-joint Count Disease Activity Score (DAS28-ESR) Remission (<2.6) at Both Week 20 and Week 24 |
19.8; 3.1 | — |
| SECONDARY Simplified Disease Activity Index (SDAI) Remission (≤3.3) at Both Week 20 and Week 24 |
14.6; 4.1 | — |
| SECONDARY Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Clinical Disease Activity Index (CDAI) Scores at 2 Consecutive Visits |
12.1; 3.4 | — |
| SECONDARY Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Simplified Disease Activity Index (SDAI) Scores at 2 Consecutive Visits |
9.8; 2.1 | — |
| SECONDARY Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using DAS28-ESR Scores at 2 Consecutive Visits |
12.1; 1.0 | — |
| SECONDARY American College of Rheumatology 20% (ACR20) Response at Week 24 |
36.5; 15.3 | — |
| SECONDARY American College of Rheumatology 50% (ACR50) Response at Week 24 |
20.8; 7.1 | — |
| SECONDARY American College of Rheumatology 70% (ACR70) Response at Week 24 |
9.4; 3.1 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24 |
-0.25; -0.03 | — |
| SECONDARY Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Scores at Week 24 |
6.0; 1.7 | — |
| SECONDARY Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Component Summary (MCS) Scores at Week 24 |
4.0; 0.5 | — |
| SECONDARY Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Functioning Domain at Week 24 |
5.1; 0.4 | — |
| SECONDARY Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Physical Domain at Week 24 |
4.7; 1.7 | — |
| SECONDARY Change From Baseline in Short Form 36-items Health Survey (SF-36) Bodily Pain Domain at Week 24 |
8.0; 2.8 | — |
| SECONDARY Change From Baseline in Short Form 36-items Health Survey (SF-36) General Health Domain at Week 24 |
5.0; 0.9 | — |
| SECONDARY Change From Baseline in Short Form 36-items Health Survey (SF-36) Vitality Domain at Week 24 |
6.4; 0.6 | — |
| SECONDARY Change From Baseline in Short Form 36-items Health Survey (SF-36) Social Functioning Domain at Week 24 |
4.3; 0.8 | — |
| SECONDARY Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Emotional Domain at Week 24 |
3.2; -0.2 | — |
| SECONDARY Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Health Domain at Week 24 |
5.2; 1.2 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (VAS) at Week 24 |
-12.4; 1.0 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS) at Week 24 |
-7.6; 2.9 | — |
| SECONDARY Change From Baseline in Fatigue Assessment Scale at Week 24 |
-1.2; 0.1 | — |
Summary
To assess the clinical efficacy and safety of certolizumab pegol as add-on therapy with stable-dose disease-modifying antirheumatic drugs (DMARDs) for achieving clinical remission in patients with moderate to low disease activity rheumatoid arthritis
Eligibility Criteria
Inclusion Criteria
- Patients with established diagnosis of low to moderate adult rheumatoid arthritis, currently on Disease Modifying AntiRheumatic Drugs (DMARDs) therapy for at least six months and not longer than 10 years
Exclusion Criteria
- All the concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment, or with the safety of the patient
- Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
- Patients must not have received any previous biological therapy for rheumatoid arthritis (RA)
Data sourced from ClinicalTrials.gov (NCT00674362). 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.