Phase 3
Completed N=131
Follow-up of Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study
Source: ClinicalTrials.gov NCT00843778 ↗Enrolled (actual)
131
Serious AEs
19.2%
Results posted
Oct 2013
Primary outcomePrimary: Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period — 70.8 percentage of participants
Summary
To continue to assess the clinical safety and efficacy of Certolizumab Pegol as add-on therapy with stable-dose Disease Modifying Anti-Rheumatic Drugs (DMARDs)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period |
70.8 | — |
| PRIMARY Percentage of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) During The Study Period |
19.2 | — |
| SECONDARY Percentage of Subjects With DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Completion/Withdrawal Visit |
34.2 | — |
| SECONDARY Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal Visit |
27.9 | — |
| SECONDARY Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal Visit |
25.8 | — |
| SECONDARY Percentage of Subjects With ACR20 (American College of Rheumatology 20 % Improvement) Response at Completion/Withdrawal Visit |
57.3 | — |
| SECONDARY Percentage of Subjects With ACR50 (American College of Rheumatology 50 % Improvement) Response at Completion/Withdrawal Visit |
35.5 | — |
| SECONDARY Percentage of Subjects With ACR70 (American College of Rheumatology 70 % Improvement) Response at Completion/Withdrawal Visit |
15.3 | — |
| SECONDARY Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) at Completion/Withdrawal Visit |
-0.36 | — |
| SECONDARY Change From Baseline in PtAAP (Patient's Assessment of Arthritis Pain) at Completion/Withdrawal Visit |
-15.90 | — |
| SECONDARY Change From Baseline in FAS (Fatigue Assessment Scale) at Completion/Withdrawal Visit |
-1.23 | — |
| SECONDARY Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Completion/Withdrawal Visit |
-13.18 | — |
| SECONDARY Geometric Mean of Plasma Concentration of Certolizumab Pegol at Week 24 Visit |
17.091 | — |
| SECONDARY Percentage of Subjects With Positive Anti-Certolizumab Pegol (CZP) Antibody Status at Any Time From Baseline of the Feeder Study C87076 to the Completion/Withdrawal Visit of the Extension Study |
10.0 | — |
| SECONDARY Percentage of Subjects Willing to Self-inject at Week 0 |
69.2 | — |
| SECONDARY Mean PRE-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0 |
7.929; 5.922; 7.462 | — |
| SECONDARY Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0 |
8.093; 8.295; 6.881; 9.206; 7.376; 6.994 | — |
| SECONDARY Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 2 |
8.076; 8.313; 6.719; 8.984; 7.250; 6.847 | — |
| SECONDARY Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 4 |
8.213; 8.434; 6.847; 9.013; 7.512; 6.995 | — |
| SECONDARY Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 6 |
8.407; 8.545; 6.777; 9.025; 7.982; 7.068 | — |
| SECONDARY Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 8 |
8.458; 8.563; 6.854; 9.214; 7.585; 7.112 | — |
| SECONDARY Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 10 |
8.446; 8.472; 7.050; 8.908; 7.792; 7.105 | — |
| SECONDARY Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 |
8.467; 8.446; 7.122; 9.038; 7.973; 7.127 | — |
| SECONDARY Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 0 |
9.588 | — |
| SECONDARY Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 2 |
9.688 | — |
| SECONDARY Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 4 |
9.804 | — |
| SECONDARY Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 6 |
9.705 | — |
| SECONDARY Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 8 |
9.634 | — |
| SECONDARY Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 10 |
9.771 | — |
| SECONDARY Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 12 |
9.611 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with established adult rheumatoid arthritis on Disease Modifying Anti-Rheumatic Drugs (DMARDs) therapy who were included in C87076 protocol and:
- either failed to achieve remission after 6 months of study treatment
- or flared after the 6 months of study treatment and completed the study (C87076 [NCT00674362])
Exclusion Criteria
- All the concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
- Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
Data sourced from ClinicalTrials.gov (NCT00843778). 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.