Phase 3
Completed N=934
An Extension to Study MA21573, Evaluating Tocilizumab in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biological DMARDs and/or Anti-tumor Necrosis Factor (TNF) Therapy
Source: ClinicalTrials.gov NCT00883753 ↗Enrolled (actual)
934
Serious AEs
6.4%
Results posted
Aug 2014
Primary outcomePrimary: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 65.0; 68.6; 73.2; 8.5 percentage of participants
Summary
This study was an extension to study MA21573 [NCT00750880], which was an open label single arm study to investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biological disease-modifying antirheumatic drugs (DMARDS), in patients with moderate to severe active rheumatoid arthritis. Patients who completed the 24 week core study, and had at least a moderate European League Against Rheumatism (EULAR) response, were eligible to enter this long-term extension study, and received tocilizumab 8 mg/kg intravenous (iv) every 4 weeks. The anticipated time on study treatment was 1-2 years, and the target sample size was > 500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
65.0; 68.6; 73.2; 8.5; 5.7; 7.3 | — |
| SECONDARY Percentage of Participants With Adverse Events Leading to Withdraw |
4.0 | — |
| SECONDARY Time to Withdrawal Due to an Adverse Event (AE) |
374.5 | — |
| SECONDARY Percentage of Participants With Discontinuation of Treatment Due to Any Cause |
11.5 | — |
| SECONDARY Time to Discontinuation of Tocilizumab Treatment for Any Cause |
339.0 | — |
| SECONDARY Percentage of Participants With Marked Lipid Abnormalities |
4.2; 0.0; 6.5; 14.9 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs) of Special Interest |
40.4; 2.4; 2.9; 0.3; 0.9; 0.3 | — |
| SECONDARY Percentage of Participants With ALT Elevations > 3*ULN |
1.9 | — |
| SECONDARY Percentage of Participants With AST Elevations > 3*ULN |
0.4 | — |
| SECONDARY Number of Participants Categorized by Highest Value for ALT (SGPT) During the Study |
874; 50; 8; 2 | — |
| SECONDARY Number of Participants Categorized by Worst Value for AST (SGOT) During the Study |
903; 26; 4; 1 | — |
| SECONDARY Number of Participants Categorized by Worst Value for LDL Cholesterol During the Study |
0; 368; 565 | — |
| SECONDARY Number of Participants Categorized by Worst Value for Total Cholesterol During the Study |
4; 194; 735 | — |
| SECONDARY Number of Participants Categorized by Worst Value for Neutrophil Count During the Study |
321; 608; 3 | — |
| SECONDARY Percentage of Participants With Clinically Meaningful Improvement in Disease Activity Score-28 (DAS28) |
94.7; 94.8; 96.4; 96.6; 97.8; 96.8 | — |
| SECONDARY Percentage of Participants With DAS28 Low Disease Activity |
75.3; 76.9; 77.3; 78.2; 80.6; 84.3 | — |
| SECONDARY Percentage of Participants With DAS28 Remission |
59.6; 61.9; 62.7; 62.7; 65.9; 69.9 | — |
| SECONDARY Change From Baseline in DAS28 |
-3.58; -3.62; -3.74; -3.80; -3.91; -3.93 | — |
| SECONDARY Change From Baseline in Tender Joint Count |
-17.45; -18.07; -18.592; -18.77; -19.16; -18.30 | — |
| SECONDARY Change From Baseline in Swollen Joint Count |
-10.16; -10.17; -10.55; -10.78; -10.83; -10.91 | — |
| SECONDARY Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS) |
-32.52; -32.59; -33.04; -32.69; -35.35; -35.24 | — |
| SECONDARY Change From Baseline in Patient Global Assessment of Disease Activity VAS |
-35.90; -35.57; -35.75; -35.56; -37.85; -36.36 | — |
| SECONDARY Change From Baseline in Physician Global Assessment of Disease Activity VAS |
-41.14; -40.86; -40.97; -42.20; -42.67; -43.74 | — |
| SECONDARY Change From Baseline in Erythrocyte Sedimentation Rate (ESR) |
-30.59; -29.96; -31.56; -31.09; -31.61; -29.62 | — |
| SECONDARY Change From Baseline in C-Reactive Protein (CRP) |
-1.72; -1.73; -1.79; -1.73; -1.82; -1.54 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology 20 (ACR20) Response |
76.1; 75.1; 72.6; 69.1; 65.6; 60.7 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology 50 (ACR50) Response |
56.3; 53.9; 53.6; 48.5; 49.2; 46.0 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology 70 (ACR70) Response |
31.4; 31.0; 32.6; 31.3; 28.2; 29.7 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology 90 (ACR90) Response |
9.9; 10.5; 12.0; 11.2; 11.0; 11.2 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Response |
-0.58; -0.59; -0.61; -0.63; -0.65; -0.64 | — |
| SECONDARY Percentage of Participants Achieving Clinical Meaningful Health Assessment Questionnaire Disability Index (HAQ-DI) Response |
73.6; 73.9; 74.1; 76.5; 76.8; 77.5 | — |
| SECONDARY Percentage of Participants Achieving Health Assessment Questionnaire Disability Index (HAQ-DI) Clinical Remission |
32.1; 33.4; 34.5; 33.2; 37.0; 34.9 | — |
| SECONDARY Change From Baseline in Quality of Life Short Form (SF-36): Physical Component Score |
9.86; 9.30; 9.54; 9.82; 10.34; 10.38 | — |
| SECONDARY Change From Baseline in Quality of Life Short Form (SF-36):Mental Component Score |
8.10; 8.37; 9.43; 8.27; 9.67; 8.30 | — |
| SECONDARY Change From Baseline in FACIT-Fatigue Score |
10.67; 10.70; 11.42; 11.02; 11.77; 10.71 | — |
Eligibility Criteria
Inclusion Criteria
- patients who completed the 24-week MA21573 core study, had at least a moderate response based on EULAR definition criteria and no adverse events (AEs), serious adverse events (SAEs) or conditions that led to unacceptable risk of continued treatment.
Exclusion Criteria
-as for MA21573.
Data sourced from ClinicalTrials.gov (NCT00883753). 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.