Phase 3
N=619
A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00531817 ↗Enrolled (actual)
619
Serious AEs
14.9%
Results posted
Aug 2010
Primary outcome: Primary: Percentage of Patients With an Improvement of at Least 50% in American College of Rheumatology (ACR) Score (ACR50) From Baseline at Week 24 — 30.1; 11.2 Percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tocilizumab (Drug); Placebo (Drug); Permitted DMARDs (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With an Improvement of at Least 50% in American College of Rheumatology (ACR) Score (ACR50) From Baseline at Week 24 |
30.1; 11.2 | <0.0001 sig |
| SECONDARY Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20, ACR50, ACR70) From Baseline at Weeks 4, 8, 12, 16, 20, and 24 |
34.2; 17.6; 46.5; 25.4; 49.6; 28.8 | — |
| SECONDARY Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 |
-1.77; -0.45; -2.32; -0.72; -2.63; -0.97 | — |
| SECONDARY Percentage of Patients With European League Against Rheumatism (EULAR) Good, Moderate, or no Response at Weeks 4, 8, 12, 16, 20, and 24 |
13.2; 2.0; 23.5; 1.0; 28.1; 5.9 | — |
| SECONDARY Mean Change From Baseline in the Routine Assessment Patient Index Data (RAPID) Score at Weeks 4, 8, 12, 16, 20, and 24 |
-1.28; -0.50; -1.70; -0.73; -1.89; -0.99 | — |
| SECONDARY Mean Change From Baseline in 12-Item Short Form Health Survey v2 (SF-12) Scores at Weeks 4, 8, 12, 16, 20, and 24 |
4.14; 1.35; 5.79; 1.95; 7.17; 2.67 | — |
| SECONDARY Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Weeks 4, 8, 12, 16, 20, and 24 |
3.93; 3.06; 5.65; 3.85; 6.63; 3.91 | — |
| SECONDARY Mean Change From Baseline in the Medical Outcomes Study (MOS) Sleep Scale Score at Weeks 4, 8, 12, 16, 20, and 24 |
-5.68; -3.87; -8.05; -6.77; -9.27; -4.80 | — |
| SECONDARY Mean Change From Baseline in Individual Components of the Routine Assessment Patient Index Data (RAPID) at Each Day During the First 7 Days of Treatment |
-0.26; -0.22; -0.35; -0.19; -0.46; -0.09 | — |
| SECONDARY Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20, ACR50, ACR70) From Baseline at Day 7 |
21; 5; 5; 0; 5; 0 | — |
| SECONDARY Mean Change From Baseline in C-reactive Protein (CRP) at Days 3 and 7 |
-2.14; -0.52; -2.69; -0.31 | — |
Summary
This 2-arm study assessed the safety and efficacy of tocilizumab versus placebo, both in combination with disease modifying antirheumatic drugs (DMARDs), in regard to reduction in signs and symptoms, in patients with moderate to severe active rheumatoid arthritis with an inadequate response to DMARDs. Patients were randomized in a ratio of 2:1 to receive either tocilizumab 8 mg/kg intravenously (IV) or placebo IV every 4 weeks. All patients also received stable antirheumatic therapy, including permitted DMARDs. The anticipated time on study treatment was 3-12 months and the target sample size was 500+ individuals.
Eligibility Criteria
Inclusion Criteria
- Adult patients, ≥18 years of age
- Active rheumatoid arthritis of >6 months duration
- Received permitted DMARDs each at a stable dose for at least 7 weeks prior to baseline
Exclusion Criteria
- Rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis
- Major surgery within 8 weeks prior to screening or planned within 6 months following randomization
- Unsuccessful treatment with a biologic agent, including an anti-TNF agent
- Previous treatment with tocilizumab
Data sourced from ClinicalTrials.gov (NCT00531817). 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.