Phase 3
Completed N=29
A Study to Assess the Effect of Tocilizumab on Signs and Symptoms in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00848120 ↗Enrolled (actual)
29
Serious AEs
3.5%
Results posted
Jan 2015
Primary outcomePrimary: Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20 Response) at Week 24 — 86 percentage of participants
Summary
This single arm, open label study will assess the safety and efficacy, with regard to reduction of signs and symptoms,of treatment with tocilizumab in patients with moderate to severe active rheumatoid arthritis. Patients will receive tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions. Patients already receiving methotrexate at entry into the study may continue with their treatment together with tocilizumab.The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20 Response) at Week 24 |
86 | — |
| SECONDARY Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) at Week 24 |
66 | — |
| SECONDARY Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) at Week 24 |
48 | — |
| SECONDARY HAQ Disability Index (HAQ-DI) Score at Baseline and Week 24 |
0.75; 0.23 | <0.001 sig |
| SECONDARY Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Baseline and Week 24 |
1.93; 1.03 | <0.001 sig |
| SECONDARY Disease Activity Score Based on 28 Joint Count - Erythrocyte Sedimentation Rate (DAS28-ESR) at Baseline and Week 24 |
6.94; 2.73 | 0.001 sig |
| SECONDARY Percentage of Participants With Disease Remission at Week 24 Assessed Using DAS28-ESR |
34 | — |
| SECONDARY Percentage of Participants With Low Disease Activity at Week 24 Assessed Using DAS28-ESR |
45 | — |
| SECONDARY Time to Onset of ACR20/50/70 Response |
4; 12; 24 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients,>=18 years of age;
- rheumatoid arthritis diagnosed >8 weeks and =8 (66 joint count) and tender joint count>=8 (68 joint count) at screening and baseline.
Exclusion Criteria
- rheumatic autoimmune disease other than rheumatoid arthritis;
- patients with functional class IV rheumatoid arthritis;
- history of, or current, inflammatory joint disease other than rheumatoid arthritis, or other systemic autoimmune disorder.
Data sourced from ClinicalTrials.gov (NCT00848120). 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.