Phase 3
Completed N=209
A Study of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis.
Source: ClinicalTrials.gov NCT00773461 ↗Enrolled (actual)
209
Serious AEs
2.4%
Results posted
Jul 2016
Primary outcomePrimary: Percentage of Participants With an American College of Rheumatology (ACR)20 Response at Week 24 — 24.6; 69.8; 24.6; 73.4 Percentage of Participants — p=<0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with DMARDs, in patients with active rheumatoid arthritis who currently have an inadequate response to DMARD therapy. Patients will be randomized 2:1 to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an American College of Rheumatology (ACR)20 Response at Week 24 |
24.6; 69.8; 24.6; 73.4 | <0.0001 sig |
| SECONDARY Percentage of Participants With ACR50 and ACR70 Responses at Week 24 |
10.1; 38.8; 2.9; 12.9 | <0.0001 sig |
| SECONDARY Number of Participants Who Received Escape Therapy |
4; 0 | — |
| SECONDARY Change in Tender and Swollen Joint Counts From Baseline to Week 24 |
-4.5; -9.9; -6.2; -16.5 | <0.0001 sig |
| SECONDARY Change in Participant's Global Assessment of Disease Activity From Baseline to Week 24 |
-8.7; -26.4 | <0.0001 sig |
| SECONDARY Change in Physician's Global Assessment of Disease Activity From Baseline to Week 24 |
-9.9; -29.1 | <0.0001 sig |
| SECONDARY Change in Participant's Global Assessment of Pain From Baseline to Week 24 |
-5.9; -23.5 | <0.0001 sig |
| SECONDARY Change in C-Reactive Protein From Baseline to Week 24 |
-0.083; -1.865 | <0.0001 sig |
| SECONDARY Change in ESR From Baseline to Week 24 |
-4.4; -42.7 | <.0001 sig |
| SECONDARY Percentage of Participants With Low Disease Activity and in Clinical Remission |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score |
2.08; 6.51 | 0.0003 sig |
| SECONDARY Mean Rheumatoid Factor at Baseline and Week 24 |
179.5; 262.2; 198.6; 204.6 | 0.0599 |
| SECONDARY Change in Hemoglobin From Baseline to Week 24 |
-1.0; 12.0 | <0.0001 sig |
| SECONDARY Change in Health Assessment Questionnaire - Disease Index (HAQ-DI) From Baseline to Week 24 |
-0.06; -0.52 | <0.0001 sig |
| SECONDARY Percentage of Participants With ACR20 Response by First Week of Onset |
17.6; 21.6; 23.5; 22.7; 5.9; 30.9 | — |
| SECONDARY Time to First Low Disease Activity |
NA; 139 | — |
| SECONDARY Time to First Remission |
NA; NA | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, 18-70 years of age;
- rheumatoid arthritis for >= 6 months;
- receiving permitted DMARDs, at a stable dose, for >= 8 weeks prior to baseline;
- current inadequate clinical response to DMARDs.
Exclusion Criteria
- major surgery, including joint surgery, within 8 weeks before entering study, or planned major surgery within 6 months following randomization;
- rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
- unsuccessful treatment with an anti-TNF agent;
- previous treatment with tocilizumab.
Data sourced from ClinicalTrials.gov (NCT00773461). 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.