Phase 3
N=656
A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01232569 ↗Enrolled (actual)
656
Serious AEs
6.7%
Results posted
Oct 2013
Primary outcome: Primary: Percentage of Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24 — 60.9; 31.5 Percentage of patients — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tocilizumab 162 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24 |
60.9; 31.5 | <0.001 sig |
| SECONDARY Percentage of Patients With ACR50 and ACR70 Responses at Week 24 |
39.8; 12.3; 19.7; 5.0 | — |
| SECONDARY Time to Onset of ACR20, ACR50, and ACR70 Responses |
57; 86; 115; NA; 174; NA | — |
| SECONDARY Change From Baseline in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 24 |
-14.8; -8.1; -9.6; -5.9 | — |
| SECONDARY Change From Baseline in C-reactive Protein at Week 24 |
-1.7; -0.1 | — |
| SECONDARY Change From Baseline in Erythrocyte Sedimentation Rate at Week 24 |
-36.4; -9.5 | — |
| SECONDARY Change From Baseline in the Patient's and the Physician's Global Assessment of Disease Activity Visual Analog (VAS) Score |
-32.0; -20.9; -36.9; -30.7 | — |
| SECONDARY Change From Baseline in the Patient's Pain Visual Analog Score |
-28.1; -15.0 | — |
| SECONDARY Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 |
-0.5; -0.3 | — |
| SECONDARY Percentage of Patients With an Improvement of ≥ 0.3 Units From Baseline in the HAQ-DI Score at Week 24 |
58.0; 46.8 | — |
| SECONDARY Change From Baseline in Disease Activity Score 28 (DAS28) at Week 24 |
-3.3; -1.8 | — |
| SECONDARY Percentage of Patients With a DAS28 Score ≤ 3.2 (DAS28 Low Disease Activity) at Week 24 |
45.2; 15.3 | — |
| SECONDARY Percentage of Patients With a DAS28 Score < 2.6 (DAS28 Remission) at Week 24 |
32.0; 4.0 | — |
| SECONDARY Percentage of Patients With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses at Week 24 |
41.7; 13.8; 44.9; 54.3; 13.4; 31.9 | — |
| SECONDARY Change From Baseline in the Van Der Heijde Modified Sharp Radiographic Score at Week 24 |
0.62; 1.23 | — |
| SECONDARY Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Week 24 |
7.2; 4.3; 6.1; 3.0 | — |
| SECONDARY Change From Baseline in Hemoglobin at Week 24 |
11.0; 0.0 | — |
Summary
This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients with active, moderate to severe rheumatoid arthritis. In the double-blind part of the study, patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study, patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from Week 24 to Week 96 using a pre-filled syringe or an auto-injector.
Eligibility Criteria
Inclusion Criteria
- Adult patients, ≥ years of age.
- Moderate to severe rheumatoid arthritis of ≥ 6 months duration.
- Receiving treatment on an outpatient basis.
- Swollen joint count (SJC) ≥ 6 (66 joint count) and tender joint count (TJC)≥ 8 (68 joint count) at screening and study start.
- On a stable dose of disease-modifying anti-rheumatic drugs for at least 8 weeks prior to study start.
Exclusion Criteria
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization.
- Rheumatic autoimmune disease other than rheumatoid arthritis, Secondary Sjögren's Syndrome with rheumatoid arthritis is allowed.
- Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis.
- Diagnosis of juvenile idiopathic arthritis or juvenile rheumatoid arthritis and/or rheumatoid arthritis before the age of 16 years.
- Prior history of or current inflammatory joint disease other than rheumatoid arthritis.
- History of malignancy, active or recurrent infections, positive to hepatitis B surface antigen or hepatitis C antibody, active tuberculosis, serious allergy to biologics, or a history of diverticular disease or other symptomatic GI conditions that might predispose to perforations.
Other inclusion and exclusion criteria applied to the study.
Data sourced from ClinicalTrials.gov (NCT01232569). 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.