Phase 4
Completed N=326
A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01119859 ↗Enrolled (actual)
326
Serious AEs
10.8%
Results posted
Feb 2013
Primary outcomePrimary: Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28) — -3.3; -1.8 Units on a scale
Summary
This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis who are intolerant of methotrexate or where continued treatment with methotrexate was considered inappropriate. Patients were randomized to receive either tocilizumab 8 mg/kg intravenously (iv) every 4 weeks plus placebo subcutaneously (sc) every 2 weeks, or adalimumab 40 mg sc every 2 weeks plus placebo iv every 4 weeks. Treatment was anticipated to last 24 weeks. With regard to the blind, the study nurse was unblinded due to the nature of the treatment administration, but the investigator and the patient remained blinded.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28) |
-3.3; -1.8 | — |
| SECONDARY Percentage of Patients With a Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Week 24 |
39.9; 10.5 | — |
| SECONDARY Percentage of Patients With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Week 24 |
51.5; 19.8 | — |
| SECONDARY Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24 |
65.0; 49.4; 47.2; 27.8; 32.5; 17.9 | — |
| SECONDARY Percentage of Patients With a European League Against Rheumatism (EULAR) Good Response at Week 24 |
51.5; 19.8 | — |
| SECONDARY Percentage of Patients With a European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24 |
77.9; 54.9 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, ≥ 18 years of age.
- Rheumatoid arthritis of > 6 months duration.
- Intolerant of methotrexate or continued treatment with methotrexate is considered inappropriate.
- All disease-modifying anti-rheumatic drugs (DMARD) are to be withdrawn prior to receiving study drug.
- Weight ≤ 150 kg.
Exclusion Criteria
- Major surgery (including joint surgery) within 12 weeks prior to baseline or planned major surgery within 6 months after baseline.
- History of or current inflammatory joint disease other than rheumatoid arthritis (RA).
- Treatment with a biologic agent at any time prior to baseline.
- Intra-articular or parenteral corticosteroids ≤ 4 weeks prior to baseline.
- Active current infection or history of recurrent bacterial, viral, fungal or mycobacterial infection.
Data sourced from ClinicalTrials.gov (NCT01119859). 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.