Phase 3
Completed N=39
A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs
Source: ClinicalTrials.gov NCT01353859 ↗Enrolled (actual)
39
Serious AEs
5.1%
Results posted
Jun 2014
Primary outcomePrimary: Percentage of Participants Achieving Low Disease Activity Score — 100 percentage of participants
Summary
This multicenter, open-label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with active rheumatoid arthritis who have an inadequate response to non-biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for a total of 6 infusions plus methotrexate 10-25 mg orally weekly. Anticipated time on study treatment is 24 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Low Disease Activity Score |
100 | — |
| SECONDARY Time to Achieve Low Disease Activity (DAS28 ≤3.2) |
9.5 | — |
| SECONDARY Percentage of Participants With a Clinically Significant Improvement in DAS28 Score |
87.2; 91.9; 94.7; 97.3; 97.3; 100 | — |
| SECONDARY Time to Clinically Significant Improvement in DAS28 |
12.5 | — |
| SECONDARY Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6) |
0.0; 20.5; 36.8; 44.7; 59.0; 74.4 | — |
| SECONDARY Time to Achieve DAS28 Remission (DAS28 <2.6) |
4.4 | — |
| SECONDARY Percentage of Participants With DAS28 <3.2 by Visit |
0.0; 30.8; 48.7; 69.2; 82.1; 89.7 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology (ACR) 20%, 50%, and 70% Improvement (ACR20, ACR50, or ACR70) Response |
20; 34; 34 | — |
| SECONDARY Erythrocyte Sedimentation Rate |
48.1; 10.7; 9.1; 6.3; 8.3; 6.6 | — |
| SECONDARY C-Reactive Protein Levels |
17.6; 2.1; 0.8; 0.5; 1.2; 1.0 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Moderate to severe active rheumatoid arthritis (RA) of >/= 6 months duration
- Prior treatment with DMARDs for >/= 12 weeks (at stable dose for >/= 8 weeks)
- Inadequate clinical response to stable dose of non-biologic DMARD (either single or in combination)
Exclusion Criteria
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
- Autoimmune disease other than RA
- History of or current inflammatory joint disease other than RA
- Previous treatment with any biologic drug that is used in the treatment of RA
- Intra-articular or parenteral corticosteroids within 6 weeks prior to baseline
- Impaired liver, renal or hematologic function
- Active current or history of recurrent infection
- History of or currently active primary or secondary immunodeficiency
Data sourced from ClinicalTrials.gov (NCT01353859). 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.