Phase 3
Completed N=121
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs (REMISSION)
Source: ClinicalTrials.gov NCT01610791 ↗Enrolled (actual)
121
Serious AEs
10.7%
Results posted
Jul 2014
Primary outcomePrimary: Percentage of Participants With Adverse Events — 48.8; 10.7; 8.3; 5.8 percentage of participants
Summary
This open label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks for 24 weeks (6 infusions).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events |
48.8; 10.7; 8.3; 5.8; 0.8; 10.7 | — |
| SECONDARY Percentage of Participants With All-Cause Discontinuation of Tocilizumab by Study Visit |
3.3; 3.3; 2.5; 2.5; 2.5; 3.3 | — |
| SECONDARY Change From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) to Highest Value |
23.6; 15.8 | <0.001 sig |
| SECONDARY Change From Baseline Low-Density Lipoprotein (LDL) and Total Cholesterol (TC) to Highest Values |
57.2; 108.6 | <0.001 sig |
| SECONDARY Percentage of Participants With Lipid Elevations by Study Visit |
53.3; 32.8; 42.9; 33.9; 18.9; 38.2 | — |
| SECONDARY Disease Activity Score Based on 28-Joint Count (DAS28) |
6.2; 4.0; 3.3; 2.8; 2.4; 2.1 | — |
| SECONDARY Percentage of Participants by DAS28 Response Category |
0.9; 31.9; 50.9; 67.9; 81.1; 88.3 | — |
| SECONDARY Percentage of Participants With a Clinically Meaningful Improvement in Disease Activity |
0; 76.7; 91.1; 91.7; 96.2; 98.1 | — |
| SECONDARY Time to Achieve Clinically Meaningful Reduction in DAS28 |
44.7 | — |
| SECONDARY Percentage of Participants Achieving Remission (DAS28 <2.6) |
0.0; 16.4; 30.4; 48.6; 63.2; 73.8 | — |
| SECONDARY Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria |
62.0; 73.2; 78.9; 85.8; 90.3; 87.9 | — |
| SECONDARY Swollen and Tender Joint Counts |
10.8; 4.8; 6.0; 3.1; 7.5; 2.8 | — |
| SECONDARY Health Assessment Questionnaire (HAQ) |
1.97; 1.44; 0.52; 1.02; 0.94; 0.80 | — |
| SECONDARY Patient Global Assessment of Disease Activity (VAS) |
64.2; 40.6; 23.6; 28.8; 35.6; 21.4 | — |
| SECONDARY Physician's Global Assessment of Disease Activity (VAS) |
61.8; 37.7; 24.3; 26.7; 35.4; 20.0 | — |
| SECONDARY Patient Assessment of of Pain (VAS) |
63.4; 41.4; 21.9; 29.1; 34.5; 21.4 | — |
| SECONDARY C-Reactive Protein (CRP) |
22.9; 6.5; 16.6; 4.9; 17.7; 5.1 | — |
| SECONDARY Erythrocyte Sedimentation Rate (ESR) |
31.4; 9.5; 21.8; 8.3; 22.4; 8.6 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Moderate to severe active rheumatoid arthritis (DAS28 > 3.2 at screening)
- Inadequate response to DMARDs
- Body weight < 150 kg
Exclusion Criteria
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months of enrollment
- Rheumatic autoimmune disease other than RA
- American College of Rheumatology (ACR) functional class IV
- Prior history of or current inflammatory joint disease other than RA
- Previous treatment with any biologic drug that is used in the treatment of RA
- Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
- Pregnant or lactating women
- Active current or history of recurrent infection, active TB within the previous 3 years, HIV infection
Data sourced from ClinicalTrials.gov (NCT01610791). 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.