Phase 3
N=65
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01245439 ↗Enrolled (actual)
65
Serious AEs
16.9%
Results posted
Nov 2015
Primary outcome: Primary: Safety: Percentage of Participants With Treatment Emergent Adverse /Serious Adverse Events — 90.8; 9.2; 52.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- tocilizumab [RoActemra/Actemra] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety: Percentage of Participants With Treatment Emergent Adverse /Serious Adverse Events |
90.8; 9.2; 52.3 | — |
| SECONDARY Percentage of Participants With All-Cause Discontinuation |
0.0 | — |
| SECONDARY Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN |
1; 0; 0; 2; 0; 0 | — |
| SECONDARY Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN |
1.5; 0.0; 0.0; 3.1; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Serious Infections |
1.5; 1.5; 1.5 | — |
| SECONDARY Number of Participants With Serious Infections |
1; 1; 1 | — |
| SECONDARY Change From Baseline to Highest Values for ALT and AST |
28.9; 21.3 | — |
| SECONDARY Change From Baseline to Highest Values for Low Density Lipoprotein (LDL) and Total Cholesterol |
29.1; 39.8 | — |
| SECONDARY Change From Baseline to Lowest Value for Absolute Neutrophil Count (ANC) |
-3.04 | — |
| SECONDARY Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines |
3; 5; 20; 7; 1; 3 | — |
| SECONDARY Percentage of Participants With Elevations in Lipids According to ATP III Guidelines |
4.8; 8.1; 31.7; 11.1; 1.8; 5.1 | — |
| SECONDARY Number of Participants Who Achieved Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) At Every Visit |
0; 48; 18; 7; 2; 4 | — |
| SECONDARY Percentage of Participants Who Achieved Clinically Meaningful Improvement in DAS28 At Every Visit |
0.0; 87.3; 33.3; 13.2; 3.7; 7.5 | — |
| SECONDARY Number of Participants Who Achieved LDA By Visit |
0; 1; 32; 45; 48; 50 | — |
| SECONDARY Percentage of Participants Who Achieved LDA By Visit |
0.0; 1.7; 56.1; 80.4; 84.2; 87.7 | — |
| SECONDARY Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed |
0.0; 1.7; 51.7; 28.3; 10.0; 1.7 | — |
| SECONDARY Number of Participants Who Achieved Remission (DAS28) By Visit |
0; 0; 24; 35; 43; 46 | — |
| SECONDARY Percentage of Participants Who Achieved Remission (DAS28) At Every Visit |
0.0; 0.0; 42.1; 62.5; 75.4; 80.7 | — |
| SECONDARY Percentage of Participants Achieving Their First Remission Status By Visit |
40.0; 25.0; 15.0; 5.0; 3.3; 3.3 | — |
| SECONDARY Disease Activity Score as Measured By DAS28 at Each Visit |
5.6; 5.6; 3.1; 2.3; 2.0; 1.8 | 0.929 |
| SECONDARY Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response |
20; 12; 5; 0; 37; 25 | — |
| SECONDARY Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response |
33.3; 20.0; 8.3; 0.0; 61.7; 41.7 | — |
| SECONDARY C-Reactive Protein Levels |
3.5; 2.3; 1.0; 0.6; 0.6; 1.0 | 0.169 |
| SECONDARY Erythrocyte Sedimentation Rate |
35.4; 36.4; 12.3; 8.0; 7.8; 7.8 | 0.981 |
| SECONDARY Mean Number of Tender and Swollen Joints |
15.1; 5.5; 16.0; 5.7; 6.1; 1.9 | 0.410 |
| SECONDARY Participant's (PT) and Investigator's (IN) Assessment of Disease Activity |
70.1; 70.3; 68.3; 41.8; 33.3; 25.3 | <0.001 sig |
| SECONDARY Participant's Assessment of Pain |
66.4; 38.8; 25.6; 22.7; 23.0; 17.8 | <0.001 sig |
| SECONDARY Health Assessment Questionnaire Score (General Score) |
1.3; 0.8; 0.6; 0.5; 0.4; 0.4 | <0.001 sig |
Summary
This open-label study will evaluate the safety, tolerability and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis (RA) on background non-biologic DMARDs who have an inadequate response to current non-biologic DMARDs. Patients will receive 8 mg/kg RoActemra/Actemra as an intravenous infusion every 24 weeks for a total of 6 infusions. The anticipated time on study treatment is 24 weeks.
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/=18 years of age
- Moderate to severe active rheumatoid arthritis (DAS28>/=3.2) of >/=6 months duration
- Body weight /=8 weeks prior to study treatment
- Patients with inadequate clinical response to a stable dose of non-biologic DMARD
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, including systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to rheumatoid arthritis
- History of or current inflammatory joint disease other than rheumatoid arthritis
Data sourced from ClinicalTrials.gov (NCT01245439). 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.