Phase 4
N=95
A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01089023 ↗Enrolled (actual)
95
Serious AEs
8.4%
Results posted
Jul 2014
Primary outcome: Primary: Percentage of Participants Reporting Any Adverse Event - Overall Summary of Events — 8.4; 0; 38.9; 45.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- tocilizumab [RoActemra/Actemra] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Reporting Any Adverse Event - Overall Summary of Events |
8.4; 0; 38.9; 45.3 | — |
| SECONDARY Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category |
66.3; 15.1; 5.5; 2.2; 3.4; 1.1 | — |
| SECONDARY Percentage of Participants Achieving a Clinically Meaningful Improvement as Measured by DAS28 |
82.8; 92.3; 95.5; 95.5; 94.3; 91.6 | — |
| SECONDARY Time to DAS28 Response by DAS28 Category |
36.430; 75.261; 89.945 | — |
| SECONDARY Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at Least 0.22 Units |
61.3; 72.5; 87.6; 93.3; 92.0; 83.2 | — |
| SECONDARY Percentage of Participants With Improvement in Physical Function by HAQ-DI Category |
13.7; 36.6; 50.5; 60.7; 73.0; 80.7 | — |
| SECONDARY HAQ-DI Score by Visit |
1.570; 1.185; 0.972; 0.805; 0.680; 0.576 | — |
| SECONDARY C-Reactive Protein (CRP) Values by Study Visit |
26.90; 8.49; 7.84; 5.32; 5.18; 5.62 | <0.0001 sig |
| SECONDARY Erythrocyte Sedimentation Rate |
45.27; 10.61; 7.66; 7.52; 5.83; 6.60 | <0.0001 sig |
Summary
This open-label single-arm study will evaluate the safety, tolerability and efficacy of tocilizumab [RoActemra/Actemra] in patients with moderate to severe rheumatoid arthritis who experience an inadequate clinical response to a stable dose of non-biologic disease modifying anti-rheumatic drugs (DMARD) or anti-tumor necrosis factors (TNFs). RoActemra/Actemra will be administered as a monotherapy or in combination with DMARDs. RoActemra/Actemra will be administered as intravenous infusion at a dose of 8 mg/kg every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.
Eligibility Criteria
Inclusion Criteria
- adult patients, >/=18 years of age
- moderate to severe rheumatoid arthritis (DAS28 >3.2) of 6 months duration
- inadequate clinical response to non-biologic DMARDs or anti-TNF
- bodyweight </=150 kg
Exclusion Criteria
- rheumatic autoimmune disease or inflammatory joint disease other than RA
- major surgery within 8 weeks prior to screening or planned major surgery within 6 months following screening
Data sourced from ClinicalTrials.gov (NCT01089023). 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.