Phase 3
Completed N=107
A Study With Tocilizumab [RoActemra/Actemra] Monotherapy or in Combination With Methotrexate in Patients With Rheumatoid Arthritis (PICTURE)
Source: ClinicalTrials.gov NCT01063062 ↗Enrolled (actual)
107
Serious AEs
16.2%
Results posted
Aug 2014
Primary outcomePrimary: Percentage of Participants Achieving Disease Activity Score 28 (DAS28) Low Disease Activity — 27.59; 18.42; 34.48; 40.79 percentage of participants
Summary
This single-arm, open-label, multicenter study evaluated the safety and tolerability and the efficacy in reducing disease activity of tocilizumab [RoActemra/Actemra] as monotherapy or in combination with methotrexate in patients with active moderate to severe rheumatoid arthritis (RA). Patients were eligible to participate in this study if they are currently experiencing an inadequate response to a stable dose of a non-biologic disease-modifying antirheumatic drug (DMARD). Patients received 8 mg/kg tocilizumab [RoActemra/Actemra] as an intravenous infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment was 24 weeks. The target sample size was 50-200 patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Disease Activity Score 28 (DAS28) Low Disease Activity |
27.59; 18.42; 34.48; 40.79; 34.48; 38.16 | — |
| PRIMARY Time to DAS28 Low Disease Activity |
107.2; 100.2 | — |
| SECONDARY Percentage of Participants Achieving DAS28 Clinically Significant Improvement |
62.07; 73.68; 75.86; 86.84; 75.86; 90.79 | — |
| SECONDARY Time to DAS28 Clinically Significant Improvement |
59.9; 41.6 | — |
| SECONDARY Percentage of Participants Achieving DAS28 Remission |
17.24; 9.21; 31.03; 23.68; 31.03; 27.63 | — |
| SECONDARY Time to DAS28 Remission |
115.9; 120.5 | — |
| SECONDARY Disease Activity Score 28 (DAS28) |
4.17; 4.48; 3.72; 3.68; 3.37; 3.54 | — |
| SECONDARY C-Reactive Protein (CRP) |
13.04; 12.28; 14.74; 6.24; 9.35; 6.89 | — |
| SECONDARY Erythrocyte Sedimentation Rate (ESR) |
21.08; 20.37; 17.18; 13.79; 14.12; 16.41 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
29; 76; 5; 12 | — |
| SECONDARY Number of Participants With AE and SAE Related Discontinuation |
8; 7; 5; 6 | — |
| SECONDARY Number of Participants With Serious Infections |
1; 1 | — |
| SECONDARY Number of Participants With Elevated AST (SGOT) and ALT (SGPT) |
3; 6; 3; 8 | — |
| SECONDARY Number of Participants With Elevated Total Cholesterol According to ATPIII Guidelines |
10; 25; 16; 41; 10; 34 | — |
| SECONDARY Number of Participants With Elevated HDL Cholesterol According to ATPIII Guidelines |
4; 20; 10; 34; 2; 26 | — |
| SECONDARY Number of Participants With Elevated LDL Cholesterol According to ATPIII Guidelines |
9; 24; 11; 35; 7; 21 | — |
| SECONDARY Number of Participants With Elevated Triglyceride According to ATPIII Guidelines |
4; 7; 6; 15; 4; 12 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients ≥ 18 years of age
- Moderate to severe rheumatoid arthritis (RA) for at least 6 months (defined as a Disease Activity Score (DAS28) > 3.2 at screening)
- Patients with active RA after more than 12 weeks of treatment with DMARDs
- Patients with inadequate response to a stable dose of non-biologic DMARD
Exclusion Criteria
- Autoimmune disease other than RA. Patients with interstitial pulmonary fibrosis and able to tolerate methotrexate (MTX) and patients with Sjögren's Syndrome and RA are permitted
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
- Prior history of or current inflammatory joint disease other than RA
Data sourced from ClinicalTrials.gov (NCT01063062). 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.