Phase 3
Completed N=2,067
An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies
Source: ClinicalTrials.gov NCT00720798 ↗Enrolled (actual)
2,067
Serious AEs
35.2%
Results posted
Sep 2014
Primary outcomePrimary: Percentage of Participants With ≥ 1 Adverse Event — 96.3 Percentage of participants
Summary
This single-arm study evaluated the long-term efficacy and safety of tocilizumab in participants who had completed treatment in the tocilizumab core studies (NCT00106522 [Roche protocol WA18062], NCT00106574 [Roche protocol WA18063], and NCT00109408 [Roche protocol WA17824]) of adults with rheumatoid arthritis. Participants received tocilizumab alone or in combination with standard anti-rheumatic treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With ≥ 1 Adverse Event |
96.3 | — |
| SECONDARY Percentage of Participants Who Withdrew From Treatment |
36.6 | — |
| SECONDARY Percentage of Participants With Concomitant Oral Corticosteroid Therapy |
55.8; 55.3; 54.6; 54.3; 53.2; 52.9 | — |
| SECONDARY Percentage of Participants Who Changed From Monotherapy to Combination Therapy |
1.2; 0.4; 15.6; 7.0; 2.5; 1.6 | — |
| SECONDARY Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 |
59.5; 66.7; 74.1; 74.3; 77.5; 78.7 | — |
| SECONDARY Percentage of Participants Who Achieved a Major Clinical Response at Weeks 48, 96, 144, 192, and 264 |
8.5; 16.2; 20.9; 22.9; 24.9 | — |
| SECONDARY Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 |
41.2; 53.0; 43.0; 56.3; 48.7; 35.6 | — |
| SECONDARY Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264 |
17.4; 8.2; 6.4; 4.2; 4.0; 3.2 | — |
| SECONDARY Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264 |
60.5; 34.4; 31.7; 29.2; 28.5; 27.4 | — |
| SECONDARY Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264 |
1.46; 1.04; 0.97; 0.89; 0.87; 0.84 | — |
| SECONDARY Erythrocyte Sedimentation Rate at Baseline and Weeks 24, 48, 108, 156, 204, and 264 |
46.2; 11.3; 10.2; 9.0; 8.9; 8.9 | — |
| SECONDARY Change in the Disease Activity Score 28 (DAS-28) From Baseline to Weeks 24, 48, 96, and 264 |
-2.82; -3.20; -3.46; -3.73 | — |
| SECONDARY Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264 |
43.3; 51.9; 61.1; 64.7; 67.8; 68.8 | — |
| SECONDARY Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264 |
67.6; 72.7; 63.4; 73.1; 64.1; 52.9 | — |
| SECONDARY Percentage of Participants With a Clinically Relevant Improvement in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 24, 36, 48, 108, 156, 204, and 264 |
59.5; 52.5; 56.0; 56.8; 56.3; 56.4 | — |
| SECONDARY Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264 |
42.4; 44.4; 45.3; 46.1; 47.1; 44.9 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who have completed participation in 1 of the core studies in adult rheumatoid arthritis.
Exclusion Criteria
- Treatment with any investigational agent since the last administration of study drug in the core studies.
- Treatment with iv gamma globulin, plasmapheresis, or prosorba column since the last administration of study drug in the core studies.
- Treatment with an anti-TNF or anti-IL1 agent, a T-cell co-stimulation modulator, or any biologic since the last administration of study drug in the core studies.
- Immunization with a live/attenuated vaccine since the last administration of study drug in the core studies.
- Previous treatment with any cell-depleting therapies, including investigational agents.
- Parenteral, intramuscular, or intra-articular corticosteroids within 6 weeks prior to baseline in this study.
Data sourced from ClinicalTrials.gov (NCT00720798). 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.