Phase 3
Completed N=51
An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local Environment
Source: ClinicalTrials.gov NCT01254331 ↗Enrolled (actual)
51
Serious AEs
5.9%
Results posted
Feb 2015
Primary outcomePrimary: Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Related AEs, Discontinuation Due to AEs, or Death — 78.4; 5.9; 15.2; 7.8 percentage of participants
Summary
This open-label, multi-center study in a local environment will evaluate the safety and the effect on disease activity with regard to reduction in signs and symptoms over 6 months of treatment in patients with moderate to severe active rheumatoid arthritis who experienced an inadequate response to a non-biologic DMARD. Tocilizumab 8 mg/kg will be administered as an intravenous infusion every 4 weeks for a total of 6 infusions as monotherapy or in combination with methotrexate (MTX). The anticipated time of study treatment is 24 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Related AEs, Discontinuation Due to AEs, or Death |
78.4; 5.9; 15.2; 7.8; 0 | — |
| SECONDARY Percentage of Participants Who Achieved Clinically Significant Improvement Assessed Using Disease Activity Score Based on 28 Joints (DAS28) |
56.9; 81.6; 83.0; 80.9; 95.7; 91.3 | — |
| SECONDARY Percentage of Participants Achieving LDA Assessed Using DAS28 |
9.8; 26.5; 34.0; 36.2; 52.2; 47.8 | — |
| SECONDARY Percentage of Participants Achieving Remission Assessed Using DAS28 |
0.0; 2.0; 12.2; 23.4; 23.4; 32.6 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70) |
29.2; 6.3; 0.0; 54.3; 21.7; 4.3 | — |
| SECONDARY Time To Achieve ACR20/ACR50/ACR70 |
8.0; 20.0; NA | — |
| SECONDARY SJC and TJC |
14.3; 7.0; 10.3; 5.2; 5.0; 3.4 | — |
| SECONDARY Assessment of Pain by the Participant Using Visual Analog Scale (VAS) |
67.6; 49.4; 40.6; 36.0; 36.1; 33.2 | — |
| SECONDARY Assessment of Global Disease by the Participant Using VAS |
64.7; 52.9; 40.9; 37.1; 34.4; 32.6 | — |
| SECONDARY Assessment of Global Disease by the Physician Using Visual Analog Scale (VAS) |
58.8; 45.9; 35.5; 31.1; 32.3; 28.9 | — |
| SECONDARY Assessment of Physical Function Using Health Assessment Questionnaire (HAQ) |
1.7; 1.2; 1.7; 0.9; 0.8; 0.8 | — |
| SECONDARY Mean C-Reactive Protein (CRP) Levels |
26.6; 10.4; 9.5; 8.4; 9.1; 10.9 | — |
| SECONDARY Mean Erythrocyte Sedimentation Rate (ESR) Levels |
44.1; 21.0; 22.1; 17.0; 16.8; 13.5 | — |
| SECONDARY Percentage of Participants Experiencing Fatigue |
22.0; 16.3; 4.2; 13.3; 10.6; 11.4 | — |
| SECONDARY Number of Participants Who Discontinued Tocilizumab |
1 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients >/=18 years of age
- Moderate to severe rheumatoid arthritis defined as DAS 28>3.2
- Body weight </=150 kg
- Patient on at least 1 non-biologic DMARD on a stable dose for at least 8 weeks at any time prior to study start
- Inadequate clinical response to a stable dose of a non-biologic DMARD
Exclusion Criteria
- Major surgery within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
- Rheumatic autoimmune disease other than rheumatoid arthritis (RA)
- Functional class IV as defined by the ACR classification
- History or current inflammatory joint disease other than RA
- Previous treatment with any cell depleting therapy
- Previous treatment with methotrexate
- Previous treatment with tocilizumab
- Previous treatment with any biologic drug that is used in the treatment of RA
Data sourced from ClinicalTrials.gov (NCT01254331). 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.