N/A
Completed N=50
A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)
Source: ClinicalTrials.gov NCT01617005 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) — 0; 38 participants
Summary
This observational study will evaluate the safety and efficacy of tocilizumab in participants with active moderate to severe RA and an inadequate response to non-biologic DMARDs. Data will be collected from each eligible participant initiating tocilizumab treatment over 6 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) |
0; 38 | — |
| SECONDARY Number of Participants With Good or Moderate Response According to European League Against Rheumatism (EULAR) Criteria |
0; 40 | — |
| SECONDARY Number of Participants Who Discontinued Treatment Due to Lack of Efficacy |
— | — |
| SECONDARY Time to Discontinuation Due to Lack of Efficacy |
— | — |
Eligibility Criteria
Inclusion Criteria
- Moderate to severe active RA (European League Against Rheumatism [EULAR] criteria)
- Inadequate response to DMARDs or tumor necrosis factor (TNF) antagonists
- Initiating treatment with tocilizumab according to SPC
Exclusion Criteria
- Rheumatic autoimmune disease other than RA
- Prior history or current inflammatory joint disease other than RA
- Previous treatment with any biological drug used in the treatment of RA
- Previous treatment with tocilizumab
- Any contraindication to treatment with tocilizumab
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
- Pregnant women or nursing (breastfeeding) mothers
Data sourced from ClinicalTrials.gov (NCT01617005). 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.