N/A
Completed N=200
A Non-Interventional Study in Rheumatoid Arthritis Patients Treated With Tocilizumab (RoActemra/Actemra)
Source: ClinicalTrials.gov NCT01613378 ↗Enrolled (actual)
200
Serious AEs
15.7%
Results posted
Oct 2016
Primary outcomePrimary: Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation — 81.5 percentage of participants
Summary
This multi-center, non-interventional study will evaluate the pattern of usage in clinical practice, efficacy and safety of tocilizumab in patients with rheumatoid arthritis. Patients initiated on treatment with tocilizumab according to the licensed Canadian product monograph recommendations will be followed for 12 months from the start of treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation |
81.5 | — |
| SECONDARY Change From Baseline in Tender Joint Count (TJC) |
-12.71 | — |
| SECONDARY Change From Baseline in Swollen Joint Count (SJC) |
-8.66 | — |
| SECONDARY Change From Baseline in Disease Activity Score 28 (DAS28) |
-3.00 | — |
| SECONDARY Change From Baseline in Duration of Morning Stiffness (Visual Analog Scale, VAS) |
-24.31 | — |
| SECONDARY Change From Baseline in Patient Global Assessment of Disease Activity (Visual Analog Scale, VAS) |
-24.90 | — |
| SECONDARY Change From Baseline in Physician Global Assessment of Disease Activity (Visual Analog Scale, VAS) |
-39.95 | — |
| SECONDARY Change From Baseline in Patient Assessment of Pain (Visual Analog Scale, VAS) |
-27.99 | — |
| SECONDARY Change From Baseline in Patient Assessment of Fatigue (Visual Analog Scale, VAS) |
-23.94 | — |
| SECONDARY Change From Baseline in C-Reactive Protein (CRP) |
-16.35 | — |
| SECONDARY Change From Baseline in Erythrocyte Sedimentation Rate (ESR) |
-16.79 | — |
| SECONDARY Percentage of Participants With Changes in Extra-Articular Manifestations at 12 Months |
3.1; 0; 2.5; 0; 0; 0 | — |
| SECONDARY Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months |
5; 0; 0; NA; 3; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Moderate to severe rheumatoid arthritis according to revised (1987) American college of rheumatology (ACR) criteria
- Initiated on tocilizumab treatment by the treating physician in accordance with the Canadian product monograph
- Informed consent to data being subject to computerized data processing
- Participant must fulfill the reimbursement criteria for treatment with tocilizumab under provincial or private health insurance coverage
Exclusion Criteria
- Received tocilizumab prior to enrolment visit
- Previously received tocilizumab in a clinical trial or for compassionate use
- Enrolled in an ongoing clinical trial and/or received treatment with any investigational agent within 4 weeks, or 5 half-lives of the investigational agent, whichever is longer, before starting treatment with tocilizumab
- Participation in another clinical trial or industry sponsored observational study
- History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis, with the exception of concomitant secondary Sjörgen's syndrome
Data sourced from ClinicalTrials.gov (NCT01613378). 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.