Rheumatoid Arthritis Clinical Trial
Official title:
Tocilizumab for the Treatment of Rheumatoid Arthritis: Findings on The Use of Tocilizumab in Daily Clinical Routine
Verified date | June 2016 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Paul-Ehrlich Institute |
Study type | Observational |
This prospective, multicenter, non-interventional study will enroll participants from routine clinical practice in Germany who are receiving tocilizumab for RA. The objective of the study is systematic collection of data on use of tocilizumab in daily routine with special emphasis on treatment decision by the prescriber, compliance with Summary of Product Characteristics (SmPC), and documentation of relevant activity scores and adverse drug reactions (ADRs). The maximum observation period will be 12 months per participant.
Status | Completed |
Enrollment | 850 |
Est. completion date | March 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Moderate to severe RA - Tocilizumab indicated in accordance with SmPC and chosen by the treating physician in advance of the study Exclusion Criteria: - None specified |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Tocilizumab Regimens Prescribed in Compliance with SmPC | Baseline to end of treatment (up to 12 months) | No | |
Primary | Number of Tocilizumab Dose Adjustments | Baseline to end of treatment (up to 12 months) | No | |
Primary | Change from Baseline in 28-Joint Disease Activity Score (DAS28) | Baseline to end of treatment (up to 12 months) | No | |
Primary | Change from Baseline in Visual Analog Scale (VAS) Score of Physician-Assessed Disease Activity | Baseline to end of treatment (up to 12 months) | No | |
Secondary | Percentage of Participants Who Discontinue Treatment | Baseline to end of treatment (up to 12 months) | No | |
Secondary | Percentage of Participants with ADRs | Baseline to end of treatment (up to 12 months) | No |
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