Rheumatoid Arthritis Clinical Trial
Official title:
An Open Label Study to Evaluate the Safety and Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARDs.
Verified date | December 2015 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Finnish Medicines Agency |
Study type | Interventional |
This single arm study will assess the safety and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to current non-biologic DMARDs. Patients will receive iv infusions of tocilizumab 8mg/kg every 4 weeks for a total of 6 infusions, either as monotherapy or in combination with their current non-biologic DMARDs.The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Status | Completed |
Enrollment | 14 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - adult patients, >=18 years of age; - moderate to severe rheumatoid arthritis; - inadequate response to current non-biologic DMARDs; - <=150kg body weight. Exclusion Criteria: - rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis; - previous treatment with other biologics. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse events;serious adverse events | Throughout study;assessments made at every 4 week visit | No | |
Secondary | DAS28;ACR20,50 and 70 responses;CRP and ESR | Throughout study;assessments made at every 4 week visit | No | |
Secondary | Premature withdrawals; ALT and AST elevations; no. of patients with lipid elevations; neutrophil count | Throughout study;assessments made at every 4 week visit | No |
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