Juvenile Chronic Arthritis Clinical Trial
Official title:
A Randomized, Multi-center, Blinded, Placebo-controlled Study With an Open-label Run-in Period to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daily, Single, Subcutaneous Injections of r-metHuIL-1ra (Anakinra) in Polyarticular-Course Juvenile Rheumatoid Arthritis
| Verified date | February 2008 |
| Source | Swedish Orphan Biovitrum |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to determine the safety of anakinra in patients with Polyarticular-Course Juvenile Rheumatoid Arthritis, a form of rheumatoid arthritis affecting children.
| Status | Completed |
| Enrollment | 86 |
| Est. completion date | November 2003 |
| Est. primary completion date | November 2003 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 2 Years to 17 Years |
| Eligibility | - Male or female age 2-17 yrs inclusive * Minimum weight 10 KG * Diagnosis of Chronic Arthritis |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The primary outcome of the study was to evaluate the safety of anakinra | 28 weeks | No |