Rheumatoid Arthritis Clinical Trial
Official title:
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study of SCIO-469 in Patients in Active Rheumatoid Arthritis Receiving Methotrexate
Verified date | April 2010 |
Source | Scios, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The main objective of the study is to evaluate the safety and tolerability of six escalating doses of SCIO-469 in RA patients. SCIO-469 belongs to a new class of treatments that inhibit p38 kinase, a stimulatory modulator of pro-inflammatory factors including tumor necrosis factor-alpha (TNF-alpha), interleukin-1 (IL-1), and cyclooxygenase-2 (COX-2), all of which are known to contribute to both symptoms and disease progression in patients with Rheumatoid Arthritis.
Status | Completed |
Enrollment | 120 |
Est. completion date | September 2003 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients who have active rheumatoid arthritis and are receiving methotrexate - meet the revised 1987 American Rheumatism Association (ARA) criteria for rheumatoid arthritis - has active RA as demonstrated by 9 tender and 6 swollen joints and one of the following: C-reactive protein 1.0 mg/dL, Erythrocyte sedimentation rate (ESR) 28 mm/hour, or Morning stiffness = 45 minutes. . Exclusion Criteria: - Patient used etanercept, infliximab, anakinra, or an experimental biologic agent within past 3 months - Had elevation of liver enzymes within past 6 months - Has a history of Tuberculosis - Vertigo, inner ear, or vestibular abnormalities - Cancer - HIV-positive - Abnormal electrocardiogram - patient has chronic or acute infection - Multiple sclerosis, neuropathy or encephalopathy |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Scios, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assess the safety and tolerability of multiple oral doses of SCIO-469 in patients with active rheumatoid arthritis (RA) who were also receiving stable doses of methotrexate (MTX). | |||
Secondary | To assess the efficacy of multiple oral doses of SCIO-469 using the American College of Rheumatology (ACR) response criteria. To determine the PK of multiple oral doses of SCIO-469 in patients with active RA who are also receiving MTX. |
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