A 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy of Oral SCIO-469 in Subjects With Active Rheumatoid Arthritis Who Are Not Receiving DMARDs Other Than Hydroxychloroquine
SCIO-469
+ Placebo
Arthritis+5
+ Arthritis, Rheumatoid
+ Autoimmune Diseases
Treatment Study
Summary
Study start date: July 1, 2004
Actual date on which the first participant was enrolled.This is a 24 week randomized (study drug assigned by chance), double blind (neither physician nor patient knows the name of the assigned drug), placebo controlled, parallel group study assessing the safety and effectiveness of oral SCIO-469 in treating patients with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic) disease-modifying anti-rheumatic drugs (DMARDs). The patient will participate in the study for approximately 183 days. Safety measures will include vital signs (blood pressure, pulse rate, breathing rate), 12-lead electro-cardiogram, adverse events, concomitant medications, and clinical laboratory evaluations (including serum chemistry, hematology, qualitative urinalysis, and liver function tests). The patient may be assigned to receive 30 mg capsule orally (by mouth) as one or two capsules three times daily, or receive 100 mg tablet orally once daily, or placebo (no active drug) orally as two capsules three times daily and placebo tablet orally once daily for 24 weeks.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.302 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Patients having active rheumatoid arthritis who are not receiving medications known as hepatotoxic disease-modifying anti-rheumatic drugs (DMARDs) * Patients taking hydroxychloroquine (Plaquenil) must be on a stable or consistent dose prior to entering study Exclusion Criteria: * Patients using Enbrel, Remicade, Kineret, Humira, or an experimental biologic agent within the past 3 months * Lab tests revealed elevated liver enzymes within the past 6 months * Medical history of Tuberculosis, cancer, multiple sclerosis, neuropathy or encephalopathy * HIV positive * Abnormal electrocardiogram * Chronic or acute infection
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
25% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
PlaceboGroup IV
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives