Clinical trial NCT00089921: SPRiNG: SCIO-469 Patients With Rheumatoid Arthritis Not Receiving Methotrexate
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthritis, Rheumatoid
Keywords: Rheumatoid Arthritis
DMARDs
Methotrexate
p38 kinase
Lead sponsor: Scios, Inc.
Sponsor class: INDUSTRY
First posted: 2004-08-20
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine the efficacy of oral SCIO-469 in patients with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic) disease-modifying anti-rheumatic drugs (DMARDs).

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: ACR20 is 20% reduction in tender and swollen joint counts and 20% improvement in three of the five remaining ACR core set measures: patient and physician global assessments, visual analog scale for pain, HAQ, and an acute-phase reactant (CRP or ESR)
timeFrame: Day 1 to approximately Day 85 of treatment
Secondary outcomes:
measure: ACR50 responders at Week 12
timeFrame: 12 weeks
measure: ACR20 and ACR50 responders at each evaluation visit other than Week 12
timeFrame: 24 weeks
measure: All individual variables of the ACR response criteria at each evaluation visit
timeFrame: 24 weeks
measure: Disease Activity Score (DAS)28 at each evaluation visit.
timeFrame: 24 Weeks
measure: The number of participants experiencing adverse events (AEs) as a measure of safety
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Scios, Inc.
name: Scios, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: