SPRiNG: SCIO-469 Patients With Rheumatoid Arthritis Not Receiving Methotrexate

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Arthritis, Rheumatoid

Intervention / Treatment
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* Drug: SCIO-469
* Drug: SCIO-469
* Drug: Placebo
* Drug: SCIO-469


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 001<br>SCIO-469 30 mg capsule three times daily for 12 weeks | Drug: SCIO-469<br>* 30 mg capsule three times daily for 12 weeks<br>|
| Experimental: 002<br>SCIO-469 60 mg capsule three times daily for 12 weeks | Drug: SCIO-469<br>* 60 mg capsule three times daily for 12 weeks<br>|
| Experimental: 003<br>SCIO-469 100 mg tablet once daily for 12 weeks | Drug: SCIO-469<br>* 100 mg tablet once daily for 12 weeks<br>|
| Placebo Comparator: 004<br>Placebo 2 capsules three times daily and one tablet daily | Drug: Placebo<br>* 2 capsules three times daily and one tablet daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | Day 1 to approximately Day 85 of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR50 responders at Week 12 |  | 12 weeks | 
| ACR20 and ACR50 responders at each evaluation visit other than Week 12 |  | 24 weeks | 
| All individual variables of the ACR response criteria at each evaluation visit |  | 24 weeks | 
| Disease Activity Score (DAS)28 at each evaluation visit. |  | 24 Weeks | 
| The number of participants experiencing adverse events (AEs) as a measure of safety |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DMARDs, Rheumatoid Arthritis, Methotrexate, p38 kinase