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”

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).

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.

Intervention(s) in this Clinical Trial

• Drug: SCIO-469
  • 60 mg capsule three times daily for 12 weeks
• Drug: SCIO-469
  • 30 mg capsule three times daily for 12 weeks
• Drug: Placebo
  • 2 capsules three times daily and one tablet daily
• Drug: SCIO-469
  • 100 mg tablet once daily for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 001
  • SCIO-469 30 mg capsule three times daily for 12 weeks
• Experimental: 002
  • SCIO-469 60 mg capsule three times daily for 12 weeks
• Experimental: 003
  • SCIO-469 100 mg tablet once daily for 12 weeks
• Placebo Comparator: 004
  • Placebo 2 capsules three times daily and one tablet daily

Primary Measures

• 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)
  • Time Frame: Day 1 to approximately Day 85 of treatment
    Safety Issue?: No

Secondary Measures

• ACR50 responders at Week 12
  • Time Frame: 12 weeks
    Safety Issue?: No
• ACR20 and ACR50 responders at each evaluation visit other than Week 12
  • Time Frame: 24 weeks
    Safety Issue?: No
• All individual variables of the ACR response criteria at each evaluation visit
  • Time Frame: 24 weeks
    Safety Issue?: No
• Disease Activity Score (DAS)28 at each evaluation visit.
  • Time Frame: 24 Weeks
    Safety Issue?: No
• The number of participants experiencing adverse events (AEs) as a measure of safety
  • Time Frame: 24 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Scios, Inc. Industry

Overall Clinical Trial Officials and Contacts

Scios, Inc. Clinical Trial Study Director Scios, Inc.  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00089921

Study ID Number: CR005167

ClinicalTrials.gov Identifier: NCT00089921

Health Authority: United States: Food and Drug Administration