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

Arthritis, Rheumatoid Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00089921
• Other study ID #: CR005167
• Secondary ID: SCIO-469ARA2003B
• Status: Completed
• Phase: Phase 2
• First received: August 17, 2004
• Last updated: October 15, 2010
• Start date: July 2004
• Est. completion date: October 2005

Study information

• Verified date: October 2010
• Source: Scios, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Scios, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	ACR50 responders at Week 12		12 weeks	No
Secondary	ACR20 and ACR50 responders at each evaluation visit other than Week 12		24 weeks	No
Secondary	All individual variables of the ACR response criteria at each evaluation visit		24 weeks	No
Secondary	Disease Activity Score (DAS)28 at each evaluation visit.		24 Weeks	No
Secondary	The number of participants experiencing adverse events (AEs) as a measure of safety		24 weeks	Yes