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

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).

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid
• Intervention / Treatment: Drug: SCIO-469; Drug: SCIO-469; Drug: SCIO-469; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 302
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Scios, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Study Completion (Actual): October 1, 2005

Study Registration Dates

• First Submitted: August 17, 2004
• First Submitted That Met QC Criteria: August 19, 2004
• First Posted (Estimate): August 20, 2004

Study Record Updates

• Last Update Posted (Estimate): October 18, 2010
• Last Update Submitted That Met QC Criteria: October 15, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Methotrexate; Rheumatoid Arthritis; DMARDs; p38 kinase
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: CR005167; B007; SCIO-469ARA2003