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
3 other identifiers
interventional
302
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2004
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 17, 2004
CompletedFirst Posted
Study publicly available on registry
August 20, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedOctober 18, 2010
October 1, 2010
August 17, 2004
October 15, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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
Study Arms (4)
001
EXPERIMENTALSCIO-469 30 mg capsule three times daily for 12 weeks
002
EXPERIMENTALSCIO-469 60 mg capsule three times daily for 12 weeks
003
EXPERIMENTALSCIO-469 100 mg tablet once daily for 12 weeks
004
PLACEBO COMPARATORPlacebo 2 capsules three times daily and one tablet daily
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Scios, Inc.lead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Scios, Inc. Clinical Trial
Scios, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 17, 2004
First Posted
August 20, 2004
Study Start
July 1, 2004
Study Completion
October 1, 2005
Last Updated
October 18, 2010
Record last verified: 2010-10