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

This study has been completed.
Sponsor:
Information provided by:
Scios, Inc.
ClinicalTrials.gov Identifier:
NCT00089921
First received: August 17, 2004
Last updated: October 15, 2010
Last verified: October 2010

August 17, 2004
October 15, 2010
July 2004
Not Provided
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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00089921 on ClinicalTrials.gov Archive Site
  • ACR50 responders at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • ACR20 and ACR50 responders at each evaluation visit other than Week 12 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • All individual variables of the ACR response criteria at each evaluation visit [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Disease Activity Score (DAS)28 at each evaluation visit. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • The number of participants experiencing adverse events (AEs) as a measure of safety [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
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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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • 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
  • Experimental: 001
    SCIO-469 30 mg capsule three times daily for 12 weeks
    Intervention: Drug: SCIO-469
  • Experimental: 002
    SCIO-469 60 mg capsule three times daily for 12 weeks
    Intervention: Drug: SCIO-469
  • Experimental: 003
    SCIO-469 100 mg tablet once daily for 12 weeks
    Intervention: Drug: SCIO-469
  • Placebo Comparator: 004
    Placebo 2 capsules three times daily and one tablet daily
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
302
October 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00089921
CR005167, SCIO-469ARA2003, B007
Not Provided
VP CLINICAL RESEARCH, Centocor Research & Development, Inc., PA, USA
Scios, Inc.
Not Provided
Study Director: Scios, Inc. Clinical Trial Scios, Inc.
Scios, Inc.
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP