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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
  Purpose

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).


Condition Intervention Phase
Arthritis, Rheumatoid
Drug: SCIO-469
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Scios, Inc.:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 302
Study Start Date: July 2004
Study Completion Date: October 2005
Arms Assigned Interventions
Experimental: 001
SCIO-469 30 mg capsule three times daily for 12 weeks
Drug: SCIO-469
30 mg capsule three times 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
Experimental: 003
SCIO-469 100 mg tablet once 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00089921

Sponsors and Collaborators
Scios, Inc.
Investigators
Study Director: Scios, Inc. Clinical Trial Scios, Inc.
  More Information

No publications provided

Responsible Party: VP CLINICAL RESEARCH, Centocor Research & Development, Inc., PA, USA
ClinicalTrials.gov Identifier: NCT00089921     History of Changes
Other Study ID Numbers: CR005167, SCIO-469ARA2003, B007
Study First Received: August 17, 2004
Last Updated: October 15, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Scios, Inc.:
Rheumatoid Arthritis
DMARDs
Methotrexate
p38 kinase

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014