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Safety Study of SCIO-469 to Treat Patients With Active Rheumatoid Arthritis Receiving Methotrexate

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ClinicalTrials.gov Identifier: NCT00043732
Recruitment Status : Completed
First Posted : August 14, 2002
Last Update Posted : April 27, 2010
Information provided by:
Scios, Inc.

Brief Summary:
The main objective of the study is to evaluate the safety and tolerability of six escalating doses of SCIO-469 in RA patients. SCIO-469 belongs to a new class of treatments that inhibit p38 kinase, a stimulatory modulator of pro-inflammatory factors including tumor necrosis factor-alpha (TNF-alpha), interleukin-1 (IL-1), and cyclooxygenase-2 (COX-2), all of which are known to contribute to both symptoms and disease progression in patients with Rheumatoid Arthritis.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: SCIO-469 Phase 2

Detailed Description:
This multicenter, randomized, double-blind, placebo-controlled, dose-escalating study will assess the safety, tolerability, efficacy, PK and pharmacodynamics of SCIO-469 in patients with active RA who also are receiving methotrexate. A total of 120 subjects will be randomly assigned and treated in one of seven dose groups with the total daily dose of SCIO-469 ranging from 0 to 180 mg. Dose groups will be staggered over four Treatment Periods. Safety and available PK data from a Treatment Period with lower dose groups will be reviewed prior to initiating higher dose groups in the next Treatment Period. Placebo subjects will be randomized in all Treatment Periods. Study drug will be taken for 30 days. Each subject will be followed for approximately 4 weeks after completing the 30-day Treatment Period. Safety will be assessed by way of physical examination, medical history, vital signs, orthostatic vital signs, chest radiograph, 12-lead electrocardiogram (ECG), clinical laboratory evaluations (including serum chemistry, hematology, qualitative urinalysis, and liver function tests), purified protein derivative test for tuberculosis, neurological tests, adverse events, and concomitant medications through out the study. Study drug will be administered for 30 days at one of the following dosage strengths; 30 mg, 60 mg, 90 mg. One group of subjects will get 60 mg for one week followed by 120 for one week followed by 180 mg for two weeks.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study of SCIO-469 in Patients in Active Rheumatoid Arthritis Receiving Methotrexate
Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Assess the safety and tolerability of multiple oral doses of SCIO-469 in patients with active rheumatoid arthritis (RA) who were also receiving stable doses of methotrexate (MTX).

Secondary Outcome Measures :
  1. To assess the efficacy of multiple oral doses of SCIO-469 using the American College of Rheumatology (ACR) response criteria. To determine the PK of multiple oral doses of SCIO-469 in patients with active RA who are also receiving MTX.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who have active rheumatoid arthritis and are receiving methotrexate
  • meet the revised 1987 American Rheumatism Association (ARA) criteria for rheumatoid arthritis
  • has active RA as demonstrated by 9 tender and 6 swollen joints and one of the following: C-reactive protein 1.0 mg/dL, Erythrocyte sedimentation rate (ESR) 28 mm/hour, or Morning stiffness = 45 minutes. .

Exclusion Criteria:

  • Patient used etanercept, infliximab, anakinra, or an experimental biologic agent within past 3 months
  • Had elevation of liver enzymes within past 6 months
  • Has a history of Tuberculosis
  • Vertigo, inner ear, or vestibular abnormalities
  • Cancer
  • HIV-positive
  • Abnormal electrocardiogram
  • patient has chronic or acute infection
  • Multiple sclerosis, neuropathy or encephalopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00043732

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

ClinicalTrials.gov Identifier: NCT00043732     History of Changes
Other Study ID Numbers: CR005173
First Posted: August 14, 2002    Key Record Dates
Last Update Posted: April 27, 2010
Last Verified: April 2010

Keywords provided by Scios, Inc.:
Rheumatoid arthritis

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