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

Sponsored by:	Scios, Inc.
Information provided by:	Scios, Inc.
ClinicalTrials.gov Identifier:	NCT00089921

Purpose

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 subjects with rheumatoid arthritis.

The primary objective of this study is to determine the efficacy of oral SCIO-469 in subjects with rheumatoid arthritis who are not receiving hepatotoxic disease-modifying anti-rheumatic drugs (DMARDs).

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: SCIO-469	Phase II

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Hydroxychloroquine Hydroxychloroquine sulfate SCIO 469

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II, 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

Further study details as provided by Scios, Inc.:

Estimated Enrollment:	300
Study Start Date:	July 2004

Eligibility

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

Criteria

Inclusion Criteria:

Subjects have active rheumatoid arthritis and are not receiving DMARDs
Subjects taking hydroxychloroquine (Plaquenil) must be on a stable dose

Exclusion Criteria:

Used Enbrel, Remicade, Kineret, Humira, or an experimental biologic agent within the past 3 months
Elevation of liver enzymes within the past 6 months
Tuberculosis
Cancer
HIV-positive
Abnormal electrocardiogram
Chronic or acute infection
Multiple sclerosis, neuropathy, encephalopathy

Contacts and Locations

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

Show 51 Study Locations

Sponsors and Collaborators

Scios, Inc.

More Information

Study ID Numbers:	SCIO-469/B007
Study First Received:	August 17, 2004
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00089921
Health Authority:	United States: Food and Drug Administration

Keywords provided by Scios, Inc.:

Rheumatoid
Arthritis
No DMARDs
No Methotrexate

Study placed in the following topic categories:

Folic Acid
Autoimmune Diseases
Musculoskeletal Diseases
Hydroxychloroquine
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents

Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009