Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00252668

Purpose

This study is an open label extension of a previously completed double-blind, randomized study comparing etanercept and methotrexate in subjects with active rheumatoid arthritis. All subjects will receive combination treatment with etanercept and methotrexate.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: Etanercept Drug: Methotrexate	Phase IV

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Etanercept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	An Open-Label, Multicentre, Extension Study of the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects

Further study details as provided by Wyeth:

Primary Outcome Measures:

To evaluate the long-term safety of the combination of etanercept and methotrexate in adults with RA who have completed the previous double-blind, randomized study.

Secondary Outcome Measures:

To evaluate the long-term clinical efficacy and x-ray progression of the combination of etanercept and methotrexate in adults with RA who have completed the previous double-blind, randomized study.

Estimated Enrollment:	300
Study Start Date:	June 2004
Estimated Study Completion Date:	September 2005

Eligibility

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

Criteria

Inclusion Criteria:

Subjects who completed the previous double-blind,randomized study.
Ability to reconstitute and self-inject test etanercept (ETN) or have a designee who can do so.

Exclusion Criteria:

Dose of prednisone>10 mg/day (or equivalent) or dose changed within 2 weeks before week 0 evaluation.
Clinically relevant concurrent medical events including: uncompensated congestive heart failure (CHF), diagnosis of multiple sclerosis or other central demyelinating diseases, presence or history of confirmed blood dyscrasias, cancer or history of cancer, serious infection within 1 month of test article administration or active infection at week 0.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252668

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For Germany, MedinfoDEU@wyeth.com
Principal Investigator:	Trial Manager	For Sweden, Denmark and Norway, MedInfoNord@wyeth.com
Principal Investigator:	Trial Manager	For Belgium, trials-BEL@wyeth.com
Principal Investigator:	Trial Manager	For Greece, decresg@wyeth.com
Principal Investigator:	Trial Manager	For Czech Republic, WPPGCLI@wyeth.com
Principal Investigator:	Trial Manager	For Romania, WPVIMED@wyeth.com
Principal Investigator:	Trial Manager	For Poland, WPWZMED@wyeth.com
Principal Investigator:	Trial Manager	For Spain, Italy, Portugal, the Netherlands, and Finland, clinicaltrialinfo@wyeth.com

More Information

Study ID Numbers:	0881A1-101631
Study First Received:	November 9, 2005
Last Updated:	May 17, 2006
ClinicalTrials.gov Identifier:	NCT00252668
Health Authority:	Germany: Ethics Commission

Keywords provided by Wyeth:

Rheumatoid Arthritis

Study placed in the following topic categories:

Folic Acid
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases
TNFR-Fc fusion protein

Additional relevant MeSH terms:

Antimetabolites
Anti-Inflammatory Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Sensory System Agents
Therapeutic Uses
Abortifacient Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics

Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Immune System Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009