Study Comparing Enbrel (Etanercept) Plus Methotrexate Versus Enbrel Alone in Active Rheumatoid Arthritis Despite Current Methotrexate Therapy

This study has been completed.

First Received: October 12, 2005 Last Updated: May 17, 2006 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00244556

Purpose

To investigate the changes in MRI-derived markers of joint inflammation and destruction and in biochemical markers of connective tissue metabolism and angiogenesis in rheumatoid arthritis patients treated with Enbrel and Enbrel+methotrexate.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: Methotrexate plus ENBREL or ENBREL alone	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Comparison of the Safety and Efficacy of Enbrel (Etanercept) Plus Methotrexate Versus Enbrel Alone in Patients With Active Rheumatoid Arthritis Despite Current Methotrexate Therapy

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Etanercept

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

To assess the efficacy and safety of substituting ENBREL versus adding ENBREL to Methotrexate in patients with active Rheumatoid Arthritis despite adequate Methotrexate therapy.

Secondary Outcome Measures:

To evaluate the effect of combination therapy with ENBREL plus Methotrexate versus ENBREL alone on health-related quality of life measures.

Estimated Enrollment:	300
Study Start Date:	March 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

In the case of contra-indications for MRI, the patient may participate in the remaining part of the project.

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244556

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	0881A-101136
Study First Received:	October 12, 2005
Last Updated:	May 17, 2006
ClinicalTrials.gov Identifier:	NCT00244556 History of Changes
Health Authority:	European Union: European Medicines Agency

Keywords provided by Wyeth:

Rheumatoid Arthritis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Arthritis, Rheumatoid
Reproductive Control Agents
TNFR-Fc fusion protein
Musculoskeletal Diseases
Sensory System Agents
Arthritis
Therapeutic Uses
Abortifacient Agents

Connective Tissue Diseases
Methotrexate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Autoimmune Diseases
Immune System Diseases
Joint Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Rheumatic Diseases
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents

ClinicalTrials.gov processed this record on November 27, 2009