Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00195494

Purpose

To compare the effects of the combination of ETN and MTX to MTX alone on radiographic change and clinical disease activity in subjects with early RA over 12 months.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A 24-Month,Randomized,Double-Blind,Two-Period Study to Evaluate the Efficacy and Safety of the Combination of Etanercept and Methotrexate and Methotrexate Alone in Subjects With Early Rheumatoid Arthritis

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 compare the effects of the combination of etanercept and methotrexate to methotrexate alone on radiographic change [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
To compare the effects of the combination of etanercept and methotrexate to methotrexate alone on clinical disease activity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluate the safety of each treatment group [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment:	541
Study Start Date:	October 2004
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1a: Active Comparator Etanercept + Methorexate for Period 1 (first 12 months) and Period 2 (Second 12 months)	Drug: Etanercept, Methotrexate Group 1a: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 & 2 Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2 Group 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2 Group 2b: Oral Methotrexate weekly for both Periods 1 and 2
1b: Active Comparator Etanercept + Methotrexate for Period 1 (First 12 months) and Etanercept alone for Period 2 (Second 12 months)	Drug: Etanercept, Methotrexate Group 1a: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 & 2 Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2 Group 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2 Group 2b: Oral Methotrexate weekly for both Periods 1 and 2
2a: Active Comparator Methotrexate alone in Period 1 (First 12 months) and etanercept + Methotrexate in Period 2 (Second 12 months)	Drug: Etanercept, Methotrexate Group 1a: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 & 2 Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2 Group 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2 Group 2b: Oral Methotrexate weekly for both Periods 1 and 2
2b: Active Comparator Methotrexate alone in Period 1 (First 12 months) and Methotrexate alone in Period 2 (Second 12 months)	Drug: Etanercept, Methotrexate Group 1a: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 & 2 Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2 Group 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2 Group 2b: Oral Methotrexate weekly for both Periods 1 and 2

Eligibility

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

Criteria

Inclusion Criteria:

Satisfies the 1987 ACR Revised Criteria for Rheumatoid Arthritis
Has RA greater than or equal to 3 months and less than or equal to 2 years

Exclusion Criteria:

Received any previous treatment with MTX
Received any previous treatment with ETN or other tumour necrosis factor antagonist

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195494

Locations

United States, Colorado

Denver, Colorado, United States, 80230

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided by Wyeth

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Emery P, Breedveld FC, Hall S, Durez P, Chang DJ, Robertson D, Singh A, Pedersen RD, Koenig AS, Freundlich B. Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET): a randomised, double-blind, parallel treatment trial. Lancet. 2008 Aug 2;372(9636):375-82. Epub 2008 Jul 16.

Responsible Party:	NCT00195494 ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0881A-101548
Study First Received:	September 13, 2005
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00195494 History of Changes
Health Authority:	European Union: European Medicines Agency

Keywords provided by Wyeth:

Rheumatoid Arthritis

Study placed in the following topic categories:

Anti-Inflammatory Agents
Antimetabolites
Autoimmune Diseases
Immunologic Factors
Joint Diseases
Arthritis, Rheumatoid
Folate
Rheumatic Diseases
Folinic Acid
TNFR-Fc fusion protein
Folic Acid Antagonists
Immunosuppressive Agents

Vitamin B9
Folic Acid
Musculoskeletal Diseases
Analgesics, Non-Narcotic
Arthritis
Connective Tissue Diseases
Methotrexate
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents

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 July 02, 2009