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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

July 8, 2008

Start Date ^ICMJE

October 2004

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

To compare the effects of the combination of etanercept and methotrexate to
methotrexate alone on radiographic change and clinical disease activity in
subjects with active early rheumatoid arthritis over 12 months.

Change History

Complete list of historical versions of study NCT00195494 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Evaluate the safety of each treatment group over 24 months; compare the effects
of the combination of ETN and MTX to MTX alone on radiographic change and
clinical disease activity over 12 months and 24 months

Descriptive Information

Brief Title ^ICMJE

Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Rheumatoid Arthritis

Intervention ^ICMJE

Drug: Etanercept, Methotrexate

Study Arms / Comparison Groups

Active Comparator: Etanercept + Methorexate for Period 1 (first 12 months) and Period 2 (Second 12 months)
Active Comparator: Etanercept + Methotrexate for Period 1 (First 12 months) and Etanercept alone for Period 2 (Second 12 months)
Active Comparator: Methotrexate alone in Period 1 (First 12 months) and etanercept + Methotrexate in Period 2 (Second 12 months)
Active Comparator: Methotrexate alone in Period 1 (First 12 months) and Methotrexate alone in Period 2 (Second 12 months)

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

541

Completion Date

March 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00195494

Responsible Party

Wyeth (Registry Contact: Clinical Trial Registry Specialist), NCT00195494

Study ID Numbers ^ICMJE

0881A-101548

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth

Information Provided By

Wyeth

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP