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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	8 January 2024
Main ID:	NCT00393471
Date of registration:	26/10/2006
Prospective Registration:	No
Primary sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Public title:	Study Comparing Etanercept Plus Methotrexate to Either Etanercept or Methotrexate Alone in Rheumatoid Arthritis.
Scientific title:	A Double-blind Study Evaluating the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Comparison to Etanercept Alone or Methotrexate Alone in Rheumatoid Arthritis Patients.
Date of first enrolment:	October 2000
Target sample size:	615
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/ct2/show/NCT00393471
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double.
Phase:	Phase 3

Countries of recruitment
Australia	Austria	Belgium	Czech Republic	Czechia	Denmark	Finland	France
Germany	Greece	Israel	Italy	Netherlands	Norway	Poland	Portugal
Romania	Spain	Sweden	United Kingdom

Contacts

Name:	Trial Manager
Address:
Telephone:
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Affiliation:	For Italy, descresg@wyeth.com

Name:	Trial Manager
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Affiliation:	For Denmark, Finland, Norway, and Sweden, medinfonord@wyeth.com

Name:	Trial Manager
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Affiliation:	For Australia, medinfo@wyeth.com

Name:	Trial Manager
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Affiliation:	For Austria, WPVIMED@wyeth.com

Name:	Trial Manager
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Affiliation:	For Belgium, trials-BEL@wyeth.com

Name:	Trial Manager
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Affiliation:	For France, infomedfrance@wyeth.com

Name:	Trial Manager
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Affiliation:	For Poland, WPWZMED@wyeth.com

Name:	Trial Manager
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Affiliation:	For Romania, WVPIMED@wyeth.com

Name:	Trial Manager
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Affiliation:	For Czech Republic, WPPGCLI@wyeth.com

Name:	Trial Manager
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Affiliation:	For Greece, decresg@wyeth.com

Name:	Trial Manager
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Affiliation:	For Spain, infomed@wyeth.com

Name:	Medical Monitor
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Affiliation:	Wyeth is now a wholly owned subsidiary of Pfizer

Name:	Trial Manager
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Affiliation:	For Germany, medinfoDEU@wyeth.com

Name:	Trial Manager
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Affiliation:	For Netherlands, trials-NL@wyeth.com

Name:	Trial Manager
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Affiliation:	For UK/Great Britian, ukmedinfo@wyeth.com

Key inclusion & exclusion criteria

Inclusion:

- Generally healthy of at least 18 years of age with active rheumatoid arthritis.

Exclusion:

- A history or presence of clinically important medical disease.

Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Active Rheumatoid Arthritis

Intervention(s)

Drug: Etanercept

Primary Outcome(s)

The objective of this study is to evaluate the therapeutic response including radiographic changes and safety of etanercept alone, methotrexate (MTX) alone, and the combination of etanercept and MTX in patients with rheumatoid arthritis (RA)

Secondary Outcome(s)

Secondary ID(s)

0881A1-308

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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