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Study Comparing Etanercept Plus Methotrexate to Either Etanercept or Methotrexate Alone in Rheumatoid Arthritis.

Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Active Rheumatoid Arthritis

Intervention: Etanercept (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Trial Manager, Principal Investigator, Affiliation: For Australia, medinfo@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Austria, WPVIMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Belgium, trials-BEL@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Czech Republic, WPPGCLI@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Denmark, Finland, Norway, and Sweden, medinfonord@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For France, infomedfrance@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Germany, medinfoDEU@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Greece, decresg@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Italy, descresg@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Netherlands, trials-NL@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Poland, WPWZMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Romania, WVPIMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Spain, infomed@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For UK/Great Britian, ukmedinfo@wyeth.com

Summary

To compare the therapeutic and radiographic effects and safety between etanercept, methotrexate, and the etanercept/methotrexate combination in patients with rheumatoid arthritis.

Clinical Details

Official 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.

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Primary outcome: 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)

Detailed description: Etanercept is an injection administered under the skin twice weekly. Methotrexate is a tablet to be taken once weekly. Patients will not know which treatment they are on. Patients will need to meet the study criteria to be enrolled in the study and sign an informed consent.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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.

Locations and Contacts

Adelaide 5000, Australia

Southport 4215, Australia

Wien 1110, Austria

Brussels 5390, Belgium

Diepenbeek 3590, Belgium

Liege 4000, Belgium

Gent 9000, Belgium

Leuven 3000, Belgium

Praha 128 500, Czech Republic

Ceska Lipa 470 01, Czech Republic

Zlin 760 01, Czech Republic

Terezin 411 55, Czech Republic

Copenhagen 2400, Denmark

Herlev 2370, Denmark

Vantaa 01400, Finland

Rauma 26100, Finland

Kuopio 70100, Finland

Tampere 3311, Finland

Paris 75013, France

Toulouse Cedex 31403, France

Creteil 94010, France

Bordeaux 33076, France

Nice Cedex 06202, France

Grenoble Cedex 38043, France

Rouen 76031, France

Paris Cedex 75475, France

Le Kremlin Bicetre 94270, France

Paris 75018, France

Montpellier Cedex 34295, France

Brest Cedex 29609, France

Strasbourg 67098, France

Herne 44652, Germany

Berlin 10117, Germany

Leipzig 04103, Germany

Erlangen 91054, Germany

Vogelsang 39245, Germany

Plauen 08525, Germany

Koln 50931, Germany

Munchen 80336, Germany

Wurzburg 97070, Germany

Athens 11525, Greece

Thessaloniki 55134, Greece

Petah-Tikva 49100, Israel

Jerusalem 91120, Israel

Milano 20162, Italy

Genova 16132, Italy

Milano 20122, Italy

Udine 33100, Italy

Pavia 27100, Italy

Firenze 50413, Italy

Ferrara 44100, Italy

Napoli 80100, Italy

Leeuwarden 8934, Netherlands

Nijmegen 6522, Netherlands

Tilburg 5042, Netherlands

Arnhem 6815, Netherlands

Maastricht 6229, Netherlands

Doetinchem 7009, Netherlands

Venlo 5912, Netherlands

Enschede 7513, Netherlands

Alkmaar 1815, Netherlands

Drammen 3004, Norway

Oslo 0319, Norway

Elblag 82-300, Poland

Warszawa 02-637, Poland

Kalisz 62-800, Poland

Wroclaw 53-137, Poland

Krakow 30-119, Poland

Lisbon 1349-019, Portugal

Lisbon 1000-247, Portugal

Cluj-Japoca 3400, Romania

Bucuresti 70231, Romania

Santiago de Compostela 15706, Spain

Madrid 28040, Spain

Madrid 28006, Spain

Madrid 28046, Spain

Santander 39008, Spain

Barcelona 08036, Spain

Guadalajara 19002, Spain

Linkoping 58185, Sweden

Uppsala 75185, Sweden

Stockholm 17176, Sweden

Kalmar 39185, Sweden

Jonkoping 55185, Sweden

Trent ST6 7AG, United Kingdom

London E11 1NR, United Kingdom

North Yorkshire HG2 7SX, United Kingdom

St. Leonards, New South Wales 2065, Australia

Additional Information

Starting date: October 2000
Ending date: October 2001
Last updated: October 26, 2006

Page last updated: June 20, 2008

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