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
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