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

NCT ID: NCT00393471

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

615 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Study Completion Date

2001-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Active Rheumatoid Arthritis

Keywords

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Arthritis Rheumatoid Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Etanercept

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion:

\- A history or presence of clinically important medical disease.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Australia, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Austria, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Belgium, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Czech Republic, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Denmark, Finland, Norway, and Sweden, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For France, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Germany, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Greece, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Italy, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Netherlands, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Poland, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Romania, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Spain, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For UK/Great Britian, [email protected]

Locations

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St Leonards, New South Wales, Australia

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Adelaide, , Australia

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Southport, , Australia

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Vienna, , Austria

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Brussels, , Belgium

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Diepenbeek, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Česká Lípa, , Czechia

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Prague, , Czechia

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Terezín, , Czechia

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Zlín, , Czechia

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Copenhagen, , Denmark

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Herlev, , Denmark

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Kuopio, , Finland

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Rauma, , Finland

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Tampere, , Finland

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Vantaa, , Finland

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Bordeaux, , France

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Brest, , France

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Créteil, , France

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Grenoble, , France

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Le Kremlin-Bicêtre, , France

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Montpellier, , France

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Nice, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Rouen, , France

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Strasbourg, , France

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Toulouse, , France

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Berlin, , Germany

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Cologne, , Germany

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Erlangen, , Germany

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Herne, , Germany

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Leipzig, , Germany

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München, , Germany

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Plauen, , Germany

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Vogelsang, , Germany

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Würzburg, , Germany

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Athens, , Greece

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Thessaloniki, , Greece

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Jerusalem, , Israel

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Petah Tikva, , Israel

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Ferrara, , Italy

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Florence, , Italy

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Genova, , Italy

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Milan, , Italy

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Milan, , Italy

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Napoli, , Italy

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Pavia, , Italy

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Udine, , Italy

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Alkmaar, , Netherlands

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Arnhem, , Netherlands

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Doetinchem, , Netherlands

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Enschede, , Netherlands

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Leeuwarden, , Netherlands

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Maastricht, , Netherlands

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Nijmegen, , Netherlands

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Tilburg, , Netherlands

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Venlo, , Netherlands

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Drammen, , Norway

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Oslo, , Norway

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Elblag, , Poland

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Kalisz, , Poland

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Krakow, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Lisbon, , Portugal

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Lisbon, , Portugal

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Bucharest, , Romania

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Cluj-Japoca, , Romania

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Barcelona, , Spain

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Guadalajara, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Santander, , Spain

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Santiago de Compostela, , Spain

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Jönköping, , Sweden

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Kalmar, , Sweden

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Linköping, , Sweden

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Stockholm, , Sweden

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Uppsala, , Sweden

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London, , United Kingdom

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North Yorks, , United Kingdom

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Trent, , United Kingdom

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Countries

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

References

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Gallo G, Brock F, Kerkmann U, Kola B, Huizinga TW. Efficacy of etanercept in combination with methotrexate in moderate-to-severe rheumatoid arthritis is not dependent on methotrexate dosage. RMD Open. 2016 Apr 21;2(1):e000186. doi: 10.1136/rmdopen-2015-000186. eCollection 2016.

Reference Type DERIVED
PMID: 27175292 (View on PubMed)

van der Heijde D, Klareskog L, Landewe R, Bruyn GA, Cantagrel A, Durez P, Herrero-Beaumont G, Molad Y, Codreanu C, Valentini G, Zahora R, Pedersen R, MacPeek D, Wajdula J, Fatenejad S. Disease remission and sustained halting of radiographic progression with combination etanercept and methotrexate in patients with rheumatoid arthritis. Arthritis Rheum. 2007 Dec;56(12):3928-39. doi: 10.1002/art.23141.

Reference Type DERIVED
PMID: 18050208 (View on PubMed)

Other Identifiers

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0881A1-308

Identifier Type: -

Identifier Source: org_study_id