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

NCT00393471 | Completed Phase 3

• 1 other identifier: 0881A1-308
• Study Type: interventional
• Target: 615
• Locations: 18 countries
• Sites: 85

Brief Summary

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

Conditions

Active Rheumatoid Arthritis

Keywords

Arthritis; Rheumatoid; Safety

Outcome Measures

Primary Outcomes (1)

• 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)

Interventions

Etanercept DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- A history or presence of clinically important medical disease.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (88)

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St Leonards, New South Wales, 2065, Australia

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Adelaide, 5000, Australia

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Southport, 4215, Australia

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Vienna, 1110, Austria

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Brussels, 5390, Belgium

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Diepenbeek, 3590, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Česká Lípa, 470 01, Czechia

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Prague, 128 500, Czechia

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Terezín, 411 55, Czechia

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Zlín, 760 01, Czechia

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Copenhagen, 2400, Denmark

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Herlev, 2370, Denmark

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Kuopio, 70100, Finland

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Rauma, 26100, Finland

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Tampere, 3311, Finland

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Vantaa, 01400, Finland

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Bordeaux, 33076, France

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Brest, 29609, France

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Créteil, 94010, France

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Grenoble, 38043, France

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Le Kremlin-Bicêtre, 94270, France

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Montpellier, 34295, France

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Nice, 06202, France

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Paris, 75013, France

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Paris, 75018, France

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Paris, 75475, France

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Rouen, 76031, France

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Strasbourg, 67098, France

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Toulouse, 31403, France

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Berlin, 10117, Germany

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Cologne, 50931, Germany

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Erlangen, 91054, Germany

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Herne, 44652, Germany

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Leipzig, 04103, Germany

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München, 80336, Germany

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Plauen, 08525, Germany

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Vogelsang, 39245, Germany

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Würzburg, 97070, Germany

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Athens, 11525, Greece

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Thessaloniki, 55134, Greece

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Jerusalem, 91120, Israel

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Petah Tikva, 49100, Israel

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Ferrara, 44100, Italy

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Florence, 50413, Italy

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Genova, 16132, Italy

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Milan, 20122, Italy

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Milan, 20162, Italy

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Napoli, 80100, Italy

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Pavia, 27100, Italy

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Udine, 33100, Italy

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Alkmaar, 1815, Netherlands

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Arnhem, 6815, Netherlands

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Doetinchem, 7009, Netherlands

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Enschede, 7513, Netherlands

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Leeuwarden, 8934, Netherlands

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Maastricht, 6229, Netherlands

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Nijmegen, 6522, Netherlands

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Tilburg, 5042, Netherlands

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Venlo, 5912, Netherlands

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Drammen, 3004, Norway

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Oslo, 0319, Norway

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Elblag, 82-300, Poland

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Kalisz, 62-800, Poland

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Krakow, 30-119, Poland

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Warsaw, 02-637, Poland

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Wroclaw, 53-137, Poland

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Lisbon, 1000-247, Portugal

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Lisbon, 1349-019, Portugal

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Bucharest, 70231, Romania

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Cluj-Japoca, 3400, Romania

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Barcelona, 08036, Spain

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Guadalajara, 19002, Spain

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Madrid, 28006, Spain

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Madrid, 28040, Spain

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Madrid, 28046, Spain

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Santander, 39008, Spain

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Santiago de Compostela, 15706, Spain

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Jönköping, 55185, Sweden

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Kalmar, 39185, Sweden

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Linköping, 58185, Sweden

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Stockholm, 17176, Sweden

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Uppsala, 75185, Sweden

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London, E11 1NR, United Kingdom

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North Yorks, HG2 7SX, United Kingdom

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Trent, ST6 7AG, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 27175292 DERIVED

• 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.

  PMID: 18050208 DERIVED

MeSH Terms

Conditions

Arthritis

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

• Trial Manager

  For Australia, medinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Austria, WPVIMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Belgium, trials-BEL@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Czech Republic, WPPGCLI@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Denmark, Finland, Norway, and Sweden, medinfonord@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For France, infomedfrance@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Germany, medinfoDEU@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Greece, decresg@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Italy, descresg@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Netherlands, trials-NL@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Poland, WPWZMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Romania, WVPIMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Spain, infomed@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For UK/Great Britian, ukmedinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 26, 2006
• First Posted: October 27, 2006
• Study Start: October 1, 2000
• Study Completion: October 1, 2001
• Last Updated: December 13, 2023

Record last verified: 2006-10

Locations

PT (2); BE (5); FR (13); ES (7); RO (2); SE (5); PL (5); NO (2); FI (4); CZ (4); IT (8); GB (3); GR (2); DK (2); DE (9); AU (1); NL (9); IL (2)