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

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.

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

Study Overview

• Status: Completed
• Conditions: Active Rheumatoid Arthritis
• Intervention / Treatment: Drug: Etanercept

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.

• Study Type: Interventional
• Enrollment: 615
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, 5000
  • Southport, Australia, 4215
  • New South Wales
    • St. Leonards, New South Wales, Australia, 2065
• Austria
  • Wien, Austria, 1110
• Belgium
  • Brussels, Belgium, 5390
  • Diepenbeek, Belgium, 3590
  • Gent, Belgium, 9000
  • Leuven, Belgium, 3000
  • Liege, Belgium, 4000
• Czechia
  • Ceska Lipa, Czechia, 470 01
  • Praha, Czechia, 128 500
  • Terezin, Czechia, 411 55
  • Zlin, Czechia, 760 01
• Denmark
  • Copenhagen, Denmark, 2400
  • Herlev, Denmark, 2370
• Finland
  • Kuopio, Finland, 70100
  • Rauma, Finland, 26100
  • Tampere, Finland, 3311
  • Vantaa, Finland, 01400
• France
  • Bordeaux, France, 33076
  • Brest Cedex, France, 29609
  • Creteil, France, 94010
  • Grenoble Cedex, France, 38043
  • Le Kremlin Bicetre, France, 94270
  • Montpellier Cedex, France, 34295
  • Nice Cedex, France, 06202
  • Paris, France, 75013
  • Paris, France, 75018
  • Paris Cedex, France, 75475
  • Rouen, France, 76031
  • Strasbourg, France, 67098
  • Toulouse Cedex, France, 31403
• Germany
  • Berlin, Germany, 10117
  • Erlangen, Germany, 91054
  • Herne, Germany, 44652
  • Koln, Germany, 50931
  • Leipzig, Germany, 04103
  • Munchen, Germany, 80336
  • Plauen, Germany, 08525
  • Vogelsang, Germany, 39245
  • Wurzburg, Germany, 97070
• Greece
  • Athens, Greece, 11525
  • Thessaloniki, Greece, 55134
• Israel
  • Jerusalem, Israel, 91120
  • Petah-Tikva, Israel, 49100
• Italy
  • Ferrara, Italy, 44100
  • Firenze, Italy, 50413
  • Genova, Italy, 16132
  • Milano, Italy, 20122
  • Milano, Italy, 20162
  • Napoli, Italy, 80100
  • Pavia, Italy, 27100
  • Udine, Italy, 33100
• Netherlands
  • Alkmaar, Netherlands, 1815
  • Arnhem, Netherlands, 6815
  • Doetinchem, Netherlands, 7009
  • Enschede, Netherlands, 7513
  • Leeuwarden, Netherlands, 8934
  • Maastricht, Netherlands, 6229
  • Nijmegen, Netherlands, 6522
  • Tilburg, Netherlands, 5042
  • Venlo, Netherlands, 5912
• Norway
  • Drammen, Norway, 3004
  • Oslo, Norway, 0319
• Poland
  • Elblag, Poland, 82-300
  • Kalisz, Poland, 62-800
  • Krakow, Poland, 30-119
  • Warszawa, Poland, 02-637
  • Wroclaw, Poland, 53-137
• Portugal
  • Lisbon, Portugal, 1000-247
  • Lisbon, Portugal, 1349-019
• Romania
  • Bucuresti, Romania, 70231
  • Cluj-Japoca, Romania, 3400
• Spain
  • Barcelona, Spain, 08036
  • Guadalajara, Spain, 19002
  • Madrid, Spain, 28006
  • Madrid, Spain, 28040
  • Madrid, Spain, 28046
  • Santander, Spain, 39008
  • Santiago de Compostela, Spain, 15706
• Sweden
  • Jonkoping, Sweden, 55185
  • Kalmar, Sweden, 39185
  • Linkoping, Sweden, 58185
  • Stockholm, Sweden, 17176
  • Uppsala, Sweden, 75185
• United Kingdom
  • London, United Kingdom, E11 1NR
  • North Yorkshire, United Kingdom, HG2 7SX
  • Trent, United Kingdom, ST6 7AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion:

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

Exclusion:

- A history or presence of clinically important medical disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Investigators: Principal Investigator: Trial Manager, For Australia, medinfo@wyeth.com; Principal Investigator: Trial Manager, For Austria, WPVIMED@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 Greece, decresg@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; Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer; Principal Investigator: Trial Manager, For Belgium, trials-BEL@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 Italy, descresg@wyeth.com; Principal Investigator: Trial Manager, For Netherlands, trials-NL@wyeth.com

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2000
• Primary Completion: December 6, 2022
• Study Completion: October 1, 2001

Study Registration Dates

• First Submitted: October 26, 2006
• First Submitted That Met QC Criteria: October 26, 2006
• First Posted (Estimated): October 27, 2006

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: October 1, 2006

More Information

Terms related to this study

• Keywords: Arthritis; Rheumatoid; Safety
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept
• Other Study ID Numbers: 0881A1-308

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No