ClinicalTrials.gg
CompletedNCT00393471Updated Dec 13, 2023

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

A Phase 3 interventional study of Etanercept in Active Rheumatoid Arthritis, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 88 sites in 19 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-13.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer (part of Pfizer) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
615
Allocation
Randomized
Ages
18 Years and older
Sex
Male
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Study summary

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

Read the 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.

02

Conditions studied

  • Active Rheumatoid Arthritis

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Keywords

  • Arthritis
  • Rheumatoid
  • Safety
03

In context

Arthritis

843 studies on the registry are indexed under Arthritis; 118 are open to participants now.

This study's enrollment of 615 is above the median of 97 across 599 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 484 studies on the registry; none are open to participants now.

First submitted before Wyeth became part of Pfizer.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion:

  • A history or presence of medical disease.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
615 participants

Interventions

06

What researchers measure

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)

07

Study locations

88 sites
  • St. Leonards, New South Wales 2065, Australia
  • Adelaide, 5000, Australia
  • Southport, 4215, Australia
  • Wien, 1110, Austria
  • Brussels, 5390, Belgium
  • Diepenbeek, 3590, Belgium
  • Gent, 9000, Belgium
  • Leuven, 3000, Belgium
  • Liege, 4000, Belgium
  • Ceska Lipa, 470 01, Czechia
  • Praha, 128 500, Czechia
  • Terezin, 411 55, Czechia
  • Zlin, 760 01, Czechia
  • Copenhagen, 2400, Denmark
  • Herlev, 2370, Denmark
  • Kuopio, 70100, Finland
  • Rauma, 26100, Finland
  • Tampere, 3311, Finland
  • Vantaa, 01400, Finland
  • Bordeaux, 33076, France
  • Brest Cedex, 29609, France
  • Creteil, 94010, France
  • Grenoble Cedex, 38043, France
  • Le Kremlin Bicetre, 94270, France
  • Montpellier Cedex, 34295, France
  • Nice Cedex, 06202, France
  • Paris Cedex, 75475, France
  • Paris, 75013, France
  • Paris, 75018, France
  • Rouen, 76031, France
  • Strasbourg, 67098, France
  • Toulouse Cedex, 31403, France
  • Berlin, 10117, Germany
  • Erlangen, 91054, Germany
  • Herne, 44652, Germany
  • Koln, 50931, Germany
  • Leipzig, 04103, Germany
  • Munchen, 80336, Germany
  • Plauen, 08525, Germany
  • Vogelsang, 39245, Germany
  • Wurzburg, 97070, Germany
  • Athens, 11525, Greece
  • Thessaloniki, 55134, Greece
  • Jerusalem, 91120, Israel
  • Petah-Tikva, 49100, Israel
  • Ferrara, 44100, Italy
  • Firenze, 50413, Italy
  • Genova, 16132, Italy
  • Milano, 20122, Italy
  • Milano, 20162, Italy
  • Napoli, 80100, Italy
  • Pavia, 27100, Italy
  • Udine, 33100, Italy
  • Alkmaar, 1815, Netherlands
  • Arnhem, 6815, Netherlands
  • Doetinchem, 7009, Netherlands
  • Enschede, 7513, Netherlands
  • Leeuwarden, 8934, Netherlands
  • Maastricht, 6229, Netherlands
  • Nijmegen, 6522, Netherlands
  • Tilburg, 5042, Netherlands
  • Venlo, 5912, Netherlands
  • Drammen, 3004, Norway
  • Oslo, 0319, Norway
  • Elblag, 82-300, Poland
  • Kalisz, 62-800, Poland
  • Krakow, 30-119, Poland
  • Warszawa, 02-637, Poland
  • Wroclaw, 53-137, Poland
  • Lisbon, 1000-247, Portugal
  • Lisbon, 1349-019, Portugal
  • Bucuresti, 70231, Romania
  • Cluj-Japoca, 3400, Romania
  • Barcelona, 08036, Spain
  • Guadalajara, 19002, Spain
  • Madrid, 28006, Spain
  • Madrid, 28040, Spain
  • Madrid, 28046, Spain
  • Santander, 39008, Spain
  • Santiago de Compostela, 15706, Spain
  • Jonkoping, 55185, Sweden
  • Kalmar, 39185, Sweden
  • Linkoping, 58185, Sweden
  • Stockholm, 17176, Sweden
  • Uppsala, 75185, Sweden
  • London, E11 1NR, United Kingdom
  • North Yorkshire, HG2 7SX, United Kingdom
  • Trent, ST6 7AG, United Kingdom
08

References and documents

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. PubMed 27175292 ↗
  • 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. PubMed 18050208 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00393471
First posted
Oct 27, 2006
Start date
Oct 2000
Completion
Oct 2001
Last update
Dec 13, 2023

Study contacts

Medical Monitor
study director · Wyeth is now a wholly owned subsidiary of Pfizer
Trial Manager
principal investigator · For Australia, medinfo@wyeth.com
Trial Manager
principal investigator · For Austria, WPVIMED@wyeth.com
Trial Manager
principal investigator · For Belgium, trials-BEL@wyeth.com
Trial Manager
principal investigator · For Czech Republic, WPPGCLI@wyeth.com
Trial Manager
principal investigator · For Denmark, Finland, Norway, and Sweden, medinfonord@wyeth.com
Trial Manager
principal investigator · For France, infomedfrance@wyeth.com
Trial Manager
principal investigator · For Germany, medinfoDEU@wyeth.com
Trial Manager
principal investigator · For Greece, decresg@wyeth.com
Trial Manager
principal investigator · For Italy, descresg@wyeth.com
Trial Manager
principal investigator · For Netherlands, trials-NL@wyeth.com
Trial Manager
principal investigator · For Poland, WPWZMED@wyeth.com
Trial Manager
principal investigator · For Romania, WVPIMED@wyeth.com
Trial Manager
principal investigator · For Spain, infomed@wyeth.com
Trial Manager
principal investigator · For UK/Great Britian, ukmedinfo@wyeth.com
View the source record on ClinicalTrials.gov ↗

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