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

December 12, 2023 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
615

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2000

Primary Completion

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 6, 2022

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2001

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2006

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2006

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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