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Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Etanercept

Methotrexate

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects who completed the previous double-blind,randomized study. Ability to reconstitute and self-inject test etanercept (ETN) or have a designee who can do so. Exclusion Criteria: Dose of prednisone>10 mg/day (or equivalent) or dose changed within 2 weeks before week 0 evaluation. Clinically relevant concurrent medical events including: uncompensated congestive heart failure (CHF), diagnosis of multiple sclerosis or other central demyelinating diseases, presence or history of confirmed blood dyscrasias, cancer or history of cancer, serious infection within 1 month of test article administration or active infection at week 0.

Sites / Locations

Outcomes

Primary Outcome Measures

To evaluate the long-term safety of the combination of etanercept and methotrexate in adults with RA who have completed the previous double-blind, randomized study.

Secondary Outcome Measures

To evaluate the long-term clinical efficacy and x-ray progression of the combination of etanercept and methotrexate in adults with RA who have completed the previous double-blind, randomized study.

Full Information

NCT ID

NCT00252668

First Posted

November 9, 2005

Last Updated

May 17, 2011

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00252668

Brief Title

Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects

Official Title

An Open-Label, Multicentre, Extension Study of the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

June 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief Summary

This study is an open label extension of a previously completed double-blind, randomized study comparing etanercept and methotrexate in subjects with active rheumatoid arthritis. All subjects will receive combination treatment with etanercept and methotrexate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Etanercept

Intervention Type

Drug

Intervention Name(s)

Methotrexate

Primary Outcome Measure Information:

Title

To evaluate the long-term safety of the combination of etanercept and methotrexate in adults with RA who have completed the previous double-blind, randomized study.

Secondary Outcome Measure Information:

Title

To evaluate the long-term clinical efficacy and x-ray progression of the combination of etanercept and methotrexate in adults with RA who have completed the previous double-blind, randomized study.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: