Open-Label Steroid Reduction Study of Adalimumab With Methotrexate in Patients With Active Rheumatoid Arthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Brief Summary

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The purpose of the study is to evaluate the clinical efficacy of scheduled versus free reduction of steroid treatment in patients with active RA treated with adalimumab + MTX

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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adalimumab (up to 9 months exposure)

Intervention Type DRUG

methotrexate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history
* Subject has a diagnosis of rheumatoid arthritis as defined by the 1987-revised ACR criteria

Exclusion Criteria

* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Female subject who is pregnant or breast-feeding or considering becoming pregnant

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Global Medical Information

Role: STUDY_DIRECTOR

Abbott

Locations

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Global Medical Information - Abbott

North Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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FRAN-04-002

Identifier Type: -

Identifier Source: org_study_id