Quality of Life Study With Adalimumab in Rheumatoid Arthritis

NCT ID: NCT00234936

Last Updated: 2007-10-03

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Brief Summary

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The purpose of the study is to evaluate the ability of adalimumab combined with methotrexate to improve the quality of life in patients with active RA.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Keywords

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rheumatoid arthritis adalimumab quality of life

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Adalimumab

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 ACR criteria
* Subjects with treatment failure criteria to Mtx or Mtx + another DMARD

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
* Previous treatment with approved biological agents (etanercept, infliximab, anakinra) in the last 2 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Principal Investigators

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Global Medical Information

Role: STUDY_DIRECTOR

Abbott

Other Identifiers

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ESCALAR

Identifier Type: -

Identifier Source: secondary_id

MEXI -P01-03

Identifier Type: -

Identifier Source: org_study_id