Adalimumab in Combination With Methotrexate vs Methotrexate Alone in Early 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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Brief Summary

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The purpose of the study is to evaluate the effectiveness of adalimumab in combination with methotrexate compared to methotrexate alone on work disability in subjects with early rheumatoid arthritis

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

DOUBLE

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-revised ACR criteria
* Subject must be in paid employment
* Subject has self-reported work impairment since onset of symptoms

Exclusion Criteria

* A subject has chronic arthritis diagnosed before age 16 years.
* Subject has been on preceding treatment with methotrexate Subject unable to withdraw from current DMARDs
* Subject has preceding treatment with any biological TNF antagonist
* 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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Beverly Paperiello

Role: STUDY_DIRECTOR

Abbott

Locations

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Global Medical Information - Abbott

Abbott Park, Illinois, United States

Site Status

Countries

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United States

References

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Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.

Reference Type DERIVED

PMID: 27338778 (View on PubMed)

Other Identifiers

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M02-527

Identifier Type: -

Identifier Source: org_study_id