Longterm Followup of Patients With Rheumatoid Arthritis Treated With Methotrexate

NCT ID: NCT02641977

Last Updated: 2018-10-19

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

Total Enrollment

271 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-08-31

Brief Summary

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Longterm followup of patients with rheumatoid arthritis 30 years after starting a baseline treatment with Methotrexate.

Detailed Description

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Objective. 30-year follow-up of rheumatoid arthritis (RA) patients treated with methotrexate (MTX) in the 1980s to analyze the association of the degree of response to MTX with long-term mortality.

Methods. In this observational cohort study, 271 RA patients who had started treatment with MTX between 1980 and 1987 were included (mean age 58 years, mean disease duration 8.5 years). One year after baseline, the treatment response to MTX was evaluated. Responders were defined as patients with at least 20% improvement. Thereafter, assessments were performed at 10 and 18 years after baseline. This re-evaluation was done to provide the data after 30 years of follow-up. Standardized mortality ratios (SMR) are calculated, Cox regression and logistic regression are performed.

Conditions

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External Causes of Morbidity and Mortality

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* rheumatoid arthritis
* treatment with methotrexate
* active disease

Exclusion Criteria

* low disease activity
* previous treatment with methotrexate
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruhr University of Bochum

OTHER

Sponsor Role lead

Responsible Party

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Dietmar Krause, MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dietmar MJ Krause, MD

Role: PRINCIPAL_INVESTIGATOR

University Bochum, Germany

Locations

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Internistische und rheumatologische Praxis Gladbeck

Gladbeck, , Germany

Site Status

Countries

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Germany

Other Identifiers

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19802015

Identifier Type: -

Identifier Source: org_study_id

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