Longterm Followup of Patients With Rheumatoid Arthritis Treated With Methotrexate

Completed

• Conditions: External Causes of Morbidity and Mortality

• Registration Number: NCT02641977
• Lead Sponsor: Ruhr University of Bochum

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-12-06
• Study First Submitted QC: 2015-12-29
• Study First Posted: 2015-12-30
• Primary Completion: 2016-04
• Study Completion: 2016-08
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-17
• Last Update Posted: 2018-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 271

Inclusion Criteria

• rheumatoid arthritis
• treatment with methotrexate
• active disease

Exclusion Criteria

• low disease activity
• previous treatment with methotrexate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mortality	30 years

Trial Locations

Locations (1)

Internistische und rheumatologische Praxis Gladbeck; 🇩🇪 Gladbeck, Germany