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Completed

NCT Number: NCT02641977

Longterm Followup of Patients With Rheumatoid Arthritis Treated With Methotrexate

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

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Key information

Conditions

External Causes of Morbidity and Mortality

Sex eligibility

All sexes

Study type

Observational

Primary location

Internistische und rheumatologische Praxis Gladbeck

Gladbeck, 45964, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • rheumatoid arthritis
  • treatment with methotrexate
  • active disease

Exclusion criteria

  • low disease activity
  • previous treatment with methotrexate

Treatment and study plan

Primary outcomes

  1. mortality

    Time frame: 30 years

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Registry information

Official study title

Longterm Followup of Patients With Rheumatoid Arthritis Treated With Methotrexate Enroled in the Ratingener Rheuma-Kohorte

Acronym: MTX

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 30, 2015
Registry last updated
Oct 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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