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CompletedNCT02641977MTXUpdated Oct 19, 2018

Longterm Followup of Patients With Rheumatoid Arthritis Treated With Methotrexate

An observational study in External Causes of Morbidity and Mortality, sponsored by Ruhr University of Bochum. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2018-10-19.

Sponsored by Ruhr University of Bochum · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
271
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • External Causes of Morbidity and Mortality
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In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 271 is above the median of 155 across 1,057 observational studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Ruhr University of Bochum is the lead sponsor of 124 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with rheumatoid arthritis

Inclusion criteria

  • rheumatoid arthritis
  • treatment with methotrexate
  • active disease

Exclusion criteria

Exclusion Criteria:

  • low disease activity
  • previous treatment with methotrexate
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
271 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. mortality

    Time frame: 30 years

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Study locations

1 site
  • Internistische und rheumatologische Praxis Gladbeck
    Gladbeck, 45964, Germany
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02641977
Lead sponsor
Ruhr University of Bochum
Responsible party
Dietmar Krause, MD (Principal investigator, Ruhr University of Bochum) — Principal investigator
First posted
Dec 30, 2015
Start date
Aug 2015
Primary completion
Apr 2016
Completion
Aug 2016
Last update
Oct 19, 2018

Study contacts

Dietmar MJ Krause, MD
principal investigator · University Bochum, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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