Longterm Followup of Patients With Rheumatoid Arthritis Treated With Methotrexate

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02641977

Acronym

MTX

Enrollment

271

Registered

2015-12-30

Start date

2015-08-31

Completion date

2016-08-31

Last updated

2018-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

External Causes of Morbidity and Mortality

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* rheumatoid arthritis * treatment with methotrexate * active disease

Exclusion criteria

* low disease activity * previous treatment with methotrexate

Design outcomes

Primary

Measure	Time frame
mortality	30 years

Countries

Germany

Outcome results