Longterm Followup of Patients With Rheumatoid Arthritis Treated With Methotrexate

External Causes of Morbidity and Mortality Clinical Trial

— MTX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02641977
• Other study ID #: 19802015
• Status: Completed
• Start date: August 2015
• Est. completion date: August 2016

Study information

• Verified date: October 2018
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: August 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• rheumatoid arthritis

• treatment with methotrexate

• active disease

Exclusion Criteria:

• low disease activity

• previous treatment with methotrexate

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• External Causes of Morbidity and Mortality

Locations

Country	Name	City	State
Germany	Internistische und rheumatologische Praxis Gladbeck	Gladbeck

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality		30 years