Methotrexate Adherence in Rheumatoid Arthritis Patients

Rheumatoid Arthritis Clinical Trial

— RA  

Official title:

Assessment of Adherence of Rheumatoid Arthritis Patients to Methotrexate and Its Effect on Quality of Life.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05535686
• Other study ID #: MTX in R.A
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: September 2022
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study was conducted for assessment of adherence of Rheumatoid Arthritis patients to Methotrexate as a gold standard drug for treatment of R.A. Moreover, evaluating the effect of drug adherence to patient quality of life.

Description:

Rheumatoid arthritis one of most common autoimmune diseases. characterized by numerous complications which may affect patient quality of life. Hence, this review aim to search the relation between patient"s drug adherence and clinical health outcome. our review utilizing survey as a tool to collect needed data from rheumatoid patients. survey consisted of number of questions , participants were required to answer these questions. participation to this questionnaire was optional.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. The study was carried out among all RA patients (adults patients = 18 years).

2. Patients not suffering from severe mental disorders.

3. Patients with a disease duration from (1-5) years.

4. Patients on MTX treatment from (1-5) years.

5. Patients taking MTX alone or in combination with other DMARDs.

Exclusion Criteria:

1. Patient who on MTX for more than 5 years

2. Patient who have complications like:-

• History of liver or kidney disease

• Diabetic patients

• Hypertensive patients

• Bone marrow hypoplasia

• Leukopenia or significant anemia

• Peptic ulcer or any GIT problems

• Hereditary alopecia.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Rheumatoid Arthritis
Rheumatoid Arthritis Disease (R.A)

Locations

Country	Name	City	State
Egypt	Marwa	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Rheumatoid Arthritis patient adherence to Methotrexate and its effect on quality of life	aim of this study was to measure Rheumatoid Arthritis patient adherence to MTX. A descriptive cross-sectional study was conducted on 300 RA patients administrating MTX for at least one year. Direct interview was used to complete the survey. The documented data were demographics (age, education , sex, work status). Patients' adherence to MTX as well as predictors for non-adherence.This investigational clinical study was conducted on RA outpatient clinic. Clinical parameters such as disease duration, duration on MTX therapy in years and current dose of MTX in milligrams per week were all documented.Structured questionnaire was designed to assessed the following areas: MTX side effects, patient adherence towards MTX, functional disability and patient awareness towards MTX. Patients were questioned about the prevalence of gastrointestinal adverse effects related to MTX. All data was collected from one direct interview with each RA patient.	Baseline