Methotrexate Adherence in Rheumatoid Arthritis Patients

NCT05535686 | Completed

• 1 other identifier: MTX in R.A
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Rheumatoid Arthritis OTHER

Rheumatoid Arthritis Disease (R.A)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The survey participants were adults diagnosed as RA patients in accordance to 2010 ACR/EULAR classification criteria.

You may qualify if:

• The study was carried out among all RA patients (adults patients ≥ 18 years).
• Patients not suffering from severe mental disorders.
• Patients with a disease duration from (1-5) years.
• Patients on MTX treatment from (1-5) years.
• Patients taking MTX alone or in combination with other DMARDs.

You may not qualify if:

• Patient who on MTX for more than 5 years
• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Marwa

Cairo, 29306062300842, Egypt

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Marwa.M.Ad El-Maboud

Study Record Dates

• First Submitted: September 3, 2022
• First Posted: September 10, 2022
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: September 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)