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OpenTrials
Completed

NCT Number: NCT05535686

Methotrexate Adherence in Rheumatoid Arthritis Patients

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marwa

Cairo, 29306062300842, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Rheumatoid arthritis

Other

Rheumatoid Arthritis Disease (R.A)

Primary outcomes

  1. Assessment of Rheumatoid Arthritis patient adherence to Methotrexate and its effect on quality of life

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Acronym: RA

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 10, 2022
Registry last updated
Sep 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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