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RA: Methotrexate Adherence in Rheumatoid Arthritis Patients

Sponsor
Beni-Suef University (Other)
Overall Status
Completed
CT.gov ID
NCT05535686
Collaborator
(none)
300
Enrollment
1
Location
12
Actual Duration (Months)
25
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Rheumatoid Arthritis

Detailed 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.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
300 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Assessment of Adherence of Rheumatoid Arthritis Patients to Methotrexate and Its Effect on Quality of Life.
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Jan 1, 2022
Actual Study Completion Date :
Jan 1, 2022

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Marwa Cairo Egypt 29306062300842

Sponsors and Collaborators

  • Beni-Suef University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marwa Mohamed Abd El-Maboud, Marwa.M.Ad El-Maboud, Beni-Suef University
ClinicalTrials.gov Identifier:
NCT05535686
Other Study ID Numbers:
  • MTX in R.A
First Posted:
Sep 10, 2022
Last Update Posted:
Sep 10, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid

Study Results

No Results Posted as of Sep 10, 2022