Pharmacogenetics of Leflunomide in the Management of Rheumatoid Arthritis (NCT07388407) | Clinical Trial Compass
RecruitingNot Applicable
Pharmacogenetics of Leflunomide in the Management of Rheumatoid Arthritis
Pakistan110 participantsStarted 2024-09-01
Plain-language summary
1. Patients taking leflunomide as the only disease-modifying anti-rheumatic drug (DMARD) will be recruited after consent.
2. Blood sample for DNA extraction will be taken The patient will be followed up till two visits 3 months apart, and efficacy and toxicity will be checked using DAS28, ultrasonography, and blood tests for ESR, CRP, anti-CCP, liver function tests, etc. The data form for toxicity will be filled.
3. DNA will be extracted in the laboratory, and SNP will be identified.
4. The efficacy and toxicity data will be studied against the SNPs found
5. An algorithm will be constructed for Pakistani RA patients taking leflunomide.
Who can participate
Age range
20 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* At baseline, all patients should fulfill the revised ACR/EULAR criteria for RA10
* Pakistani individuals
* between ages of 20-75 years
* New cases started on Leflunomide/ those already taking for less than a month and their biochemical and clinical data is available
Exclusion Criteria:
* Patients not willing to participate/ consent not given
* Patients below the age of 20
* Non- Pakistani origin
* Taking another DMARD simultaneously
* Compromised renal and hepatic functions
* Cognitive impairment, neurological disease
* Pregnant/ lactating patients
* Patients having inflammatory bowel disease/ Irritable bowel syndrome
* Patients with active infective diseases -Patients who fail to complete 3 months of leflunomide therapy-
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.