NCT07388407 Pharmacogenetics of Leflunomide in the Management of Rheumatoid Arthritis
| NCT ID | NCT07388407 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Foundation University Islamabad |
| Condition | Rhematoid Arthritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 110 participants in total. It began in 2024-09-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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-
Contact & Investigator
Prof Muzammil Hassan Najmi
STUDY DIRECTOR
Foundation University Islamabad
Frequently Asked Questions
Who can join the NCT07388407 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 65 Years, studying Rhematoid Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07388407 currently recruiting?
Yes, NCT07388407 is actively recruiting participants. Contact the research team at zarafshan.bader@fui.edu.pk for enrollment information.
Where is the NCT07388407 trial being conducted?
This trial is being conducted at Islamabad, Pakistan, Rawalpindi, Pakistan.
Who is sponsoring the NCT07388407 clinical trial?
NCT07388407 is sponsored by Foundation University Islamabad. The principal investigator is Prof Muzammil Hassan Najmi at Foundation University Islamabad. The trial plans to enroll 110 participants.