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 range20 Years – 65 Years

SexALL

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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-

What they're measuring

DAS Score Measurement

Timeframe: 2 years

Trial details

NCT IDNCT07388407

SponsorFoundation University Islamabad

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06-30

Contact for this trial

Dr. Zarafshan Bader, MPhil, MBBS

0923005177254 zarafshan.bader@fui.edu.pk