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Pharmacogenetics of Leflunomide in the Management of Rheumatoid Arthritis

Recruitingn/aAges 20 Years - 65 YearsAllFoundation University Islamabad
NCT07388407 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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-
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What it tests

  • Study for the correlation of SNPs with efficacy and toxicity of Leflunomide in RA patients
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Where

2 sites
Shifa International Hospital
Islamabad, Pakistan
Fauji Foundation Hospital, Rawalpindi
Rawalpindi, Pakistan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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