How genetic differences affect leflunomide response in Pakistani rheumatoid arthritis patients
Pharmacogenetics of Leflunomide in the RA Management
This project will test whether specific genetic variants (SNPs) predict how well leflunomide works and whether it causes side effects in Pakistani adults with rheumatoid arthritis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | All |
| Sponsor | Foundation University Islamabad Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 2 sites (Islamabad, Punjab Province and 1 other locations) |
| Trial ID | NCT07388407 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll Pakistani adults with rheumatoid arthritis who are starting leflunomide as their only DMARD or have been on it for less than a month. Participants will give a blood sample for DNA extraction and be followed across two visits three months apart while clinicians record disease activity (DAS28), ultrasound findings, and laboratory markers including ESR, CRP, anti-CCP, and liver tests. SNPs will be identified in the laboratory and correlated with measures of efficacy and toxicity using the collected clinical and biochemical data. The investigators plan to use these correlations to build an algorithm tailored to Pakistani RA patients to help guide leflunomide use.
Who should consider this trial
Good fit: Adults aged 20–75 of Pakistani origin with rheumatoid arthritis who are starting leflunomide as the sole DMARD (with or without steroids), can consent, and can provide blood samples are the intended participants.
Not a fit: People who are not Pakistani, are taking other DMARDs, have significant renal or liver impairment, are pregnant or lactating, have active infections, or cannot complete three months of leflunomide therapy are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this work could help doctors predict which patients are likely to benefit from leflunomide and which are at higher risk of side effects, enabling more personalized treatment.
How similar studies have performed: Pharmacogenetic work on leflunomide and related drugs has reported some SNP associations with drug levels and toxicity but findings are limited and not yet definitive or widely implemented.
Eligibility criteria
Show full inclusion / exclusion 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-
Where this trial is running
Islamabad, Punjab Province and 1 other locations
- Shifa International Hospital — Islamabad, Punjab Province, Pakistan (Completed)
- Fauji Foundation Hospital, Rawalpindi — Rawalpindi, Punjab Province, Pakistan (Recruiting)
Study contacts
- Study coordinator: Dr. Zarafshan Bader, MPhil, MBBS
- Email: zarafshan.bader@fui.edu.pk
- Phone: 0923005177254
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.