How genetic differences affect leflunomide response in Pakistani rheumatoid arthritis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fauji Foundation Hospital, Rawalpindi
  Rawalpindi, Punjab Province, Pakistan Recruiting
• Shifa International Hospital
  Islamabad, Punjab Province, Pakistan Completed

Study contacts

• Study coordinator: Dr. Zarafshan Bader, MPhil, MBBS
• Email: zarafshan.bader@fui.edu.pk
• Phone: 0923005177254

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.