Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic Approaches

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Leflunomide 20Mg Tab

• Registration Number: NCT04022525
• Lead Sponsor: Assiut University

Brief Summary

The RA patients receiving leflunomide for more than one month, and not receiving other DMARDs (except hydroxychloroquine), will be enrolled to assess their disease activity. Blood samples will be collected for genetic studies and pharmacokinetic assay of the blood levels of the drug and its active metabolite.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2019-07-15
• Study First Submitted QC: 2019-07-15
• Study First Posted: 2019-07-17
• Primary Completion: 2019-08-31
• Study Completion: 2019-12-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-06
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Rheumatoid arthritis patients already receiving leflunomide with or without Hydroxychloroquine but without other Disease modifying agents

Exclusion Criteria

• Those diagnosed with other rheumatic diseases or Rheumatoid patients receiving disease modifying agents other than leflunomide

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
leflunomide responsive vs non-responsive	Leflunomide 20Mg Tab	-

Primary Outcome Measures

Name	Time	Method
Detection of single nucleotide polymorphisms associated with response to the drug	one -two years	SNPs associated with the response or adverse drug reactions will be detected and correlated with the ratio of leflunomide to its active metabolite

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt