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NCT04022525 Clinical Trial

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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04022525
Other study ID # 2016/12/28-006
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2018
Est. completion date December 31, 2019

Study information
Verified date September 2020
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date December 31, 2019
Est. primary completion date August 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Leflunomide 20Mg Tab
blood samples of rheumatoid patients will be collected for SNPs detection and drug assay

Locations
Country Name City State
Egypt Assiut University Hospital Assiut

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Detection of single nucleotide polymorphisms associated with response to the drug SNPs associated with the response or adverse drug reactions will be detected and correlated with the ratio of leflunomide to its active metabolite one -two years
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