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

NCT ID: NCT04022525

Last Updated: 2020-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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leflunomide responsive vs non-responsive

Leflunomide 20Mg Tab

Intervention Type DRUG

blood samples of rheumatoid patients will be collected for SNPs detection and drug assay

Interventions

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Leflunomide 20Mg Tab

blood samples of rheumatoid patients will be collected for SNPs detection and drug assay

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Alaa Abdelkhalik Ahmed Mohamed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University Hospital

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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2016/12/28-006

Identifier Type: -

Identifier Source: org_study_id

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