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

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ClinicalTrials.gov Identifier: NCT04022525
Recruitment Status : Completed
First Posted : July 17, 2019
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Alaa Abdelkhalik Ahmed Mohamed, 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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Leflunomide 20Mg Tab

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic Approaches
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : August 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Leflunomide

Group/Cohort Intervention/treatment
leflunomide responsive vs non-responsive Drug: Leflunomide 20Mg Tab
blood samples of rheumatoid patients will be collected for SNPs detection and drug assay




Primary Outcome Measures :
  1. Detection of single nucleotide polymorphisms associated with response to the drug [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Rheumatoid arthritis patients from both sexes with different disease activity status receiving solely leflunomide with or without hydroxychloroquine
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04022525


Locations
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Egypt
Assiut University Hospital
Assiut, Egypt
Sponsors and Collaborators
Assiut University
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Responsible Party: Alaa Abdelkhalik Ahmed Mohamed, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04022525    
Other Study ID Numbers: 2016/12/28-006
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Leflunomide
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs