- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03599986
Clinical Efficacy and Safety of Leflunomide in Egyptian Patients With Active Rheumatoid Arthritis (CLEAR)
A Phase IV, Multi-Centric, Prospective, Observational Study to Assess the Clinical Efficacy and Safety of Leflunomide in Egyptian Patients With Active Rheumatoid Arthritis
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cairo, Egypt, 1152
- Private clinics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients are between 18 and 60 years of age, with Active Rheumatoid Arthritis selected according to the ACR/EULAR classification criteria with score ≥ 6 points.
Patients are Leflunomide naïve or with previous Leflunomide administration (after at least 6-month wash out period from date of baseline visit).
Patients are with or without other DMARDs including Methotrexate, Sulfasalazine and/or Hydroxychloroquine with or without steroids use who experienced therapy resistance, inadequate response or intolerance.
Description
Inclusion Criteria:
- Active Rheumatoid Arthritis patients selected according to the ACR/EULAR classification 2010 criteria with score ≥ 6 points.
- Male or female patients aged 18-60 years old.
- Leflunomide naïve patients or patients with previous Leflunomide administration (after at least 6 month wash out period from date of baseline visit) who will be prescribed Leflunomide at the sole decision of the treating physician.
- Patients with or without another DMARDs including Methotrexate, Sulfasalazine and/or Hydroxychloroquine with or without steroids use who experienced therapy resistance, inadequate response or intolerance.
- Patients read, understand and signed informed consent prior to inclusion.
- Patients willing to complete and literate in the language of the available Health Assessment Questionnaire (HAQ Disability Index) either alone or with minimal assistance from caregivers and/or trained site personnel.
Exclusion Criteria:
- Female patients who are pregnant or lactating at the time of inclusion or those who are planning for pregnancy within the coming year from the time of inclusion to the study.
- Patients with contraindications to active constituent of Leflunomide.
- Patients with severe concurrent infection (necessitating IV antibiotics or hospitalization).
- Patients with history of non-treated hepatitis B &/or C infection.
- Patients with history of severe liver disease (child C class).
- Patients with history of severe renal insufficiency (creatinine clearance ≤30 ml/min.).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients With Remission, Low, Moderate or High Disease Activity (in Terms of CDAI Scores) in Visits 1 and 6.
Time Frame: 9 months
|
Assessing the clinical efficacy of leflunomide as first-line therapy and as add-on therapy to other DMARDs, with or without steroids in Egyptian patients with active rheumatoid arthritis [in terms of the number of patients in remission (i.e. CDAI score 0.0 - 2.8), of low disease activity (i.e. CDAI score 2.9 - 10.0), of moderate disease activity (i.e. CDAI score 10.1 - 22.0) and of high disease activity (i.e. CDAI score 22.1 - 76.0) in visits 1 (at baseline) and 6 (at week 36)]. CDAI score: The sum of Tender joint score, Swollen joint score, Patient global score, and Patient global score. CDAI score interpretation: 0.0 - 2.8: Remission 2.9 - 10.0: Low Activity 10.1 - 22.0: Moderate Activity 22.1 - 76.0: High Activity |
9 months
|
Number of Patients With Different Disability Scores in Terms of the Mean Relative Change in Health Assessment Questionnaire - Disability Index Score on Visits 1 and 6.
Time Frame: 9 months
|
Assessing the clinical efficacy of leflunomide as first-line therapy and as add-on therapy to other DMARDs, with or without steroids in Egyptian patients with active rheumatoid arthritis [in terms of the number of patients with mild difficulties to moderate disability, moderate to severe disability and severe to very severe disability; according to the mean relative change in health assessment questionnaire - disability index score (HAQ-DI) at visits 1 (at baseline) and 6 (at week 36)]. A HAQ-DI score of 0.0 - 1 indicates mild difficulties to moderate disability, a HAQ-DI score of 1.1 - 2 indicates moderate to severe disability and a HAQ-DI score of 2.1 - 3 indicates severe to very severe disability. There are eight categories; first score within each category: Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Total score is the mean of the eight category scores. Higher scores indicate greater disability. |
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Adverse Events (AEs)/ Serious Adverse Events (SAEs) Experienced by Rheumatoid Arthritis Patients Receiving Leflunomide as First-line Therapy and as add-on Therapy to Other DMARD, With or Without Steroids and Their Relation to Study Medication.
Time Frame: 9 months
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Identifying the safety profile of leflunomide whether used as first-line therapy and/or as add-on therapy to other DMARDs with or without steroids in Egyptian patients with active rheumatoid arthritis.
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9 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Adel Elsayed, MD, Professor, Department of Internal Medicine, Rheumatology and Immunology, Ain Shams University; Egypt
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EVA_CLEAR_11022017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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