Clinical Efficacy and Safety of Leflunomide in Egyptian Patients With Active Rheumatoid Arthritis

NCT03599986 | Completed Results

• 1 other identifier: EVA_CLEAR_11022017
• Study Type: observational
• Target: 398
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase IV, Multi-Centric, Prospective, Observational Study to Assess the Clinical Efficacy and Safety of Leflunomide in Egyptian Patients with Active Rheumatoid Arthritis. (CLEAR)

Conditions

Active Rheumatoid Arthritis

Keywords

RA

Outcome Measures

Primary Outcomes (2)

• Number of Patients With Remission, Low, Moderate or High Disease Activity (in Terms of CDAI Scores) in Visits 1 and 6.

  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.

  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 Outcomes (1)

• 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.

  9 months

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Eva Pharma: lead
• DataClin: collaborator

Study Sites (1)

Private clinics

Cairo, 1152, Egypt

Location

Results Point of Contact

• Title: Medical Writer
• Organization: DataClin

mariam.abdalla@dataclin.com

(+2) 01001566602

Study Officials

• Adel Elsayed, MD

  Professor, Department of Internal Medicine, Rheumatology and Immunology, Ain Shams University; Egypt

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine, Rheumatology and Immunology

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: July 26, 2018
• Study Start: June 16, 2017
• Primary Completion: October 13, 2018
• Study Completion: October 13, 2018
• Last Updated: June 30, 2020
• Results First Posted: June 30, 2020

Record last verified: 2020-06

Locations

EG (1)