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

NCT ID: NCT03599986

Last Updated: 2020-06-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 398 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-16
• Study Completion Date: 2018-10-13

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)

Detailed Description

CLEAR is a phase IV, multi-centric, prospective, observational study to assess the clinical efficacy and safety of Leflunomide as first-line therapy and as add-on therapy to other DMARDs (such as Methotrexate, Hydroxychloroquine, Sulfasalazine) with or without Steroids use in Egyptian patients with Active Rheumatoid Arthritis.

Conditions

Active Rheumatoid Arthritis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Active Rheumatoid Arthritis patients selected according to the ACR/EULAR classification 2010 criteria with score ≥ 6 points.

2. Male or female patients aged 18-60 years old.

3. 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.

4. 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.

5. Patients read, understand and signed informed consent prior to inclusion.

6. 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

1. 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.

2. Patients with contraindications to active constituent of Leflunomide.

3. Patients with severe concurrent infection (necessitating IV antibiotics or hospitalization).

4. Patients with history of non-treated hepatitis B &/or C infection.

5. Patients with history of severe liver disease (child C class).

6. Patients with history of severe renal insufficiency (creatinine clearance ≤30 ml/min.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DataClin

INDUSTRY

Sponsor Role: collaborator

Eva Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Adel Mahmoud Elsayed

Professor of Internal Medicine, Rheumatology and Immunology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adel Elsayed, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Private clinics

Cairo, , Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EVA_CLEAR_11022017

Identifier Type: -

Identifier Source: org_study_id