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

• ClinicalTrials.gov Identifier: NCT03599986
• Recruitment Status: Completed
• First Posted: July 26, 2018
• Results First Posted: June 30, 2020
• Last Update Posted: June 30, 2020
• Sponsor: Eva Pharma
• Collaborator: DataClin
• Information provided by (Responsible Party): Adel Mahmoud Elsayed, Eva Pharma

Study Description

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)

Condition or disease
Active Rheumatoid Arthritis

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 398 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: A Phase IV, Multi-Centric, Prospective, Observational Study to Assess the Clinical Efficacy and Safety of Leflunomide in Egyptian Patients With Active Rheumatoid Arthritis
• Actual Study Start Date: June 16, 2017
• Actual Primary Completion Date: October 13, 2018
• Actual Study Completion Date: October 13, 2018

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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

2. 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.

Secondary Outcome Measures :

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. [ Time Frame: 9 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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.).

Contacts and Locations

Locations

Egypt

Private clinics

Cairo, Egypt, 1152

Sponsors and Collaborators

Eva Pharma

DataClin

Investigators

• Principal Investigator: Adel Elsayed, MD; Professor, Department of Internal Medicine, Rheumatology and Immunology, Ain Shams University; Egypt

  Study Documents (Full-Text)

Documents provided by Adel Mahmoud Elsayed, Eva Pharma:

Study Protocol and Statistical Analysis Plan  [PDF] June 19, 2017

More Information

Additional Information:

Related Info 

• Responsible Party: Adel Mahmoud Elsayed, Professor of Internal Medicine, Rheumatology and Immunology, Eva Pharma
• ClinicalTrials.gov Identifier: NCT03599986
• Other Study ID Numbers: EVA_CLEAR_11022017
• First Posted: July 26, 2018
• Results First Posted: June 30, 2020
• Last Update Posted: June 30, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Not yet

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Adel Mahmoud Elsayed, Eva Pharma:

RA

Additional relevant MeSH terms:

Arthritis; Arthritis, Rheumatoid; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases