N/A
Completed N=398
Clinical Efficacy and Safety of Leflunomide in Egyptian Patients With Active Rheumatoid Arthritis
Active Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT03599986 ↗
Enrolled (actual)
398
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Number of Patients With Remission, Low, Moderate or High Disease Activity (in Terms of CDAI Scores) in Visits 1 and 6. — 0; 70; 10; 116 Participants
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Remission, Low, Moderate or High Disease Activity (in Terms of CDAI Scores) in Visits 1 and 6. |
0; 70; 10; 116; 53; 113 | — |
| PRIMARY 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. |
112; 318; 200; 43; 54; 5 | — |
| SECONDARY 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. |
6; 2; 2; 2; 1; 1 | — |
Eligibility Criteria
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.).
Data sourced from ClinicalTrials.gov (NCT03599986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.