Laquinimod Study in Systemic Lupus Erythematosus (SLE) Patients With Active Lupus Arthritis

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The study aims to evaluate the safety and clinical effect of daily oral treatment with laquinimod capsules (0.5mg /day and 1mg /day) in active lupus arthritis patients. Laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. For Multiple Sclerosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Pharmaceutical Industries

Criteria

Inclusion Criteria:

1. Subjects diagnosed with SLE.

2. Subjects with active lupus arthritis as evident by

• At least 4 tender and 4 swollen joints

• Active synovitis ≥ 1 joint with some loss of functional range of movement

Exclusion Criteria:

1. Subjects with severe renal impairment or dialysis

2. Severe, unstable and/or progressive CNS lupus

3. Subjects with a clinically significant or unstable medical or surgical condition

4. Women who are pregnant or nursing or who intend to be during the study period.

5. Women of child-bearing potential who do not practice an acceptable method of birth control