Conditions: Lupus Arthritis
Keywords: Systemic Lupus Erythematosus (SLE) Lupus Arthritis Laquinimod
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 82
Healthy volunteers: no

Brief summary:
The study aims to evaluate the safety and clinical effect of daily oral treatment with laquinimod capsules (0.5 milligrams \[mg\] and 1 mg) in participants with active lupus arthritis. Laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for Multiple Sclerosis.

Detailed description:

Arms:
arm 1: Participants will receive 2 capsules of placebo matched to laquinimod orally once daily for 12 weeks. arm 2: Participants will receive 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally once daily for 12 weeks. arm 3: Participants will receive 2 capsules of laquinimod 0.5 mg orally once daily for 12 weeks.

Interventions: intervention 1: Laquinimod intervention 2: Placebo
Intervention descriptions: intervention 1: Laquinimod will be administered per dose and schedule specified in the arm description. intervention 2: Placebo matching to laquinimod will be administered per schedule specified in the arm description.

Protocol document: