Multiple Sclerosis Clinical Trial
A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Arthritis
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.
Participants diagnosed with SLE.
Participants with active lupus arthritis as evident by at least 4 tender and 4 swollen joints at screening and baseline visits, and moderate or severe arthritis with active synovitis in at least 1 joint, with some loss of functional range of movement present at screening and baseline visits.
The participant's estimated glomerular filtration rate (eGFR) was less than or equal to 30 milliliters (mL)/minute/1.73 square meter (m^2), as calculated by the Modification of Diet in Renal Disease (MDRD) formula at the screening visit.
Participants with severe, unstable and/or progressive central nervous system (CNS) lupus and/or associated with significant cognitive impairment (upon the investigators' judgement).
Participants with a clinically significant or unstable medical or surgical condition that, in the investigator's opinion, would preclude safe and complete study participation.
Women who are pregnant or nursing or who intend to be during the study period.
Women of child-bearing potential who do not practice an acceptable method of birth control.
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There are 22 Locations for this study
Birmingham Alabama, 35216, United States
Los Angeles California, 90048, United States
Los Angeles California, 90095, United States
San Francisco California, 94143, United States
San Leandro California, 94578, United States
Stanford California, 94305, United States
Chicago Illinois, 60637, United States
Baltimore Maryland, 21205, United States
Cumberland Maryland, 21502, United States
Hagerstown Maryland, 21740, United States
Bronx New York, 10467, United States
Manhasset New York, 11030, United States
New York New York, 10016, United States
Charlotte North Carolina, 28210, United States
Columbus Ohio, 43210, United States
Charleston South Carolina, 29425, United States
Edmonton Alberta, T6G 2, Canada
Vancouver British Columbia, V5Z 1, Canada
Winnipeg Manitoba, R3A 1, Canada
London Ontario, N6A 4, Canada
Toronto Ontario, M5T 2, Canada
Montreal Quebec, H3G 1, Canada
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