Multiple Sclerosis Clinical Trial

A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Arthritis

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

82

Study ID:

NCT01085084

Recruitment Status:

Completed

Sponsor:

Teva Branded Pharmaceutical Products R&D, Inc.

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There are 22 Locations for this study

See Locations Near You

Teva Investigational Site 1363
Birmingham Alabama, 35216, United States
Teva Investigational Site 1368
Los Angeles California, 90048, United States
Teva Investigational Site 1359
Los Angeles California, 90095, United States
Teva Investigational Site 1352
San Francisco California, 94143, United States
Teva Investigational Site 1365
San Leandro California, 94578, United States
Teva Investigational Site 1357
Stanford California, 94305, United States
Teva Investigational Site 1367
Chicago Illinois, 60637, United States
Teva Investigational Site 1370
Baltimore Maryland, 21205, United States
Teva Investigational Site 1362
Cumberland Maryland, 21502, United States
Teva Investigational Site 1360
Hagerstown Maryland, 21740, United States
Teva Investigational Site 1369
Bronx New York, 10467, United States
Teva Investigational Site 1353
Manhasset New York, 11030, United States
Teva Investigational Site 1355
New York New York, 10016, United States
Teva Investigational Site 1356
Charlotte North Carolina, 28210, United States
Teva Investigational Site 1354
Columbus Ohio, 43210, United States
Teva Investigational Site 1366
Charleston South Carolina, 29425, United States
Teva Investigational Site 1139
Edmonton Alberta, T6G 2, Canada
Teva Investigational Site 1141
Vancouver British Columbia, V5Z 1, Canada
Teva Investigational Site 1138
Winnipeg Manitoba, R3A 1, Canada
Teva Investigational Site 1136
London Ontario, N6A 4, Canada
Teva Investigational Site 1137
Toronto Ontario, M5T 2, Canada
Teva Investigational Site 1142
Montreal Quebec, H3G 1, Canada

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

82

Study ID:

NCT01085084

Recruitment Status:

Completed

Sponsor:


Teva Branded Pharmaceutical Products R&D, Inc.

How clear is this clinincal trial information?

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