A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Arthritis
NCT ID: NCT01085084
Last Updated: 2022-07-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
82 participants
INTERVENTIONAL
2010-10-04
2012-11-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis
NCT01085097
Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
NCT02446912
Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
NCT02446899
BI 705564 in Patients With Systemic Lupus Erythematosus (SLE)
NCT03771885
Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus
NCT02265744
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Participants will receive 2 capsules of placebo matched to laquinimod orally once daily for 12 weeks.
Placebo
Placebo matching to laquinimod will be administered per schedule specified in the arm description.
Laquinimod 0.5 mg
Participants will receive 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally once daily for 12 weeks.
Laquinimod
Laquinimod will be administered per dose and schedule specified in the arm description.
Placebo
Placebo matching to laquinimod will be administered per schedule specified in the arm description.
Laquinimod 1 mg
Participants will receive 2 capsules of laquinimod 0.5 mg orally once daily for 12 weeks.
Laquinimod
Laquinimod will be administered per dose and schedule specified in the arm description.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Laquinimod
Laquinimod will be administered per dose and schedule specified in the arm description.
Placebo
Placebo matching to laquinimod will be administered per schedule specified in the arm description.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Teva Medical Expert, M.D.
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Teva Investigational Site 1363
Birmingham, Alabama, United States
Teva Investigational Site 1368
Los Angeles, California, United States
Teva Investigational Site 1359
Los Angeles, California, United States
Teva Investigational Site 1352
San Francisco, California, United States
Teva Investigational Site 1365
San Leandro, California, United States
Teva Investigational Site 1357
Stanford, California, United States
Teva Investigational Site 1367
Chicago, Illinois, United States
Teva Investigational Site 1370
Baltimore, Maryland, United States
Teva Investigational Site 1362
Cumberland, Maryland, United States
Teva Investigational Site 1360
Hagerstown, Maryland, United States
Teva Investigational Site 1353
Manhasset, New York, United States
Teva Investigational Site 1355
New York, New York, United States
Teva Investigational Site 1369
The Bronx, New York, United States
Teva Investigational Site 1356
Charlotte, North Carolina, United States
Teva Investigational Site 1354
Columbus, Ohio, United States
Teva Investigational Site 1366
Charleston, South Carolina, United States
Teva Investigational Site 1139
Edmonton, Alberta, Canada
Teva Investigational Site 1141
Vancouver, British Columbia, Canada
Teva Investigational Site 1138
Winnipeg, Manitoba, Canada
Teva Investigational Site 1136
London, Ontario, Canada
Teva Investigational Site 1137
Toronto, Ontario, Canada
Teva Investigational Site 1142
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LA-LAQ-202
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.