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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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30 May 2022 |
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Main ID: |
NCT01085084 |
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Date of registration:
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09/03/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Arthritis
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Scientific title:
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A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Systemic Lupus Erythematosus Patients With Active Lupus Arthritis |
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Date of first enrolment:
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October 4, 2010 |
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Target sample size:
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82 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01085084 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Teva Medical Expert, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Teva Branded Pharmaceutical Products R&D, Inc. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lupus Arthritis
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Intervention(s)
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Drug: Placebo
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Drug: Laquinimod
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Primary Outcome(s)
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Percent Change from Baseline in Swollen Joint Count at Week 12
[Time Frame: Baseline, week 12]
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Percent Change from Baseline in Tender Joint Count at Week 12
[Time Frame: Baseline, week 12]
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Number of Participants with Adverse Event (AEs)
[Time Frame: Baseline up to week 16]
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Secondary ID(s)
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LA-LAQ-202
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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