Clinical trial NCT01085084: A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Arthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lupus Arthritis
Keywords: Systemic Lupus Erythematosus (SLE)
Lupus Arthritis
Laquinimod
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2010-03-11
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline up to Week 16
measure: Percent Change From Baseline in Swollen Joint Count at Week 12
timeFrame: Baseline, Week 12
measure: Percent Change From Baseline in Tender Joint Count at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Teva Investigational Site 1363
state: Alabama
city: Los Angeles
country: United States
facility: Teva Investigational Site 1368
state: California
city: Los Angeles
country: United States
facility: Teva Investigational Site 1359
state: California
city: San Francisco
country: United States
facility: Teva Investigational Site 1352
state: California
city: San Leandro
country: United States
facility: Teva Investigational Site 1365
state: California
city: Stanford
country: United States
facility: Teva Investigational Site 1357
state: California
city: Chicago
country: United States
facility: Teva Investigational Site 1367
state: Illinois
city: Baltimore
country: United States
facility: Teva Investigational Site 1370
state: Maryland
city: Cumberland
country: United States
facility: Teva Investigational Site 1362
state: Maryland
city: Hagerstown
country: United States
facility: Teva Investigational Site 1360
state: Maryland
city: Bronx
country: United States
facility: Teva Investigational Site 1369
state: New York
city: Manhasset
country: United States
facility: Teva Investigational Site 1353
state: New York
city: New York
country: United States
facility: Teva Investigational Site 1355
state: New York
city: Charlotte
country: United States
facility: Teva Investigational Site 1356
state: North Carolina
city: Columbus
country: United States
facility: Teva Investigational Site 1354
state: Ohio
city: Charleston
country: United States
facility: Teva Investigational Site 1366
state: South Carolina
city: Edmonton
country: Canada
facility: Teva Investigational Site 1139
state: Alberta
city: Vancouver
country: Canada
facility: Teva Investigational Site 1141
state: British Columbia
city: Winnipeg
country: Canada
facility: Teva Investigational Site 1138
state: Manitoba
city: London
country: Canada
facility: Teva Investigational Site 1136
state: Ontario
city: Toronto
country: Canada
facility: Teva Investigational Site 1137
state: Ontario
city: Montreal
country: Canada
facility: Teva Investigational Site 1142
state: Quebec
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, M.D.
role: STUDY_DIRECTOR
References: