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

• Register: ClinicalTrials.gov
• Last refreshed on: 30 May 2022
• Main ID: NCT01085084
• Date of registration: 09/03/2010
• Prospective Registration: Yes
• Primary sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Public title: A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Arthritis
• Scientific 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
• Date of first enrolment: October 4, 2010
• Target sample size: 82
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01085084
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Canada, United States

Contacts

• Name: Teva Medical Expert, M.D.
• Affiliation: Teva Branded Pharmaceutical Products R&D, Inc.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lupus Arthritis

Intervention(s)

Drug: Laquinimod

Drug: Placebo

Primary Outcome(s)

Number of Participants with Adverse Event (AEs) [Time Frame: Baseline up to week 16]

Percent Change from Baseline in Swollen Joint Count at Week 12 [Time Frame: Baseline, week 12]

Percent Change from Baseline in Tender Joint Count at Week 12 [Time Frame: Baseline, week 12]

Secondary ID(s)

LA-LAQ-202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors