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

Phase 2

Completed

• Conditions: Lupus Arthritis
• Interventions: Drug: Laquinimod; Drug: Placebo

• Registration Number: NCT01085084
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-09
• Study First Submitted QC: 2010-03-09
• Study First Posted: 2010-03-11
• Study Start: 2010-10-04
• Primary Completion: 2012-11-12
• Study Completion: 2012-11-12
• Disposition First Submitted: 2013-09-23
• Disposition First Submitted QC: 2013-09-23
• Disposition First Posted: 2013-10-01
• Status Verified: 2022-06
• Results First Submitted: 2022-06-09
• Results First Submitted QC: 2022-06-09
• Last Update Submitted: 2022-06-09
• Results First Posted: 2022-07-07
• Last Update Posted: 2022-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laquinimod 0.5 mg	Laquinimod	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 0.5 mg	Placebo	Participants will receive 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally once daily for 12 weeks.
Placebo	Placebo	Participants will receive 2 capsules of placebo matched to laquinimod orally once daily for 12 weeks.
Laquinimod 1 mg	Laquinimod	Participants will receive 2 capsules of laquinimod 0.5 mg orally once daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	Baseline up to Week 16	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Percent Change From Baseline in Swollen Joint Count at Week 12	Baseline, Week 12	The number of swollen joints was used to assess lupus arthritis activity. Joint swelling was defined as soft tissue swelling that was detectable along the joint margins. 66 joints were examined for swelling. These joints include the temporomandibular (n = 2), sternoclavicular (n =2), acromioclavicular (n = 2), shoulder (n = 2), elbow (n = 2), wrist (n = 2), metacarpophalageal (n= 10), interphalangeal of thumb (n = 2), distal interphalangeal (n = 8), proximal interphalangeal (n =8), knee (n = 2), ankle mortise (n = 2), ankle tarsus (n = 2), metatarsophalangeal (n = 10), interphalangeal of great toe (n = 2), and proximal/distal interphalangeal of the toes (n = 8).
Percent Change From Baseline in Tender Joint Count at Week 12	Baseline, Week 12	The number of tender joints was used to assess lupus arthritis activity. Joint tenderness was defined as the presence or absence of tenderness and/or pain in a joint at rest with pressure or on passive movement of the joint and joint manipulation. 68 joints were examined for tenderness. These joints include the temporomandibular (n = 2), sternoclavicular (n =2), acromioclavicular (n = 2), shoulder (n = 2), elbow (n = 2), wrist (n = 2), metacarpophalageal (n= 10), interphalangeal of thumb (n = 2), distal interphalangeal (n = 8), proximal interphalangeal (n =8), hip (n = 2), knee (n = 2), ankle mortise (n = 2), ankle tarsus (n = 2), metatarsophalangeal (n = 10), interphalangeal of great toe (n = 2), and proximal/distal interphalangeal of the toes (n = 8).

Trial Locations

Locations (22)

Teva Investigational Site 1366; 🇺🇸 Charleston, South Carolina, United States

Teva Investigational Site 1369; 🇺🇸 Bronx, New York, United States

Teva Investigational Site 1142; 🇨🇦 Montreal, Quebec, Canada

Teva Investigational Site 1356; 🇺🇸 Charlotte, North Carolina, United States

Teva Investigational Site 1136; 🇨🇦 London, Ontario, Canada

Teva Investigational Site 1355; 🇺🇸 New York, New York, United States

Teva Investigational Site 1138; 🇨🇦 Winnipeg, Manitoba, Canada

Teva Investigational Site 1359; 🇺🇸 Los Angeles, California, United States

Teva Investigational Site 1365; 🇺🇸 San Leandro, California, United States

Teva Investigational Site 1370; 🇺🇸 Baltimore, Maryland, United States

Teva Investigational Site 1363; 🇺🇸 Birmingham, Alabama, United States

Teva Investigational Site 1368; 🇺🇸 Los Angeles, California, United States

Teva Investigational Site 1352; 🇺🇸 San Francisco, California, United States

Teva Investigational Site 1354; 🇺🇸 Columbus, Ohio, United States

Teva Investigational Site 1367; 🇺🇸 Chicago, Illinois, United States

Teva Investigational Site 1360; 🇺🇸 Hagerstown, Maryland, United States

Teva Investigational Site 1137; 🇨🇦 Toronto, Ontario, Canada

Teva Investigational Site 1353; 🇺🇸 Manhasset, New York, United States

Teva Investigational Site 1357; 🇺🇸 Stanford, California, United States

Teva Investigational Site 1362; 🇺🇸 Cumberland, Maryland, United States

Teva Investigational Site 1139; 🇨🇦 Edmonton, Alberta, Canada

Teva Investigational Site 1141; 🇨🇦 Vancouver, British Columbia, Canada