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

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

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.

Study Overview

• Status: Completed
• Conditions: Lupus Arthritis
• Intervention / Treatment: Drug: Placebo; Drug: Laquinimod

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Teva Investigational Site 1139
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1L7
      • Teva Investigational Site 1141
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1M4
      • Teva Investigational Site 1138
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • Teva Investigational Site 1136
    • Toronto, Ontario, Canada, M5T 2S8
      • Teva Investigational Site 1137
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • Teva Investigational Site 1142
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Teva Investigational Site 1363
  • California
    • Los Angeles, California, United States, 90048
      • Teva Investigational Site 1368
    • Los Angeles, California, United States, 90095-7077
      • Teva Investigational Site 1359
    • San Francisco, California, United States, 94143-0792
      • Teva Investigational Site 1352
    • San Leandro, California, United States, 94578
      • Teva Investigational Site 1365
    • Stanford, California, United States, 94305
      • Teva Investigational Site 1357
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Teva Investigational Site 1367
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Teva Investigational Site 1370
    • Cumberland, Maryland, United States, 21502
      • Teva Investigational Site 1362
    • Hagerstown, Maryland, United States, 21740
      • Teva Investigational Site 1360
  • New York
    • Bronx, New York, United States, 10467
      • Teva Investigational Site 1369
    • Manhasset, New York, United States, 11030
      • Teva Investigational Site 1353
    • New York, New York, United States, 10016
      • Teva Investigational Site 1355
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Teva Investigational Site 1356
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Teva Investigational Site 1354
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Teva Investigational Site 1366

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will receive 2 capsules of placebo matched to laquinimod orally once daily for 12 weeks.	Drug: Placebo; Placebo matching to laquinimod will be administered per schedule specified in the arm description.
Experimental: 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.	Drug: Placebo; Placebo matching to laquinimod will be administered per schedule specified in the arm description.; Drug: Laquinimod; Laquinimod will be administered per dose and schedule specified in the arm description.
Experimental: Laquinimod 1 mg; Participants will receive 2 capsules of laquinimod 0.5 mg orally once daily for 12 weeks.	Drug: Laquinimod; Laquinimod will be administered per dose and schedule specified in the arm description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AEs)	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'.	Baseline up to Week 16
Percent Change From Baseline in Swollen Joint Count at 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).	Baseline, Week 12
Percent Change From Baseline in Tender Joint Count at 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).	Baseline, Week 12

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2010
• Primary Completion (Actual): November 12, 2012
• Study Completion (Actual): November 12, 2012

Study Registration Dates

• First Submitted: March 9, 2010
• First Submitted That Met QC Criteria: March 9, 2010
• First Posted (Estimate): March 11, 2010

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Systemic Lupus Erythematosus (SLE); Laquinimod; Lupus Arthritis
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Arthritis; Lupus Erythematosus, Systemic
• Other Study ID Numbers: LA-LAQ-202