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

NCT01085084 | Completed Phase 2 Results DMC

• 1 other identifier: LA-LAQ-202
• Study Type: interventional
• Target: 82
• Locations: 2 countries
• Sites: 22

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.

Conditions

Lupus Arthritis

Keywords

Systemic Lupus Erythematosus (SLE); Lupus Arthritis; Laquinimod

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants will receive 2 capsules of placebo matched to laquinimod orally once daily for 12 weeks.

Drug: Placebo

Laquinimod 0.5 mg

EXPERIMENTAL

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: Laquinimod; Drug: Placebo

Laquinimod 1 mg

EXPERIMENTAL

Participants will receive 2 capsules of laquinimod 0.5 mg orally once daily for 12 weeks.

Drug: Laquinimod

Interventions

Laquinimod DRUG

Laquinimod will be administered per dose and schedule specified in the arm description.

Laquinimod 0.5 mg; Laquinimod 1 mg

Placebo DRUG

Placebo matching to laquinimod will be administered per schedule specified in the arm description.

Laquinimod 0.5 mg; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (22)

Teva Investigational Site 1363

Birmingham, Alabama, 35216, United States

Location

Teva Investigational Site 1368

Los Angeles, California, 90048, United States

Location

Teva Investigational Site 1359

Los Angeles, California, 90095-7077, United States

Location

Teva Investigational Site 1352

San Francisco, California, 94143-0792, United States

Location

Teva Investigational Site 1365

San Leandro, California, 94578, United States

Location

Teva Investigational Site 1357

Stanford, California, 94305, United States

Location

Teva Investigational Site 1367

Chicago, Illinois, 60637, United States

Location

Teva Investigational Site 1370

Baltimore, Maryland, 21205, United States

Location

Teva Investigational Site 1362

Cumberland, Maryland, 21502, United States

Location

Teva Investigational Site 1360

Hagerstown, Maryland, 21740, United States

Location

Teva Investigational Site 1353

Manhasset, New York, 11030, United States

Location

Teva Investigational Site 1355

New York, New York, 10016, United States

Location

Teva Investigational Site 1369

The Bronx, New York, 10467, United States

Location

Teva Investigational Site 1356

Charlotte, North Carolina, 28210, United States

Location

Teva Investigational Site 1354

Columbus, Ohio, 43210, United States

Location

Teva Investigational Site 1366

Charleston, South Carolina, 29425, United States

Location

Teva Investigational Site 1139

Edmonton, Alberta, T6G 2B7, Canada

Location

Teva Investigational Site 1141

Vancouver, British Columbia, V5Z 1L7, Canada

Location

Teva Investigational Site 1138

Winnipeg, Manitoba, R3A 1M4, Canada

Location

Teva Investigational Site 1136

London, Ontario, N6A 4V2, Canada

Location

Teva Investigational Site 1137

Toronto, Ontario, M5T 2S8, Canada

Location

Teva Investigational Site 1142

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

laquinimod

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products R&D, Inc.

USMedInfo@tevapharm.com

1-888-483-8279

Study Officials

• Teva Medical Expert, M.D.

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2010
• First Posted: March 11, 2010
• Study Start: October 4, 2010
• Primary Completion: November 12, 2012
• Study Completion: November 12, 2012
• Last Updated: July 7, 2022
• Results First Posted: July 7, 2022

Record last verified: 2022-06

Locations

CA (6); US (16)