Laquinimod Study in Systemic Lupus Erythematosus (SLE) Patients With Active Lupus Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01085084
First received: March 9, 2010
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

The study aims to evaluate the safety and clinical effect of daily oral treatment with laquinimod capsules (0.5mg /day and 1mg /day) in active lupus arthritis patients. Laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. For Multiple Sclerosis.


Condition Intervention Phase
Lupus Arthritis
Drug: Laquinimod
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Safety, Tolerability, Change in swollen and tender joint counts [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: July 2010
Study Completion Date: October 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laquinimod 0.5 mg arm
laquinimod 0.5 mg + placebo
Drug: Laquinimod
Laquinimod 0.5 mg + placebo oral once daily for 12 weeks
Experimental: Laquinimod 1 mg
laquinimod 1 mg
Drug: Laquinimod
Laquinimod 1 mg oral once daily for 12 weeks
Placebo Comparator: Placebo
placebo
Other: Placebo
Placebo oral once daily for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects diagnosed with SLE.
  2. Subjects with active lupus arthritis as evident by

    • At least 4 tender and 4 swollen joints
    • Active synovitis ≥ 1 joint with some loss of functional range of movement

Exclusion Criteria:

  1. Subjects with severe renal impairment or dialysis
  2. Severe, unstable and/or progressive CNS lupus
  3. Subjects with a clinically significant or unstable medical or surgical condition
  4. Women who are pregnant or nursing or who intend to be during the study period.
  5. Women of child-bearing potential who do not practice an acceptable method of birth control
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085084

Locations
United States, Alabama
Teva Investigational Site 1363
Birmingham, Alabama, United States
United States, California
Teva Investigational Site 1359
Los Angeles, California, United States
Teva Investigational Site 1352
San Francisco, California, United States
Teva Investigational Site 1365
San Leandro, California, United States
Teva Investigational Site 1368
West Hollywood, California, United States
United States, Illinois
Teva Investigational Site 1367
Chicago, Illinois, United States
United States, Maryland
Teva Investigational Site 1370
Baltimore, Maryland, United States
Teva Investigational Site 1362
Cumberland, Maryland, United States
Teva Investigational Site 1360
Hagerstown, Maryland, United States
United States, New York
Teva Investigational Site 1369
Bronx, New York, United States
Teva Investigational Site 1353
Manhasset, New York, United States
Teva Investigational Site 1355
New York, New York, United States
United States, North Carolina
Teva Investigational Site 1356
Charlotte, North Carolina, United States
United States, Ohio
Teva Investigational Site 1354
Columbus, Ohio, United States
United States, South Carolina
Teva Investigational Site 1366
Charleston, South Carolina, United States
Canada, Alberta
Teva Investigational Site 1139
Edmonton, Alberta, Canada
Canada, Ontario
Teva Investigational Site 1136
London, Ontario, Canada
Teva Investigational Site 1137
Toronto, Ontario, Canada
Canada, Quebec
Teva Investigational Site 1142
Montreal, Quebec, Canada
Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Principal Investigator: David Wofsy, MD University of California, San Francisco, Clinical Trials Center
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01085084     History of Changes
Other Study ID Numbers: LA-LAQ-202
Study First Received: March 9, 2010
Last Updated: September 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Systemic Lupus Erythematosus (SLE)
Lupus Arthritis
Laquinimod

Additional relevant MeSH terms:
Arthritis
Lupus Erythematosus, Systemic
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 26, 2014