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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01085084
Recruitment Status : Completed
First Posted : March 11, 2010
Last Update Posted : July 20, 2016
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

Brief Summary:
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 or disease Intervention/treatment Phase
Lupus Arthritis Drug: Laquinimod Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : July 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis Lupus

Arm Intervention/treatment
Experimental: Laquinimod 0.5 mg arm
laquinimod 0.5 mg + placebo
Drug: Laquinimod
Laquinimod 0.5 mg once daily for 12 weeks

Other: Placebo
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




Primary Outcome Measures :
  1. Safety, Tolerability, Change in swollen and tender joint counts [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085084


Locations
Show Show 19 study locations
Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
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Principal Investigator: David Wofsy, MD University of California, San Francisco, Clinical Trials Center
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Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01085084    
Other Study ID Numbers: LA-LAQ-202
First Posted: March 11, 2010    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016
Keywords provided by Teva Pharmaceutical Industries:
Systemic Lupus Erythematosus (SLE)
Lupus Arthritis
Laquinimod
Additional relevant MeSH terms:
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Arthritis
Lupus Erythematosus, Systemic
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases