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A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Arthritis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT01085084•Teva Branded Pharmaceutical Products R&D, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (22)

Teva Investigational Site 1363

Birmingham, Alabama, United States

Teva Investigational Site 1368

Los Angeles, California, United States

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 1357

Stanford, California, United States

Teva Investigational Site 1367

Chicago, Illinois, United States

Teva Investigational Site 1370

Baltimore, Maryland, United States

Teva Investigational Site 1362

Cumberland, Maryland, United States

Teva Investigational Site 1360

Hagerstown, Maryland, United States

Key Dates

Start Date

October 4, 2010

Primary Completion Date

November 12, 2012

Completion Date

November 12, 2012

Last Updated

July 7, 2022

Enrollment

ACTUAL participants

Conditions

Lupus Arthritis

Interventions

Laquinimod

DRUG

Placebo

DRUG

Safety Study of AMG 557 in Subjects With Lupus Arthritis

NCT01683695

Lupus Arthritis, Systemic Lupus Erythematosus

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 7, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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