Trial record 1 of 2 for:
laquinimod lupus
Laquinimod Study in Systemic Lupus Erythematosus (SLE) Patients With Active Lupus Arthritis
This study has been completed.
Sponsor:
Teva Pharmaceutical Industries
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01085084
First received: March 9, 2010
Last updated: January 9, 2013
Last verified: January 2013
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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:
- Subjects diagnosed with SLE.
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:
- Subjects with severe renal impairment or dialysis
- Severe, unstable and/or progressive CNS lupus
- Subjects with a clinically significant or unstable medical or surgical condition
- 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
Contacts and Locations
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: | January 9, 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 May 19, 2013