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Sponsored by: |
Teva Pharmaceutical Industries |
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Information provided by: | Teva Pharmaceutical Industries |
ClinicalTrials.gov Identifier: | NCT00203151 |
It is thought that Edratide may be able to reduce the symptoms of SLE.
Condition | Intervention | Phase |
---|---|---|
Systemic Lupus Erythematosus |
Drug: edratide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-National, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Parallel Group Study to Assess the Efficacy, Tolerability and Safety of Three Doses of Edratide (TV-4710) for Injection Administered Subcutaneously to Systemic Lupus Erythematosus (SLE) Patients |
Estimated Enrollment: | 260 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | November 2007 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: edratide
0.5 mg, 1.0 mg, 2.5 mg injection once weekly
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2: Placebo Comparator |
Drug: edratide
0.5 mg, 1.0 mg, 2.5 mg injection once weekly
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Teva is developing edratide for injection for the treatment of SLE. Edratide is an immunomodulating drug expected to attenuate the general autoimmune process and to provide effective treatment for the overall clinical manifestations of SLE. The study duration is 26 weeks.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Boling Clinical Trials | |
Upland, California, United States, 91786 | |
UCLA School of Medicine | |
Los Angeles, California, United States | |
East Bay Rheumatology Medical Group | |
San Leandro, California, United States | |
Wallace Research | |
Los Angeles, California, United States | |
United States, Connecticut | |
University of Connecticut Health Center - Division of Rheumatology, MC1310 | |
Farmington, Connecticut, United States | |
United States, Illinois | |
University of Chicago - Dept. of Rheumatology/MC 0930 | |
Chicago, Illinois, United States | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States | |
United States, New York | |
NYU - Hospital for Joint Diseases | |
New York, New York, United States, 10003 | |
North Shore - LIJ Health System | |
Lake Success, New York, United States | |
SUNY - Downstate Medical Center | |
Brooklyn, New York, United States | |
United States, North Carolina | |
Carolina Bone and Joint | |
Charlotte, North Carolina, United States, 28210 | |
University of North Carolina - Chapel Hill | |
Chapel Hill, North Carolina, United States | |
United States, Oklahoma | |
Oklahoma Medical Research Foundation | |
Oklahoma City, Oklahoma, United States |
Study Director: | Dan Goldsatub, Ph.D. | Teva Pharmaceutical Industries |
Responsible Party: | Teva Neuroscience ( Rivka Kreitman, Ph.D., Vice President, Innovative Research & Development ) |
Study ID Numbers: | TV-4710/201 (PRELUDE) |
Study First Received: | September 13, 2005 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00203151 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Germany: Federal Institute for Drugs and Medical Devices; European Union: European Medicines Agency |
Autoimmune Diseases Lupus Erythematosus, Systemic Lupus Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Lupus Erythematosus, Systemic Connective Tissue Diseases |