A Study to Evaluate the Tolerability, Safety and Effectiveness of Edratide in the Treatment of Lupus

This study has been terminated.

( TV-4710/201 did not meet its primary endpoints in patients with SLE )

First Received: September 13, 2005 Last Updated: January 12, 2009 History of Changes

Sponsored by:	Teva Pharmaceutical Industries
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00203151

Purpose

It is thought that Edratide may be able to reduce the symptoms of SLE.

Condition	Intervention	Phase
Systemic Lupus Erythematosus	Drug: edratide	Phase II

MedlinePlus related topics: Lupus

Drug Information available for: Edratide

U.S. FDA Resources

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

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:

Improvement of Disease Activity Score [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
Steriod Tapering [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	260
Study Start Date:	October 2005
Estimated Study Completion Date:	November 2007

Arms	Assigned Interventions
1: Experimental	Drug: edratide 0.5 mg, 1.0 mg, 2.5 mg injection once weekly
2: Placebo Comparator	Drug: edratide 0.5 mg, 1.0 mg, 2.5 mg injection once weekly

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Willing and able to give written informed consent
Between the ages of 18 and 65 years (inclusive)
Fulfilled at least 4 ACR classification criteria
SLE patients with moderate, active disease
Subjects on stable dose of SLE medications for at least 4 weeks before randomization.
Women of child-bearing potential must practice a medically acceptable method of contraception..
Must understand the requirements of the study and agree to comply with the study protocol.

Exclusion Criteria:

Any condition which the investigator feels may interfere with participation in the study.
Subjects having a history of chronic infection
Subjects with a history of immunodeficiency syndrome or malignancy,
Subjects who received any investigational medication (including DHEA) within 3 months prior to randomization,
Subjects treated with any cytotoxic agents in the 3 months prior to randomization.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203151

Locations

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

Sponsors and Collaborators

Teva Pharmaceutical Industries

Investigators

Study Director:

Dan Goldsatub, Ph.D.

Teva Pharmaceutical Industries

More Information

No publications provided

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

Study placed in the following topic categories:

Autoimmune Diseases
Lupus Erythematosus, Systemic
Lupus
Connective Tissue Diseases

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 07, 2009