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

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: NCT00203151
Recruitment Status : Terminated (TV-4710/201 did not meet its primary endpoints in patients with SLE)
First Posted : September 20, 2005
Last Update Posted : April 12, 2011
Information provided by:
Teva Branded Pharmaceutical Products R&D, Inc.

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

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: edratide Phase 2

Expanded Access : Teva Branded Pharmaceutical Products R&D, Inc. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Edratide for Subcutaneous Injection in Systemic Lupus Erythematosus (SLE)
Study Start Date : July 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: 1 Drug: edratide
0.5 mg, 1.0 mg, 2.5 mg injection once weekly

Placebo Comparator: 2 Drug: edratide
0.5 mg, 1.0 mg, 2.5 mg injection once weekly

Primary Outcome Measures :
  1. Improvement of Disease Activity Score [ Time Frame: 30 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

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): NCT00203151

Sponsors and Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
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Study Director: Dan Goldsatub, Ph.D. Teva Branded Pharmaceutical Products R&D, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rivka Kreitman, Ph.D., Vice President, Innovative Research & Development, Teva Neuroscience
ClinicalTrials.gov Identifier: NCT00203151    
Other Study ID Numbers: TV-4710/201
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 12, 2011
Last Verified: April 2011
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases