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

This study has been terminated.
(TV-4710/201 did not meet its primary endpoints in patients with SLE)
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00203151
First received: September 13, 2005
Last updated: April 8, 2011
Last verified: April 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Systemic Lupus Erythematosus
 Drug: edratide
 Phase 2

Teva Pharmaceutical Industries has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

MedlinePlus related topics: Lupus
U.S. FDA Resources

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 ]

Enrollment: 340
Study Start Date: July 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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

Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Study Director: Dan Goldsatub, Ph.D. Teva Pharmaceutical Industries
  More Information

No publications provided

Responsible Party: Rivka Kreitman, Ph.D., Vice President, Innovative Research & Development, Teva Neuroscience
ClinicalTrials.gov Identifier: NCT00203151     History of Changes
Other Study ID Numbers: TV-4710/201
Study First Received: September 13, 2005
Last Updated: April 8, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
European Union: European Medicines Agency

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013