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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014