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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
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date April 12, 2011
Study Start Date  ICMJE July 2005
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2011)
Improvement of Disease Activity Score [ Time Frame: 30 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • AMS (Adjusted Mean SLEDAI 2K) calculated from the AUC of SLEDAI change from Baseline adjusted over time.
  • Landmark analysis (change-from-baseline) of SLEDAI 2K measurement scores.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Tolerability, Safety and Effectiveness of Edratide in the Treatment of Lupus
Official Title  ICMJE 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)
Brief Summary It is thought that Edratide may be able to reduce the symptoms of SLE.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE Drug: edratide
0.5 mg, 1.0 mg, 2.5 mg injection once weekly
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: edratide
  • Placebo Comparator: 2
    Intervention: Drug: edratide
Publications * Urowitz MB, Isenberg DA, Wallace DJ. Safety and efficacy of hCDR1 (Edratide) in patients with active systemic lupus erythematosus: results of phase II study. Lupus Sci Med. 2015 Aug 11;2(1):e000104. doi: 10.1136/lupus-2015-000104. eCollection 2015.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 8, 2011)
340
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
260
Actual Study Completion Date  ICMJE February 2007
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00203151
Other Study ID Numbers  ICMJE TV-4710/201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rivka Kreitman, Ph.D., Vice President, Innovative Research & Development, Teva Neuroscience
Study Sponsor  ICMJE Teva Pharmaceutical Industries
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dan Goldsatub, Ph.D. Teva Pharmaceutical Industries
PRS Account Teva Pharmaceutical Industries
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP