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

Systemic Lupus Erythematosus Clinical Trial

— PRELUDE  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00203151
• Other study ID #: TV-4710/201
• Status: Terminated
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: April 8, 2011
• Start date: July 2005
• Est. completion date: February 2007

Study information

• Verified date: April 2011
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaGermany: Federal Institute for Drugs and Medical DevicesEuropean Union: European Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 340
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• edratide
0.5 mg, 1.0 mg, 2.5 mg injection once weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of Disease Activity Score		30 weeks	No