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

Phase 2

Terminated

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: edratide

• Registration Number: NCT00203151
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-08
• Last Update Posted: 2011-04-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 340

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	edratide	-
2	edratide	-

Primary Outcome Measures

Name	Time	Method
Improvement of Disease Activity Score	30 weeks