Status:
TERMINATED
A Study to Evaluate the Tolerability, Safety and Effectiveness of Edratide in the Treatment of Lupus
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
It is thought that Edratide may be able to reduce the symptoms of SLE.
Eligibility Criteria
Inclusion
- Willing and able to give written informed consent
- Between the ages of 18 and 65 years (inclusive)
- Fulfilled at least 4 ACR classification criteria
- SLE patients with moderate, active disease
- Subjects on stable dose of SLE medications for at least 4 weeks before randomization.
- Women of child-bearing potential must practice a medically acceptable method of contraception..
- Must understand the requirements of the study and agree to comply with the study protocol.
Exclusion
- Any condition which the investigator feels may interfere with participation in the study.
- Subjects having a history of chronic infection
- Subjects with a history of immunodeficiency syndrome or malignancy,
- Subjects who received any investigational medication (including DHEA) within 3 months prior to randomization,
- Subjects treated with any cytotoxic agents in the 3 months prior to randomization.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT00203151
Start Date
July 1 2005
End Date
February 1 2007
Last Update
April 12 2011
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