Systemic Lupus Erythematosus
Conditions
Brief summary
It is thought that Edratide may be able to reduce the symptoms of SLE.
Interventions
DRUGedratide
0.5 mg, 1.0 mg, 2.5 mg injection once weekly
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of Disease Activity Score | 30 weeks |
Outcome results
None listed