GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids

Study Overview
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Brief Summary
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Open label safety and efficacy follow-up.

Detailed Description
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This was a randomized, multi-center, open-label, parallel-group, trial of prasterone 200 or 100 mg/day for 12 months in women with lupus receiving glucocorticoid therapy who had completed an earlier 6-month randomized, placebo-controlled study (NCT00053560. Bone Mineral Density assessments were performed at baseline and at months 6 and 12.

Official Title
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A Multi-Center, Open-Label Study to Assess the Durability and Safety of the Prevention of Bone Loss by Treatment With GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: Prasterone (GL701)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has completed the full 6 month treatment period with study drug in the previous Genelabs' clinical study GL02-01. Concomitant treatment with prednisone (or equivalent) at a dose of ≥ 5mg/day. Patient has read and signed an Informed Consent Form. If the patient is not fluent in English, the Informed Consent must be signed in her native language. Exclusion Criteria: Patient has had a serious study drug related adverse reaction at any time during the previous GL02-01 study. Any condition which in the Investigator's or Sponsor's opinion is sufficient to prevent adequate compliance with the study or likely to confuse follow-up evaluation (e.g., alcoholism, drug addiction, acute withdrawal from chemical dependency, psychiatric disease). MEDICATIONS PROHIBITED AT ANY TIME DURING THE STUDY Calcitonin Bisphosphonates Fluoride at pharmacologic dose Strontium at pharmacologic dose Estrogenic steroids (except oral contraceptives) Selective Estrogen Receptor Modulator (raloxifene) Parathyroid hormone Any androgens, including prescription or nutritional supplement DHEA, other than study drug Additional Calcium supplements other than those prescribed as part of this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Prasterone (GL701)|There were 4 arms to the study: During a previous 6 month db RCT, patients received either prasterone 200 mg/day or placebo. Upon entry into this open-label study, they were re-assigned by randomized allocation to receive either prasterone 200 mg/day or 100 mg/day. Hence, there were 4 possible treatment arms extending over the 18 months of observation between the double-blind study and the subsequent 12 month open-label extension study.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of bone mineral density (BMD) in women with systemic lupus erythematosus receiving glucocorticoids. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lupus, Systemic Lupus Erythematosus, SLE, Bone Loss, DHEA