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

Genelabs Technologies114 enrolled

Overview

Open label safety and efficacy follow-up.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

114

Conditions

Systemic Lupus Erythematosus

Interventions

Prasterone (GL701)DRUG

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (22)

University of Arizona

Tucson, Arizona, United States

Outcomes

Primary Outcomes

Maintenance of bone mineral density (BMD) in women with systemic lupus erythematosus receiving glucocorticoids.

Time frame: 12 months

Data from ClinicalTrials.gov

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