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

Sponsor

Genelabs Technologies (Industry)

Overall Status

Completed

CT.gov ID

NCT00082511

Collaborator

(none)

114

Enrollment

Locations

Duration (Months)

5.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Open label safety and efficacy follow-up.

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus	Drug: Prasterone (GL701)	Phase 3

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

114 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2003

Actual Primary Completion Date :

Aug 1, 2005

Actual Study Completion Date :

Aug 1, 2005

Outcome Measures

Primary Outcome Measures

Maintenance of bone mineral density (BMD) in women with systemic lupus erythematosus receiving glucocorticoids. [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona	Tucson	Arizona	United States	85724
2	Wallace Rheumatic Study Center	Los Angeles	California	United States	90048
3	Lifestyles Health Science Center	Rancho Mirage	California	United States	92270
4	University of California San Diego	San Diego	California	United States	92093-0943
5	East Bay Rheumatology Group	San Leandro	California	United States	94578
6	Center for Rheumatology, Immunology and Arthritis	Fort Lauderdale	Florida	United States	33334
7	Rheumatology Associates of Central Florida	Orlando	Florida	United States	32806-6264
8	Tampa Medical Group, P.A.	Tampa	Florida	United States	33614
9	Northwestern University	Chicago	Illinois	United States	60611
10	Johns Hopkins University	Baltimore	Maryland	United States	21205
11	St. John's Medical Research Group	Springfield	Missouri	United States	65804
12	Washington University School of Medicine	St. Louis	Missouri	United States	63110
13	Albert Einstein Medical School	Bronx	New York	United States	10461
14	SUNY Downstate Medical Center	Brooklyn	New York	United States	11203
15	North Shore University Hospital, Division of Rheumatology	Manhasset	New York	United States	11030
16	Oklahoma Center for Arthritis Therapy	Tulsa	Oklahoma	United States	74114
17	Oregon Health & Science University	Portland	Oregon	United States	97201
18	Altoona Center for Clinical Research	Duncansville	Pennsylvania	United States	16635
19	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15261
20	Sentara Medical Group DBA	Virginia Beach	Virginia	United States	23462
21	Seattle Rheumatology Associates	Seattle	Washington	United States	98104
22	Immunology/Rheumatology Instituto Nacional de Ciencias Medicas y Nutricion, S.Z.	Mexico City		Mexico	14000