- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004662
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Active Systemic Lupus Erythematosus
OBJECTIVES:
I. Evaluate the safety and efficacy of synthetic dehydroepiandrosterone, GL701, in women with active systemic lupus erythematosus.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by participating institution.
Patients are randomly assigned to daily oral dehydroepiandrosterone or placebo for 52 weeks. Patients are evaluated every 13 weeks on study and return for a follow-up 6 weeks after completion of therapy.
Concurrent therapy with estrogen replacement and stable doses of prednisone, azathioprine, methotrexate (with folate supplementation), hydroxychloroquine, and nonsteroidal anti-inflammatory drugs is allowed. Other investigational medications and immunosuppressants are prohibited.
Study Type
Enrollment
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Systemic lupus erythematosus by 1982 American College of Rheumatology criteria Diagnosed for at least 6 months
Systemic Lupus Activity Measure score at least 7 Points for erythrocyte sedimentation rate excluded
SLEDAI score of greater than 2 at both screening and qualifying visits
--Prior/Concurrent Therapy--
No prior participation in any dehydroepiandrosterone (DHEA) study
No investigational agent within the longer of 30 days or 10 half-lives of the agent
Prednisone (or equivalent) dose 0 to 10 mg/day Unchanged for at least 6 weeks prior to entry
At least 3 months since immunosuppressants other than azathioprine and methotrexate, including:
- DHEA
- Adrenocorticotropin hormone
- Androgens
- Cyclophosphamide
- Cyclosporine
- Immune globulin
At least 6 weeks since change in azathioprine, methotrexate, or hydroxychloroquine
--Patient Characteristics-- Renal: No requirement for hemodialysis
Cardiovascular: No serious abnormality on electrocardiogram
Other:
- No hypersensitivity to DHEA or inactive ingredients in GL701 formulation, i.e., cornstarch, lactose, or magnesium stearate
- No history of breast cancer or reproductive tract malignancy
- Cervical carcinoma eligible if surgically cured, i.e., no evidence of disease for 5 years
- No condition that would prevent compliance or follow-up, e.g.: Alcoholism Drug addiction Acute withdrawal from chemical dependency
- Psychiatric disease
- No pregnant or nursing women
- Negative pregnancy test required of fertile women
- Reliable contraception required of fertile women
- No estrogen-containing oral contraceptives on study
- At least 3 weeks since estrogen-containing oral contraceptives
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Rosalind Ramsey-Goldman, Northwestern University
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 199/11918
- NU-584
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Systemic Lupus Erythematosus
-
SanofiCompletedCutaneous Lupus Erythematosus-Systemic Lupus ErythematosusJapan
-
Kyowa Kirin Co., Ltd.RecruitingHealthy Volunteers | Systemic Lupus Erythematosus (SLE) | Cutaneous Lupus Erythematosus (CLE)Japan
-
Second Xiangya Hospital of Central South UniversityNational Natural Science Foundation of China; Hunan Provincial Natural Science... and other collaboratorsActive, not recruitingCutaneous Lupus Erythematosus | Systemic Lupus Erythematosus RashChina
-
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate...CompletedSystemic Lupus Erythematosus | Cutaneous Lupus ErythematosusSpain, Bulgaria, Germany, Moldova, Republic of, North Macedonia, Ukraine
-
University Hospital, BrestRecruitingSystemic Lupus Erythematosus (SLE)France
-
Beijing InnoCare Pharma Tech Co., Ltd.RecruitingSystemic Lupus Erythematosus, SLEChina
-
Novartis PharmaceuticalsActive, not recruitingSystemic Lupus Erythematosus (SLE)Hungary, Spain, Germany, Israel, Thailand, France, Russian Federation, China, Japan, Taiwan, Korea, Republic of, Poland, Australia, Argentina, Czechia
-
TJ Biopharma Co., Ltd.TerminatedSystemic Lupus Erythematosus (SLE)China
-
AstraZenecaActive, not recruitingActive Systemic Lupus ErythematosusThailand, Korea, Republic of, Philippines, China, Taiwan, Hong Kong
-
AstraZenecaPRA Health SciencesCompletedActive Systemic Lupus ErythematosusUnited States, France, Germany, Spain, Belgium, Russian Federation, Japan, Korea, Republic of, Argentina, Bulgaria, South Africa, Mexico, Canada, Brazil, Lithuania
Clinical Trials on dehydroepiandrosterone
-
Inflabloc PharmaceuticalsCompletedAn Efficacy and Safety Evaluation of Inflabloc Cap in the Treatment of Patients With Crohn's DiseaseCrohn's DiseaseUnited States, Canada
-
University of HelsinkiUppsala University; Göteborg UniversityUnknownSjogren's SyndromeFinland
-
EndoCeutics Inc.Completed
-
Monash UniversityCompletedQuality of Life | Menopausal Syndrome | Libido DisorderAustralia
-
Taipei Veterans General Hospital, TaiwanNational YangMing UniversityCompletedDehydroepiandrosterone | DHEAS | Gene Expression of Cumulus Cells. | Ovarian Hyper-stimulation Protocol. | Artificial Reproduction Technology.Taiwan
-
National Center for Research Resources (NCRR)Northwestern UniversityCompletedSystemic Lupus Erythematosus
-
National Center for Research Resources (NCRR)Northwestern UniversityCompleted
-
Meir Medical CenterCompletedOvarian StimulationIsrael
-
Chinese University of Hong KongTerminatedGenitourinary Syndrome of MenopauseHong Kong
-
EndoCeutics Inc.Completed