- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding
Fase
- Fase 3
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Maskning: Dobbelt
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: Rosalind Ramsey-Goldman, Northwestern University
Datoer for undersøgelser
Studer store datoer
Studiestart
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 199/11918
- NU-584
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