Dehydroepiandrosterone Administration in Women With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome

Sjogren's Syndrome Clinical Trial

Official title:

Fatigue and General Well-Being in Patients With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome: Effects of Dehydroepiandrosterone Administration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00391924
• Other study ID #: NR 98-2-301
• Status: Completed
• Phase: Phase 2
• First received: October 24, 2006
• Last updated: October 24, 2006
• Start date: May 2000
• Est. completion date: January 2003

Study information

• Verified date: October 2006
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to examine whether dehydroepiandrosterone (DHEA) administration improves fatigue and general well-being in patients with systemic lupus erythematosus or primary Sjögren's syndrome

Description:

Fatigue and reduced general well-being are frequent complaints in patients with the chronic autoimmune disorder systemic lupus erythematosus (SLE) or primary Sjögren's syndrome (pSS). Uncontrolled studies suggested that the administration of dehydroepiandrosterone (DHEA) may improve such complaints. The aim of our randomized double-blind placebo-controlled study is to examine the effect of daily oral 200 mg DHEA on fatigue, well-being, and functioning in women with SLE or pSS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• pSS with a focus score >= 1 on minor salivary gland biopsy and fulfilling European classification criteria (Ann Rheum Dis 1996;55:116-21)

• SLE according to ACR classification criteria (Arthritis Rheum 1982;25:1271-7)

• Willingness to apply effective contraception (premenopausal women)

• Written informed consent.

Exclusion Criteria:

• Pregnancy

• Pregnancy wish

• Serum creatinine > 150 µmol/L

• Glucocorticoid use at a daily dose > 10 mg prednisone (or equivalent)

• Cyclophosphamide treatment in the preceding year

• Hyper- or hypothyroidism

• History of malignancy within the previous 5 years with exception of squamous or basal cell carcinoma of the skin

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Sjogren's Syndrome
• Syndrome

Intervention

Drug:
• Dehydroepiandrosterone

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (3)

Lead Sponsor	Collaborator
UMC Utrecht	Dutch Arthritis Association, University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

Hartkamp A, Geenen R, Bijl M, Kruize AA, Godaert GL, Derksen RH. Serum cytokine levels related to multiple dimensions of fatigue in patients with primary Sjogren's syndrome. Ann Rheum Dis. 2004 Oct;63(10):1335-7. — View Citation

Hartkamp A, Geenen R, Godaert GL, Bijl M, Bijlsma JW, Derksen RH. The effect of dehydroepiandrosterone on lumbar spine bone mineral density in patients with quiescent systemic lupus erythematosus. Arthritis Rheum. 2004 Nov;50(11):3591-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General fatigue
Primary	Depressive mood
Primary	Mental well-being
Primary	Physical functioning
Primary	(all measures at baseline, after 3, 6, and 12 months of intake of study medication, and 6 months after cessation of medication intake)
Secondary	Self-reported pain,
Secondary	Fibromyalgia tender points
Secondary	Erythrocyte sedimentation rate
Secondary	Hemoglobin
Secondary	Serum Immunoglobulin-G
Secondary	Self-reported ocular dryness (in pSS only)
Secondary	Self-reported oral dryness (in pSS only)
Secondary	Ocular tear production (in pSS only)
Secondary	SLE disease activity index (in SLE only)
Secondary	Bone mineral density (in SLE only)
Secondary	Dose of glucocorticoids (in SLE only)