Dehydroepiandrosterone Administration in Women With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome - Full Text View

Sponsor:	UMC Utrecht
Collaborators:	University Medical Centre Groningen Dutch Arthritis Association
Information provided by:	UMC Utrecht
ClinicalTrials.gov Identifier:	NCT00391924

Purpose

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

Condition	Intervention	Phase
Lupus Erythematosus, Systemic Sjogren's Syndrome	Drug: Dehydroepiandrosterone	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Fatigue and General Well-Being in Patients With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome: Effects of Dehydroepiandrosterone Administration

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Fatigue Lupus Minerals Sjogren's Syndrome

Drug Information available for: Prasterone Dehydroepiandrosterone sulfate

U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:

General fatigue
Depressive mood
Mental well-being
Physical functioning
(all measures at baseline, after 3, 6, and 12 months of intake of study medication, and 6 months after cessation of medication intake)

Secondary Outcome Measures:

Self-reported pain,
Fibromyalgia tender points
Erythrocyte sedimentation rate
Hemoglobin
Serum Immunoglobulin-G
Self-reported ocular dryness (in pSS only)
Self-reported oral dryness (in pSS only)
Ocular tear production (in pSS only)
SLE disease activity index (in SLE only)
Bone mineral density (in SLE only)
Dose of glucocorticoids (in SLE only)

Estimated Enrollment:	120
Study Start Date:	May 2000
Estimated Study Completion Date:	January 2003

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391924

Locations

Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700RB
University Medical Center Utrecht
Utrecht, Netherlands, 3508GA

Sponsors and Collaborators

UMC Utrecht

University Medical Centre Groningen

Dutch Arthritis Association

Investigators

Study Chair:

Ronald HW Derksen, MD,PhD

UMC Utrecht

More Information

Publications:

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.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hartkamp A, Geenen R, Godaert GL, Bijl M, Bijlsma JW, Derksen RH. Effects of dehydroepiandrosterone on fatigue and well-being in women with quiescent systemic lupus erythematosus: a randomised controlled trial. Ann Rheum Dis. 2010 Jun;69(6):1144-7. Epub 2009 Oct 22.

ClinicalTrials.gov Identifier:	NCT00391924 History of Changes
Other Study ID Numbers:	NR 98-2-301
Study First Received:	October 24, 2006
Last Updated:	October 24, 2006
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:

Dehydroepiandrosterone
Fatigue
Quality of life

Lupus Erythematosus, Systemic
Sjogren's Syndrome
Bone mineral density

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic
Sjogren's Syndrome
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia

Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012