NCT00391924

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2000

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2006

Completed
Last Updated

October 25, 2006

Status Verified

October 1, 2006

First QC Date

October 24, 2006

Last Update Submit

October 24, 2006

Conditions

Lupus Erythematosus, SystemicSjogren's Syndrome

Keywords

DehydroepiandrosteroneFatigueQuality of lifeLupus Erythematosus, SystemicSjogren's SyndromeBone mineral density

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (11)

  • Self-reported pain,

  • Fibromyalgia tender points

  • Erythrocyte sedimentation rate

  • Hemoglobin

  • Serum Immunoglobulin-G

  • +6 more secondary outcomes

Interventions

DehydroepiandrosteroneDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3508GA, Netherlands

Location

Related Publications (3)

  • 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. doi: 10.1002/art.20610.

    PMID: 15529389RESULT

  • 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. doi: 10.1136/ard.2003.011825.

    PMID: 15361396RESULT

  • 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. doi: 10.1136/ard.2009.117036. Epub 2009 Oct 22.

    PMID: 19854713DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, SystemicSjogren's SyndromeFatigue

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesArthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds17-KetosteroidsKetosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsTestosterone CongenersGonadal Steroid HormonesGonadal Hormones

Study Officials

  • Ronald HW Derksen, MD,PhD

    UMC Utrecht

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 24, 2006

First Posted

October 25, 2006

Study Start

May 1, 2000

Study Completion

January 1, 2003

Last Updated

October 25, 2006

Record last verified: 2006-10

Locations

NL(2)