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

Primary Purpose

Lupus Erythematosus, Systemic, Sjogren's Syndrome

Status

Completed

Phase

Phase 2

Locations

Netherlands

Study Type

Interventional

Intervention

Dehydroepiandrosterone

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring Dehydroepiandrosterone, Fatigue, Quality of life, Lupus Erythematosus, Systemic, Sjogren's Syndrome, Bone mineral density

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

University Medical Center Groningen
University Medical Center Utrecht

Outcomes

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)

Full Information

NCT ID

NCT00391924

First Posted

October 24, 2006

Last Updated

October 24, 2006

Sponsor

UMC Utrecht

Collaborators

University Medical Center Groningen, Dutch Arthritis Association

1. Study Identification

Unique Protocol Identification Number

NCT00391924

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2006

Overall Recruitment Status

Completed

Study Start Date

May 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

UMC Utrecht

Collaborators

University Medical Center Groningen, Dutch Arthritis Association

4. Oversight

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lupus Erythematosus, Systemic, Sjogren's Syndrome

Keywords

Dehydroepiandrosterone, Fatigue, Quality of life, Lupus Erythematosus, Systemic, Sjogren's Syndrome, Bone mineral density

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

120 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Dehydroepiandrosterone

Primary Outcome Measure Information:

Title

General fatigue

Title

Depressive mood

Title

Mental well-being

Title

Physical functioning

Title

(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 Measure Information:

Title

Self-reported pain,

Title

Fibromyalgia tender points

Title

Erythrocyte sedimentation rate

Title

Hemoglobin

Title

Serum Immunoglobulin-G

Title

Self-reported ocular dryness (in pSS only)

Title

Self-reported oral dryness (in pSS only)

Title

Ocular tear production (in pSS only)

Title

SLE disease activity index (in SLE only)

Title

Bone mineral density (in SLE only)

Title

Dose of glucocorticoids (in SLE only)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald HW Derksen, MD,PhD

Organizational Affiliation

UMC Utrecht

Official's Role

Study Chair

Facility Information:

Facility Name

University Medical Center Groningen

City

Groningen

ZIP/Postal Code

9700RB

Country

Netherlands

Facility Name

University Medical Center Utrecht

City

Utrecht

ZIP/Postal Code

3508GA

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

15529389

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. doi: 10.1002/art.20610.

Results Reference

result

PubMed Identifier

15361396

Citation

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.

Results Reference

result

PubMed Identifier

19854713

Citation

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.

Results Reference

derived

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

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