Lupus Erythematosus, SystemicPhase 2NCT00391924
Dehydroepiandrosterone Administration in Women With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome
A Phase 2 study testing Dehydroepiandrosterone in people with Lupus Erythematosus, Systemic and Sjogren's Syndrome, run by UMC Utrecht at 2 sites in Netherlands.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lupus Erythematosus, Systemic, Sjogren's Syndrome
- What is being tested?
- Dehydroepiandrosterone
- How many people
- 120 participants
- Where
- 2 sitesNetherlands
- Study dates
- May 2000to Jan 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
University Medical Center Groningen
Groningen, 9700RB
University Medical Center Utrecht
Utrecht, 3508GA
About this study
Official title: Fatigue and General Well-Being in Patients With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome: Effects of Dehydroepiandrosterone Administration
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
Read the 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.
- Conditions
- Lupus Erythematosus, Systemic, Sjogren's Syndrome
- Being tested
- Dehydroepiandrosterone
- Keywords
- Dehydroepiandrosterone, Fatigue, Quality of life, Lupus Erythematosus, Systemic, Sjogren's Syndrome, Bone mineral density
- Medical subject headings
- Lupus Erythematosus, Systemic, Sjogren's Syndrome, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DehydroepiandrosteroneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2006 (estimated)
- Study startMay 2000
- Study completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen, Dutch Arthritis Association
- Investigators
- Ronald HW Derksen, MD,PhD, Study chair, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391924
- Sponsor's protocol ID
- NR 98-2-301
- Status last verified
- Oct 2006
- First submitted
- 24 Oct 2006
- Last updated
- 25 Oct 2006
- Results posted
- No
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. doi: 10.1002/art.20610.
PubMed 15529389Hartkamp 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.
PubMed 15361396Hartkamp 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.
PubMed 19854713
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue and General Well-Being in Patients With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome: Effects of Dehydroepiandrosterone Administration
- ClinicalTrials.gov ID
- NCT00391924
- Acronym / sponsor ID
- NR 98-2-301
- Conditions
- Lupus Erythematosus, Systemic, Sjogren's Syndrome
- Keywords
- Dehydroepiandrosterone, Fatigue, Quality of life, Lupus Erythematosus, Systemic, Sjogren's Syndrome, Bone mineral density
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- University Medical Center Groningen, Dutch Arthritis Association
- Study start
- May 2000
- Study completion
- Jan 2003
- First posted
- 25 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dehydroepiandrosterone | Drug | – |
Primary outcome
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)
11 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2006.
- Results publication: PubMed 15529389Hartkamp 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 publication: PubMed 15361396Hartkamp 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.
- Derived from this study: PubMed 19854713Hartkamp 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald HW Derksen, MD,PhD study chair
UMC Utrecht
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dehydroepiandrosterone in people with Lupus Erythematosus, Systemic and Sjogren's Syndrome, run by UMC Utrecht at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General fatigue. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00391924, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2006.