Systemic Lupus ErythematosusNCT01616472
WEUKBRE5716: Steroid-related Damage in Systemic Lupus Erythematosus (Hopkins)
An observational study of Systemic Lupus Erythematosus, run by GlaxoSmithKline.
Trial summary
The study is designed to assess the association between steroid exposure and five potentially steroid-related adverse events within a cohort of individuals with systemic lupus erythematosus (SLE). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Cumulative corticosteroid exposure
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Jan 2016
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cases and controls will be identified from the Hopkins Lupus Cohort, a prospective longitudinal study of lupus activity, organ damage, and quality of life in patients with SLE which has followed patients up since 1987. The cohort database is continually updated and includes socio-demographic information, medical and reproductive history, comorbidities, SLE complications, and treatment. Data, collected at each patient visit, includes SLE clinical activity indices, laboratory data and treatment (medication and dose).
Who may be able to join
- Newly diagnosed SLE as per ACR criteria
- No history of "case" event of interest in follow-up time prior to SLE diagnosis (case) or during follow-up time since SLE diagnosis that is equivalent to length of case at-risk time period (controls)
Who cannot join
- None
About this study
Official title: WEUKBRE5716: Quantifying the Burden of Steroid-related Damage in Systemic Lupus Erythematosus in the Hopkins Lupus Cohort
The study is designed to assess the association between steroid exposure and five potentially steroid-related adverse events within a cohort of individuals with systemic lupus erythematosus (SLE). Study objectives are to quantify the fraction of the risk of new (i) diabetes, (ii) hypertension, (iii) cataracts, (iv) osteoporosis and (v) avascular necrosis that is attributable to cumulative corticosteroid exposure in SLE patients. The study will consist of five matched case-control analyses nested within the Hopkins Lupus Cohort. Cases will be incident SLE cases who have developed one of the case outcomes (diabetes, hypertension, cataracts, osteoporosis with fracture or vertebral collapse or avascular necrosis). Controls will be matched to cases on time since SLE diagnosis. The primary exposures to be assessed are cumulative dose of steroid (g) and cumulative duration of exposure to steroids. The extent of the risk associated with steroids will be explored through modeling of the relationship and through calculation of attributable risks of exposure (number of cases associated with the highest exposure quartile of each primary exposure).
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Cumulative corticosteroid exposure
- Keywords
- hypertension, avascular necrosis, systemic lupus erythematosus, osteoporosis, Steroid, diabetes, cataracts
- Medical subject headings
- Lupus Erythematosus, Systemic, Hypertension, Osteonecrosis, Osteoporosis, Diabetes Mellitus, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cumulative corticosteroid exposureDrug
Cumulative steroid exposure will be modeled as cumulative dose (prednisone equivalent mg), cumulative days of exposure at any dose, cumulative days of exposure to doses ≥7.5mg and cumulative days of exposure to doses ≥20mg.
| Study group | Role | What they receive |
|---|---|---|
| Incident diabetes cases | Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who are newly diagnosed with diabetes during follow-up, subsequent to SLE diagnosis. Receives: Drug: Cumulative corticosteroid exposure | |
| Incident diabetes controls | Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who have no record of diabetes during follow-up time (years) since SLE diagnosis that is equivalent to length of case at-risk time. Controls are matched to cases on decade of SLE diagnosis: 1987-1989, 1990-1999, 2000-2009, 2010+ Receives: Drug: Cumulative corticosteroid exposure | |
| Incident hypertension cases | Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who are newly diagnosed with hypertension during follow-up, subsequent to SLE diagnosis. Receives: Drug: Cumulative corticosteroid exposure | |
| Incident hypertension controls | Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who have no record of hypertension during follow-up time (years) since SLE diagnosis that is equivalent to length of case at-risk time. Controls are matched to cases on decade of SLE diagnosis: 1987-1989, 1990-1999, 2000-2009, 2010+ Receives: Drug: Cumulative corticosteroid exposure | |
| Incident cataract cases | Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who are newly diagnosed with cataract during follow-up, subsequent to SLE diagnosis. Receives: Drug: Cumulative corticosteroid exposure | |
| Incident cataract controls | Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who have no record of cataract during follow-up time (years) since SLE diagnosis that is equivalent to length of case at-risk time. Controls are matched to cases on decade of SLE diagnosis: 1987-1989, 1990-1999, 2000-2009, 2010+ Receives: Drug: Cumulative corticosteroid exposure | |
| Incident osteoporosis cases | Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who are newly diagnosed with osteoporosis during follow-up, subsequent to SLE diagnosis. Receives: Drug: Cumulative corticosteroid exposure | |
| Incident osteoporosis controls | Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who have no record of osteoporosis during follow-up time (years) since SLE diagnosis that is equivalent to length of case at-risk time. Controls are matched to cases on decade of SLE diagnosis: 1987-1989, 1990-1999, 2000-2009, 2010+ Receives: Drug: Cumulative corticosteroid exposure | |
| Incident avascular necrosis cases | Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who are newly diagnosed with avascular necrosis during follow-up, subsequent to SLE diagnosis Receives: Drug: Cumulative corticosteroid exposure | |
| Incident avascular necrosis controls | Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who have no record of avascular necrosis during follow-up time (years) since SLE diagnosis that is equivalent to length of case at-risk time. Controls are matched to cases on decade of SLE diagnosis: 1987-1989, 1990-1999, 2000-2009, 2010+ Receives: Drug: Cumulative corticosteroid exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
New diagnoses of diabetes, hypertension, cataracts, osteoporosis, or avascular necrosis
New diagnoses of diabetes, hypertension, cataracts, osteoporosis, or avascular necrosis recorded after SLE diagnosis in the Hopkins Lupus cohort
Measured: Over a period of 25 years from 1987-2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616472
- Sponsor's protocol ID
- 116015
- Other IDs
- WEUKBRE5716
- Status last verified
- Apr 2016
- First submitted
- 7 Jun 2012
- Last updated
- 25 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Davidson JE, Fu Q, Rao S, Magder LS, Petri M. Quantifying the burden of steroid-related damage in SLE in the Hopkins Lupus Cohort. Lupus Sci Med. 2018 May 14;5(1):e000237. doi: 10.1136/lupus-2017-000237. eCollection 2018.
PubMed 29765616
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WEUKBRE5716: Quantifying the Burden of Steroid-related Damage in Systemic Lupus Erythematosus in the Hopkins Lupus Cohort
- ClinicalTrials.gov ID
- NCT01616472
- Acronym / sponsor ID
- 116015
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- hypertension, avascular necrosis, systemic lupus erythematosus, osteoporosis, Steroid, diabetes, cataracts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 11 Jun 2012 (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 study is designed to assess the association between steroid exposure and five potentially steroid-related adverse events within a cohort of individuals with systemic lupus erythematosus (SLE). Study objectives are to quantify the fraction of the risk of new (i) diabetes, (ii) hypertension, (iii) cataracts, (iv) osteoporosis and (v) avascular necrosis that is attributable to cumulative corticosteroid exposure in SLE patients. The study will consist of five matched case-control analyses nested within the Hopkins Lupus Cohort. Cases will be incident SLE cases who have developed one of the case outcomes (diabetes, hypertension, cataracts, osteoporosis with fracture or vertebral collapse or avascular necrosis). Controls will be matched to cases on time since SLE diagnosis. The primary exposures to be assessed are cumulative dose of steroid (g) and cumulative duration of exposure to steroids. The extent of the risk associated with steroids will be explored through modeling of the relationship and through calculation of attributable risks of exposure (number of cases associated with the highest exposure quartile of each primary exposure).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Incident diabetes cases | – | Drug: Cumulative corticosteroid exposureIndividuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who are newly diagnosed with diabetes during follow-up, subsequent to SLE diagnosis. |
| Incident diabetes controls | – | Drug: Cumulative corticosteroid exposureIndividuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who have no record of diabetes during follow-up time (years) since SLE diagnosis that is equivalent to length of case at-risk time. Controls are matched to cases on decade of SLE diagnosis: 1987-1989, 1990-1999, 2000-2009, 2010+ |
| Incident hypertension cases | – | Drug: Cumulative corticosteroid exposureIndividuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who are newly diagnosed with hypertension during follow-up, subsequent to SLE diagnosis. |
| Incident hypertension controls | – | Drug: Cumulative corticosteroid exposureIndividuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who have no record of hypertension during follow-up time (years) since SLE diagnosis that is equivalent to length of case at-risk time. Controls are matched to cases on decade of SLE diagnosis: 1987-1989, 1990-1999, 2000-2009, 2010+ |
| Incident cataract cases | – | Drug: Cumulative corticosteroid exposureIndividuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who are newly diagnosed with cataract during follow-up, subsequent to SLE diagnosis. |
| Incident cataract controls | – | Drug: Cumulative corticosteroid exposureIndividuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who have no record of cataract during follow-up time (years) since SLE diagnosis that is equivalent to length of case at-risk time. Controls are matched to cases on decade of SLE diagnosis: 1987-1989, 1990-1999, 2000-2009, 2010+ |
| Incident osteoporosis cases | – | Drug: Cumulative corticosteroid exposureIndividuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who are newly diagnosed with osteoporosis during follow-up, subsequent to SLE diagnosis. |
| Incident osteoporosis controls | – | Drug: Cumulative corticosteroid exposureIndividuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who have no record of osteoporosis during follow-up time (years) since SLE diagnosis that is equivalent to length of case at-risk time. Controls are matched to cases on decade of SLE diagnosis: 1987-1989, 1990-1999, 2000-2009, 2010+ |
| Incident avascular necrosis cases | – | Drug: Cumulative corticosteroid exposureIndividuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who are newly diagnosed with avascular necrosis during follow-up, subsequent to SLE diagnosis |
| Incident avascular necrosis controls | – | Drug: Cumulative corticosteroid exposureIndividuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who have no record of avascular necrosis during follow-up time (years) since SLE diagnosis that is equivalent to length of case at-risk time. Controls are matched to cases on decade of SLE diagnosis: 1987-1989, 1990-1999, 2000-2009, 2010+ |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cases and controls will be identified from the Hopkins Lupus Cohort, a prospective longitudinal study of lupus activity, organ damage, and quality of life in patients with SLE which has followed patients up since 1987. The cohort database is continually updated and includes socio-demographic information, medical and reproductive history, comorbidities, SLE complications, and treatment. Data, collected at each patient visit, includes SLE clinical activity indices, laboratory data and treatment (medication and dose).
Key inclusion criteria (2 listed)
- Newly diagnosed SLE as per ACR criteria
- No history of "case" event of interest in follow-up time prior to SLE diagnosis (case) or during follow-up time since SLE diagnosis that is equivalent to length of case at-risk time period (controls)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Cumulative corticosteroid exposureCumulative steroid exposure will be modeled as cumulative dose (prednisone equivalent mg), cumulative days of exposure at any dose, cumulative days of exposure to doses ≥7.5mg and cumulative days of exposure to doses ≥20mg. | Drug | Incident avascular necrosis cases, Incident avascular necrosis controls, Incident cataract cases, Incident cataract controls, Incident diabetes cases, Incident diabetes controls, Incident hypertension cases, Incident hypertension controls, Incident osteoporosis cases, Incident osteoporosis controls |
Primary outcome
New diagnoses of diabetes, hypertension, cataracts, osteoporosis, or avascular necrosis
Time frame: Over a period of 25 years from 1987-2011
New diagnoses of diabetes, hypertension, cataracts, osteoporosis, or avascular necrosis recorded after SLE diagnosis in the Hopkins Lupus cohort
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 Apr 2016.
- Derived from this study: PubMed 29765616Davidson JE, Fu Q, Rao S, Magder LS, Petri M. Quantifying the burden of steroid-related damage in SLE in the Hopkins Lupus Cohort. Lupus Sci Med. 2018 May 14;5(1):e000237. doi: 10.1136/lupus-2017-000237. eCollection 2018.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by GlaxoSmithKline.
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 2 inclusion and 1 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 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
New diagnoses of diabetes, hypertension, cataracts, osteoporosis, or avascular necrosis (time frame: Over a period of 25 years from 1987-2011). 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 NCT01616472, which also lists 1 linked publication.
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 Apr 2016.