Systemic Lupus ErythematosusNCT03804723
Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus
A study testing oral Prednisone 5mg in people with Systemic Lupus Erythematosus and Glucocorticoids, run by University of Pisa.
Trial summary
This is a 36 months, randomized, double-blind, placebo-controlled, parallel-groups, equivalence multicenter trial in patients with inactive Systemic Lupus Erythematosus to evaluate if low disease activity can be sustained with withdrawal of glucocorticoids in patients on stable clinical remission or low disease… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Systemic Lupus Erythematosus, Glucocorticoids, Therapy Withdrawal
- What is being tested?
- oral Prednisone 5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 321 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to Sep 2023
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of SLE according to the EULAR/ACR criteria within three years from screening visit
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national subject privacy regulations
- Aged 18 to 75 years old, inclusive, at the time of informed consent
- Documented diagnosis of SLE according to the current ACR criteria
- Stable immunosuppressive treatment for SLE for a minimum of one year/six months
- Stable treatment with antimalarials for a minimum of 3 months
- stable (lasting for at least 6 months) low disease activity
Who cannot join
- Disease activity (non LLDAS) within 6 months prior to screening
- Concomitant ongoing conditions (e.g. asthma, Crohn's disease) that require treatment with systemic GC (excluding topical or inhaled GC).
- Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, social) likely to affect the subject returning for follow-up visits on schedule
- Nursing mothers, pregnant women or women planning to become pregnant during the study.
Trial locations and contacts
No sites are listed yet.
Chiara Tani, MD contact
About this study
Official title: Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus: a Randomized Placebo-controlled Equivalence Trial
This is a 36 months, randomized, double-blind, placebo-controlled, parallel-groups, equivalence multicenter trial in patients with inactive Systemic Lupus Erythematosus to evaluate if low disease activity can be sustained with withdrawal of glucocorticoids in patients on stable clinical remission or low disease activity.
- Being tested
- oral Prednisone 5mg
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral Prednisone 5mgDrug
patients randomized to this arm will stop prednisone 5 mg
| Study group | Role | What they receive |
|---|---|---|
| GC withdrawal | Experimental | Not described Receives: Drug: oral Prednisone 5mg |
| non GC withdrawal | Placebo comparator | Not described Receives: Drug: oral Prednisone 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease flare
The primary endpoint is the proportion of patients who will experience a disease during the follow-up period in the groups given prednisone 5 mg or placebo in the double-blind period.
Measured: 35 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study startJun 2019 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a 36 month, randomized, double-blind, placebo-controlled, parallel-groups, equivalence multicenter trial in patients with inactive SLE to evaluate if low disease activity can be sustained with withdrawal of glucocorticoids
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 321 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Mosca, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804723
- Sponsor's protocol ID
- 001
- Status last verified
- Jan 2019
- First submitted
- 11 Jan 2019
- Last updated
- 18 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus: a Randomized Placebo-controlled Equivalence Trial
- ClinicalTrials.gov ID
- NCT03804723
- Acronym / sponsor ID
- 001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 321 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 15 Jan 2019 (actual)
- 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.
This is a 36 months, randomized, double-blind, placebo-controlled, parallel-groups, equivalence multicenter trial in patients with inactive Systemic Lupus Erythematosus to evaluate if low disease activity can be sustained with withdrawal of glucocorticoids in patients on stable clinical remission or low disease activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a 36 month, randomized, double-blind, placebo-controlled, parallel-groups, equivalence multicenter trial in patients with inactive SLE to evaluate if low disease activity can be sustained with withdrawal of glucocorticoids
| Arm | Type | Receives |
|---|---|---|
| GC withdrawal | Experimental | Drug: oral Prednisone 5mg |
| non GC withdrawal | Placebo comparator | Drug: oral Prednisone 5mg |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of SLE according to the EULAR/ACR criteria within three years from screening visit
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national subject privacy regulations
- Aged 18 to 75 years old, inclusive, at the time of informed consent
- Documented diagnosis of SLE according to the current ACR criteria
- Stable immunosuppressive treatment for SLE for a minimum of one year/six months
Key exclusion criteria (4 listed)
- Disease activity (non LLDAS) within 6 months prior to screening
- Concomitant ongoing conditions (e.g. asthma, Crohn's disease) that require treatment with systemic GC (excluding topical or inhaled GC).
- Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, social) likely to affect the subject returning for follow-up visits on schedule
- Nursing mothers, pregnant women or women planning to become pregnant during the study.
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 |
|---|---|---|
| oral Prednisone 5mgpatients randomized to this arm will stop prednisone 5 mg | Drug | GC withdrawal, non GC withdrawal |
Primary outcome
disease flare
Time frame: 35 months
The primary endpoint is the proportion of patients who will experience a disease during the follow-up period in the groups given prednisone 5 mg or placebo in the double-blind period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
Chiara Tani, MD contact
Questions about this trial
What is this clinical trial studying?
A study testing oral Prednisone 5mg in people with Systemic Lupus Erythematosus and Glucocorticoids, run by University of Pisa.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Jan 2019. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta Mosca, MD (050992519, marta.mosca@med.inipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease flare (time frame: 35 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2019.