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Systemic Lupus ErythematosusPhase 3CORTICOLUPNCT02558517

Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment in Quiescent Systemic Lupus

A Phase 3 study testing prednisone discontinuation in people with Systemic Lupus Erythematosus, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Systemic Lupus (SLE) is a chronic disease for which long term treatments are warranted. The aim of this study was to study the possibility of corticosteroids interruption in patients with quiescent SLE treated since at least one year with 5 milligrams of predonisone per day. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
prednisone discontinuation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteFrance
Study dates
Jan 2014to Jan 2018
Phase
Phase 3
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with SLE according to the ACR revised criteria.
  • Quiescent disease without flare since at least one year (SELENA SLEDAI < or equal to 4, BILAG C, D or E, PGA 0) _ Treatment with 5 milligrams/day of prednisone since at least 1 year

Who cannot join

  • failure to sign the informed consent or unable to consent
  • Patient participating to another clinical trial
  • Pregnancy or plan to become pregnant

Trial locations and contacts

1 site in 1 country.

Zahir AMOURA, MD contact

+33 1 42 17 80 01

zahir.amoura@aphp.fr

Fleur COHEN AUBART, PD, PhD contact

+33 1 42 17 82 42

fleur.cohen@aphp.fr

France1 site, 1 recruiting

  • Groupe Hospitalier Pitié Salpêtrière, Service de médecine Interne 2, Institut e3m

    Paris, 75 013

    Zahir AMOURA, MD, +33 1 42 17 80 01, zahir.amoura@aphp.fr

    Recruiting

Other trials in France

About this study

Official title: Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment (Prednisone 5 Milligram Per Day) in Quiescent Systemic Lupus

Systemic Lupus (SLE) is a chronic disease for which long term treatments are warranted. The aim of this study was to study the possibility of corticosteroids interruption in patients with quiescent SLE treated since at least one year with 5 milligrams of predonisone per day.

Being tested
prednisone discontinuation
Keywords
Systemic Lupus Erythematosus, Corticosteroids, Chronic disease
Medical subject headings
Lupus Erythematosus, Systemic, Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • prednisone discontinuationDrug

    Also called prednisone maintenance

    randomization

Study groups in NCT02558517
Study groupRoleWhat they receive
Prednisone maintenanceNo interventionPatients will be kept under Prednisone 5 milligrams/day. Other treatments will be maintained (in particular HYDROXYCHLOROQUINE, METHOTEXATE etc..)
Prednisone discontinuationExperimentalPrednisone will be stopped and remplaced by HYDROCORTISONE for one month (20 mg/day). Other treatments will be maintained (in particular HYDROXYCHLOROQUINE, METHOTEXATE etc..)
Receives: Drug: prednisone discontinuation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurence of mild or moderate flares of SLE defined by the SLE FLARE Index

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2015 (estimated)
  2. Study startJan 2014
  3. Primary completionJan 2017 (estimated)
  4. Study completionJan 2018 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
136 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02558517
Sponsor's protocol ID
medint002
Acronym
CORTICOLUP
Status last verified
Aug 2016
First submitted
22 Sep 2015
Last updated
11 Aug 2016
Results posted
No
Data monitoring committee
No

Publications

  • Mathian A, Pha M, Haroche J, Cohen-Aubart F, Hie M, Pineton de Chambrun M, Boutin THD, Miyara M, Gorochov G, Yssel H, Cherin P, Devilliers H, Amoura Z. Withdrawal of low-dose prednisone in SLE patients with a clinically quiescent disease for more than 1 year: a randomised clinical trial. Ann Rheum Dis. 2020 Mar;79(3):339-346. doi: 10.1136/annrheumdis-2019-216303. Epub 2019 Dec 18.

    PubMed 31852672

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing prednisone discontinuation in people with Systemic Lupus Erythematosus, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.

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 3 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 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Zahir AMOURA, MD (+33 1 42 17 80 01, zahir.amoura@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurence of mild or moderate flares of SLE defined by the SLE FLARE Index (time frame: 12 months). 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 NCT02558517, 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 11 Aug 2016.

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