Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment in Quiescent Systemic Lupus (CORTICOLUP)

Groupe Hospitalier Pitie-Salpetriere

Status and phase: Unknown; Phase 3

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: prednisone discontinuation

Study type: Interventional

Funder types: Other

Identifiers

NCT02558517

medint002

Details and patient eligibility

About

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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Prednisone maintenance

No Intervention group

Description:

Patients will be kept under Prednisone 5 milligrams/day. Other treatments will be maintained (in particular HYDROXYCHLOROQUINE, METHOTEXATE etc..)

Prednisone discontinuation

Experimental group

Description:

Prednisone will be stopped and remplaced by HYDROCORTISONE for one month (20 mg/day). Other treatments will be maintained (in particular HYDROXYCHLOROQUINE, METHOTEXATE etc..)

Treatment:

Drug: prednisone discontinuation