Personalised approach to the tapering of corticosteroid treatment in systemic lupus patients

Phase 1

• Conditions: MedDRA version: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Systemic lupus erythematosus; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-002050-36-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-03
• Last Update Posted: 6 November 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1) Patient aged >= 6 years
2) Patient who met the American College of Rheumatology criteria (ACR) or the Systemic Lupus International Collaborating Clinics Classification (SLICC) for systemic lupus erythematosus (Addenda 3)
3) Patient needs initiation of oral prednisone regimen at least at 0,5 mg/Kg/d in combination with mycophenolate mofetyl at usual dose (2 to 3 g/d in adults; 1200 mg/m2 in children with dose <= 2 g/d), including
i) patient who will receive bolus of methylprednisolone within the first week of inclusion for treating the lupus flare,
ii) patient who was previously treated by a low-dose prednisone (<= 7,5 mg/day for patient >= 60 kg and 0,1 mg/kg/day for patients < 60 kg).
4) Patients does not receive other immunosuppressive or biological drugs at inclusion
5) Signed Informed consent form by the patient (if aged >= 18 years), or by parents / legal guardian and patient's agreement (if aged < 18 years)
6) Patient affiliated to the health insurance system
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1) Patient presents contraindications to corticosteroids and/or MMF
2) Patients cannot be treated by oral way
3) Patient whose physician has planned to stop prednisone in less than 3 months
4) Patient (or parents for minor) are unable to give a written informed consent for physical or psychical reasons
5) Patient disagrees with the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified