Five-Year Single-Blind, Phase III Effectiveness Randomised Actively Controlled Clinical Trial in New Onset Juvenile Systemic Lupus Erythematosus Nephritis: Oral Cyclophosphamide Versus High Dose Intravenous Cyclophosphamide Versus Intermediate Dose Intravenous Cyclophosphamide

NCT00336414 Phase 3 WITHDRAWN

This is a 5-year project, involving 185 partners from 46 countries (110 in 21 EU States and 75 in 25 extra-EU States), with a randomised clinical trials (RCT) in juvenile systemic lupus erythematosus (JSLE): 5-year phase III single-blind, RCT in children with newly diagnosed, WHO class III, IV JSLE proliferative nephritis: PDN and oral cyclophosphamide (CYC) versus high dose intravenous (iv) CYC versus intermediate dose iv CYC, followed by maintenance with azathioprine.The trial is aimed to find out the treatment regimen associated with the lowest occurrence of flare and the lowest drug related toxicity.

Details

Lead sponsor	Istituto Giannina Gaslini
Phase	Phase 3
Status	WITHDRAWN
Start date	2006-06
Completion	2007-06

Conditions

• Systemic Lupus Erythematosus Nephritis

Interventions

• cyclophosphamide-prednisone-azathioprine

Primary outcomes

• Primary: 50% improvement in at least 2 core set variables with no more tha 1 of the remaining variables worsened by> 30%
• core set variables:
• physician's global assessment of disease activity on a 10 cm visual analogue scale; global disease activity measure by the mean of the European Consensus Lupus Activity parent's/patient's global assessment of overall well-being on a 10 cm VAS;
• health-related quality of life assessment.

Countries

Italy