Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336414
Status:
WITHDRAWN
Last Update Posted:
2018-03-20
First Post:
2006-06-12
Brief Title:
Five-Year Actively Controlled Clinical Trial in New Onset Juvenile Systemic Lupus Erythematosus Nephritis
Sponsor:
Istituto Giannina Gaslini
Organization:
Istituto Giannina Gaslini
Study Overview
Official Title:
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
Status:
WITHDRAWN
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
the study is withdrawn due to low and unexpected enrollment rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 azathioprineThe trial is aimed to find out the treatment regimen associated with the lowest occurrence of flare and the lowest drug related toxicity
Detailed Description:
Scientific objectives The proposed project is aimed to improve treatment approaches for rare severe and disabling paediatric rheumatic diseases PRD This goal will be achieved by the Paediatric Rheumatology International Trials Organisation PRINTO an international network whose main function is to provide a scientific base for current PRD treatments for which no evidence based data exist in the literature and for drugs for which there is no support from industries
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 JSLE RCT is aimed to find out the treatment regimen associated with the lowest occurrence of flare and the lowest drug related toxicity The retention on treatment will be used as main measure of effectiveness
Methodology The present protocol is the natural follow up of previous work conducted by PRINTO In particular the RCT foreseen in this protocol is modelled after the successful completion of an early phase trial with MTX in juvenile idiopathic arthritis and will use validated JSLE outcome measures for the evaluation of response to therapy
It is the basic premise of this protocol that without i the involvement of the international paediatric rheumatology community ii the innovative type of mechanism described herein these studies would never be conducted
Objectives The goals of the current protocol is therefore the natural follow-up of the objectives achieved with the previous grants and in particular of projects designed to discern new models for the successful conduct of clinical trials in children with rare diseases and to develop standardized and validated measures for the evaluation of response to therapy in JSLE
The proposed trials in in JSLE oral cyclophosphamide CYC versus intermediate dose intravenous iv CYC versus high dose iv CYC followed by maintenance therapy with azathioprine AZA should serve as a model for the successful running of early phase clinical trials for severe and disabling rare diseases of childhood The ultimate aim of these trials is to provide evidence-based information about the clinical utility of drugs in the management of rare paediatric conditions
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 JSLE RCT is aimed to find out the treatment regimen associated with the lowest occurrence of flare and the lowest drug related toxicity The retention on treatment will be used as main measure of effectiveness
Methodology The present protocol is the natural follow up of previous work conducted by PRINTO In particular the RCT foreseen in this protocol is modelled after the successful completion of an early phase trial with MTX in juvenile idiopathic arthritis and will use validated JSLE outcome measures for the evaluation of response to therapy
It is the basic premise of this protocol that without i the involvement of the international paediatric rheumatology community ii the innovative type of mechanism described herein these studies would never be conducted
Objectives The goals of the current protocol is therefore the natural follow-up of the objectives achieved with the previous grants and in particular of projects designed to discern new models for the successful conduct of clinical trials in children with rare diseases and to develop standardized and validated measures for the evaluation of response to therapy in JSLE
The proposed trials in in JSLE oral cyclophosphamide CYC versus intermediate dose intravenous iv CYC versus high dose iv CYC followed by maintenance therapy with azathioprine AZA should serve as a model for the successful running of early phase clinical trials for severe and disabling rare diseases of childhood The ultimate aim of these trials is to provide evidence-based information about the clinical utility of drugs in the management of rare paediatric conditions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None