Ignite Creation Date:
2024-05-06 @ 12:26 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01570764
Status:
COMPLETED
Last Update Posted:
2019-11-18
First Post:
2012-04-02
Brief Title:
Cyclophosphamide Systemic Sclerosis Associated Interstitial Lung Disease
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Intravenous Cyclophosphamide for the Treatment of Systemic Sclerosis Associated Interstitial Lung Disease
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCLEROCYC
Brief Summary:
By including in this study patients with significant worsening of their lung volumes and or their DLCO carbon monoxide diffusing capacity in the previous year on the basis of an open retrospective study we recently conducted we hope to demonstrate that a strategy combining prednisone and intravenous cyclophosphamide therapy is accompanied by an increase in the frequency stabilization improvement of lung volumes and or DLCO of patients at 12 months of 15 in the placebo and prednisone cyclophosphamide 50 in cyclophosphamide and prednisoneWe also hope to demonstrate significant decrease in the number of patients excluded for failure in the CYC arm as compared to the placebo arm
Detailed Description:
This is a randomized prospective multicenter study evaluating the efficacy against placebo of cyclophosphamide in combination with prednisone in the treatment of systemic sclerosis related interstitial lung disease Patients will be allocated after randomization into two groups receiving both corticosteroids a group of patients receiving placebo of cyclophosphamide and a group of patients treated with cyclophosphamide Cyclophosphamide will be administered IV at a dose of 07 g m maximum 1200 mg every 4 weeks In patients over 65 or if the creatinine clearance below 30 ml min the dose should be reduced to 06 g m² The duration of treatment with cyclophosphamide will be 12 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-004709-26 | EUDRACT_NUMBER | None | None |