Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104299
Status:
COMPLETED
Last Update Posted:
2017-04-21
First Post:
2005-02-24
Brief Title:
Rituximab for the Treatment of Wegeners Granulomatosis and Microscopic Polyangiitis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Rituximab Therapy for the Induction of Remission and Tolerance in ANCA-Associated Vasculitis ITN021AI
Status:
COMPLETED
Status Verified Date:
2017-03
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:
RAVE
Brief Summary:
Antineutrophil cytoplasmic antibodies ANCA-associated vasculitis is the most common type of small blood vessel inflammation in adults ANCA-associated vasculitis includes Wegeners granulomatosis WG and microscopic polyangiitis MPA Rituximab is a man-made antibody used to treat certain types of cancer The purpose of this study is to determine the effectiveness of rituximab in treating patients with WG and MPA
Study hypothesis Rituximab is not inferior to conventional therapy in its ability to induce disease remission by Month 6
Study hypothesis Rituximab is not inferior to conventional therapy in its ability to induce disease remission by Month 6
Detailed Description:
Current conventional therapies for ANCA-associated vasculitis AAV are associated with high incidences of treatment failure disease relapse substantial toxicity and patient morbidity and mortality Rituximab is a monoclonal antibody used to treat non-Hodgkins lymphoma This study will evaluate the efficacy of rituximab with glucocorticoids in inducing disease remission in patients with severe forms of AAV WG and MPA
The study consists of two phases a 6-month remission induction phase followed by a 12-month remission maintenance phase All participants will receive at least 1 g of pulse intravenous methylprednisolone or a dose-equivalent of another glucocorticoid preparation Depending on the participants condition he or she may receive up to 3 days of intravenous methylprednisolone for a total of 3 g of methylprednisolone or a dose-equivalent During the remission induction phase all participants will receive oral prednisone daily 1 mgkgday not to exceed 80 mgday Prednisone tapering will be completed by the Month 6 study visit
Next participants will be randomly assigned to one of two arms Arm 1 participants will receive rituximab 375 mgm2 infusions once weekly for 4 weeks and cyclophosphamide CYC placebo daily for 3 to 6 months Arm 2 participants will receive rituximab placebo infusions once weekly for 4 weeks and CYC daily for 3 to 6 months During the remission maintenance phase participants in Arm 1 will discontinue CYC placebo and start oral azathioprine AZA placebo daily until Month 18 Participants in Arm 2 will discontinue CYC and start AZA daily until Month 18 Participants who fail treatment before Month 6 will be crossed over to the other treatment arm unless there are specific contraindications Participants in either group who reach clinical remission before they complete 6 months of therapy may switch from CYCplacebo to AZAplacebo if directed by their physicians
All participants will be followed for at least 18 months Initially study visits are weekly progressing to monthly and then quarterly visits as the study proceeds Blood collection will occur at each study visit
The study consists of two phases a 6-month remission induction phase followed by a 12-month remission maintenance phase All participants will receive at least 1 g of pulse intravenous methylprednisolone or a dose-equivalent of another glucocorticoid preparation Depending on the participants condition he or she may receive up to 3 days of intravenous methylprednisolone for a total of 3 g of methylprednisolone or a dose-equivalent During the remission induction phase all participants will receive oral prednisone daily 1 mgkgday not to exceed 80 mgday Prednisone tapering will be completed by the Month 6 study visit
Next participants will be randomly assigned to one of two arms Arm 1 participants will receive rituximab 375 mgm2 infusions once weekly for 4 weeks and cyclophosphamide CYC placebo daily for 3 to 6 months Arm 2 participants will receive rituximab placebo infusions once weekly for 4 weeks and CYC daily for 3 to 6 months During the remission maintenance phase participants in Arm 1 will discontinue CYC placebo and start oral azathioprine AZA placebo daily until Month 18 Participants in Arm 2 will discontinue CYC and start AZA daily until Month 18 Participants who fail treatment before Month 6 will be crossed over to the other treatment arm unless there are specific contraindications Participants in either group who reach clinical remission before they complete 6 months of therapy may switch from CYCplacebo to AZAplacebo if directed by their physicians
All participants will be followed for at least 18 months Initially study visits are weekly progressing to monthly and then quarterly visits as the study proceeds Blood collection will occur at each study visit
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