Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study (RITE)
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|ClinicalTrials.gov Identifier: NCT02947945|
Recruitment Status : Recruiting
First Posted : October 28, 2016
Last Update Posted : September 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Reslizumab||Phase 2|
This study is open-label which means that all subjects will receive the study medication. The study medicine - reslizumab - will be given to the participants in addition to the medicines they are already taking to treat their EGPA such as oral steroids (e.g. prednisone) and medicines that reduce the activity of their immune system (the study doctor will tell the participants which medications these are) - this is what is meant by 'standard of care' and can vary in different countries. Drugs that are sometimes used (i.e., 'standard of care') to reduce the activity of the immune system in EGPA (in addition to oral steroids) include azathioprine, methotrexate, mycophenolate mofetil and cyclophosphamide. Information about how the study drug affects the human body and health will be collected through a number of tests, procedures and questions.
The study medicine, reslizumab, will be given to the participants at a dose of 3mg/kg intravenously (within a vein) every four weeks for 28 weeks for a total of 7 treatments. During the treatment phase of this study, a study staff member will call the participants every two weeks to see how they are doing, what medications they are taking, and if they are able to decrease their steroid use. The study is a total of 11 study visits in a 44 week time period. Everyone who takes part in the study will continue to receive his/her existing treatments for EGPA (although the dose of oral steroids may be reduced during the study).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label, to Evaluate the Efficacy and Safety of Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study: RITE Study|
|Actual Study Start Date :||September 12, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
all subjects will receive the study medication- reslizumab.
All subjects will receive Reslizumab
Other Name: Cinqair
- Document the safety of reslizumab therapy in patients with EGPA [ Time Frame: up to 12 months ]All adverse events will be reported to the sponsor and the IRB in accordance with the policy of National Jewish Health and the FDA. Adverse events will be recorded on Case Report Forms as non-serious or serious events (DAEs). Serious adverse events, whether or not considered related to the investigational drug, will be recorded on the Serious Adverse Event form and faxed to the IRB and the sponsor as soon as site personnel are aware of the event. Every attempt will be made to collect discharge summaries for each hospitalization should they occur to provide further details.
- Demonstrate the steroid sparing effect of reslizumab therapy by titrating corticosteroid dosage [ Time Frame: up to 12 months ]Goal is to demonstrate the steroid sparing effect of reslizumab therapy by titrating corticosteroid dosage while using this anti-IL-5 therapy or to reduce the rate of EGPA exacerbations during the study period. Change in steroid dose will be assessed by comparing the corticosteroid dose of subjects at the end of the steroid stable phase and compare to steroid dose at the end of the treatment period. Change in the rate of exacerbations will be assessed by comparing the rate of exacerbations during the study period with the rate during the washout and safety-monitoring period as well as with the self-reported rate of exacerbations from the year prior to the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947945
|Contact: Michael Wechsler, MDemail@example.com|
|Contact: Juno Pakfirstname.lastname@example.org|
|United States, Colorado|
|National Jewish Health||Recruiting|
|Denver, Colorado, United States, 80206|
|Contact: Michael Wechsler, MD 303-398-1085 email@example.com|
|Principal Investigator:||Michael Wechsler, MD||National Jewish Health|