Corticosteroids
DrugInitial dosage of corticosteroids is no less than predinisone 1mg/kg/d or other corticosteroids with equal equivalence
NCT Number: NCT05899725
This study is a prospective multicenter randomized controlled Interventional study, to assess the clinical efficacy and safety of corticosteroids compared to corticosteroids in combination with Ruxolitinib in the treatment of severe checkpoint inhibitor pneumonitis.
Looking for future studies?
Notify Me15 year–80 year
All sexes
Interventional
Not applicable
Department of Respiratory Medicine, Peking Union Medical College Hospita, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Initial dosage of corticosteroids is no less than predinisone 1mg/kg/d or other corticosteroids with equal equivalence
Initial dosage of corticosteroids is no less than predinisone 1mg/kg/d or other corticosteroids with equal equivalence, add-on oral Ruxolitinib 5mg twice a day for 2 weeks, following with Ruxolitinib
Time frame: 8 weeks
Proportion of patients with dosage of corticosteroids no more than 10mg daily at improvement to CIP with CTCAE grade 1.
Time frame: 8 weeks
Mortality of severe CIP patients at 8 weeks.
Time frame: 8 weeks
Proportion of invasive ventilator assisted respiration treatment for severe CIP patients at 8 weeks.
Time frame: 8 weeks
Incidence of pulmonary infection in severe CIP patients in 8 weeks.
Time frame: 8 weeks.
Total corticosteroids usage for severe CIP patients in 8 weeks.
Time frame: 8 weeks.
The incidence of treatment with immunosuppressants and the incidence of treatment with IVIG for severe CIP patients in 8 weeks.
Peking Union Medical College Hospital
Other
The Efficacy and Safety of Corticosteroids in Combination With Biological Agents in the Management of Severe Immune Related Adverse Events Cohort A: The Efficacy and Safety of Corticosteroids or Corticosteroids Combination With Ruxolitinib in Patients With Severe Checkpoint Inhibitor Pneumonia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.