The Efficacy and Safety of Tofacitinib in Patients With G... | NCT06393972

Studies
The Efficacy and Safety of Tofacitinib in Patients With Glucocorticoid Resistant ICIs-related Myocarditis

NCT06393972

Sponsor

Shanghai Zhongshan Hospital

Status

Not yet recruiting

Last Update Posted

May 1, 2024Actual

Enrollment

25Estimated

Phase

Phase 2

Conditions

Glucocorticoid Resistant ICIs-related Myocarditis

Interventions

Tofacitinib 5 MG BID

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2024Estimated

Primary Completion Date

Nov 30, 2025Estimated

Completion Date

Nov 30, 2026Estimated

First Submitted Date

Nov 23, 2023

First Submission Date that Met QC Criteria

Apr 26, 2024

First Posted Date

May 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2024

Last Update Posted Date

May 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Label	Type	Description	Intervention Names
Tofacitinib	Experimental	Tofacitinib in patients with glucocorticoid resistant ICIs-related myocarditis	Drug: Tofacitinib 5 MG BID

Name	Type	Description	Arm Group Labels	Other Names
Tofacitinib 5 MG BID	Drug	Tofacitinib 5 MG BID	Tofacitinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-cause mortality within three months	All-cause mortality within three months	The first three months after tofacitinib administration

Secondary Outcomes

Measure	Description	Time Frame
All-cause mortality within six months	All-cause mortality within six months	The firs six months after tofacitinib administration
Progression-free survival	Progression-free survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years old
Patients treated with ICI immunotherapy (monotherapy or combination), including anti-PD1, anti-PDL1, anti-CTLA4; and including any type of cancer (even those in which ICI is not currently approved by regulatory)
Definite, probable or possible ICI-induced myocarditis according to the diagnostic criteria of the most recent expert consensus recommendations (e.g27, to be updated with any new recommendations to be published)
corticosteroid-resistant ICI-myocarditis: Corticosteroid-resistant ICI-myocarditis is defined by the absence of decrease in troponin levels or the appearance/persistence of severity criteria despite receiving prednisone dose ≥0.5 mg/kg/day for ≥2 days.
Signature of informed consent before any trial procedure from the patient or legal representative or the close relative
Patients covered by social security regimen (excepting AME)
Withhold of ICI

Exclusion Criteria:

Untreated and/or uncontrolled bacterial, fungal, or viral infection Pregnancy, breast-feeding or planning to become pregnant during the study period
For women of childbearing age, lack of effective contraception throughout the duration of participation in the study
Being treated with tofacitinib within 3 months prior to inclusion Known hypersensitivity to abatacept or belatacept
Being treated with anti-thymoglobulin, or alemtuzumab within 6 weeks of the first scheduled dose of abatacept
Patient participating to another interventional study (RIPH 1 only) People under legal protection measure (tutorship, curatorship or safeguard measures)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
C479163	tofacitinib
C494814	BID protein, human