IMVT-1401-2401 12+

Name: IMVT-1401-2401
Author: ERT,INC

ERT,INC

iPad対応

- 無料

説明

The Immunovant eCOA App is intended for use to collect weekly study dosing information in a dosing diary relating to the IMVT-1401-2401 clinical trial. Patients must be given accounts by a participating site in order to log in to the app.

2024年3月27日

バージョン 2.12.7 (33)

1) Cohort C eligibility message and functionality during Screening Visit and Visit 13 have been updated per latest protocol.
Inclusion Criteria: Patients have an INCAT score of ≥ 2 points at the Screening and Period 1 Baseline Visits. Note: Participants with an INCAT score of 2 at study entry must have this score exclusively from the leg disability score; for participants with an INCAT score of ≥ 3 at study entry, there are no specific requirements for arm or leg.
2) Site has the ability to make a decision to discontinue the patient from study treatment at the end of any visit if the patient chooses to, regardless of worsening or relapse status, and based on that decision the Clario system will either move the patient to Follow up or the appropriate Early Termination Phase, dependent upon the current visit and whether all Early Termination forms have been completed.
3) Joing Blinded assessor & C-SSRS rater role has been removed from tablet setup.
4) INCAT Score Check Form added in all Visits of Period 1 to monitor Worsening.