Open Label, Controlled, Post Marketing, Registry Study of Ribociclib (Ribo) Treatment Adherence and Patient Reported Outcomes in Participants Using ReX Technology Platform

Conditions

• Any Solid Oral Medication

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Use of ReX to dispense and monitor solid oral medication therapy. — DEVICE
  ReX Remote Digital Nurse comprising hand-held dispenser, disposable drug cartridge and web application (ReX Treatment Manager).

Study Details

Primary Objective: • To assess the persistence of ReX technology platform use, measured by the percentage (%) of participants who used ReX: 1) throughout the study period and 2) before the treatment discontinuation. Secondary Objective: • To evaluate the impact of the ReX technology platform on ribo treatment duration and ribo dose taking adherence as compared to control group.

Key Dates

Start date

Mar 30, 2024

Status verified

Aug 2024

Primary completion

Mar 30, 2025

Completion

Jan 30, 2026

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Control Study Group
  The control group of the study is designed to capture baseline data especially regarding ribo therapy duration of patients prescribed with ribociclib. Data will be collected by reviewing historical patient records as captured within the electronic medical record (chart review) by recording demographics, International Classification of Diseases (ICD-10) codes, prescription fill rates and Current Procedural Terminology (CPT) codes. De-identified data of patients treated with ribociclib for HR+/HER2 negative metastatic Breast Cancer (mBC) during June 2022 to April 2024 and collated in a de-identified database by Dosentrx will be retrospectively analyzed. The results of the treatment duration for these participants will be used as a baseline for the ReX study group. A minimum of 50 and a maximum of 200 patient charts are expected to be reviewed for the control study group.
• Experimental: ReX Platform Study Group
  The ReX platform study group will utilize data, collected from the same study sites that were chosen for control study group. A database consisting of at least fifty (50) female and male participants who initiated ribociclib for metastatic breast cancer and signed IRB research consent will be used for ReX study group. This group will include participants who started the recommended ribo dose of 600 mg QD and additional doses, delivered by the ReX technology platform. Physical examinations and laboratory tests will be performed in accordance with routine clinical practice; however, these parameters will not be collected for the study.

Primary Outcome Measure

Outcome MeasureReX Platform Study Group [ Time Frame: Up to 12 months ]

Central Contacts

• Mark Summers
  +1 612 817 0959
  [email protected]

Locations (4)

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