Managed Access Programs for Ruxolitinib (INC424)

Sponsor: Novartis Pharmaceuticals

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04745637

Provider View

This information provides details about Managed Access Programs (MAPs) for the medication Ruxolitinib, which is used to treat certain medical conditions.

Patient Parameters

Program Overview

The purpose of this information is to list the Managed Access Programs (MAPs) that are available for Ruxolitinib (also known as INC424). These programs are designed to provide access to Ruxolitinib for patients with specific health conditions.

Description

  • CINC424A2405: This program is no longer available. It was a Managed Access Program to provide Ruxolitinib for patients with Primary Myelofibrosis (PMF), Post Polycythemia Myelofibrosis (PPV MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF).

  • CINC424A2001M: This program is no longer available. It was a Managed Access Program for patients diagnosed with severe or very severe COVID-19 illness to access Ruxolitinib.

  • CINC424B2002I: This program is no longer available. It was a Managed Access Program to provide Ruxolitinib for patients with Polycythemia Vera (PV).

  • CINC424C2001M: This program is currently available. It is a Managed Access Program to provide Ruxolitinib for patients with steroid-refractory acute and chronic Graft versus Host Disease (SR aGVHD and SR cGVHD).

Eligibility Criteria

Inclusion criteria

  1. An independent request was received from a licensed physician.
  2. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
  3. The patient is not eligible or able to enroll in a clinical trial or continue participation in such trial.
  4. There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
  5. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).
  6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
  7. Managed Access provision is allowed per local laws/regulations.

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