Continuation Study for Patients Benefiting from Sabatolimab Treatment in Previous Novartis Trials

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05201066

Provider View

This study is for patients who have completed a previous Novartis trial with sabatolimab and are still benefiting from the treatment. It aims to gather safety information from long-term use of the medication.

Patient Parameters

Program Overview

This study is designed to collect safety information from patients who have completed a previous Novartis trial with sabatolimab and are still benefiting from the treatment. The study includes patients who can tolerate the treatment and aims to identify any rare side effects that might occur with long-term use.

Description

This study allows patients who have been part of a previous Novartis trial with sabatolimab and are still benefiting from the treatment to continue receiving it. There is no separate screening period; patients will move directly from their previous trial to this continuation study. The decision to join this study is based on the investigator's assessment of the patient's benefit from the treatment.

Patients will continue to receive sabatolimab, either alone or with other medications, as they did in the previous trial. The study will monitor for any side effects, and patients will be asked about their health at each visit. This study aims to ensure the continued safety of sabatolimab treatment over a longer period.

Eligibility Criteria

Inclusion Criteria

  • Currently enrolled in a Novartis trial with sabatolimab and meeting all requirements of that trial.
  • Benefiting from sabatolimab treatment as determined by the trial guidelines and the investigator.
  • Following the rules and requirements of the previous trial.
  • Willing and able to attend scheduled visits and follow the treatment plan.
  • Have signed a consent form to join this continuation study.

Exclusion Criteria

  • Not receiving sabatolimab in the previous trial.
  • Stopped taking sabatolimab in the previous trial due to side effects, not following the study rules, or other reasons.
  • Currently experiencing side effects that have paused sabatolimab treatment (can join once side effects are resolved).
  • Pregnant or breastfeeding women.
  • Not willing to follow birth control requirements from the previous trial.
  • Have access to sabatolimab outside of the trial for the same condition.

Other specific criteria may apply.

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