CINC424A2X01B Rollover Protocol
This roll-over protocol allows patients who are still receiving clinical benefit to continue to be treated from multiple protocols in one program spanning multiple indications during the completion of the parent study/(ies). The population for the roll-over study should be consistent with the population defined in the program parent study/(ies). The primary eligibility criteria for a patient to enter the roll-over protocol is the participation and completion of a Novartis OGD&GMA/Incyte study with ruxolitinib. Efficacy parameters would not be measured; however safety data will be collected.
Patients who have completed a prior study with ruxolitinib and who are assessed by the Investigator to continue to benefit from ongoing treatment with the investigational ruxolitinib will be eligible.
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||An Open Label, Multi-center, Phase IV Roll-over Protocol for Patients Who Have Completed a Prior Global Novartis or Incyte Sponsored Ruxolitinib (INC424) Study and Are Judged by the Investigator to Benefit From Continued Treatment|
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: through study completion estimated to be approximately 5 years ]Adverse Events wll be monitored throughout the trial.
|Actual Study Start Date:||March 6, 2015|
|Estimated Study Completion Date:||September 14, 2021|
|Estimated Primary Completion Date:||September 14, 2021 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02386800
|Contact: Novartis Pharmaceuticals||+41613241111|
|Contact: Novartis Pharmaceuticals|
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|