CINC424A2X01B Rollover Protocol
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|ClinicalTrials.gov Identifier: NCT02386800|
Recruitment Status : Recruiting
First Posted : March 12, 2015
Last Update Posted : February 6, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Splenomegaly||Drug: Ruxolitinib||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||171 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 5, 2015|
|Estimated Primary Completion Date :||September 17, 2020|
|Estimated Study Completion Date :||September 17, 2020|
|Experimental: Ruxolitinib||Drug: Ruxolitinib|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02386800
|Contact: Novartis Pharmaceuticals||+41613241111|
|Contact: Novartis Pharmaceuticals|
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|