Janssen Cilag

This sponsor has funded 13 studies across 39 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
5565 Finalised EU RMP category 3 EDURANT / EVIPLERA Health Care Professional Survey (HCP survey on RPV) Yes Yes
9708 Finalised EU RMP category 3 An observational study on growth in HIV-infected children and adolescents on antiretroviral therapy in Europe, with special reference to darunavir... Yes Yes
12694 Finalised EU RMP category 3 Pharmacovigilance study to define the long term safety profile of etravirine in HIV-infected children and adolescents in Europe Yes Yes
17190 Ongoing Not included in RMP Retrospective non-interventional chart review study of the relationship of fecal calprotectin and long-term outcomes in adult patients with Crohn's... No No
21285 Finalised Not included in RMP Therapeutic strategy in metastatic castration-resistant prostate cancer: target population and changes between 2012 and 2014. Two sequential cohorts... Yes No
24728 Finalised Not included in RMP Retrospective non-interventional chart review study of the dosing and short-term clinical outcomes of patients with Crohn’s Disease treated with... No No
29875 Finalised EU RMP category 3 Meta-Analysis of Amputation Events from Clinical Trials DIA3008 (CANVAS), DIA4003 (CANVAS-R), and DNE3001 (CREDENCE) No Yes
30920 Finalised Not included in RMP Retrospective non-interventional chart review study of the dosing and short-term clinical outcomes of patients with Crohn’s Disease treated with... No No
34845 Ongoing Not included in RMP Treatment patterns and outcomes of Crohn’s disease and ulcerative colitis patients initiated with biologic therapies in Denmark (IBDBIODK) No No
36129 Ongoing EU RMP category 3 An observational post-authorization safety study to describe the safety of ustekinumab and other treatments of ulcerative colitis in a cohort of... No No
39376 Finalised Not included in RMP Retrospective non-interventional chart review study of the clinical outcomes of guselkumab in the treatment of Finnish patients with plaque psoriasis... No No
41732 Ongoing Not included in RMP Retrospective Observational non-interventional chart review study of patients with Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic... No No
49873 Finalised EU RMP category 3 An Observational Longitudinal Post-authorization Safety Study of STELARA® in the Treatment of Psoriasis and Psoriatic Arthritis: Analysis of Major... Yes Yes

PAS by Risk Management Plan (RMP) requirement

Janssen Cilag

The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.

Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.