Janssen

This sponsor has funded 20 studies across 52 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
7607 Ongoing Unspecified Spanish Registry of Systemic Treatments in Psoriasis (Biobadaderm) Yes No
11484 Finalised EU RMP category 3 A Non-interventional Observational Longitudinal Post-Authorization Safety Study (PASS) of SIMPONI® in Treatment of Ulcerative Colitis using Nordic... Yes Yes
19506 Ongoing EU RMP category 3 An Observational Post-authorization Safety Study of Ustekinumab in the Treatment of Pediatric Patients Aged 6 Years and Older With Moderate to Severe... No No
20119 Finalised EU RMP category 3 RRA-19284 Survey of the Effectiveness of the DARZALEX® Educational Materials Regarding the Minimization of Risk of Interference for Blood Typing with... No No
20781 Ongoing EU RMP category 3 An observational post-approval safety study of golimumab in treatment of polyarticular Juvenile Idiopathic Arthritis (pJIA) using the German Biologics... Yes No
21954 Finalised EU RMP category 3 An Observational Post-authorization Safety Study to Describe the Safety of Ustekinumab and Other Crohn’s Disease Treatments in a Cohort of Patients... Yes Yes
24731 Finalised Not included in RMP Etude d’impact de la communication menée auprès des médecins prescripteurs d’Epitomax® et ses génériques en France No No
28564 Ongoing Not included in RMP Persistence and adherence to novel systemic pharmacological treatment of moderate to severe psoriasis vulgaris and psoriatic arthritis – A... No No
32946 Finalised Not included in RMP Prospective, multicentric, national,observational cohort of patients receiving a systemic treatment for psoriasis No No
35544 Planned Not included in RMP Cardiovascular outcomes among patients with castration-resistant prostate cancer: A comparative safety study within US real world databases No No
35920 Finalised Not included in RMP Neuropsychiatric Adverse Events of Abiraterone Acetate and Enzalutamide: Meta-analysis of Randomized Clinical Trials with Real World Reporting... No No
38144 Planned EU RMP category 3 Survey to Assess the Effectiveness of SPRAVATO® Educational Materials for Additional Risk Minimization Measures in the European Union (PCSNSP002812) Yes No
39096 Ongoing EU RMP category 3 COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER) No No
42328 Ongoing EU RMP category 3 Brand-specific COVID-19 vaccine effectiveness against severe COVID-19 disease in Europe A contribution of COVIDRIVE, a public-private partnership to... Yes No
42556 Ongoing EU RMP category 1 Drug Utilization, Adherence, Effectiveness and Resistance: A Prospective Observational Cohort Study in People living with HIV (PLWH) initiating ARV... Yes No
42609 Ongoing EU RMP category 3 C2C: COMBINE-2 for Cabotegravir+Rilpivirine LA Regimen - A Prospective Cohort Study to Monitor Effectiveness, Adherence and Resistance (215160) Yes No
44885 Ongoing EU RMP category 3 An Observational Postauthorization Safety Study To Describe The Safety Of Ustekinumab and Other Biologic Treatments in a Cohort of Patients With... No No
45362 Ongoing EU RMP category 3 An Observational Post-Authorization Safety Study to Assess the Safety of Ad26.COV2.S Using European Healthcare Data through VAC4EU (COVID-19) No No
49836 Ongoing EU RMP category 3 An Observational Post-Authorization Safety Study to Assess the Safety of Ad26.COV2.S Using Health Insurance Databases in the United States No No
107763 Planned EU RMP category 3 Survey to Assess the Effectiveness of Ponvory® Educational Materials for Additional Risk Minimization Measures in the European Union No No

PAS by Risk Management Plan (RMP) requirement

Janssen

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.