Galapagos

This sponsor has funded 7 studies across 12 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
35746 Finalised Not included in RMP Utilization patterns, access to healthcare facilities and economic assessment of JAKi drugs used in rheumatoid arthritis patients in Tuscany: the... Yes Yes
39767 Ongoing Not included in RMP A prospective, non-interventional study of the effectiveness, safety, and health related outcomes in patients with moderate to severe active... No No
46020 Ongoing Not included in RMP A prospective, non-interventional study in female patients with moderate to severe active rheumatoid arthritis in France receiving filgotinib for 2... No No
46852 Ongoing EU RMP category 3 Non-interventional post-authorization cohort safety study evaluating the effectiveness of the additional risk minimization measures for filgotinib... Yes No
46856 Ongoing EU RMP category 3 Non-interventional post-authorization safety study of filgotinib in the treatment of patients with moderate to severe active rheumatoid arthritis... Yes No
50214 Ongoing Not included in RMP A prospective, non-interventional, multi-country cohort study of the effectiveness and safety of filgotinib in adult patients with moderately to... No No
106566 Ongoing EU RMP category 3 Non-interventional, post-authorization prospective safety study of filgotinib in patients with moderately to severely active ulcerative colitis: a... Yes No

PAS by Risk Management Plan (RMP) requirement

Galapagos

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.