Study identification

PURI

https://redirect.ema.europa.eu/resource/107193

EU PAS number

EUPAS107192

Study ID

107193

Official title and acronym

Post-Authorisation Active Safety Surveillance Program Among Patients Treated With Tofacitinib for Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Juvenile Psoriatic Arthritis (PsA) Within the German Biologics in Pediatric Rheumatology Registry (BiKeR) and Juvenile Arthritis Methotrexate/Biologics Long-term Observation (JuMBO) Registries (BiKeRJuMBO)

DARWIN EU® study

No

Study countries

Germany

Study description

Juvenile idiopathic arthritis (JIA) is a heterogenous group of conditions, defined as arthritis persisting for 6 weeks or longer with no other identifiable cause and onset prior to age 16. JIA is the most common pediatric rheumatic illness, with an annual incidence in developed countries of 2 to 20 per 100,000 children and a prevalence of 16 to 150 per 100,000. Tofacitinib (Xeljanz®) is an oral Janus Kinase (JAK) inhibitor approved in the European Union (EU) in adult populations for the treatment of moderate to severe rheumatoid arthritis (RA), active PsA, and moderate to severe ulcerative colitis (UC). The important identified and potential risks associated with use of tofacitinib listed in the Risk Management Plan (RMP) include (but not limited to): venous thromboembolism, serious infections (including tuberculosis), herpes zoster or HZ, fractures, malignancy excluding NMSC and NMSC, lymphoma, lung cancer, interstitial lung disease, gastrointestinal perforations,all-cause mortality, PML, myocardial infarction (MI), and cardiovascular risk (excluding MI). Within the JIA population, additional events of interest include growth or development disturbances, and response to vaccination. Furthermore, drug hypersensitivity is considered as an identified risk and listed in the Summary of Product Characteristics (SmPC) but does not meet the criteria to be included in the RMP. As part of the tofacitinib pharmacovigilance plan, Pfizer will implement a post-approval, active surveillance study of patients with pJIA or juvenile PsA initiating tofacitinib and those treated with approved bDMARDs using prospectively collected data included in the BiKeR and JuMBO registries from Germany to actively monitor the safety events of interest in the post-approval real-world setting, including events associated with long-term use.

Study status

Planned
Research institutions and networks

Institutions

Pfizer
First published:
01/02/2024
Institution
Juvenile Arthritis Methotrexate/Biologics Long-term Observation (JuMBO) Register

Contact details

Sampada Gandhi

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer 100%
Study protocol
Initial protocol
English (674.18 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)