Study identification

PURI

https://redirect.ema.europa.eu/resource/107204

EU PAS number

EUPAS107203

Study ID

107204

Official title and acronym

Post-Authorisation Active Safety Surveillance Program Among Patients Treated WithTofacitinib for Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Juvenile Psoriatic Arthritis (PsA) Within the United Kingdom (UK) Juvenile Idiopathic Arthritis (JIA) Biologics Register

DARWIN EU® study

No

Study countries

United Kingdom

Study description

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, malignancy excluding NMSC, NMSC, lymphoma, lung cancer, interstitial lung disease, fractures, 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 UK JIA Biologics Register 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

Contact details

Andrea Leapley

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
Study protocol
Initial protocol
English (630.84 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)