An Active Safety Surveillance Study to Estimate Incidence Rates of Safety Events of Interest among Patients Treated with Tofacitinib for Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA) within the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry in the United States

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/103627
• EU PAS number:
  EUPAS103626
• Study ID:
  103627
• Official title and acronym:
  An Active Safety Surveillance Study to Estimate Incidence Rates of Safety Events of Interest among Patients Treated with Tofacitinib for Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA) within the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry in the United States
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Tofacitinib (Xeljanz®) is an oral Janus Kinase (JAK) inhibitor approved in the United States (US) in September 2020 for use in patients with polyarticular course juvenile idiopathic arthritis (pcJIA) (5mg immediate release (IR) tablet and 1mg/mL oral solution). The safety of tofacitinib 5 mg IR tablet and weight-based equivalent oral solution dosed twice daily (BID) has been evaluated in an integrated population of 251 subjects aged 2 to <18 years with juvenile idiopathic arthritis (JIA) and was shown to have an acceptable safety profile and was well-tolerated. The understanding of the safety profile of tofacitinib in patients with JIA was further informed by comparison to a larger database of RA studies, which includes 24 completed RA clinical studies and 3,969 patients exposed to tofacitinib 5mg IR tablet BID. The safety profile of tofacitinib in the pJIA clinical program was consistent with that for the adult RA clinical program, and no new safety risks were identified. To enable long-term assessment of safety outcomes, a post-approval, active surveillance study of tofacitinib-exposed pcJIA patients will be conducted using data collected within the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry. This noninterventional study is designated as a Post-Authorization Safety Study (PASS) and is a commitment to the Food and Drug Administration (FDA).
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

Networks

Childhood Arthritis and Rheumatology Research Alliance

Study timelines

Date when funding contract was signed

Planned: 08/02/2021

Actual: 08/02/2021

Study start date

Planned: 31/01/2026

Date of interim report, if expected

Planned: 31/07/2026

Date of final study report

Planned: 30/09/2030

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

A3921371_CARRA PROTOCOL V3.0 _29 JULY 2022

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable