Study identification

PURI

https://redirect.ema.europa.eu/resource/49437

EU PAS number

EUPAS31129

Study ID

49437

Official title and acronym

An active surveillance, post-authorization safety study of serious infection, malignancy, cardiovascular and other safety events of interest among patients treated with tofacitinib for moderately to severely active rheumatoid arthritis within the Spanish registry of adverse events of biological therapies and biosimilars in rheumatoid diseases (BIOBADASER) (Safety of tofacitinib in BIOBADASER)

DARWIN EU® study

No

Study countries

Spain

Study description

Tofacitinib is a potent, selective inhibitor of the Janus kinase (JAK) family of kinases with a high degree of selectivity relative to other kinases in the human genome. Tofacitinib was approved in the European Union in March 2017 at a dose of 5 mg administered twice daily for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have responded inadequately to, or who are intolerant to, one or more disease modifying antirheumatic drugs (DMARDs). To enable assessment of adverse outcomes of special interest including rare events and endpoints with long latency periods, Pfizer will implement a post-approval active surveillance study of tofacitinib-exposed patients using actively collected prospective data in BIOBADASER. Objective is to estimate the rates of serious infections, malignancy, CV and other specified outcomes among patients with RA in a Spanish register who initiate tofacitinib. Rates will also be estimated among cohorts of patients initiating biologic DMARDS to provide context for rates observed on tofacitinib.

Study status

Ongoing
Research institution and networks

Institutions

Pfizer
First published:
01/02/2024
Institution

Networks

Contact details

Michelle Iannacone

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:
Actual:

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

A3921316 NIS PROTOCOL_21AUG2019 w-approval record

English (1.12 MB - PDF)View document
Updated protocol

A3921316_PROTOCOL VERSION 3.0_CLEAN_14Feb2022

English (560.88 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)