Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000322

EU PAS number

EUPAS1000000322

Study ID

1000000322

Official title and acronym

DARWIN EU® - Azathioprine - user characteristics

DARWIN EU® study

Yes

Study countries

Germany
Netherlands
Spain
United Kingdom

Study description

Azathioprine is a purine analogue and prodrug of mercaptopurine that is used as an immunosuppressive medication alone or in combination with other immunosuppressive therapy to prevent rejection following organ transplantation and to treat certain autoimmune diseases, where it is considered a steroid-sparing agent. Examples of autoimmune diseases that could be treated with azathioprine are rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus (SLE), polymyositis, dermatomyositis, multiple sclerosis (MS) and myasthenia gravis.(1-7)
Azathioprine is associated with minor usually transient and asymptomatic elevations of aminotransferase levels and with rare instances of acute cholestatic liver injury and with long-term use, portal hypertension may occur.(8, 9)
A signal procedure regarding a potential association between azathioprine and non-cirrhotic portal hypertension/portosinusoidal vascular disease (PSVD) - which is a rare disorder characterised by signs of portal hypertension in the absence of an identifiable etiology, such as cirrhosis - is needed. A liver biopsy is mandatory for the diagnosis of PSVD.(10) Specific histologic signs include obliterative portal venopathy, nodular regenerative hyperplasia and incomplete septal fibrosis.(10)
This study is intended to support the signal evaluation by providing information about the use of azathioprine, including the most frequent indications, the age- and sex distribution at initiation of treatment, and the treatment duration for all indications combined, and for each indication separately.

Study status

Ongoing
Research institution and networks

Institutions

Networks

Contact details

Katia Verhamme

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Study protocol
Initial protocol

DARWIN EU_Protocol_P3-C1-014_Azathioprine_V4.pdf

English (717.97 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable