Incidence of Gastrointestinal Perforation in Users of ACTEMRA® (Tocilizumab), Abatacept and Anti-Tumor Necrosis Factor Alpha Agents

Study identification

• EU PAS number:
  EUPAS16143
• Study ID:
  28348
• Official title and acronym:
  Incidence of Gastrointestinal Perforation in Users of ACTEMRA® (Tocilizumab), Abatacept and Anti-Tumor Necrosis Factor Alpha Agents
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The current study seeks to compare the incidence of GI perforation among users of abatacept, rituximab, the class of anti-TNF alpha agents and Actemra®, an interleukin-6 (IL-6) receptor inhibitor indicated for the treatment of moderately to severely active rheumatoid arthritis in adult patients who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. For the purpose of this study anti-TNF alpha agents are Infliximab, Etanercept, Adalimumab, Certolizumab, and Golimumab
• Study status:
  Finalised

Research institutions and networks

Institutions

NA

Study timelines

Date when funding contract was signed

Actual:10/04/2015

Study start date

Actual:15/06/2015

Date of final study report

Actual:08/10/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Roche

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)

Other study registration identification numbers and links

GA30111