Incidence of Interstitial Lung Disease (ILD) in Users of ACTEMRA® (Tocilizumab), Rituxan® (Rituximab), Abatacept and Anti-Tumor Necrosis Factor Alpha Agents

Study identification

• EU PAS number:
  EUPAS16482
• Study ID:
  103379
• Official title and acronym:
  Incidence of Interstitial Lung Disease (ILD) in Users of ACTEMRA® (Tocilizumab), Rituxan® (Rituximab), 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 interstitial lung disease among users of abatacept, Rituxan®, individual and 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 biologic therapies.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Actual:01/02/2013

Study start date

Actual:28/02/2013

Data analysis start date

Actual:28/02/2013

Date of final study report

Actual:27/09/2013

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)?:
  Not applicable

Other study registration identification numbers and links

GA29301