A Multi-National, Prospective, Observational Study in Patients with Unresectable or Metastatic Melanoma (IMAGE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39442
• EU PAS number:
  EUPAS2723
• Study ID:
  39442
• Official title and acronym:
  A Multi-National, Prospective, Observational Study in Patients with Unresectable or Metastatic Melanoma (IMAGE)
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Austria

  Brazil

  Canada

  France

  Germany

  Greece

  Hungary

  Ireland

  Norway

  Poland

  Spain

  Sweden

  Switzerland

  United Kingdom
• Study description:
  The IMAGE study is a multi-national, prospective, observational study with a minimum of 3 years follow-up to understand how ipilimumab is being used in previously-treated patients diagnosed with unresectable or metastatic melanoma, its safety profile, and the manner in which adverse reactions are managed in routine clinical practice worldwide. Further, this study will provide information on the influence that the availability of ipilimumab as a treatment option exerts on the following health outcomes for patients with unresectable or metastatic melanoma: real-world patterns of care, humanistic outcomes of treatment, such as quality of life and work productivity, healthcare resource utilization, treatment effectiveness (overall survival).
• Study status:
  Finalised

Research institutions and networks

Institutions

Bristol-Myers Squibb (BMS)

Multiple centres: 200 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 30/08/2011

Study start date

Planned: 30/04/2012

Actual: 26/04/2012

Date of final study report

Planned: 28/12/2018

Actual: 06/11/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bristol-Myers Squibb Company

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)