Achieving Minimal Disease Activity and Predictors of clinical response in Patients with Psoriatic Arthritis treated with Golimumab in clinical practice: a Multicenter Observational Study (MK-8259-039)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47237
• EU PAS number:
  EUPAS8426
• Study ID:
  47237
• Official title and acronym:
  Achieving Minimal Disease Activity and Predictors of clinical response in Patients with Psoriatic Arthritis treated with Golimumab in clinical practice: a Multicenter Observational Study (MK-8259-039)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  This study aims to develop a clinical prediction model for the achievement of 6-month minimal disease activity (MDA) in psoriatic arthritis (PsA) patients starting golimumab. PsA patients who have been newly prescribed golimumab in routine clinical practice will be invited to participate in the study. Data in this observational study will be collected from multiple clinics throughout Italy. Information from a clinical predictive model will permit clinicians to tailor treatments to individual patients and practice more effective and personalized medicine, optimizing the outcomes of patients with PsA.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck & Co.

Prof. Guido Valesini Sapienza University of Rome

Study timelines

Date when funding contract was signed

Actual: 25/06/2014

Study start date

Planned: 20/04/2015

Actual: 23/04/2015

Data analysis start date

Planned: 29/11/2016

Actual: 29/11/2016

Date of final study report

Planned: 21/08/2017

Actual: 20/07/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharpe & Dohme LLC

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable