A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (UC)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48639
• EU PAS number:
  EUPAS21010
• Study ID:
  48639
• Official title and acronym:
  A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (UC)
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Austria

  Belgium

  Canada

  Croatia

  Denmark

  France

  Germany

  Greece

  Ireland

  Israel

  Italy

  Mexico

  Netherlands

  New Zealand

  Norway

  Puerto Rico

  Spain

  Sweden

  United Kingdom

  United States
• Study description:
  This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in adult patients with moderately to severely active UC who are treated as recommended in the product label.
• Study status:
  Ongoing

Study timelines

Date when funding contract was signed

Planned: 01/01/2011

Actual: 01/01/2011

Study start date

Planned: 29/04/2013

Actual: 29/04/2013

Date of final study report

Planned: 25/05/2031

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AbbVie

Study protocol

Initial protocol

p11282 synopsis

Updated protocol

p11282-protocol-amendment4-synopsis

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)

Other study registration identification numbers and links

P11-282