A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA (adalimumab) in Pediatric Patients with Moderately to Severely Active Crohn’s Disease (CD) - CAPE

Study identification

• EU PAS number:
  EUPAS6213
• Study ID:
  48820
• Official title and acronym:
  A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA (adalimumab) in Pediatric Patients with Moderately to Severely Active Crohn’s Disease (CD) - CAPE
• DARWIN EU® study:
  No
• Study countries:
  Bosnia and Herzegovina

  Bulgaria

  Canada

  Croatia

  Denmark

  Estonia

  France

  Germany

  Greece

  Ireland

  Israel

  Italy

  Lithuania

  Netherlands

  Portugal

  Puerto Rico

  Romania

  Spain

  Sweden

  United Kingdom

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

Study timelines

Date when funding contract was signed

Planned:01/01/2012

Actual:01/01/2012

Study start date

Planned:28/07/2014

Actual:28/08/2014

Date of final study report

Planned:31/10/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AbbVie

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

P11-292