A Long-term, Multi-center, Longitudinal Post-marketing, Observational Study to Assess Long Term Safety and Effectiveness of HUMIRA® (Adalimumab) in Children With Moderately to Severely Active Polyarticular or Polyarticular-course Juvenile Idiopathic Arthritis (JIA) (STRIVE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48817
• EU PAS number:
  EUPAS30576
• Study ID:
  48817
• Official title and acronym:
  A Long-term, Multi-center, Longitudinal Post-marketing, Observational Study to Assess Long Term Safety and Effectiveness of HUMIRA® (Adalimumab) in Children With Moderately to Severely Active Polyarticular or Polyarticular-course Juvenile Idiopathic Arthritis (JIA) (STRIVE)
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Austria

  Czechia

  Denmark

  France

  Germany

  Greece

  Hungary

  Italy

  Netherlands

  Norway

  Portugal

  Puerto Rico

  Slovakia

  Spain

  Sweden

  United States
• Study description:
  This is a global registry, to evaluate the long-term safety of Humira® in patients with moderate to severe polyarticular Juvenile Idiopathic Arthritis (JIA), that are treated as recommended in the Humira® product label. Patients treated with MTX will be considered a reference group. Patients will be followed in both the Humira® and Methotrexate (MTX) arms for 10 years from the enrollment date into one of the treatment arms.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Actual: 19/08/2008

Study start date

Actual: 11/07/2008

Date of final study report

Actual: 27/06/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AbbVie

Study protocol

Initial protocol

p10262-protocol-amendment6_Redacted_05Aug2019

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

P10-262