One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort Study

Completed

• Conditions: Arthritis, Psoriatic; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Crohn's Disease; Colitis, Ulcerative
• Interventions: Drug: Adalimumab; Drug: Infliximab

• Registration Number: NCT03662919
• Lead Sponsor: Biogen

Brief Summary

A study to describe the one-year persistence in participants treated by Flixabi (infliximab) or Imraldi (Adalimumab) as prescribed by the physician for each of the 5 following indications: Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA), Crohn's Disease (CD) \[adults and children\] and Ulcerative Colitis (UC) \[adults for both treatments and children only for Flixabi\].

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-02
• Study First Submitted: 2018-09-06
• Study First Submitted QC: 2018-09-06
• Study First Posted: 2018-09-10
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-17
• Last Update Posted: 2022-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2274

Inclusion Criteria

• Adult participant (18 years and over)

  • treated for one of the following conditions: RA, AS, PsA, CD, UC.
  • either active substance naïve or treated with the originator or another biosimilar at baseline.
  • for whom the treating physician has decided to treat by (naïve) or switch from originator or another biosimilar to Flixabi or Imraldi.
  • participants who had initiated Flixabi or Imraldi at most 12 months before the baseline will also be included in the cohort.

• Paediatric participants (6-17 years):

  • treated for one of the following conditions: CD, UC.
  • either active substance naïve or treated with another biosimilar at baseline.
  • for whom the treating physician has decided to treat by (naïve) or switch to Flixabi (for both indications) or Imraldi (only for Crohn's disease).
  • participants who had initiated Flixabi or Imraldi at most 12 months before the baseline will also be included in the cohort.

Key

Exclusion Criteria

• Participant treated for psoriasis.
• Participant who are not to be followed up in the same investigator site for 2 years after baseline.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Imraldi	Adalimumab	Adalimumab naive participants or participants who were previously treated with other adalimumab biosimilars will receive Imraldi (adalimumab) as prescribed by physician according to the local prescribing procedures.
Flixabi	Infliximab	Infliximab naive participants or participants who were previously treated with other infliximab biologics will receive Flixabi (infliximab) as prescribed by physician according to the local prescribing procedures.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants who are Still Treated with Either Flixabi or Imraldi at 12 Months	Up to 12 months	Percentage of participants, either infliximab naïve or switched from Remicade or CT-P13 to Flixabi, who are still treated with Flixabi, and either adalimumab naïve or switched from Humira or other adalimumab biosimilars to Imraldi, who are still treated with Imraldi, at 12 months for RA, AS, PsA, CD (adults and children), and UC (adults for both treatments and children only for Flixabi) will be reported.

Trial Locations

Locations (11)

Research Site; 🇫🇷 Toulon, Provence-Alpes-Côte d'Azur, France

Research Site 2; 🇫🇷 La Rochelle, Nouvelle-Aquitaine, France

Research Site 3; 🇫🇷 Paris, Ile De France, France

Research Site 4; 🇫🇷 Paris, Ile De France, France

Research Site 6; 🇫🇷 Paris, Ile De France, France

Research Site 7; 🇫🇷 Paris, Ile De France, France

Research Site 8; 🇫🇷 Paris, Ile De France, France

Research Site 1; 🇫🇷 Marseille, Provence-Alpes-Côte d'Azur, France

Research Site 10; 🇫🇷 Paris, Ile De France, France

Research Site 5; 🇫🇷 Paris, Ile De France, France

Research Site 9; 🇫🇷 Paris, Ile De France, France