Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

One-year Persistence to Treatment of Participants Receiving Flixabi: a French Cohort Study (PERFUSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662919
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:
A study to describe the one-year persistence (participants still treated by Flixabi at 12 Months) in participants treated by Flixabi (infliximab) 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 and children].

Condition or disease Intervention/treatment
Arthritis, Rheumatoid Spondylitis, Ankylosing Arthritis, Psoriatic Crohn's Disease Colitis, Ulcerative Drug: Infliximab

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PERFUSE - One-year Persistence to Treatment of Patients Receiving Flixabi®: a French Cohort Study
Actual Study Start Date : July 2, 2018
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Group/Cohort Intervention/treatment
Flixabi
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.
Drug: Infliximab
Administered as specified in the treatment arm.
Other Name: Flixabi




Primary Outcome Measures :
  1. Percentage of Participants who are Still Treated by Flixabi at 12 Months [ Time Frame: 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 at 12 months for RA, AS, PsA, CD (adults and children), and UC (adults and children) will be reported.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants either infliximab naïve or switched from Remicade or CT-P13 to Flixabi who are treated with Flixabi for RA, AS, PsA, CD, and UC as prescribed by the physician in clinical practice.
Criteria

Inclusion/ Exclusion Criteria

Key Inclusion Criteria:

  • Adult participant (18 years and over)

    • treated for one of the following conditions: RA, AS, PsA, CD, UC.
    • either infliximab naïve or treated with Remicade or CT-P13 at baseline.
    • for whom the treating physician has decided to treat by (naïve) or switch to Flixabi (Remicade or CT-P13).
    • participants who had initiated Flixabi 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 infliximab naïve or treated with Remicade or CT-P13 at baseline.
    • for whom the treating physician has decided to treat by (naïve) or switch to Flixabi (Remicade or CT-P13).
    • participants who had initiated Flixabi 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662919


Contacts
Layout table for location contacts
Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com

Locations
Layout table for location information
France
Research Site Recruiting
Bobigny, France
Research Site Recruiting
Clichy, France
Research Site Recruiting
Creteil, France
Research Site Recruiting
Paris, France, 75013
Research Site 1 Recruiting
Paris, France
Research Site 2 Recruiting
Paris, France
Research Site 3 Recruiting
Paris, France
Research Site 4 Recruiting
Paris, France
Research Site 5 Recruiting
Paris, France
Research Site 6 Recruiting
Paris, France
Sponsors and Collaborators
Biogen
Investigators
Layout table for investigator information
Study Director: Medical Director Biogen

Layout table for additonal information
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT03662919     History of Changes
Other Study ID Numbers: FRA-FLX-17-11226
2017-A03220-53 ( Registry Identifier: ID-RCB )
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Spondylitis
Arthritis
Arthritis, Rheumatoid
Arthritis, Psoriatic
Spondylitis, Ankylosing
Crohn Disease
Colitis, Ulcerative
Joint Diseases
Musculoskeletal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Spondylarthropathies
Spondylarthritis
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ankylosis