Crohn's Disease Clinical Trial
— PERFUSEOfficial title:
PERFUSE - One-year Persistence to Treatment of Patients Receiving Flixabi or Imraldi: a French Cohort Study
| Verified date | October 2022 |
| Source | Biogen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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].
| Status | Completed |
| Enrollment | 2274 |
| Est. completion date | June 30, 2022 |
| Est. primary completion date | June 30, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Years and older |
| Eligibility | 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 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Research Site | Amiens | Hauts-de-France |
| France | Research Site | Angers | Pays De La Loire |
| France | Research Site | Bayonne | Nouvelle-Aquitaine |
| France | Research Site | Bobigny | Ile De France |
| France | Research Site 1 | Bobigny | Ile De France |
| France | Research Site | Bordeaux | Nouvelle-Aquitaine |
| France | Research Site | Brest | Bretagne |
| France | Research Site 1 | Brest | Bretagne |
| France | Research Site | Caen | Normandie |
| France | Research Site | Caluire et Cuire | Auvergne-Rhône-Alpes |
| France | Research Site | Cannes | Provence-Alpes-Côte d'Azur |
| France | Research Site | Chambray les Tours | Centre-Val De Loire |
| France | Research Site | Clermont-Ferrand | Auvergne-Rhône-Alpes |
| France | Research Site 1 | Clermont-Ferrand | Auvergne-Rhône-Alpes |
| France | Research Site | Clichy | Ile De France |
| France | Research Site | Colombes | Ile De France |
| France | Research Site | Créteil | Ile De France |
| France | Research Site | Dijon | Bourgogne-Franche-Comté |
| France | Research Site | La Crau | Provence-Alpes-Côte d'Azur |
| France | Research Site | La Rochelle | Nouvelle-Aquitaine |
| France | Research Site 1 | La Rochelle | Nouvelle-Aquitaine |
| France | Research Site 2 | La Rochelle | Nouvelle-Aquitaine |
| France | Research Site | Le Kremlin-Bicêtre | Ile De France |
| France | Research Site | Lille | Hauts-de-France |
| France | Research Site 1 | Lille | Hauts-de-France |
| France | Research Site | Limoges | Nouvelle-Aquitaine |
| France | Research Site | Lyon | Auvergne-Rhône-Alpes |
| France | Research Site | Marseille | Provence-Alpes-Côte d'Azur |
| France | Research Site 1 | Marseille | Provence-Alpes-Côte d'Azur |
| France | Research Site | Montpellier | Occitanie |
| France | Research Site 1 | Montpellier | Occitanie |
| France | Research Site | Nantes | Pays De La Loire |
| France | Research Site 1 | Nantes | Pays De La Loire |
| France | Research Site | Nice | Provence-Alpes-Côte d'Azur |
| France | Research Site | Nîmes | Occitanie |
| France | Research Site 1 | Nîmes | Occitanie |
| France | Research Site | Orléans | Centre-Val De Loire |
| France | Research Site | Paris | Ile De France |
| France | Research Site 1 | Paris | Ile De France |
| France | Research Site 10 | Paris | Ile De France |
| France | Research Site 2 | Paris | Ile De France |
| France | Research Site 3 | Paris | Ile De France |
| France | Research Site 4 | Paris | Ile De France |
| France | Research Site 5 | 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 9 | Paris | Ile De France |
| France | Research Site | Pierre-Bénite | Auvergne-Rhône-Alpes |
| France | Research Site 1 | Pierre-Bénite | Auvergne-Rhône-Alpes |
| France | Research Site | Reims | Grand Est |
| France | Research Site | Rennes | Bretagne |
| France | Research Site | Rouen | Normandie |
| France | Research Site | Saint-Etienne | Auvergne-Rhône-Alpes |
| France | Research Site | Strasbourg | Grand Est |
| France | Research Site | Toulon | Provence-Alpes-Côte d'Azur |
| France | Research Site | Toulouse | Occitanie |
| France | Research Site 1 | Toulouse | Occitanie |
| France | Research Site | Vandoeuvre-lès-Nancy | Grand Est |
| France | Research Site 1 | Vandoeuvre-lès-Nancy | Grand Est |
| Lead Sponsor | Collaborator |
|---|---|
| Biogen |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants who are Still Treated with Either Flixabi or Imraldi at 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. | Up to 12 months |
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