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National Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life
National Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life

NCT02925338

CompletedN/A

Sponsor: Pfizer

Conditions: Crohn Disease, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis

Interventions: QOL questionaire

Countries: France

National, prospective, multicentre observational study designed for eligible patients treated with Inflectra. Its objectives are to describe under real conditions of use, the profile of patients treated with Inflectra and the response to treatment.

Eligibility overview

Sex: ALL

Age: 6 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

* Adult patients treated with Inflectra™ regardless of treatment phase in one of the following indications consistent with the SPC: Crohn's Disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis.
* Paediatric patients (children and adolescents between 6 and 17 years old) treated with Inflectra™, regardless of treatment phase from the time when Inflectra™ is prescribed in accordance with the indications listed in the SPC Crohn's Disease or ulcerative colitis Patients (or their legal representatives) who have received information (verbally and in writing) about the study and agreed to take part in it.
* Patients who have given their agreement for their clinical data and their medical file to be accessed by signing the information leaflet.

Exclusion Criteria:

* Patients who refuse access to their medical file for collection of: their medical data
* Patients not treated with Inflectra™.
* Patients treated with Inflectra™ for psoriasis.
* Patients with a past history of hypersensitivity to infliximab, to other murine proteins or to one of the excipients in Inflectra™.
* Patients with tuberculosis or any other severe infection such as sepsis, abscess or opportunistic infection .
* Patients with moderate to severe heart failure (NYHA III/IV)
Locations (67)
  • Strasbourg, Alsace, France
  • Nantes, Loire-atlantique, France
  • Clermont-Ferrand, Puy-de-dôme, France
  • Aix-en-Provence, France
  • Aix-en-Provence, France
  • Bayonne, France
  • Besançon, France
  • Besançon, France
  • Bordeaux, France
  • Bordeaux, France
  • Bordeaux, France
  • Bruges, France
  • Bruges, France
  • Caen, France
  • Cannes, France
  • Cannes, France
  • Cannes, France
  • Carcassonne, France
  • Cholet, France
  • Cholet, France
  • Clermont-Ferrand, France
  • Clichy, France
  • Contamine Sur Avre, France
  • Créteil, France
  • Échirolles, France
  • Grenoble, France
  • Grenoble, France
  • La Roche-sur-Yon, France
  • La Tronche, France
  • La Tronche, France
  • + 37 more on CT.gov