Last updated on February 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Ulcerative Colitis | Ulcerative Colitis (Pediatric) | Ankylosing spondylitis | Crohn Desease | PSORIATIC ARTHRITIS | Rheumatoid Arthritis (Pediatric) | Rheumatoid Arthritis
  • Age: Between 6 - 100 Years
  • Gender: Male or Female

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)

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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