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

  • STATUS
    Recruiting
  • days left to enroll
    82
  • participants needed
    1200
  • sponsor
    Pfizer
Updated on 26 January 2021
infliximab
ulcerative colitis
arthritis
crohn's disease
biosimilar
rheumatoid arthritis
spondylitis
psoriatic arthritis
ankylosing spondylitis
polyarticular arthritis

Summary

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.

Details
Condition Ankylosing spondylitis, Psoriasis, PSORIATIC ARTHRITIS, Rheumatoid Arthritis, Ulcerative Colitis, Arthritis, Arthritis and Arthritic Pain, Psoriasis and Psoriatic Disorders, Rheumatoid Arthritis (Pediatric), Crohn Desease, Arthritis and Arthritic Pain (Pediatric), Ulcerative Colitis (Pediatric)
Treatment QOL questionaire
Clinical Study IdentifierNCT02925338
SponsorPfizer
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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