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

Last updated on April 1, 2019

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Study Location
Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre
Strasbourg, Alsace, 67098 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Crohn Desease, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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)

NCT02925338
Pfizer
Recruiting
National Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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