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

Last updated on December 6, 2018

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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.
Show details

- 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.
Show details

- 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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National Observational Study On The Use Of Inflectra? An Infliximab Biosimilar In Real Life
Observatoire National D'Utilisation D'Inflectra? En Vie Réelle.

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

  • Crohn Desease
  • Ulcerative Colitis
  • Rheumatoid Arthritis
  • Ankylosing Spondylitis
  • Psoriatic Arthritis
Other: QOL questionaire
Health assessment questionnaire disability index for rheumatoide polyarthritis questionnair
Patients treated with Inflectra
Intervention: Other: QOL questionaire
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
September 23, 2020
September 23, 2020   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
6 Years and older   (Child, Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
France
 
 
NCT02925338
C1231004
REFLECT ( Other Identifier: Alias Study Number )
No
Not Provided
Plan to Share IPD: Undecided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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