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

Last updated on October 9, 2019

FOR MORE INFORMATION
Study Location
Polyclinique Jean Vilar
Bruges, , 33520 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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Descriptive Information
Brief TitleNational Observational Study On The Use Of Inflectra? An Infliximab Biosimilar In Real Life
Official TitleOBSERVATOIRE NATIONAL D'UTILISATION D'INFLECTRA? EN VIE RÉELLE.
Brief 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.

Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study Population

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

Condition
  • Crohn Desease
  • Ulcerative Colitis
  • Rheumatoid Arthritis
  • Ankylosing Spondylitis
  • Psoriatic Arthritis
InterventionOther: QOL questionaire
Health assessment questionnaire disability index for rheumatoide polyarthritis questionnair
Study Groups/CohortsPatients treated with Inflectra
Intervention: Other: QOL questionaire
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusRecruiting
Estimated Enrollment
 (submitted: October 4, 2016)
1200
Original Estimated EnrollmentSame as current
Estimated Study Completion DateApril 29, 2021
Estimated Primary Completion DateSeptember 23, 2020   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study:All
Ages6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy VolunteersNo
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location CountriesFrance
Removed Location Countries  
 
Administrative Information
NCT NumberNCT02925338
Other Study ID NumbersC1231004
REFLECT ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2019

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]

Call Now