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

NCT02925338

Last updated date
Study Location
Polyclinique Jean Vilar
Bruges, , 33520, France
Contact
1-800-718-1021

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[email protected]

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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)

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Crohn Desease, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic ArthritisNational Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life
NCT02925338
  1. Bruges,
  2. Clermont Ferrand Cedex,
  3. Nice Cedex 3,
  4. Rouen,
  5. Strasbourg,
  6. Thonon les Bains,
  7. Vitre,
  8. Strasbourg, Alsace
  9. Nantes cedex 1, Loire-atlantique
  10. Clermont Ferrand Cedex, Puy-de-dôme
  11. Aix En Provence,
  12. Aix-En-Provence,
  13. Bayonne,
  14. Besancon,
  15. Besancon,
  16. Bordeaux Cedex,
  17. Bordeaux,
  18. Bordeaux,
  19. Bruges,
  20. Bruges,
  21. Caen,
  22. Cannes Cedex,
  23. Cannes,
  24. Cannes,
  25. Carcassonne,
  26. Cholet,
  27. Cholet,
  28. Clermont Ferrand,
  29. Clichy,
  30. Clichy,
  31. Colombes Cedex,
  32. Contamine Sur Avre,
  33. Creteil,
  34. Créteil,
  35. Echirolles,
  36. GRENOBLE Cedex 9,
  37. Grenoble,
  38. La Roche Sur Yon,
  39. La Roche Sur Yon,
  40. La Tronche,
  41. La Tronche,
  42. La Tronche,
  43. Lille,
  44. Limoges,
  45. Little Cedex,
  46. Lomme,
  47. Lomme,
  48. Lyon Cedex 03,
  49. Lyon,
  50. Metz Tessy,
  51. Montauban Cedex,
  52. Montivilliers,
  53. Montpellier,
  54. Montpellier,
  55. Montpellier,
  56. Montpellier,
  57. Montpellier,
  58. NICE Cedex 3,
  59. Nimes,
  60. Paris Cedex 18,
  61. Paris,
  62. Paris,
  63. Pessac Cedex,
  64. Pierre Benite Cedex,
  65. Pierre Benite,
  66. Reims cedex,
  67. Reims CEDEX,
  68. Rouen,
  69. Rouen,
  70. Saint Etienne,
  71. St. Priest En Jarez,
  72. Talence Cedex,
  73. Tarbes,
  74. Thonon Les Bains,
  75. Toulouse cedex 04,
  76. Toulouse Cedex 09,
  77. Toulouse,
  78. Toulouse,
  79. Troyes,
  80. Vandoeuvre Les Nancy,
ALL GENDERS
6 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title National Observational Study On The Use Of Inflectra? An Infliximab Biosimilar In Real Life
Official Title OBSERVATOIRE 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 Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability 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
Intervention Other: QOL questionaire
Health assessment questionnaire disability index for rheumatoide polyarthritis questionnair
Study Groups/Cohorts Patients 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 Status Recruiting
Estimated Enrollment
 (submitted: October 4, 2016)
1200
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 1, 2021
Estimated Primary Completion Date September 1, 2021   (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
Ages 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02925338
Other Study ID Numbers C1231004
REFLECT ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not 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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2020