Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease

NCT02539368

Last updated date
Study Location
UZ Leuven Campus Gasthuisberg
Leuven, Vlaams Brabant, 3000, Belgium
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. At least 12 years of age at the time of initial confirmed diagnosis of CD or UC and at least 18 years of age at the time of enrolment to the study.

2. Patients who are prescribed CT-P13 or Remicade for the treatment of CD or UC prescribed according to the corresponding summary of product characteristics (SmPC) as determined by the Investigator. Patients with stomas or surgery/pouch will be included.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Any reported contraindications for CT-P13 or Remicade, according to the SmPC.


2. Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its
excipients or other murine proteins, at the time of enrolment.


3. Prior history of failure to respond to Remicade or CT-P13.

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Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn's DiseasePost-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease NCT02539368
  1. Leuven, Vlaams Brabant
  2. Edegem,
  3. Hradec Kralove,
  4. Hradec Kralove,
  5. Ostrava - Vitkovice,
  6. Prague,
  7. Praha 8 Liben,
  8. Jyvaskyla,
  9. Oulu,
  10. Turku,
  11. Amiens,
  12. Angers,
  13. Besancon,
  14. Caen,
  15. Charenton,
  16. Clermont-ferrand,
  17. Clichy,
  18. Colombes,
  19. Grenoble,
  20. Lille,
  21. Lyon,
  22. Marseille,
  23. Marseille,
  24. Montpellier,
  25. Nimes,
  26. Paris,
  27. Paris,
  28. Paris,
  29. Paris,
  30. Paris,
  31. Pierre-Bénite,
  32. Pringy,
  33. Reims,
  34. Rouen,
  35. Saint Priez En Jarez,
  36. Strasbourg,
  37. Toulouse,
  38. Toulouse,
  39. Vandoeuvre les Nancy,
  40. Venissieux,
  41. Ludwigshafen am Rhein, Gartenstadt
  42. Altenholz,
  43. Alzey,
  44. Aschaffenburg,
  45. Berlin,
  46. Burghausen,
  47. Frankfurt am Main,
  48. Friedrichsthal,
  49. Grevenbroich,
  50. Hamburg,
  51. Herne,
  52. Koethen,
  53. Leipzig,
  54. Lörrach,
  55. Mannheim,
  56. Mannheim,
  57. Minden,
  58. Muenchen-Nymphenburg,
  59. Muenster,
  60. Muenster,
  61. Regensburg,
  62. Remscheid,
  63. Saarbrücken,
  64. Schweinfurt,
  65. Stuttgart,
  66. Rio, Patra, Achaia
  67. Athens, Attiki
  68. Heraklion, Crete
  69. Athens,
  70. Ioannina,
  71. Larissa,
  72. Thessaloniki,
  73. Budapest,
  74. Budapest,
  75. Szeged,
  76. San Cataldo (Caltanisetta), Caltanisetta
  77. Empoli, FI
  78. Firenze, FI
  79. San Donato Milanese, Milano
  80. Parma, PR
  81. Negrar, Verona
  82. Brescia,
  83. Catania,
  84. Catania,
  85. Chieti,
  86. Fermo,
  87. Firenze,
  88. Genova,
  89. Macerata,
  90. Messina,
  91. Modena,
  92. Palermo,
  93. Palermo,
  94. Pisa,
  95. Pisa,
  96. Roma,
  97. Rome,
  98. Udine,
  99. Ede,
  100. Eindhoven,
  101. Gelderland,
  102. Amadora, Lisbon
  103. Santa Maria da Feira, Porto
  104. Barreiro,
  105. Lisboa,
  106. Banska Bystrica,
  107. Bratislava,
  108. Ferrol, A Coruna
  109. Santiago de Compostela, A Coruna
  110. Badalona, Barcelona
  111. Girona, Barcelona
  112. Sabadell, Barcelona
  113. Usansolo, Bizkaia
  114. Las Palmas De Gran Canari, Canarias
  115. Palma. Mallorca, Illes Balears
  116. Alcorcon, Madrid
  117. Fuenlabrada, Madrid
  118. San Sebastian De Los Reye, Madrid
  119. Pamplona, Navarra
  120. Madrid,
  121. Madrid,
  122. Madrid,
  123. Madrid,
  124. Madrid,
  125. Madrid,
  126. Pontevedra,
  127. Valencia,
  128. Valencia,
  129. Valencia,
  130. Valladolid,
  131. Exeter, Devon
  132. Dorchester, Dorset
  133. Gloucester, Gloucestershire
  134. Llantrisant, Wales
  135. Coventry, WEST Midlands
  136. Salisbury, Wiltshire
  137. Birmingham,
  138. Bournemouth,
  139. Hampshire,
  140. Southampton,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease
Official Title POST-MARKETING OBSERVATIONAL COHORT STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) TREATED WITH CT-P13 IN USUAL CLINICAL PRACTICE (CONNECT-IBD)
Brief Summary

This is a post-marketing observational study of patients with Inflammatory Bowel Disease (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed CT-P13 (infliximab) or Remicade (infliximab) for treatment. CT-P13 (brand names Inflectra and Remsima) is a biosimilar medicine to Remicade, meaning it is a biologic medicine that contains the same active substance as Remicade (infliximab). The key study objectives are as follows:

  • To characterize the population and drug utilization patterns of patients treated with CT-P13 for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade
  • To explore the long-term safety profile of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade
  • To assess the effectiveness of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade
Detailed Description The study will be conducted in accordance with legal and regulatory requirements with scientific purpose, value and rigor following generally accepted research practices described in Guidelines for Good Pharmacoepidemiology Practices (GPP), Good Epidemiological Practice (GEP), Good Practices for Outcomes Research, International Ethical Guidelines for Epidemiological Research, European Medicines Agency (EMA) European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in Pharmacoepidemiology, and FDA Guidance for Industry. Data sources will be validated and will consist of the hospital medical records and monitoring will be organized on a regular basis. Data for the study will be entered into a web based electronic data capture (EDC) system at enrolment and then approximately every 3 months (at a minimum) thereafter up to 2 years. Adverse events will be encoded according to MedDRA 17.1 or later. The sample size will be approximately 2500 patients recruited over a 30 month period and followed up to 2 years. No inferential analyses are planned. Statistical analysis will be descriptive in nature.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

The target study population will include patients with CD or UC, who are being treated, or initiating treatment, with CT-P13 or Remicade at the time of study enrolment. This would include the following treatment subgroups:

  • Biologic-naïve patients initiating CT-P13 (or Remicade);
  • Patients currently being treated with CT-P13 (or Remicade);
  • Patients who are considered stable by the Investigator under Remicade therapy for CD or UC, who switch to CT-P13;
  • Patients switching to CT-P13 or Remicade from an alternative biologic therapy (e.g. adalimumab) due to non-responsiveness to or intolerance;
  • Patients re-initiating CT-P13 or Remicade after having successfully completed and exited a previous course of infliximab therapy in the past.
  • Patients with fistulating disease or stomas and those receiving combination therapy will be included.
Condition
  • Inflammatory Bowel Diseases
  • Ulcerative Colitis
  • Crohn's Disease
Intervention
  • Drug: CT-P13
    biosimilar infliximab
    Other Names:
    • Inflectra
    • Remsima
  • Drug: Remicade
    infliximab
Study Groups/Cohorts
  • CT-P13
    biosimilar infliximab
    Intervention: Drug: CT-P13
  • Remicade
    infliximab
    Intervention: Drug: Remicade
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 Completed
Actual Enrollment
 (submitted: November 26, 2018)
2565
Original Estimated Enrollment
 (submitted: August 31, 2015)
3300
Actual Study Completion Date October 31, 2018
Actual Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. At least 12 years of age at the time of initial confirmed diagnosis of CD or UC and at least 18 years of age at the time of enrolment to the study.
  2. Patients who are prescribed CT-P13 or Remicade for the treatment of CD or UC prescribed according to the corresponding summary of product characteristics (SmPC) as determined by the Investigator. Patients with stomas or surgery/pouch will be included.

Exclusion Criteria:

  1. Any reported contraindications for CT-P13 or Remicade, according to the SmPC.
  2. Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrolment.
  3. Prior history of failure to respond to Remicade or CT-P13.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium,   Czechia,   Finland,   France,   Germany,   Greece,   Hungary,   Italy,   Netherlands,   Portugal,   Slovakia,   Spain,   United Kingdom
Removed Location Countries Czech Republic,   Ireland
 
Administrative Information
NCT Number NCT02539368
Other Study ID Numbers ZOB INF 1402
C1231001 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
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 Hospira, now a wholly owned subsidiary of Pfizer
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2020