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Infliximab Biosimilar "Pfizer" Drug Use Investigation (Crohn's Disease or Ulcerative Colitis)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884439
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
To collect information on the safety and effectiveness of Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" against Crohn's disease or ulcerative colitis under actual status of use.

Condition or disease Intervention/treatment
Crohn's Disease Ulcerative Colitis Drug: Infliximab [infliximab biosimilar 3]

Detailed Description:

This study will be conducted with all-case investigation system in patients with Crohn's disease or ulcerative colitis.

This study will be conducted in patients who used this drug after the day of approval of dosage and administration for Crohn's disease or ulcerative colitis at contracted medical institutions. Patients who used this drug before conclusion of the contract with the medical institution will also be included in this study (retrospective patients will be included).

Therefore, Time Perspective is retrospective and prospective.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Crohn's Disease or Ulcerative Colitis)
Actual Study Start Date : March 18, 2019
Estimated Primary Completion Date : March 13, 2023
Estimated Study Completion Date : March 13, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Group/Cohort Intervention/treatment
Infliximab [infliximab biosimilar 3]
Patients with Crohn's Disease or Ulcerative Colitis treated by Infliximab BS
Drug: Infliximab [infliximab biosimilar 3]
<Crohn's disease> The usual dose is 5 mg as Infliximab [Infliximab Biosimilar 3] for every kg of body weight given as an intravenous infusion. After an initial dose is given, the subsequent doses are given at Weeks 2 and 6, and every 8 weeks thereafter. After a dose at Week 6 is given, the dose may be increased or the dosing interval may be reduced for patients who have reduced effects. At an increased dose, the dose may be adjusted to 10 mg for every kg of body weight. At a reduced dosing interval, the dose of 5 mg for every kg of body weight may be given at the minimum dosing interval of 4 weeks. <Ulcerative colitis> The usual dose is 5 mg as Infliximab [Infliximab Biosimilar 3] for every kg of body weight given as an intravenous infusion. After an initial dose is given, the subsequent doses are given at Weeks 2 and 6, and every 8 weeks thereafter.
Other Name: Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer"




Primary Outcome Measures :
  1. Incidence of adverse drug reactions [ Time Frame: 30 weeks from the day of initial dose ]

Secondary Outcome Measures :
  1. Percentage of Participants With Remission (Clinical Disease Activity Index (CDAI)) for Crohn's disease [ Time Frame: Week 30 ]
  2. Percentage of Participants With Improvement (Clinical Disease Activity Index (CDAI)) for Crohn's disease [ Time Frame: Week 30 ]
  3. Percentage of Participants With Remission (Mayo) score for ulcerative colitis [ Time Frame: Week 30 ]
  4. Percentage of Participants With Improvement (Mayo) score for ulcerative colitis [ Time Frame: Week 30 ]
  5. Partial mayo Score [ Time Frame: Baseline, Week 30 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Crohn's Disease or Ulcerative Colitis treated by Infliximab BS
Criteria

Inclusion Criteria:

  • Patients with Crohn's disease or ulcerative colitis who started treatment with this drug
  • Patients who received this drug for the first time at the medical institution after the day of launch of this drug.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884439


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Japan
Pfizer Local Country Office Recruiting
Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03884439    
Other Study ID Numbers: B5371008
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (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/data_requests.
Keywords provided by Pfizer:
Crohn's Disease
Ulcerative Colitis
Infliximab
biosimilar
Additional relevant MeSH terms:
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Crohn Disease
Colitis
Colitis, Ulcerative
Ulcer
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents