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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 March 2024 |
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Main ID: |
NCT03884439 |
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Date of registration:
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04/03/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Infliximab Biosimilar "Pfizer" Drug Use Investigation (Crohn's Disease or Ulcerative Colitis)
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Scientific title:
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Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Crohn's Disease or Ulcerative Colitis) |
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Date of first enrolment:
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March 18, 2019 |
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Target sample size:
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428 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03884439 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Japan
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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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.
Age minimum:
0 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Crohn's Disease
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Intervention(s)
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Drug: Infliximab [infliximab biosimilar 3]
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Primary Outcome(s)
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Incidence of adverse drug reactions
[Time Frame: 30 weeks from the day of initial dose]
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Secondary Outcome(s)
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Percentage of Participants With Improvement (Clinical Disease Activity Index (CDAI)) for Crohn's disease
[Time Frame: Week 30]
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Percentage of Participants With Remission (Partial Mayo) score for ulcerative colitis
[Time Frame: Week 30]
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Mayo Score
[Time Frame: Baseline, Week 30]
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Percentage of Participants With Improvement (Partial Mayo) score for ulcerative colitis
[Time Frame: Week 30]
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Percentage of Participants With Remission (Clinical Disease Activity Index (CDAI)) for Crohn's disease
[Time Frame: Week 30]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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