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Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Rheumatoid Arthritis)

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ClinicalTrials.gov Identifier: NCT03885037
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : April 29, 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 rheumatoid arthritis under actual status of use.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Infliximab [infliximab biosimilar 3]

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Study Type : Observational
Estimated Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Rheumatoid Arthritis)
Actual Study Start Date : March 20, 2019
Estimated Primary Completion Date : April 30, 2025
Estimated Study Completion Date : April 30, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Group/Cohort Intervention/treatment
Infliximab [infliximab biosimilar 3]
Patients with Rheumatoid Arthritis treated by Infliximab BS
Drug: Infliximab [infliximab biosimilar 3]
<Rheumatoid arthritis> The usual dose is 3 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 an incomplete response or reduced effects. These adjustments should be made in a stepwise manner. The maximum dose is 10 mg for every kg of body weight at the dosing interval of 8 weeks and 6 mg for every kg of body weight at a reduced dosing interval. The minimum dosing interval is 4 weeks. This drug should be given in combination with methotrexate.
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. Disease Activity Score Based on 28-joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) [ Time Frame: Week 30 ]
  2. Percentage of Participants With Remission (DAS28-4[CRP]) [ Time Frame: Baseline, Week30 ]


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 Rheumatoid Arthritis treated by Infliximab BS
Criteria

Inclusion Criteria:

  • Patients with rheumatoid arthritis who started treatment with this drug
  • Patients who received this drug for the first time 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): NCT03885037


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: NCT03885037     History of Changes
Other Study ID Numbers: B5371006
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 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:
Rheumatoid Arthritis
Infliximab
biosimilar

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents