Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Rheumatoid Arthritis)
NCT03885037
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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.
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Advanced Information
| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title | Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Rheumatoid Arthritis) | ||||
| Official Title | Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Rheumatoid Arthritis) | ||||
| 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients with Rheumatoid Arthritis treated by Infliximab BS | ||||
| Condition | Rheumatoid Arthritis | ||||
| Intervention | 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" | ||||
| Study Groups/Cohorts | Infliximab [infliximab biosimilar 3]
Patients with Rheumatoid Arthritis treated by Infliximab BS Intervention: Drug: Infliximab [infliximab biosimilar 3] | ||||
| 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 | 300 | ||||
| Original Estimated Enrollment | 1 | ||||
| Estimated Study Completion Date | March 12, 2025 | ||||
| Estimated Primary Completion Date | March 12, 2025 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria:
| ||||
| Sex/Gender |
| ||||
| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | Japan | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03885037 | ||||
| Other Study ID Numbers | B5371006 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | October 2019 | ||||