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Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Cheladv74" Drug Use Investigation (Rheumatoid Arthritis)

Last updated on November 8, 2019

FOR MORE INFORMATION
Study Location
Cheladv74 Local Country Office
Tokyo, , Japan
Contact
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
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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating 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.

NCT03885037
Cheladv74
Recruiting
Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Cheladv74" Drug Use Investigation (Rheumatoid Arthritis)

NEED INFO?

Questions about a trial? Call or email to reach a Cheladv74 Clinical Trial Contact Center Representative

Cheladv74 Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

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Descriptive Information
Brief TitleInfliximab Biosimilar for Intravenous Drip Infusion 100 mg "Cheladv74" Drug Use Investigation (Rheumatoid Arthritis)
Official TitleInfliximab BS for Intravenous Drip Infusion 100 mg "Cheladv74" General Investigation (Rheumatoid Arthritis)
Brief SummaryTo collect information on the safety and effectiveness of Infliximab BS for Intravenous Drip Infusion 100 mg "Cheladv74" against rheumatoid arthritis under actual status of use.
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationPatients with Rheumatoid Arthritis treated by Infliximab BS
ConditionRheumatoid Arthritis
InterventionDrug: Infliximab [infliximab biosimilar 3]
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 "Cheladv74"
Study Groups/CohortsInfliximab [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 StatusRecruiting
Estimated Enrollment
 (submitted: October 7, 2019)
300
Original Estimated Enrollment
 (submitted: March 20, 2019)
1
Estimated Study Completion DateMarch 12, 2025
Estimated Primary Completion DateMarch 12, 2025   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study:All
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
Contacts
Contact: Cheladv74 CT.gov Call Center1-800-718-1021[email protected]
Listed Location CountriesJapan
Removed Location Countries  
 
Administrative Information
NCT NumberNCT03885037
Other Study ID NumbersB5371006
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Cheladv74 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 Cheladv74's data sharing criteria and process for requesting access can be found at: http://cheladv74.ru/science/clinical_trials/trial_data_and_results/da....
Responsible PartyCheladv74
Study SponsorCheladv74
CollaboratorsNot Provided
Investigators
Study Director:Cheladv74 CT.gov Call CenterCheladv74
PRS AccountCheladv74
Verification DateOctober 2019

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Cheladv74 Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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