To Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis
NCT ID: NCT03707535
Last Updated: 2021-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
270 participants
INTERVENTIONAL
2018-11-12
2021-03-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis
NCT05489224
An Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1
NCT01571219
A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis
NCT03789292
An Efficacy And Safety Study of CNTO 6785 In Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy
NCT01909427
PK Similarity Prospective Phase 3 Study in Patients With Rheumatoid Arthritis
NCT02149121
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CT-P13
CT-P13
3 mg/kg, 2-hour infusion per dose co-administered with methotrexate and folic acid
China-approved Remicade
Remicade
3 mg/kg, 2-hour infusion per dose co-administered with methotrexate and folic acid
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CT-P13
3 mg/kg, 2-hour infusion per dose co-administered with methotrexate and folic acid
Remicade
3 mg/kg, 2-hour infusion per dose co-administered with methotrexate and folic acid
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Has active disease as defined in DAS28 Criteria
Exclusion Criteria
* Has previously received a biological agent
* Has previously received a tumor necrosis factor alpha (TNF α) inhibitor
* Allergies to any of the excipients of infliximab or hypersensitivity to murine and/or human proteins or immunoglobulin products
* Pregnant or lactating
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Celltrion
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peking Union Medical College Hospital
Beijing, , China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CT-P13 3.6
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.