Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in RA Patients(PLANETRA)
NCT ID: NCT01217086
Last Updated: 2013-03-12
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
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COMPLETED
PHASE3
617 participants
INTERVENTIONAL
2010-10-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CT-P13
Infliximab
Infliximab 3mg/kg is going to be administered for both arm as a 2-hour infusion per dose.
Remicade
Infliximab
Infliximab 3mg/kg is going to be administered for both arm as a 2-hour infusion per dose.
Interventions
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Infliximab
Infliximab 3mg/kg is going to be administered for both arm as a 2-hour infusion per dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* at least 3 months of treatment with methotrexate
Exclusion Criteria
* serious infection
18 Years
75 Years
ALL
No
Sponsors
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Celltrion
INDUSTRY
Responsible Party
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Principal Investigators
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Dae Hyun Yoo
Role: PRINCIPAL_INVESTIGATOR
Hanyang University
Locations
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Hanyang University Medical Center
Seoul, , South Korea
Countries
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References
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Eser A, Reinisch W, Schreiber S, Ahmad T, Boulos S, Mould DR. Increased Induction Infliximab Clearance Predicts Early Antidrug Antibody Detection. J Clin Pharmacol. 2021 Feb;61(2):224-233. doi: 10.1002/jcph.1732. Epub 2020 Sep 9.
Yoo DH, Racewicz A, Brzezicki J, Yatsyshyn R, Arteaga ET, Baranauskaite A, Abud-Mendoza C, Navarra S, Kadinov V, Sariego IG, Hong SS, Lee SY, Park W. A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study. Arthritis Res Ther. 2016 Apr 2;18:82. doi: 10.1186/s13075-016-0981-6.
Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, Kovalenko V, Prodanovic N, Abello-Banfi M, Gutierrez-Urena S, Morales-Olazabal L, Tee M, Jimenez R, Zamani O, Lee SJ, Kim H, Park W, Muller-Ladner U. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013 Oct;72(10):1613-20. doi: 10.1136/annrheumdis-2012-203090. Epub 2013 May 16.
Other Identifiers
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CT-P13 3.1
Identifier Type: -
Identifier Source: org_study_id
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