Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in RA Patients(PLANETRA)

Conditions

Rheumatoid Arthritis

Brief summary

This is the trial to see how our product is similar to remicade by comparing the results of blood samples when co-administered with methotrexate between 12.5 to 25 mg/week, oral or parenteral dose and folic acid in rheumatoid arthritis patients who are not receiving adequate response to methotrexate alone up to week 30.

Combe B, Allanore Y, Alten R, Caporali R, Durez P, Iannone F, Nurmohamed MT, Toumi M, Lee SJ, Kwon TS, Noh J, Park G, Yoo DH.

2021-04-1612 citations

10.1186/s13075-021-02487-x

Increased Induction Infliximab Clearance Predicts Early Antidrug Antibody Detection

Alexander Eser, Walter Reinisch, Stefan Schreiber, Tariq Ahmad, Suliman Boulos et al. (6 authors)

The Journal of Clinical Pharmacology2020-09-0914 citations

10.1002/jcph.1732

Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study.

Yoo DH, Prodanovic N, Jaworski J, Miranda P, Ramiterre E, Lanzon A, Baranauskaite A, Wiland P, Abud-Mendoza C, Oparanov B, Smiyan S, Kim H, Lee SJ, Kim S, Park W.

2016-04-29187 citations

10.1136/annrheumdis-2015-208786

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

Dae‐Hyun Yoo, Artur Racewicz, Jan Brzezicki, Roman Yatsyshyn, E. Tobias Arteaga et al. (13 authors)

Arthritis Research & Therapy2016-04-02170 citations

10.1186/s13075-016-0981-6

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.

Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, Kovalenko V, Prodanovic N, Abello-Banfi M, Gutierrez-Ureña S, Morales-Olazabal L, Tee M, Jimenez R, Zamani O, Lee SJ, Kim H, Park W, Müller-Ladner U.

2013-05-16462 citations

10.1136/annrheumdis-2012-203090

Interventions

DRUGInfliximab

Infliximab 3mg/kg is going to be administered for both arm as a 2-hour infusion per dose.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

* diagnosed with active rheumatoid arthritis * at least 3 months of treatment with methotrexate

Exclusion criteria

* have allergies to infliximab * serious infection

Design outcomes

Primary

Measure	Time frame
PK equivalence to remicade	PK sampling at week 30

Secondary

Measure	Time frame	Description
efficacy endpoint	up to week 54.	-ACR criteria comparison with Baseline at Weeks 14,30,54

Countries

South Korea

Outcome results

None listed