Clinical trial NCT01217086: Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in RA Patients(PLANETRA)
Official title: Randomized, Double-blind, Parallel-group, Phase 3 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2010-10-08
Enrollment: 617
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* have allergies to infliximab
* serious infection

Primary outcomes:
measure: PK equivalence to remicade
timeFrame: PK sampling at week 30
Secondary outcomes:
measure: efficacy endpoint
timeFrame: up to week 54.
measure: efficacy endpoint
timeFrame: Up to week 54.
measure: efficacy endpoint
timeFrame: Up to week 54.
measure: efficacy endpoint
timeFrame: Up to week 54.
measure: efficacy endpoint
timeFrame: Up to week 54.
measure: efficacy endpoint
timeFrame: Up to week 54.
measure: efficacy endpoint
timeFrame: Up to week 54.
measure: efficacy endpoint
timeFrame: Up to week 54.
measure: efficacy endpoint
timeFrame: Up to week 54.
measure: efficacy endpoint
timeFrame: Up to week 54.
measure: efficacy endpoint
timeFrame: Up to week 54.
measure: efficacy endpoint
timeFrame: Up to week 54.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
Study officials:
affiliation: Hanyang University
name: Dae Hyun Yoo
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.