Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis

Conditions

Rheumatoid Arthritis

Keywords

RA, Biosimilar

Brief summary

This randomized,controlled, multicenter, 2-arm, parallel-group, double-blind, prospective, Phase 1 study is designed to demonstrate comparable pharmacokinetics in terms of AUC0-last and Cmax (after second infusion) between CT-P10 and MabThera in patients with active RA concomitantly treated with MTX during the Core Study Period.

Won Park, Ljubinka Božić-Majstorović, Dragana Milaković, Alfredo Berrocal Kasay, Elias Chalouhi El-Khouri et al. (27 authors)

mAbs2018-07-1652 citations

10.1080/19420862.2018.1487912

Efficacy and Safety of Switching from Innovator Rituximab to Biosimilar CT-P10 Compared with Continued Treatment with CT-P10: Results of a 56-Week Open-Label Study in Patients with Rheumatoid Arthritis.

Park W, Suh CH, Shim SC, Molina FFC, Jeka S, Medina-Rodriguez FG, Hrycaj P, Wiland P, Lee EY, Shesternya P, Kovalenko V, Myasoutova L, Stanislav M, Radominski S, Lim MJ, Choe JY, Lee SJ, Lee SY, Kim SH, Yoo DH.

2017-08-0131 citations

10.1007/s40259-017-0233-6

Efficacy, Safety and Pharmacokinetics of Up to Two Courses of the Rituximab Biosimilar CT-P10 Versus Innovator Rituximab in Patients with Rheumatoid Arthritis: Results up to Week 72 of a Phase I Randomized Controlled Trial

Dae‐Hyun Yoo, Chang‐Hee Suh, Seung Cheol Shim, Sławomir Jeka, Francisco Fidencio Cons Molina et al. (21 authors)

BioDrugs2017-06-1332 citations

10.1007/s40259-017-0232-7

A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis.

Yoo DH, Suh CH, Shim SC, Jeka S, Cons-Molina FF, Hrycaj P, Wiland P, Lee EY, Medina-Rodriguez FG, Shesternya P, Radominski S, Stanislav M, Kovalenko V, Sheen DH, Myasoutova L, Lim MJ, Choe JY, Lee SJ, Lee SY, Kwon TS, Park W.

2016-09-1359 citations

10.1136/annrheumdis-2016-209540

Global Phase I/III Pharmacokinetic and Efficacy Study Comparing CT-P10, a Biosimilar Candidate to the Rituximab Reference Product in Patients with Advanced Stage Follicular Lymphoma (AFL)

Won Seog Kim, Michinori Ogura, Christian Buske, Bertrand Coiffier, Juan‐Manuel Sancho et al. (16 authors)

Blood2015-12-035 citations

10.1182/blood.v126.23.5111.5111

Interventions

BIOLOGICALrituximab

1000 mg by intravenous (IV) infusion. Each patient may receive 2 courses of treatment.

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

1. Patient has a diagnosis of RA according to the revised 1987 ACR classification criteria (Arnett et al 1987) for at least 6 months prior to randomization. 2. Patient has active disease as defined by the presence of 6 or more swollen joints (of 66 assessed) and 6 or more tender joints (of 68 assessed), and serum CRP ≥1.5 mg/dL or an ESR ≥28 mm/hour.

Exclusion criteria

1. Patient is unresponsive or intolerable to more than 2 biologic agents. 2. Patient has allergies or hypersensitivity to murine, chimeric, human, or humanized proteins. 3. Patient has current or past history of chronic infection with hepatitis B, hepatitis C, or infection with human immunodeficiency virus (HIV)-1 or -2 or who has a positive result to the screening test for these infections.

Design outcomes

Primary

Measure	Time frame	Description
PK in terms of Cmax	Up to Week 24	maximum serum concentration

Countries

South Korea

Outcome results

None listed