NCT01534884

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Feb 2012

Typical duration for phase_1 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

1.5 years

First QC Date

February 8, 2012

Last Update Submit

May 20, 2015

Conditions

Rheumatoid Arthritis

Keywords

RA, Biosimilar

Outcome Measures

Primary Outcomes (1)

  • PK in terms of Cmax

    maximum serum concentration

    Up to Week 24

Study Arms (2)

MabThera

ACTIVE COMPARATOR

rituximab

Biological: rituximab

CT-P10

ACTIVE COMPARATOR

rituximab

Biological: rituximab

Interventions

rituximabBIOLOGICAL

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

CT-P10MabThera

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • Patient is unresponsive or intolerable to more than 2 biologic agents.
  • Patient has allergies or hypersensitivity to murine, chimeric, human, or humanized proteins.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanyang University Medical Center

Seoul, South Korea

Location

Related Publications (2)

  • Yoo DH, Suh CH, Shim SC, Jeka S, Molina FFC, 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, Kim SH, Park W. 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. BioDrugs. 2017 Aug;31(4):357-367. doi: 10.1007/s40259-017-0232-7.

    PMID: 28612179DERIVED

  • 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. A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Mar;76(3):566-570. doi: 10.1136/annrheumdis-2016-209540. Epub 2016 Sep 13.

    PMID: 27624791DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Rituximab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • DaeHyun Yoo, M.D., Ph.D.

    Hanyang University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2012

First Posted

February 17, 2012

Study Start

February 1, 2012

Primary Completion

August 1, 2013

Study Completion

February 1, 2014

Last Updated

May 22, 2015

Record last verified: 2015-05

Locations

KR(1)