NCT03707535

Brief Summary

To demonstrate that CT-P13 is equivalent to China-approved Remicade at Week 14, in terms of efficacy as determined by clinical response according to the change from baseline in disease activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P50-P75 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Nov 2018

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

First Submitted

Initial submission to the registry

October 12, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

November 12, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2020

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2021

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

1.3 years

First QC Date

October 12, 2018

Last Update Submit

September 13, 2021

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Efficacy assessment: DAS28 (CRP) at Week 14

    Clinical response according to the change from baseline in disease activity as measured by the Disease Activity Score using 28 joint counts (DAS28) (C-reactive protein\[CRP\])

    Week 14

Study Arms (2)

CT-P13

EXPERIMENTAL
Biological: CT-P13

China-approved Remicade

ACTIVE COMPARATOR
Biological: Remicade

Interventions

CT-P13BIOLOGICAL

3 mg/kg, 2-hour infusion per dose co-administered with methotrexate and folic acid

CT-P13
RemicadeBIOLOGICAL

3 mg/kg, 2-hour infusion per dose co-administered with methotrexate and folic acid

China-approved Remicade

Eligibility Criteria

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

You may qualify if:

  • Has a diagnosis of rheumatoid arthritis
  • Has active disease as defined in DAS28 Criteria

You may not qualify if:

  • Has a history of tuberculosis (TB) or a current diagnosis of TB
  • Has previously received a biological agent
  • Has previously received a tumor necrosis factor alpha (TNF α) inhibitor
  • Allergies to any of the excipients of infliximab or hypersensitivity to murine and/or human proteins or immunoglobulin products
  • Pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

CT-P13Infliximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2018

First Posted

October 16, 2018

Study Start

November 12, 2018

Primary Completion

March 16, 2020

Study Completion

March 5, 2021

Last Updated

September 14, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)