NCT01270997

Brief Summary

The objective is to prove the equivalence in efficacy and safety of HD203 and Enbrel® in combination with Methotrexate in patients with rheumatoid arthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
294

participants targeted

Target at P50-P75 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_3 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

December 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 2, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 6, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

July 15, 2014

Status Verified

July 1, 2014

Enrollment Period

1.4 years

First QC Date

January 2, 2011

Last Update Submit

July 13, 2014

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • To prove the equivalence between two groups by comparing the ACR20 of W24 with the baseline after injecting HD203 and Enbrel® into rheumatoid arthritis patients for 24 weeks.

    24week

Secondary Outcomes (1)

  • To compare the efficacy of ACR20, ACR50 and ACR70 along with safety and immunogenicity between two groups with baseline after injecting HD203 and Enbrel® into rheumatoid arthritis patients for 48 weeks

    12W, 24W, 48W

Study Arms (2)

HD203

EXPERIMENTAL

Subcutaneous injection (SC) HD203 25mg twice a week for 48 weeks

Biological: Etanercept

Enbrel

ACTIVE COMPARATOR

Subcutaneous injection (SC) Enbrel® 25mg twice a week for 48 weeks.

Biological: Etanercept

Interventions

EtanerceptBIOLOGICAL

Subcutaneous injection (SC) Etanercept 25mg twice a week for 48 weeks

Also known as: HD203
HD203

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females who are 20 or over
  • Patients who satisfy the classification criteria of Rheumatoid Arthritis according to American Colleague of Rheumatology (ACR 1987)
  • Patients who are applicable to functional status I - III of American Colleague of Rheumatology

You may not qualify if:

  • Patients who have autoimmune diseases other than rheumatoid arthritis or have significant secondary systematic disease caused by rheumatoid arthritis
  • Patients who are currently participating in other clinical studies or receiving treatment for drugs not sold in the market or for experiment
  • Patients who have significant other diseases that may affect the clinical trial when judged by the clinical trial Investigator
  • In the opinion of the investigator, may put the patient at risk because of participation on the study or may influence the patients' ability to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospetal for Rheumatic Diseases Hanyang University Medical Center

Seoul, 133-792, South Korea

Location

Related Publications (1)

  • Bae SC, Kim J, Choe JY, Park W, Lee SH, Park YB, Shim SC, Lee SS, Sung YK, Choi CB, Lee SR, Park H, Ahn Y; HERA Study Investigators. A phase III, multicentre, randomised, double-blind, active-controlled, parallel-group trial comparing safety and efficacy of HD203, with innovator etanercept, in combination with methotrexate, in patients with rheumatoid arthritis: the HERA study. Ann Rheum Dis. 2017 Jan;76(1):65-71. doi: 10.1136/annrheumdis-2015-207613. Epub 2016 Feb 23.

    PMID: 26905864DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Officials

  • Sang Chul Bae, MD, PhD, MPH

    Hanyang University College of Medicine

    PRINCIPAL INVESTIGATOR

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

January 2, 2011

First Posted

January 6, 2011

Study Start

December 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

July 15, 2014

Record last verified: 2014-07

Locations

KR(1)