Rheumatoid ArthritisPhase 3NCT01270997
Randomized Double-blind Parallel Trial to Evaluate Equivalence in Efficacy and Safety of HD203 and Enbrel in RA Patients
A Phase 3 study testing Etanercept in people with Rheumatoid Arthritis, run by Hanwha Chemical at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Etanercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2010to May 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hospetal for Rheumatic Diseases Hanyang University Medical Center
Seoul, 133-792
About this study
Official title: A Multicenter Randomized Double-blind Active-controlled Parallel Group Phase Ⅲ Trial to Evaluate the Equivalence in Efficacy and Safety of HD203 and Enbrel in Combination With Methotrexate in Patients With Rheumatoid Arthritis
The objective is to prove the equivalence in efficacy and safety of HD203 and Enbrel® in combination with Methotrexate in patients with rheumatoid arthritis.
Read the detailed description
Primary Objective:
To prove the equivalence between two groups by comparing the ACR20 of W24 with the baseline after injecting HD203 25mg and (Enbrel®) 25mg into the patients with rheumatoid arthritis for 24 weeks.
Secondary Objective:
To compare the efficacy of ACR20, ACR50 and ACR70, etc along with safety in adverse event, vital signs, Laboratory test, physical examination and immunogenicity, etc between two groups with baseline after injecting HD203 25mg and (Enbrel®) 25mg into patients with rheumatoid arthritis for 48 weeks.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Etanercept
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptBiological
Also called HD203
Subcutaneous injection (SC) Etanercept 25mg twice a week for 48 weeks
EtanerceptBiological
Also called Enbrel
Subcutaneous injection (SC) Etanercept 25mg twice a week for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| HD203 | Experimental | Subcutaneous injection (SC) HD203 25mg twice a week for 48 weeks Receives: Biological: Etanercept |
| Enbrel | Active comparator | Subcutaneous injection (SC) Enbrel® 25mg twice a week for 48 weeks. Receives: Biological: Etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 12W, 24W, 48W
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanwha Chemical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sang Chul Bae, MD, PhD, MPH, Principal investigator, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270997
- Sponsor's protocol ID
- EAGLE-III-10
- Status last verified
- Jul 2014
- First submitted
- 2 Jan 2011
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26905864
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Double-blind Active-controlled Parallel Group Phase Ⅲ Trial to Evaluate the Equivalence in Efficacy and Safety of HD203 and Enbrel in Combination With Methotrexate in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01270997
- Acronym / sponsor ID
- EAGLE-III-10
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Hanwha ChemicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 6 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to prove the equivalence in efficacy and safety of HD203 and Enbrel® in combination with Methotrexate in patients with rheumatoid arthritis.
Detailed description
Primary Objective:
To prove the equivalence between two groups by comparing the ACR20 of W24 with the baseline after injecting HD203 25mg and (Enbrel®) 25mg into the patients with rheumatoid arthritis for 24 weeks.
Secondary Objective:
To compare the efficacy of ACR20, ACR50 and ACR70, etc along with safety in adverse event, vital signs, Laboratory test, physical examination and immunogenicity, etc between two groups with baseline after injecting HD203 25mg and (Enbrel®) 25mg into patients with rheumatoid arthritis for 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HD203 | Experimental | Biological: EtanerceptSubcutaneous injection (SC) HD203 25mg twice a week for 48 weeks |
| Enbrel | Active comparator | Biological: EtanerceptSubcutaneous injection (SC) Enbrel® 25mg twice a week for 48 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtanerceptAlso: HD203Subcutaneous injection (SC) Etanercept 25mg twice a week for 48 weeks | Biological | HD203 |
| EtanerceptAlso: EnbrelSubcutaneous injection (SC) Etanercept 25mg twice a week for 48 weeks | Biological | Enbrel |
Primary outcome
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.
Time frame: 24week
1 secondary outcome
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
Time frame: 12W, 24W, 48W
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
- Derived from this study: PubMed 26905864Bae 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang Chul Bae, MD, PhD, MPH principal investigator
Hanyang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Etanercept in people with Rheumatoid Arthritis, run by Hanwha Chemical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 24week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01270997, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2014.