Rheumatoid ArthritisPhase 3ENIA11NCT01709760

A Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With Methotrexate Versus Methotrexate Alone in Patients With RA

A Phase 3 study testing Methotrexate and ENIA11 in people with Rheumatoid Arthritis, run by Mycenax Biotech Inc. at 8 sites in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination with Methotrexate versus Methotrexate Alone 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?: Methotrexate and ENIA11
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 91 participants
Where: 8 sitesTaiwan
Study dates: Nov 2012to Dec 2019
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

Male or female patients aged ≥ 20 years old;
Patient meet ACR criteria for rheumatoid arthritis over 6 month duration;
Patient with active disease at the time of screening as defined by six or more swollen joints and six or more tender joints;
Presence of at least one of the following criteria:
Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/h,
C-Reactive Protein (CRP) ≥ 10 mg/L,

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RA functional class I, II, or III;
Patients have been treated on methotrexate for at least 3 month, and maintained at stable dose of 15-25 mg/week for at least 8 weeks; MTX low dose as 10 mg per week is allowed for patients who had a documented history of constitutional symptoms at higher doses.
Patient is willing and able to comply with study procedures and sign informed consent.

Who cannot join

Active autoimmune disease (other than RA) requiring immunosuppressive therapy;
In the opinion of the investigator, the patient shows persistent signs of immunosuppression;
Known hypersensitivity to etanercept or ENIA11 or any of its components;
Previous unsuccessful treatment with etanercept, anti-TNF monoclonal antibodies or a soluble TNF receptor (e.g., infliximab);
Suspected or diagnosed pulmonary tuberculosis, or other chronic or current infectious disease at discretion of investigator;
Patients who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, hematological, gastrointestinal or psychiatric disease as determined by the clinical judgment of the investigator;

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Patients with any of the following laboratory abnormalities: ALT/AST > 3 times ULN, creatinine > 2 mg/dl, WBC < 3,000/mm3, Hgb < 8.5 g/dL, platelet count < 100,000/mm3;
Patients have received live attenuated vaccination program within 3 months or BCG vaccine within 12 months prior enrollment;
Female patient of childbearing potential who:
is lactating; or
has positive urine pregnancy test at Visit 1; or
refuse to adopt reliable method of contraception during the study;
Diagnosis of primary fibromyalgia or other joint inflammatory disease including but not limited to gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease;
Known or suspected positive serology for human immunodeficiency, hepatitis B or C virus;
Patient has received any investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product;
Patient has history of substance abuse, drug addiction or alcoholism;
Patient who have had participated in prior phase I/II clinical trial.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Taiwan8 sites

Changhua Christian Hospital
Changhua
Buddhist Tzu Chi General Hospital
Chiayi City
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Kaohsiung Veterans General Hospital
Kaohsiung City
Taichung Veterans General Hospital
Taichung, 407
China Medical University Hospital
Taichung
Chung Shan Medical University Hospital
Taichung
Taipei City Hospital
Taipei

Other trials in Taiwan

About this study

Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With Methotrexate Versus Methotrexate Alone in Patients With Rheumatoid Arthritis

Read the detailed description

The objectives of the study are to evaluate the efficacy and safety of ENIA11 in combination with methotrexate versus methotrexate alone in patients with rheumatoid arthritis.

This is a multi-center, double-blind, randomized, parallel-group, placebo-controlled study to evaluate the efficacy and safety of ENIA11 in combination with methotrexate versus methotrexate alone in patients with rheumatoid arthritis.

Subject participation duration: A total of 28 weeks, including: 2 weeks of screening, 24 weeks of treatment and 2 weeks of follow-up

Conditions: Rheumatoid Arthritis
Being tested: Methotrexate, ENIA11, Placebo
Keywords: ENIA11, MTX, RA, TNF
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MethotrexateDrug
Methotrexate 15-25 mg/week
ENIA11Drug
Also called TuNEX
ENIA11 25 mg, sc twice weekly
PlaceboDrug
Placebo, sc twice weekly

Study groups in NCT01709760
Study group	Role	What they receive
methotrexate & ENIA11	Experimental	ENIA11 25 mg, sc twice weekly Receives: Drug: Methotrexate; Drug: ENIA11
methotrexate & Placebo	Active comparator	Placebo, sc twice weekly Receives: Drug: Methotrexate; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

ACR20 responder at last treatment visit
The primary efficacy endpoint is defined as ACR20 responder at last treatment visit (Week 24).
Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Dec 2019

First posted18 Oct 2012 (estimated)
Study startNov 2012
Primary completionDec 2017
Study completionDec 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Double blind
Who is masked: Care provider, Investigator
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01709760
Sponsor's protocol ID: TSHEN1101
Acronym: ENIA11
Status last verified: Apr 2018
First submitted: 16 Oct 2012
Last updated: 17 Apr 2018
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With Methotrexate Versus Methotrexate Alone in Patients With Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT01709760
Acronym / sponsor ID: ENIA11 / TSHEN1101
Conditions: Rheumatoid Arthritis
Keywords: ENIA11, MTX, RA, TNF
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 91 participants (actual)
Lead sponsor: Mycenax Biotech Inc.Industry (pharma, biotech, devices)
Study start: Nov 2012
Primary completion: Dec 2017 (actual)
Study completion: Dec 2019 (estimated)
First posted: 18 Oct 2012 (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.

Detailed description

The objectives of the study are to evaluate the efficacy and safety of ENIA11 in combination with methotrexate versus methotrexate alone in patients with rheumatoid arthritis.

Subject participation duration: A total of 28 weeks, including: 2 weeks of screening, 24 weeks of treatment and 2 weeks of follow-up

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (care provider, investigator)
Number of arms: 2

Arm	Type	Receives
methotrexate & ENIA11	Experimental	Drug: Methotrexate, Drug: ENIA11ENIA11 25 mg, sc twice weekly
methotrexate & Placebo	Active comparator	Drug: Methotrexate, Drug: PlaceboPlacebo, sc twice weekly

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Male or female patients aged ≥ 20 years old;
Patient meet ACR criteria for rheumatoid arthritis over 6 month duration;
Patient with active disease at the time of screening as defined by six or more swollen joints and six or more tender joints;
Presence of at least one of the following criteria:
RA functional class I, II, or III;

Key exclusion criteria (17 listed)

Active autoimmune disease (other than RA) requiring immunosuppressive therapy;
In the opinion of the investigator, the patient shows persistent signs of immunosuppression;
Known hypersensitivity to etanercept or ENIA11 or any of its components;
Previous unsuccessful treatment with etanercept, anti-TNF monoclonal antibodies or a soluble TNF receptor (e.g., infliximab);
Suspected or diagnosed pulmonary tuberculosis, or other chronic or current infectious disease at discretion of investigator;

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
MethotrexateMethotrexate 15-25 mg/week	Drug	methotrexate & ENIA11, methotrexate & Placebo
ENIA11Also: TuNEXENIA11 25 mg, sc twice weekly	Drug	methotrexate & ENIA11
PlaceboPlacebo, sc twice weekly	Drug	methotrexate & Placebo

Primary outcome

ACR20 responder at last treatment visit
Time frame: Week 24
The primary efficacy endpoint is defined as ACR20 responder at last treatment visit (Week 24).

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.

Related trials for Rheumatoid Arthritis

Active, not recruitingPhase 1
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
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Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
Not yet recruitingObservational study
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RecruitingObservational study
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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.

Joung-Liang Lan, PHD principal investigator

China Medical University Hospital

Chung-Ming Huang, MD principal investigator

China Medical University Hospital

Der-Yuan Chen, PHD principal investigator

Taichung Veterans General Hospital

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Methotrexate and ENIA11 in people with Rheumatoid Arthritis, run by Mycenax Biotech Inc. at 8 sites in Taiwan.

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 9 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Taiwan. 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?

Results are not available in the source record.

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?

ACR20 responder at last treatment visit (time frame: Week 24). 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 NCT01709760.

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 17 Apr 2018.