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

NCT ID: NCT01709760

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2019-12-31

Brief 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

methotrexate & ENIA11

ENIA11 25 mg, sc twice weekly

Group Type: EXPERIMENTAL

Methotrexate

Intervention Type: DRUG

Methotrexate 15-25 mg/week

ENIA11

Intervention Type: DRUG

ENIA11 25 mg, sc twice weekly

methotrexate & Placebo

Placebo, sc twice weekly

Group Type: ACTIVE_COMPARATOR

Methotrexate

Intervention Type: DRUG

Methotrexate 15-25 mg/week

Placebo

Intervention Type: DRUG

Placebo, sc twice weekly

Interventions

Methotrexate

Methotrexate 15-25 mg/week

Intervention Type: DRUG

ENIA11

ENIA11 25 mg, sc twice weekly

Intervention Type: DRUG

Placebo

Placebo, sc twice weekly

Intervention Type: DRUG

Other Intervention Names

TuNEX

Eligibility Criteria

Inclusion Criteria

1. Male or female patients aged ≥ 20 years old;

2. Patient meet ACR criteria for rheumatoid arthritis over 6 month duration;

3. Patient with active disease at the time of screening as defined by six or more swollen joints and six or more tender joints;

4. Presence of at least one of the following criteria:

• Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/h,
• C-Reactive Protein (CRP) ≥ 10 mg/L,

5. RA functional class I, II, or III;

6. 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.

7. Patient is willing and able to comply with study procedures and sign informed consent.

Exclusion Criteria

1. Active autoimmune disease (other than RA) requiring immunosuppressive therapy;

2. In the opinion of the investigator, the patient shows persistent signs of immunosuppression;

3. Known hypersensitivity to etanercept or ENIA11 or any of its components;

4. Previous unsuccessful treatment with etanercept, anti-TNF monoclonal antibodies or a soluble TNF receptor (e.g., infliximab);

5. Suspected or diagnosed pulmonary tuberculosis, or other chronic or current infectious disease at discretion of investigator;

6. 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;

7. 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;

8. Patients have received live attenuated vaccination program within 3 months or BCG vaccine within 12 months prior enrollment;

9. 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;

10. Diagnosis of primary fibromyalgia or other joint inflammatory disease including but not limited to gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease;

11. Known or suspected positive serology for human immunodeficiency, hepatitis B or C virus;

12. Patient has received any investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product;

13. Patient has history of substance abuse, drug addiction or alcoholism;

14. Patient who have had participated in prior phase I/II clinical trial.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mycenax Biotech Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joung-Liang Lan, PHD

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Chung-Ming Huang, MD

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Der-Yuan Chen, PHD

Role: PRINCIPAL_INVESTIGATOR

Taichung Veterans General Hospital

Ling-Ying Lu, PHD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Veterans General Hospital.

Ning-Sheng Lai, PHD

Role: PRINCIPAL_INVESTIGATOR

Buddhist Tzu Chi General Hospital

Tien-Tsai Cheng, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Gregory J Tsay, PHD

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Ying-Ming Chiu, MD

Role: PRINCIPAL_INVESTIGATOR

Changhua Christian Hospital

Locations

Changhua Christian Hospital

Changhua, , Taiwan

Buddhist Tzu Chi General Hospital

Chiayi City, , Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Taichung Veterans General Hospital

Taichung, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

Chung Shan Medical University Hospital

Taichung, , Taiwan

Taipei City Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

TSHEN1101

Identifier Type: -

Identifier Source: org_study_id