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

NCT ID: NCT01787149

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• 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 DMARDs versus DMARDs 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 DMARDs versus DMARDs 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 DMARDs versus DMARDs alone in patients with rheumatoid arthritis.

The study period for each patient will be 28 weeks, during which the patient will undergo screening for up to 14 days, followed by treatment of 24 weeks and follow-up period of 2 weeks. Each patient will be required to make a total of 9 visits.

Conditions

Combination With DMARDs

Study Design

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

Study Groups

Placebo

DMARDs alone

Group Type: PLACEBO_COMPARATOR

DMARDs

Intervention Type: DRUG

ENIA11

ENIA11 25 mg

Group Type: EXPERIMENTAL

DMARDs

Intervention Type: DRUG

Interventions

DMARDs

Intervention Type: DRUG

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 received stable doses of permitted DMARDs (methotrexate, hydroxychloroquine, sulfasalazine, azathioprine, and leflunomide) for at least 8 weeks prior enrollment.

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

Hsiao-Yi Lin, PHD

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

Cathay General Hospital

Taipei, , Taiwan

Cheng Hsin General Hospital

Taipei, , Taiwan

Far Eastern Memorial Hospital

Taipei, , Taiwan

Mackay Memorial Hospital Institutional

Taipei, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei City Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

TSHEN1201

Identifier Type: -

Identifier Source: org_study_id