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

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

Study Overview

• Status: Unknown
• Conditions: Combination With DMARDs
• Intervention / Treatment: Drug: DMARDs

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.

• Study Type: Interventional
• Enrollment (Anticipated): 98
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital
  • Taipei, Taiwan
    • Taipei Veterans General Hospital
  • Taipei, Taiwan
    • Far Eastern Memorial Hospital
  • Taipei, Taiwan
    • Cheng Hsin General Hospital
  • Taipei, Taiwan
    • Taipei City Hospital
  • Taipei, Taiwan
    • Cathay General Hospital
  • Taipei, Taiwan
    • Mackay Memorial Hospital Institutional

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; DMARDs alone	Drug: DMARDs
Experimental: ENIA11; ENIA11 25 mg	Drug: DMARDs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACR20 responder at last treatment visit	The primary efficacy endpoint is defined as ACR20 responder at last treatment visit (Week 24).	Week 24

Collaborators and Investigators

• Sponsor: Mycenax Biotech Inc.
• Investigators: Principal Investigator: Hsiao-Yi Lin, PHD, Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): December 1, 2017
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: February 6, 2013
• First Submitted That Met QC Criteria: February 7, 2013
• First Posted (Estimate): February 8, 2013

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 13, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: DMARDs; TNF; RA; ENIA11
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: TSHEN1201