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

Sponsor

Mycenax Biotech Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01787149

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Combination With DMARDs	Drug: DMARDs	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

98 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 DMARDs Versus DMARDs Alone in Patients With Rheumatoid Arthritis

Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Placebo Comparator: Placebo

DMARDs alone

Drug: DMARDs

Experimental: ENIA11

ENIA11 25 mg

Drug: DMARDs

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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,

RA functional class I, II, or III;
Patients have been received stable doses of permitted DMARDs (methotrexate, hydroxychloroquine, sulfasalazine, azathioprine, and leflunomide) for at least 8 weeks prior enrollment.
Patient is willing and able to comply with study procedures and sign informed consent.

Exclusion Criteria:

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;
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.

Contacts and Locations

Locations

	Site	City	Country
1	Cathay General Hospital	Taipei	Taiwan
2	Cheng Hsin General Hospital	Taipei	Taiwan
3	Far Eastern Memorial Hospital	Taipei	Taiwan
4	Mackay Memorial Hospital Institutional	Taipei	Taiwan
5	National Taiwan University Hospital	Taipei	Taiwan
6	Taipei City Hospital	Taipei	Taiwan
7	Taipei Veterans General Hospital	Taipei	Taiwan