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
=================
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.

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

Conditions
-----------------
Combination With DMARDs

Intervention / Treatment
-----------------
* Drug: DMARDs


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>DMARDs alone | Drug: DMARDs<br> <br> |
| Experimental: ENIA11<br>ENIA11 25 mg | Drug: DMARDs<br> <br> |

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ENIA11, DMARDs, RA, TNF