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

NCT01787149 | Unknown Phase 3 DMC

• 1 other identifier: TSHEN1201
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 7

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

Conditions

Combination With DMARDs

Keywords

ENIA11; DMARDs; RA; TNF

Outcome Measures

Primary Outcomes (1)

• ACR20 responder at last treatment visit

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

  Week 24

Study Arms (2)

Placebo

PLACEBO COMPARATOR

DMARDs alone

Drug: DMARDs

ENIA11

EXPERIMENTAL

ENIA11 25 mg

Drug: DMARDs

Interventions

DMARDs DRUG

ENIA11; Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Mycenax Biotech Inc.: lead

Study Sites (7)

Cathay General Hospital

Taipei, Taiwan

Location

Cheng Hsin General Hospital

Taipei, Taiwan

Location

Far Eastern Memorial Hospital

Taipei, Taiwan

Location

Mackay Memorial Hospital Institutional

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei City Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Interventions

Antirheumatic Agents

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Hsiao-Yi Lin, PHD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 8, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2019
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

TW (7)