A Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With Methotrexate Versus Methotrexate Alone in Patients With RA (ENIA11)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
TSH Biopharm Corporation Limited
ClinicalTrials.gov Identifier:
NCT01709760
First received: October 16, 2012
Last updated: April 12, 2016
Last verified: February 2016
  Purpose
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination with Methotrexate versus Methotrexate Alone in Patients with Rheumatoid Arthritis

Condition Intervention Phase
Rheumatoid Arthritis
Drug: Methotrexate
Drug: ENIA11
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, 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 Methotrexate Versus Methotrexate Alone in Patients With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by TSH Biopharm Corporation Limited:

Primary Outcome Measures:
  • ACR20 responder at last treatment visit [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
    The primary efficacy endpoint is defined as ACR20 responder at last treatment visit (Week 24).


Enrollment: 91
Study Start Date: November 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: methotrexate & ENIA11
ENIA11 25 mg, sc twice weekly
Drug: Methotrexate
Methotrexate 15-25 mg/week
Drug: ENIA11
ENIA11 25 mg, sc twice weekly
Other Name: TuNEX
Active Comparator: methotrexate & Placebo
Placebo, sc twice weekly
Drug: Methotrexate
Methotrexate 15-25 mg/week
Drug: Placebo
Placebo, sc twice weekly

Detailed Description:

The objectives of the study are to evaluate the efficacy and safety of ENIA11 in combination with methotrexate versus methotrexate 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 methotrexate versus methotrexate alone in patients with rheumatoid arthritis.

Subject participation duration: A total of 28 weeks, including: 2 weeks of screening, 24 weeks of treatment and 2 weeks of follow-up

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 treated on methotrexate for at least 3 month, and maintained at stable dose of 15-25 mg/week for at least 8 weeks; MTX low dose as 10 mg per week is allowed for patients who had a documented history of constitutional symptoms at higher doses.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709760

Locations
Taiwan
Changhua Christian Hospital
Changhua, Taiwan
Buddhist Tzu Chi General Hospital
Chiayi, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan, 407
China Medical University Hospital
Taichung, Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan
Taipei City Hospital
Taipei, Taiwan
Sponsors and Collaborators
TSH Biopharm Corporation Limited
Investigators
Principal Investigator: Joung-Liang Lan, PHD China Medical University Hospital
Principal Investigator: Chung-Ming Huang, MD China Medical University Hospital
Principal Investigator: Der-Yuan Chen, PHD Taichung Veterans General Hospital
Principal Investigator: Ling-Ying Lu, PHD Kaohsiung Veterans General Hospital.
Principal Investigator: Ning-Sheng Lai, PHD Buddhist Tzu Chi General Hospital
Principal Investigator: Tien-Tsai Cheng, MD Chang Gung Memorial Hospital
Principal Investigator: Gregory J Tsay, PHD Chung Shan Medical University
Principal Investigator: Ying-Ming Chiu, MD Changhua Christian Hospital
  More Information

Responsible Party: TSH Biopharm Corporation Limited
ClinicalTrials.gov Identifier: NCT01709760     History of Changes
Other Study ID Numbers: TSHEN1101 
Study First Received: October 16, 2012
Last Updated: April 12, 2016
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by TSH Biopharm Corporation Limited:
ENIA11
MTX
RA
TNF

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 01, 2016