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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by TSH Biopharm Corporation Limited
Sponsor:
Information provided by (Responsible Party):
TSH Biopharm Corporation Limited
ClinicalTrials.gov Identifier:
NCT01709760
First received: October 16, 2012
Last updated: November 25, 2013
Last verified: November 2013

October 16, 2012
November 25, 2013
November 2012
January 2015   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01709760 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With Methotrexate Versus Methotrexate Alone in Patients With RA
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

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

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: Methotrexate
    Methotrexate 15-25 mg/week
  • Drug: ENIA11
    ENIA11 25 mg, sc twice weekly
    Other Name: TuNEX
  • Drug: Placebo
    Placebo, sc twice weekly
  • Experimental: methotrexate & ENIA11
    ENIA11 25 mg, sc twice weekly
    Interventions:
    • Drug: Methotrexate
    • Drug: ENIA11
  • Active Comparator: methotrexate & Placebo
    Placebo, sc twice weekly
    Interventions:
    • Drug: Methotrexate
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
129
December 2015
January 2015   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact: Jane Huang 886-2-2655-8525 jane@tshbiopharm.com
Taiwan
 
NCT01709760
TSHEN1101
Yes
TSH Biopharm Corporation Limited
TSH Biopharm Corporation Limited
Not Provided
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 Kaohsiung Chang Gung Memorial Hospital
Principal Investigator: Gregory J Tsay, PHD Chung Shan Medical University Hospital
Principal Investigator: Ying-Ming Chiu, MD Changhua Christian Hospital
TSH Biopharm Corporation Limited
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP