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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01787149
• Date of registration: 06/02/2013
• Prospective Registration: Yes
• Primary sponsor: Mycenax Biotech Inc.
• Public 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
• Scientific 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
• Date of first enrolment: September 2013
• Target sample size: 98
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT01787149
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Taiwan

Contacts

• Name: Hsiao-Yi Lin, PHD
• Affiliation: Taipei Veterans General Hospital, Taiwan

Key inclusion & exclusion 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 received stable doses of permitted DMARDs (methotrexate,
hydroxychloroquine, sulfasalazine, azathioprine, and leflunomide) for at least 8 weeks
prior enrollment.

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.



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Combination With DMARDs

Intervention(s)

Drug: DMARDs

Primary Outcome(s)

ACR20 responder at last treatment visit [Time Frame: Week 24]

Secondary ID(s)

TSHEN1201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors