Overview

This trial is active, not recruiting.

Condition combination with dmards
Treatment dmards
Phase phase 3
Sponsor TSH Biopharm Corporation Limited
Start date September 2013
End date December 2016
Trial size 98 participants
Trial identifier NCT01787149, TSHEN1201

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
DMARDs alone
dmards
(Experimental)
ENIA11 25 mg
dmards

Primary Outcomes

Measure
ACR20 responder at last treatment visit
time frame: Week 24

Eligibility Criteria

Male or female participants at least 20 years old.

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.

Additional Information

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
Principal investigator Hsiao-Yi Lin, PHD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by TSH Biopharm Corporation Limited.