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

M

Mycenax Biotech

Status and phase

Unknown
Phase 3

Conditions

Combination With DMARDs

Treatments

Drug: DMARDs

Study type

Interventional

Funder types

Industry

Identifiers

NCT01787149
TSHEN1201

Details and patient eligibility

About

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

Full 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.

Enrollment

98 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

98 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
DMARDs alone
Treatment:
Drug: DMARDs
ENIA11
Experimental group
Description:
ENIA11 25 mg
Treatment:
Drug: DMARDs

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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