Study to Assess if ABP710 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Infliximab

This is an interventional treatment trial for Arthritis, Rheumatoid Read More

Inclusion Criteria:

• Subject (man or woman) is ≥ 18 and ≤ 80 years old.
• Subject is diagnosed with rheumatoid arthritis (RA) as determined by meeting the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism classification criteria for RA.
• Subject has RA duration of at least 3 months.

• Subject has active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints (based on 66/68 joint count excluding distal interphalangeal joints) at screening and baseline and at least 1 of the following at screening:

  • erythrocyte sedimentation rate ≥ 28 mm/hr
  • serum C-reactive protein > 1.0 mg/dL
• Subject has a positive rheumatoid factor or anti-cyclic citrullinated peptide at screening.
• Subject has taken methotrexate (MTX) for ≥ 12 consecutive weeks and is on a stable dose of oral or subcutaneous MTX 7.5 to 25 mg/week for ≥ 8 weeks before receiving the investigational product and is willing to remain on a stable dose throughout the study.
• For a subject on nonsteroidal anti-inflammatory drugs (NSAIDs) or low potency analgesics such as tramadol, Soma Compounds, Fioricet, or Fiorinal, the dose should be stable for ≥ 2 weeks before screening.
• For a subject on oral corticosteroids (≤ 10 mg prednisone or equivalent), the dose should be stable for ≥ 4 weeks before screening.
• Subject has no known history of active tuberculosis.

• Subject has a negative test for tuberculosis during screening defined as either:

  • negative purified protein derivative (PPD) defined as < 5 mm of induration at 48 to 72 hours after test is placed OR
  • negative Quantiferon test
• Subject with a positive PPD and a history of Bacillus Calmette-Guérin vaccination is allowed with a negative Quantiferon test.

• Subject with a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination) or a subject with a positive or indeterminate Quantiferon test is allowed if they have all of the following:

  • no symptoms of tuberculosis according to the worksheet provided by the sponsor, Amgen Inc.
  • documented history of adequate prophylaxis initiation before receiving investigational product in accordance with local recommendations
  • no known exposure to a case of active tuberculosis after most recent prophylaxis

Exclusion Criteria:

• Subject has a history of prosthetic or native joint infection.

• Subject has an active infection or history of infections as follows:

  • any active infection for which systemic anti-infectives were used within 28 days before first dose of investigational product
  • a serious infection, defined as requiring hospitalization or intravenous (IV) anti-infective(s) within 8 weeks before the first dose of investigational product
  • recurrent or chronic infections or other active infection that, in the opinion of the investigator, might cause this study to be detrimental to the subject
• Subject has a positive blood test for human immunodeficiency virus (HIV).
• Subject has a positive hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus antibody result at screening.
• Subject has uncontrolled, clinically significant systemic disease such as diabetes mellitus, cardiovascular disease including moderate or severe heart failure (New York Heart Association Class III/IV), renal disease, liver disease, or hypertension.
• Subject had a malignancy within 5 years EXCEPT for treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, OR in situ breast ductal carcinoma.
• Subject has a history of neurologic symptoms suggestive of central or peripheral nervous system demyelinating disease.
• Subject has a major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sjögren's syndrome.
• Subject has a concurrent medical condition that, in the opinion of the investigator, could cause this study to be detrimental to the subject.

• Subject has laboratory abnormalities at screening, including any of the following:

  • hemoglobin < 9 g/dL
  • platelet count < 100 000/mm³
  • white blood cell count < 3 000/mm³
  • aspartate aminotransferase and/or alanine aminotransferase ≥ 2.0 x the upper limit of normal
  • creatinine clearance < 50 mL/min (Cockroft-Gault formula)
  • any other laboratory abnormality, that, in the opinion of the investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results.

• Subject has used commercially available or investigational biologic therapies for RA as follows:

  • anakinra, etanercept within 1 month before the first dose of investigational product
  • abatacept, tocilizumab, adalimumab, golimumab, certolizumab within 3 months before the first dose of investigational product
  • other experimental or commercially available biologic therapies for RA within 3 months or 5 half-lives (whichever is longer) before the first dose of investigational product
  • rituximab within 9 months before the investigational product along with evidence of incomplete B cell recovery
• Subject has received live vaccines within 28 days before the first dose of investigational product or plans to receive live vaccines during the course of the study.
• Subject has previously received Remicade® (infliximab) or a biosimilar of infliximab.
• Woman who is pregnant or breast feeding, or plans to become pregnant while enrolled in the study and for 6 months after the last dose of investigational product.
• Women of childbearing potential (ie, neither surgically sterile nor postmenopausal) and do not agree to use adequate contraception (eg, true abstinence, sterilization, birth control pills, Depo-Provera® [medroxyprogesterone] injections, or contraceptive implants) while on study and for 6 months after the last dose of investigational product.