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

Completed · Phase 3

Conditions studied: Arthritis, Rheumatoid

In brief

The main purpose of the study was to compare rheumatoid arthritis symptom improvement in participants who were given ABP 710 to those who were given infliximab, 22 weeks after starting treatment.

Key facts

Study ID: NCT02937701
Run by: Amgen
People needed: 558
Starts: 2016-10-10
Expected to finish: 2018-08-13
Last updated by the study team: 2019-08-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Research Site — Tuscaloosa, Alabama, United States
Research Site — Peoria, Arizona, United States
Research Site — Covina, California, United States
Research Site — Hemet, California, United States
Research Site — Upland, California, United States
Research Site — Van Nuys, California, United States
Research Site — Aventura, Florida, United States
Research Site — Miami Lakes, Florida, United States
Research Site — Orlando, Florida, United States
Research Site — Sarasota, Florida, United States
Research Site — Vero Beach, Florida, United States
Research Site — Lexington, Kentucky, United States
Research Site — Grand Blanc, Michigan, United States
Research Site — Flowood, Mississippi, United States
Research Site — St Louis, Missouri, United States
Research Site — Omaha, Nebraska, United States
Research Site — Voorhees Township, New Jersey, United States
Research Site — Charlotte, North Carolina, United States
Research Site — Charleston, South Carolina, United States
Research Site — Memphis, Tennessee, United States
Research Site — Carrollton, Texas, United States
Research Site — Dallas, Texas, United States
Research Site — Houston, Texas, United States
Research Site — League City, Texas, United States
Research Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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