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

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 550
• Participant gender: Both

Summary

This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA).

This study will assess if the investigational medicine is safe and effective in

treating moderate or severe RA compared to the licensed medicine.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Infliximab; Pharmaceutical Solutions
• Last Updated: 2016-11-23

Criteria

Inclusion Criteria:

• Subject (man or woman) is ≥ 18 and ≤ 80 years old.

• Subject is diagnosed with RA as determined by meeting the 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 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 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.

• 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.

• Woman who is of childbearing potential (ie, neither surgically sterile nor postmenopausal) and does 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.