Rheumatoid arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: ABP 710
Product Code: ABP 710
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ABP 710
Current Sponsor code: ABP 710
Other descriptive name: ABP 710 - Bios
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subject (man or woman) is = 18 and = 80 years old. 2.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. 3.Subject has RA duration of at least 3 months. 4.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 5.Subject has at least one of the following: a positive rheumatoid factor or anti-cyclic citrullinated peptide at screening. 6.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. 7.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. 8.For a subject on oral corticosteroids (= 10 mg prednisone or equivalent), the dose should be stable for = 4 weeks before screening. 9.Subject has no known history of active tuberculosis. Subject must meet any 1 of the following 3 criteria 10.Subject has a negative test for tuberculosis during screening defined as either: -negative purified protein derivative (PPD) defined as =65 years) yes F.1.3.1 Number of subjects for this age range 55
Exclusion criteria
Exclusion criteria: 1.Subject has a history of prosthetic or native joint infection. 2.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 3.Subject has a positive blood test for human immunodeficiency virus. 4.Subject has a positive hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus antibody result at screening. 5.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. 6.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. 7.Subject has a history of neurologic symptoms suggestive of central or peripheral nervous system demyelinating disease. 8.Subject has a major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sjögren’s syndrome. 9.Subject has a concurrent medical condition that, in the opinion of the investigator, could cause this study to be detrimental to the subject. 10.Subject has laboratory abnormalities at screening, including any of the following: -hemoglobin < 9 g/dL -platelet count < 100 000/mm3 -white blood cell count < 3000/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. 11.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 12.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. 13.Subject has previously received Remicade® (infliximab) or a biosimilar of infliximab. 14.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. 15.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, contraceptive implants, or other effective methods) while on study and for 6 mo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective for this study is to assess the efficacy of ABP 710 compared with US-licensed infliximab (infliximab).;Secondary Objective: The secondary objectives are to assess the safety and immunogenicity of ABP 710 compared with infliximab.;Primary end point(s): The primary endpoint is response difference of ACR20 at week 22;Timepoint(s) of evaluation of this end point: To achieve ACR20 response, at least 20% improvement compared with baseline is required for both swollen joint count (SJC) and tender joint count (TJC) (66/68 joint counts), as well as for 3 out of the following 5 additional parameters: •Subject's Global Health Assessment (on a 100-mm visual analogue scale [VAS]) •Investigator's Global Health Assessment (on a 100-mm VAS) •subject's assessment of pain (on a 100-mm VAS) •Health Assessment Questionnaire-Disability Index (HAQ-DI) •serum CRP | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints will be response difference of ACR20 and ACR50/ACR70, and DAS28-CRP.;Timepoint(s) of evaluation of this end point: Secondary Endpoint evaluations: •response difference of ACR20 at weeks 2, 6, 14, 30, 34, 38, 46, and 50 •response difference of 50% improvement in ACR core set measurements (ACR50) and 70% improvement in ACR core set measurements (ACR70) at weeks 2, 6, 14, 22, 30, 34, 38, 46, and 50 •disease activity score in 28 joints - C-reactive protein (DAS28-CRP) change from baseline at weeks 2, 6, 14, 22, 30, 34, 38, 46, and 50 Safety endpoints: •treatment-emergent adverse events, serious adverse events, and adverse events of special interest •clinically significant changes in laboratory values and vital signs •incidence of antidrug antibodies Exploratory Endpoint: •trough serum concentrations of ABP 710 and infliximab at weeks 2, 6, 14, and 22 | — |
Countries
Australia, Bulgaria, Canada, Czech Republic, Germany, Hungary, Poland, Romania, Spain, United States
Contacts
Public ContactIHQ Medical Info-Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed