Moderate to Severe Rheumatoid Arthritis MedDRA version: 18.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: ABP 501
Product Code: ABP 501
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: N/A
CAS Number: 1446410-95-2
Current Sponsor code: ABP 501
Other desc
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject must sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved nformed consent form before any study specific procedures. 2. Subject was randomized into protocol 20120262 and has completed the week 26 visit. 3. Women with childbearing potential should have a negative urine pregnancy test prior to the first investigational product (IP) dose. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 385 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Subject experienced a serious adverse event (SAE) or an adverse event (AE) in the 20120262 study that, in the opinion of the Investigator, could cause extension of treatment to be detrimental to the subject. 2. Subject is currently experiencing an infection requiring the use of oral or intravenous antibiotics. Subject is ineligible until the infection is resolved in the opinion of the Investigator. 3. Subject has completed study 20120262 but cannot be dosed within 4 weeks of the week 26 visit of study 20120262. 4. Subject has laboratory abnormalities during screening for this study 20130258, including: - Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT); > 2.0 x upper limit of normal - Hemoglobin < 9 g/dL - Platelet count < 100,000/mm3 - White blood cell count < 3,000 cells/mm3 - Estimated creatinine clearance < 50 mL/min (Cockroft-Gault formula) - Any other laboratory abnormality, which, in the opinion of the Investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results 5. Subject has developed significant concurrent medical condition during study 20120262, including: - Uncontrolled, clinically significant systemic disease such as diabetes mellitus, cardiovascular disease including moderate to severe heart failure (New York Heart Association [NYHA] class III/IV), renal disease, liver disease, or hypertension - Major chronic inflammatory disease or connective tissue disease other than RA (eg, systemic lupus erythematosus), with the exception of secondary Sjögren’s syndrome - Multiple sclerosis or any other demyelinating disease - Malignancy EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, OR in situ breast ductal carcinoma - Any condition that, in the opinion of the Investigator, could cause this study to be detrimental to the subject 6. Subject will not be available for protocol-required study visits, to the best of the subject’s and Investigator’s knowledge 7. Subject is pregnant or breast feeding, or planning to become pregnant while enrolled in the study and 5 months after the last dose of IP 8. Sexually active subjects and their partners who are of childbearing potential (ie, neither surgically sterile nor postmenopausal) and not agreeing to use adequate contraception (eg, true abstinence, sterilization, birth control pills, Depo-Provera injections, or contraceptive implants) while on study and for 5 months after the last dose of study drug. Male subjects must agree not to donate sperm during the study and for 5 months following treatment with IP or until the scheduled end of the stud (whichever is longer) 9. Known sensitivity to mammalian cell-derived drug products or hypersensitivity to the active substance or to any of the excipients of ABP 501 10. Any physical or psychiatric disorder which, in the opinion of the Investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results 11. Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures 12. Active substance abuse, in the opinion of the Investigator 13. Any subject, who in the opinion of the Investigator, will not benefit from the long-term treatment in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis. ;Secondary Objective: Not applicable;Primary end point(s): Safety Endpoints: - treatment-emergent adverse events and SAEs - clinically significant changes in laboratory analytes - antidrug antibody incidence;Timepoint(s) of evaluation of this end point: During entire duration of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy Endpoints: - Disease Activity Score (DAS)28 and ACR20 (20% improvement in American College of Rheumatology [ACR] core set measurements) at all measured time points;Timepoint(s) of evaluation of this end point: ACR20 and DAS28 will be summarized descriptively during the study. Evaluations to be performed at weeks 4, 24, 48 and 70. | — |
Countries
Argentina, Bulgaria, Canada, Czech Republic, Germany, Hungary, Mexico, Poland, Romania, Russian Federation, Spain, United Kingdom, United States
Contacts
Public ContactIHQ Medical Info-Clinical Trials
Amgen (Europe) GmbH
Outcome results
None listed