The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis
- Conditions
- Moderate to Severe Rheumatoid ArthritisMedDRA version: 17.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2013-004654-13-RO
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 467
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method