The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis

• Register: EUCTR
• Last refreshed on: 17 January 2022
• Main ID: EUCTR2013-004654-13-RO
• Date of registration: 30/05/2014
• Prospective Registration: Yes
• Primary sponsor: Amgen Inc.
• Public title: The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis
• Scientific title: An Open-Label, Single-arm Extension Study to Evaluate the Long-term Safety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis
• Date of first enrolment: 27/06/2014
• Target sample size: 425
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004654-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Bulgaria, Canada, Czech Republic, Germany, Hungary, Mexico, Poland, Romania, Russian Federation, Spain, United Kingdom, United States

Contacts

• Name: IHQ Medical Info-Clinical Trials
• Affiliation: Amgen (Europe) GmbH

• Name: IHQ Medical Info-Clinical Trials
• Affiliation: Amgen (Europe) GmbH

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Moderate to Severe Rheumatoid Arthritis
MedDRA version: 17.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

Product Name: ABP 501
Product Code: ABP 501
Pharmaceutical Form: Solution for injection in pre-filled syringe
CAS Number: 1446410-95-2
Current Sponsor code: ABP 501
Other descriptive name: ABP 501
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

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.

Timepoint(s) of evaluation of this end point: During entire duration of the study.

Primary end point(s): Safety Endpoints:
- treatment-emergent adverse events and SAEs
- clinically significant changes in laboratory analytes
- antidrug antibody incidence

Secondary Objective: Not applicable

Secondary Outcome(s)

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.

Secondary ID(s)

20130258

2013-004654-13-CZ

Source(s) of Monetary Support

Amgen Inc.

Ethics review

Status: Approved
Approval date: 12/05/2014
Contact:

Results

• Results available: Yes
• Date Posted: 01/04/2017
• Date Completed: 11/04/2016
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-004654-13/results