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

• Register: EUCTR
• Last refreshed on: 16 February 2015
• Main ID: EUCTR2013-000525-31-RO
• Date of registration: 12/02/2015
• Prospective Registration: No
• Primary sponsor: Amgen Inc
• Public title: The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis
• Scientific title: A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis
• Date of first enrolment: 24/03/2014
• Target sample size: 500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000525-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

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.Subjects must sign an IRB/IEC-approved ICF before any study specific procedures
2.Men or women = 18 and = 80 years old
3.Subjects must be diagnosed with RA as determined by meeting 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA
4.Duration of RA of at least 3 months
5.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 one of the following at screening:
•ESR = 28 mm/hr
•serum CRP > 1.0 mg/dL
6.Positive rheumatoid factor or anti-cyclic citrullinated peptide (CCP) at screening
7.Subjects must be taking MTX for = 12 consecutive weeks and on a stable dose of 7.5 to 25 mg/week for > 8 weeks prior to receiving the study drug and be willing to remain on stable dose throughout the study
8.For subjects on nonsteroidal anti-inflammatory drugs (NSAIDs) or low potency analgesics such as tramadol, soma compounds, fioricet, fiorinal, dose should be stable for = 2 weeks prior to screening
9.For subjects on oral corticosteroids, (= 10 mg prednisone or equivalent), stable doses for = 4 weeks prior to screening
10.Subject has no known history of active tuberculosis
11.Subject has a negative test for tuberculosis during screening defined as either:
•negative purified protein derivative (PPD; < 5 mm of induration at 48 to 72 hours after test is placed) OR
•negative Quantiferon test
12.Subjects with a positive PPD and a history of Bacillus Calmette-Guérin vaccination are allowed with a negative Quantiferon test
13.Subjects with a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination) or subjects with a positive or indeterminate Quantiferon test are allowed if they have all of the following:
•no symptoms per tuberculosis worksheet provided by the sponsor, Amgen
•documented history of adequate prophylaxis initiation prior to receiving study drug in accordance with local recommendations
•no known exposure to a case of active tuberculosis after most recent prophylaxis
•no evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of IP

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 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion criteria:
Rheumatoid Arthritis related
1.Class IV RA according to ACR revised response criteria (Section 17.2)
2.Felty’s syndrome (RA, splenomegaly, and granulocytopenia)
3.History of prosthetic or native joint infection
Other medical conditions
4.Planned surgical intervention during the duration of the study
5.Active infection or history of infections as follows:
•any active infection for which systemic anti-infectives were used within 28 days prior to first dose of IP
•a serious infection, defined as requiring hospitalization or intravenous (IV) anti infectives within 8 weeks prior to 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
6.Known history of human immunodeficiency virus
7.Hepatitis B surface antigen (HbsAg) or Hepatitis C virus (HCV) antibody positivity at screening
8.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
9.Malignancy within 5 years EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, OR in situ breast ductal carcinoma
10.History of neurologic symptoms suggestive of central nervous system demyelinating disease
11.Major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sjögren’s syndrome
12.Concurrent medical condition that, in the opinion of the Investigator, could cause this study to be detrimental to the subject
Laboratory abnormalities
13.Laboratory abnormalities at screening, including any of the following:
•Hemoglobin < 9 g/dL
•Platelet count < 100,000/mm3
•White blood cell count < 3,000 cells/mm3
•Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) = 2.0 x the upper limit of normal
•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




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

Health Condition(s) or Problem(s) studied

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

Moderate to Severe Rheumatoid Arthritis
MedDRA version: 17.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

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

Trade Name: Humira
Product Name: Adalimumab
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Other descriptive name: Humira
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: The primary efficacy endpoint is risk ratio (RR) of ACR20 (20% improvement in ACR core set measurements) at week 24. To achieve ACR20 response, at least 20% improvement compared to baseline is required for both swollen and tender joint counts), as well as for 3 out of the following 5 additional parameters:
•Subject's Global Health Assessment (on a 0 to 10 horizontal scale)
•Investigator's Global Health Assessment (on a 0 to 10 horizontal scale)
•Subject's assessment of pain (on a 100-mm visual analogue scale (VAS);
•Health Assessment Questionnaire – Disability Index
•CRP

Main Objective: The primary objective for this study is to assess the efficacy of ABP 501 compared with adalimumab.

Primary end point(s): The primary efficacy endpoint is risk ratio (RR) of ACR20 (20% improvement in ACR core set measurements)

Secondary Objective: The secondary objectives are to assess the safety and immunogenicity of ABP 501 compared with adalimumab.

Secondary Outcome(s)

Secondary end point(s): Secondary efficacy endpoints include change from baseline of DAS28-CRP, RR of ACR20 responses, and RR of ACR50 (50% improvement in ACR core set measurements) and ACR70 (70% improvement in ACR core set measurements)

Timepoint(s) of evaluation of this end point: Secondary efficacy endpoints include change from baseline of DAS28-CRP at each time point (weeks 2, 4, 8, 12, 18, and 24), RR of ACR20 responses at weeks 2 and 8, and RR of ACR50 and ACR70 responses at week 24.

Secondary ID(s)

20120262

2013-000525-31-GB

Source(s) of Monetary Support

Amgen Inc