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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 28 February 2019
Main ID:  EUCTR2014-004704-29-BG
Date of registration: 15/09/2016
Prospective Registration: Yes
Primary sponsor: Amgen Inc.
Public title: This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.
Scientific title: A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable
Date of first enrolment: 29/11/2016
Target sample size: 550
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004704-29
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no 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  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Australia Bulgaria Canada Czech Republic Germany Hungary Poland Romania
Spain United States
Contacts
Name: IHQ Medical Info-Clinical Trials   
Address:  Dammstrasse 23, PO Box 1557 CH-6300 Zug Switzerland
Telephone:
Email: Medinfointernational@amgen.com
Affiliation:  Amgen (EUROPE) GmbH
Name: IHQ Medical Info-Clinical Trials   
Address:  Dammstrasse 23, PO Box 1557 CH-6300 Zug Switzerland
Telephone:
Email: Medinfointernational@amgen.com
Affiliation:  Amgen (EUROPE) GmbH
Key inclusion & exclusion 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 < 5 mm of induration at 48 to 72 hours after test is placed
OR
-negative Quantiferon test
11.Subject with a positive PPD and a history of Bacillus Calmette-Guérin vaccination is allowed with a negative Quantiferon test.
12.Subject with a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination) or a subject with a positive or indeterminate Quantiferon test is allowed if they have all of the following:
-no symptoms of tuberculosis according to the worksheet provided by the sponsor, Amgen Inc.
-documented history of adequate prophylaxis initiation before receiving investigational product in accordance with local recommendations
-no known exposure to a case of active tuberculosis after most recent prophylaxis

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 495
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Rheumatoid arthritis
MedDRA version: 20.0 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 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 - Biosimilar to infliximab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Trade Name: Remicade
Product Name: infliximab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

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
Main Objective: The primary objective for this study is to assess the efficacy of ABP 710 compared with US-licensed infliximab (infliximab).
Primary end point(s): The primary endpoint is response difference of ACR20 at week 22
Secondary Objective: The secondary objectives are to assess the safety and immunogenicity of ABP 710 compared with infliximab.
Secondary Outcome(s)

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


Secondary end point(s): Secondary efficacy endpoints will be response difference of ACR20 and ACR50/ACR70, and DAS28-CRP.
Secondary ID(s)
2014-004704-29-CZ
20140111
Source(s) of Monetary Support
Amgen Inc.
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Results
Results available: Yes
Date Posted: 24/08/2019
Date Completed: 13/08/2018
URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-004704-29/results
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