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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02937701




Registration number
NCT02937701
Ethics application status
Date submitted
30/08/2016
Date registered
19/10/2016
Date last updated
28/08/2019

Titles & IDs
Public title
Study to Assess if ABP710 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Infliximab
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
Secondary ID [1] 0 0
2014-004704-29
Secondary ID [2] 0 0
20140111
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - ABP 710
Other interventions - Infliximab

Experimental: ABP 710 - Participants randomized to receive a 3 mg/kg intravenous (IV) infusion of ABP 710 on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.
At week 22 participants continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46.

Active Comparator: Infliximab - Participants randomized to receive a 3 mg/kg IV infusion of infliximab on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22.
At week 22 participants were re-randomized in a 1:1 ratio to either continue receiving 3 mg/kg infliximab every 8 weeks or transition to receive 3 mg/kg ABP 710 every 8 weeks through week 46.


Other interventions: ABP 710
Administered by intravenous infusion

Other interventions: Infliximab
Administered by intravenous infusion

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 22 - The primary efficacy endpoint was the response difference (RD) of 20% improvement in ACR core set measurements (ACR20) at week 22.
A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met:
= 20% improvement in 68 tender joint count;
= 20% improvement in 66 swollen joint count; and
= 20% improvement in at least 3 of the 5 following parameters:
Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global health assessment (measured on a 100 mm VAS);
Investigator's global health assessment (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
C-reactive protein concentration.
Timepoint [1] 0 0
Baseline and week 22
Secondary outcome [1] 0 0
Percentage of Participants With an ACR20 Response Through Week 14 - A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met:
= 20% improvement in 68 tender joint count;
= 20% improvement in 66 swollen joint count; and
= 20% improvement in at least 3 of the 5 following parameters:
Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global health assessment (measured on a 100 mm VAS);
Investigator's global health assessment (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
C-reactive protein concentration.
Timepoint [1] 0 0
Baseline and weeks 2, 6, and 14
Secondary outcome [2] 0 0
Percentage of Participants With an ACR20 Response After Week 22 - A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met:
= 20% improvement in 68 tender joint count;
= 20% improvement in 66 swollen joint count; and
= 20% improvement in at least 3 of the 5 following parameters:
Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global health assessment (measured on a 100 mm VAS);
Investigator's global health assessment (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
C-reactive protein concentration.
Timepoint [2] 0 0
Baseline and weeks 30, 34, 38, 46, and 50
Secondary outcome [3] 0 0
Percentage of Participants With an ACR50 Response Through Week 22 - A positive ACR50 response is defined if the following 3 criteria for improvement from baseline were met:
= 50% improvement in 68 tender joint count;
= 50% improvement in 66 swollen joint count; and
= 50% improvement in at least 3 of the 5 following parameters:
Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global health assessment (measured on a 100 mm VAS);
Investigator's global health assessment (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
C-reactive protein concentration.
Timepoint [3] 0 0
Baseline and weeks 2, 6, 14, and 22
Secondary outcome [4] 0 0
Percentage of Participants With an ACR50 Response After Week 22 - A positive ACR50 response is defined if the following 3 criteria for improvement from baseline were met:
= 50% improvement in 68 tender joint count;
= 50% improvement in 66 swollen joint count; and
= 50% improvement in at least 3 of the 5 following parameters:
Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global health assessment (measured on a 100 mm VAS);
Investigator's global health assessment (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
C-reactive protein concentration.
Timepoint [4] 0 0
Baseline and weeks 30, 34, 38, 46, and 50
Secondary outcome [5] 0 0
Percentage of Participants With an ACR70 Response Through Week 22 - A positive ACR70 response is defined if the following 3 criteria for improvement from baseline were met:
= 70% improvement in 68 tender joint count;
= 70% improvement in 66 swollen joint count; and
= 70% improvement in at least 3 of the 5 following parameters:
Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global health assessment (measured on a 100 mm VAS);
Investigator's global health assessment (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
C-reactive protein concentration.
Timepoint [5] 0 0
Baseline and weeks 2, 6, 14, and 22
Secondary outcome [6] 0 0
Percentage of Participants With an ACR70 Response After Week 22 - A positive ACR70 response is defined if the following 3 criteria for improvement from baseline were met:
= 70% improvement in 68 tender joint count;
= 70% improvement in 66 swollen joint count; and
= 70% improvement in at least 3 of the 5 following parameters:
Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global health assessment (measured on a 100 mm VAS);
Investigator's global health assessment (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
C-reactive protein concentration.
Timepoint [6] 0 0
Baseline and weeks 30, 34, 38, 46, and 50
Secondary outcome [7] 0 0
Change From Baseline in Disease Activity Score 28 (DAS28) Through Week 22 - The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count
28 swollen joint count
C-reactive protein (CRP)
Patient's global health assessment measured on a 100 mm VAS, where 0 mm = no RA activity and 100 mm = worst RA activity imaginable.
DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.
Timepoint [7] 0 0
Baseline and weeks 2, 6, 14, and 22
Secondary outcome [8] 0 0
Change From Baseline in Disease Activity Score 28 (DAS28) After Week 22 - The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count
28 swollen joint count
C-reactive protein (CRP)
Patient's global health assessment measured on a 100 mm VAS, where 0 mm = no RA activity and 100 mm = worst RA activity imaginable.
DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.
Timepoint [8] 0 0
Baseline and weeks 30, 34, 38, 46, and 50

Eligibility
Key inclusion criteria
- Subject (man or woman) is = 18 and = 80 years old.

- Subject is diagnosed with rheumatoid arthritis (RA) as determined by meeting the 2010
American College of Rheumatology (ACR)/European League Against Rheumatism
classification criteria for RA.

- Subject has RA duration of at least 3 months.

- 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

- Subject has a positive rheumatoid factor or anti-cyclic citrullinated peptide at
screening.

- Subject has taken methotrexate (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.

- For a subject on nonsteroidal anti-inflammatory drugs (NSAIDs) or low potency
analgesics such as tramadol, Soma Compounds, Fioricet, or Fiorinal, the dose should be
stable for = 2 weeks before screening.

- For a subject on oral corticosteroids (= 10 mg prednisone or equivalent), the dose
should be stable for = 4 weeks before screening.

- Subject has no known history of active tuberculosis.

- 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

- Subject with a positive PPD and a history of Bacillus Calmette-Guérin vaccination is
allowed with a negative Quantiferon test.

- 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
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject has a history of prosthetic or native joint infection.

- 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

- Subject has a positive blood test for human immunodeficiency virus (HIV).

- Subject has a positive hepatitis B surface antigen, hepatitis B core antibody, or
hepatitis C virus antibody result at screening.

- 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.

- 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.

- Subject has a history of neurologic symptoms suggestive of central or peripheral
nervous system demyelinating disease.

- Subject has a major chronic inflammatory disease or connective tissue disease other
than RA, with the exception of secondary Sjögren's syndrome.

- Subject has a concurrent medical condition that, in the opinion of the investigator,
could cause this study to be detrimental to the subject.

- Subject has laboratory abnormalities at screening, including any of the following:

- hemoglobin < 9 g/dL

- platelet count < 100 000/mm³

- white blood cell count < 3 000/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.

- 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

- 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.

- Subject has previously received Remicade® (infliximab) or a biosimilar of infliximab.

- Woman who is pregnant or breast feeding, or plans to become pregnant while enrolled in
the study and for 6 months after the last dose of investigational product.

- Women of childbearing potential (ie, neither surgically sterile nor postmenopausal)
and do not agree to use adequate contraception (eg, true abstinence, sterilization,
birth control pills, Depo-Provera® [medroxyprogesterone] injections, or contraceptive
implants) while on study and for 6 months after the last dose of investigational
product.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Research Site - Woodville
Recruitment hospital [2] 0 0
Research Site - Fitzroy
Recruitment postcode(s) [1] 0 0
5011 - Woodville
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Mississippi
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Sofiya
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Pleven
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Plovdiv
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Sliven
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Varna
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
State/province [21] 0 0
Newfoundland and Labrador
Country [22] 0 0
Czechia
State/province [22] 0 0
Jihormoravsky KRAJ
Country [23] 0 0
Czechia
State/province [23] 0 0
Moravskoslezsky
Country [24] 0 0
Czechia
State/province [24] 0 0
Praha
Country [25] 0 0
Czechia
State/province [25] 0 0
Severocesky KRAJ
Country [26] 0 0
Czechia
State/province [26] 0 0
Severomoravsky KRAJ
Country [27] 0 0
Czechia
State/province [27] 0 0
Vychodocesky KRAJ
Country [28] 0 0
Germany
State/province [28] 0 0
Mecklenburg-vorpommern
Country [29] 0 0
Germany
State/province [29] 0 0
Niedersachsen
Country [30] 0 0
Germany
State/province [30] 0 0
Sachsen-anhalt
Country [31] 0 0
Germany
State/province [31] 0 0
Hamburg
Country [32] 0 0
Hungary
State/province [32] 0 0
Bekes
Country [33] 0 0
Hungary
State/province [33] 0 0
Csongrad
Country [34] 0 0
Hungary
State/province [34] 0 0
Gyor-moson-sopron
Country [35] 0 0
Hungary
State/province [35] 0 0
Veszprem
Country [36] 0 0
Poland
State/province [36] 0 0
Dolnoslaskie
Country [37] 0 0
Poland
State/province [37] 0 0
Kujawsko-pomorskie
Country [38] 0 0
Poland
State/province [38] 0 0
Lodzkie
Country [39] 0 0
Poland
State/province [39] 0 0
Lubelskie
Country [40] 0 0
Poland
State/province [40] 0 0
Malopolskie
Country [41] 0 0
Poland
State/province [41] 0 0
Mazowieckie
Country [42] 0 0
Poland
State/province [42] 0 0
Podkarpackie
Country [43] 0 0
Poland
State/province [43] 0 0
Podlaskie
Country [44] 0 0
Poland
State/province [44] 0 0
Pomorskie
Country [45] 0 0
Poland
State/province [45] 0 0
Slaskie
Country [46] 0 0
Poland
State/province [46] 0 0
Warminsko-mazurskie
Country [47] 0 0
Poland
State/province [47] 0 0
Wielkopolskie
Country [48] 0 0
Spain
State/province [48] 0 0
Barcelona
Country [49] 0 0
Spain
State/province [49] 0 0
Madrid
Country [50] 0 0
Spain
State/province [50] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The main purpose of the study was to compare rheumatoid arthritis symptom improvement in
participants who were given ABP 710 to those who were given infliximab, 22 weeks after
starting treatment.
Trial website
https://clinicaltrials.gov/show/NCT02937701
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications