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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: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02937701
Date of registration: 30/08/2016
Prospective Registration: Yes
Primary sponsor: Amgen
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
Date of first enrolment: October 10, 2016
Target sample size: 558
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02937701
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 3
Countries of recruitment
Australia Bulgaria Canada Czech Republic Czechia Germany Hungary Poland
Spain United States
Contacts
Name:     MD
Address: 
Telephone:
Email:
Affiliation:  Amgen
Key inclusion & exclusion criteria

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

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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Arthritis, Rheumatoid
Intervention(s)
Biological: ABP 710
Biological: Infliximab
Primary Outcome(s)
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 22 [Time Frame: Baseline and week 22]
Secondary Outcome(s)
Change From Baseline in Disease Activity Score 28 (DAS28) After Week 22 [Time Frame: Baseline and weeks 30, 34, 38, 46, and 50]
Change From Baseline in Disease Activity Score 28 (DAS28) Through Week 22 [Time Frame: Baseline and weeks 2, 6, 14, and 22]
Percentage of Participants With an ACR20 Response After Week 22 [Time Frame: Baseline and weeks 30, 34, 38, 46, and 50]
Percentage of Participants With an ACR20 Response Through Week 14 [Time Frame: Baseline and weeks 2, 6, and 14]
Percentage of Participants With an ACR50 Response After Week 22 [Time Frame: Baseline and weeks 30, 34, 38, 46, and 50]
Percentage of Participants With an ACR50 Response Through Week 22 [Time Frame: Baseline and weeks 2, 6, 14, and 22]
Percentage of Participants With an ACR70 Response After Week 22 [Time Frame: Baseline and weeks 30, 34, 38, 46, and 50]
Percentage of Participants With an ACR70 Response Through Week 22 [Time Frame: Baseline and weeks 2, 6, 14, and 22]
Secondary ID(s)
2014-004704-29
20140111
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 28/08/2019
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02937701
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