Study to Assess if ABP710 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Infliximab
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 1/13/2019 |
Start Date: | October 10, 2016 |
End Date: | August 13, 2018 |
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
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.
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.
Inclusion Criteria:
- Subject (man or woman) is ≥ 18 and ≤ 80 years old.
- 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.
- 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 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 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.
- 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.
- Woman who is of childbearing potential (ie, neither surgically sterile nor
postmenopausal) and does 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.
We found this trial at
27
sites
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