| Eligibility |
Inclusion Criteria:
- Provides written informed consent
- Has rheumatoid arthritis (RA) as defined by having a score of 6 or higher on the 2010
ACR-EULAR classification criteria
- Is currently on Enbrel therapy and has received once-weekly Enbrel injections for at
least 12 weeks with no more than 1 missed dose in the 12 weeks prior to Screening.
- Must meet the following disease criteria:
Have a DAS28(CRP) score > 2.9 at Screening Have a DAS28(ESR) score > 3.2 at Screening
Swollen joint count = 3 (28-joint count) and Tender joint count = 3 (28-joint count) at
Screening and Baseline
- If on oral or subcutaneous MTX (up to 25 mg/week) or other permitted oral conventional
synthetic disease-modifying anti-rheumatic drugs (DMARDs) (i.e., leflunomide, up to 20
mg/day; hydroxychloroquine, up to 400 mg/day; or sulfasalazine, up to 3 g/day), must
be on stable dose (MTX = 12 weeks and other permitted DMARDs = 8 weeks) within the
specified ranges prior to Baseline. Note: if on methotrexate (MTX), subjects must be
on a stable dose of folic acid (total = 5 mg per week for = 12 weeks) prior to
Baseline and must continue a stable dose during the course of the study.
- If taking regular nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2
(COX-2) inhibitors, paracetamol/acetaminophen, or oral glucocorticoids for treatment
of RA symptoms, must be on stable dose and route of administration for at least 2
weeks before Baseline
- Females of childbearing potential must agree to use acceptable method(s) of
contraception for the duration of the study and for 3 months after the last dose of
study drug
Exclusion Criteria:
- Has participated in a clinical trial with a drug or device within 30 days prior to
Screening
- Prior treatment with investigational therapy within 30 days or 5 half-lives before
Screening (whichever is longer)
- History of hypersensitivity to any recombinant protein drugs or any of the excipients
used in Enbrel
- Has skin contact sensitivities (due to SOFUSA device adhesive) or allergies to iodine
(due to the iodine in ICG)
- Lack of any clinical response to Enbrel in the Investigator's opinion
- Treatment with other biologic agents (e.g., interleukin [IL] 6, IL17, IL12/23
inhibitors; abatacept, tumor necrosis factor [TNF] inhibitors) besides Enbrel within
24 weeks before Baseline
- Previous treatment with more than 2 other tumor necrosis factor (TNF) inhibitor
therapies (besides Enbrel), more than 2 targeted therapies with different mechanisms
of action (e.g., Janus kinase inhibitors, T cell costimulation inhibitor, IL-6
receptor antagonist), or any cell depleting agents (e.g., anti-CD20)
- Use of chlorambucil or cyclophosphamide within 24 weeks of Baseline
- Use of leflunomide within 8 weeks of Baseline, if washing out of leflunomide, unless a
cholestyramine washout has been performed, then use of leflunomide within 4 weeks of
Baseline
- Use of MTX, hydroxychloroquine, or sulfasalazine within 4 weeks of Baseline, if
washing out of MTX, hydroxychloroquine, or sulfasalazine
- Any systemic nonbiologic DMARD (e.g., Janus kinase inhibitor, cyclosporine,
azathioprine) within 4 weeks of Baseline
- History of or ongoing inflammatory, autoimmune, or painful musculoskeletal diseases
(except for Sjogren's syndrome or fibromyalgia) which could interfere with the RA
assessments as determined by the Investigator
- Functional RA status of class IV according to the ACR 1991 revised criteria at
Screening or Baseline
- Oral glucocorticoids > 10 mg/day prednisone equivalent within 4 weeks prior to
Baseline
- Opioid tolerant: defined as the use of opiate analgesics at a dose of > 30 mg/day of
oral morphine equivalent on 4 of the last 7 days prior to Baseline
- Use of intramuscular, intravenous, or intraarticular corticosteroid therapy within 4
weeks prior to Baseline
- Treatment with any intra-articular hyaluronic acid preparation within 12 weeks prior
to Baseline
- Chronic arthritis diagnosis before the age of 17 years
- Presence of any extra-articular manifestations of RA, except for rheumatoid nodules
- Joint surgery within the preceding 8 weeks before Screening
- History of, or presence of cancer (if < 5 years from successful treatment even with no
evidence of recurrent disease) or lymphoproliferative or hematologic disease, other
than a successfully and completely treated nonmetastatic cutaneous squamous cell or
basal cell carcinoma and/or localized carcinoma in situ of the cervix and/or removed
non-invasive colon or bladder polyps, with no evidence of recurrence
- History of uncontrolled diabetes, unstable ischemic heart disease, congestive heart
failure (New York Heart Association III-IV), active peptic ulcer disease, recent
stroke, myocardial infarction, or thromboembolism (within 6 months), or any other
condition which, in the opinion of the Investigator, would put the patient at risk by
participation in the study
- Previous diagnosis or signs of demyelinating disease
- History of clinically significant hematologic (e.g. severe anemia, leukopenia,
thrombocytopenia), renal or liver disease (e.g. glomerulonephritis, fibrosis,
cirrhosis, hepatitis) or abnormal clinical laboratory tests at Screening
- Receipt of any blood products within 12 weeks of Baseline
- History of persistent chronic infection; recurrent infection (more than 3 infections
requiring antimicrobial therapy within the last 12 months); or active infections
requiring hospitalization or treatment with systemic anti-infective therapy within 4
weeks before Screening (counted from anti-infective therapy stop date), except for
fungal infection of nails or nail beds
- History of or current active tuberculosis or presence of latent tuberculosis as
detected by imaging (e.g., chest radiograph) and/ or QuantiFERON®-TB Gold Plus test
(QFT) NOTE: Positive QFT (or 2 or more tests that are indeterminate) and/or positive
imaging result (within 12 weeks prior to Screening or at Screening) excludes a patient
from participation in the study (except for patients who have documentation of
completing an acceptable regimen for treatment of latent tuberculosis with no known
re-exposure to tuberculosis since treatment completion)
- History or evidence of opportunistic infections (eg, histoplasmosis, listeriosis,
legionellosis)
- Known immune deficiency, known human immunodeficiency virus (HIV) positive or positive
at Screening, or immunocompromised for other reasons
- Serology positive for hepatitis B virus (HBV) surface antigen (HBsAg) or core antibody
(HBcAb) or hepatitis C virus (HCV) antibody (HCV-Ab) or ribonucleic acid (HCV RNA).
Patients treated for HCV and considered cured (negative HCV RNA) may participate in
the study
- Positive RT-PCR or the equivalent COVID-19 test at Screening
- History or evidence of ongoing significant drug or alcohol abuse
- Known depression or other psychiatric condition, which in the Investigator's opinion
may decrease likelihood of participant adherence to the study protocol requirements
- History of vaccination with live vaccines within the preceding 8 weeks prior to
Baseline or known to require vaccination with live vaccines during the study period
- For female participants, currently breastfeeding (lactating) or less than 12 weeks
from cessation of lactation
- Pregnant woman where pregnancy is defined as the state of a woman after conception and
until the termination of gestation, confirmed by a positive serum pregnancy test at
Screening or positive urine pregnancy test at Baseline
- Patient is considered by the Investigator, for any reason, to be an unsuitable
candidate for the study
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