RHYTHM (Formerly Escape II Myocardium)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: TNF inhibitors; DMARDs
Intervention description: TNF inhibitors are an FDA approved class of medications indicated for the treatment of RA when initial treatment (usually with methotrexate) has failed to achieve remission of RA disease activity. TNF inhibitors are part of the standard of care management of RA.
The possible TNF inhibitors are: Remicade, Humira, Enbrel, Cimzia, Simponi.; Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs.
Intervention MeSH terms: Tumor Necrosis Factor Inhibitors; Antirheumatic Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 149.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rheumatoid Arthritis; Cardiovascular disease; Myocardium; TNF-alpha inhibitors; ESCAPE; Co-morbidities; RHYTHM

Summary:

      For aim 1, the proposed studies will be performed in 150 patients with RA and 25 subjects
      without RA (healthy volunteers) who will function as controls.

      For aim 2, 25 of the patients enrolled in aim 1 (who are in need for further treatment due to
      increased RA activity despite their current treatment) will be recruited to continue in the
      study for an additional 24 (+/- 2) weeks (or 6 months). These patient will receive a TNF
      inhibitor in addition to their current treatment in an open label protocol for increased
      disease activity and in the context of standard of care.

      The investigators hypothesize that anti-TNF agents in RA patients without heart disease will
      not adversely affect the heart (will not cause a detrimental change in heart structure or its
      function).
    

Eligibility criteria:

        For RA patients (150 patients):

        INCLUSION CRITERIA

          -  Diagnosis of Rheumatoid Arthritis by 2010 American College of Rheumatology (ACR) and
             the European League Against Rheumatism (EULAR) diagnostic criteria

          -  Age>18 years old

          -  Moderate to high RA disease activity defined by a Clinical Disease Activity Index
             (CDAI) of >10

          -  Stable dose of Methotrexate for 6 weeks prior to enrollment

          -  Stable doses of Nonsteroidal anti-inflammatory drug (NSAID) and prednisone (if already
             taking these medications) for 2 weeks prior to study

        EXCLUSION CRITERIA

          -  Prior self reported or physician diagnosed CV event (MI; angina; stroke or Transient
             Ischemic Attach (TIA); Heart Failure (HF); prior CV procedure (e.g., coronary artery
             bypass graft, angioplasty, valve replacement, pacemaker)

          -  Contraindications to having a PET-CT scan or receive adenosine or Fludeoxyglucose
             (FDG)

          -  Active treatment for Cancer

          -  Uncontrolled hypertension

          -  Diabetes

          -  Smoking

          -  Treatment with a TNF inhibitor or other biologic currently or within the last 6 months

          -  Current treatment with "Triple Therapy" or within the last 2 months

          -  Untreated positive purified protein derivative (PPD) tuberculosis skin test or active
             tuberculosis

          -  History of Lymphoma and Melanoma

          -  Ejection Fraction (EF) < 40% (if not known in advance then the Study Visit I
             Echocardiogram results will be used to exclude the patient from randomization and
             follow up)

          -  Change in NSAID/Prednisone dosage in last 2 weeks

          -  Participation in other research studies involving imaging/radiation exposure

        For non-RA subjects (25 controls):

        INCLUSION CRITERIA

          -  Age>18 years old

          -  Absence of diagnosis of RA

        EXCLUSION CRITERIA

          -  Prior self reported or physician diagnosed CV event (MI; angina; stroke or Transient
             Ischemic Attach (TIA); Heart Failure (HF); prior CV procedure (e.g., coronary artery
             bypass graft, angioplasty, valve replacement, pacemaker)

          -  Contraindications to having a PET-CT scan or receive adenosine or FDG

          -  Uncontrolled hypertension

          -  Participation in other research studies involving imaging/radiation exposure