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Clinical Studies


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  • A Clinical Outcomes Study to Evaluate the Effects of IL-6 Receptor Blockade With Tocilizumab (TCZ) in Comparison With Etanercept (ETA) on the Rate of Ischemic Cardiovascular Events in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Rochester, Minn.

    This randomized, open-label, parallel-group, multicenter study will evaluate the rate of cardiovascular events of RoActemra/Actemra (tocilizumab) in comparison to etanercept in patients with rheumatoid arthritis. Patients will be randomized to receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks or 50 mg etane rcept subcutaneously weekly. The anticipated time on study drug is up to 5 years.

  • Etiologies of Patient-Provider Discordance in Rheumatoid Arthritis Rochester, Minn.

    The purpose of this study is to explicate factors contributing to inadequate improvement in physical function and health-related quality of life despite appropriate disease-modifying treatment in persons with rheumatoid arthritis (RA) and inflammatory arthritis (IA) who meet 2010 ACR/EULAR classification criteria for RA. To do this, this study focuses on the contract of discordance, whereby the patient judges her/his disease to be either more or less active than the rheumatologist. The positive impact of this award is anticipated to be the development of a clinical framework and approach to managing the various causes of inadequate clinical improvement, ultimately improving patient-physician communication and long-term patient-centered functional outcomes.

  • Microbiome Biomarkers of Treatment Response in Rheumatoid Arthritis Rochester, Minn.

    Objective: Identify a microbial biomarker signature that is predictive of treatment response in patients with rheumatoid arthritis (RA).

  • Phase 3b/4 Randomized Safety Endpoint Study of 2 Doses of Tofacitinib in Comparison to a Tumor Necrosis Factor (Tnf) Inhibitor in Subjects with Rheumatoid Arthritis Rochester, Minn.

    The purpose of this post-marketing study is to compare the safety of tofacitinib versus tumor necrosis factor inhibitor with respect to major cardiovascular adverse events and malignancies, excluding non-melanoma skin cancers, when given to subjects with rheumatoid arthritis. Other safety events, including non-melanoma skin cancers, hepatic events, infections, and effectiveness parameters will be collected and evaluated in the study.

  • Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis (StopRA) Rochester, Minn.

    The purpose of this study is to determine if hydroxychloroquine is safe and effective for the prevention of a future onset of rheumatoid arthritis (RA) in individuals who have elevations of an autoantibody, anti-cyclic citrullinated peptide (anti-CCP).

  • The Mayo Clinic Early Arthritis Cohort Study Rochester, Minn., Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

    The purpose of this study is to establish a cohort of clinical and biological samples of patients with early rheumatoid arthritis or arthritis like undifferentiated inflammatory arthritis in order to address multiple critical barriers that exist to improved outcomes for patients with RA and other chronic inflammatory arthritides, including: (1) gaps in understanding disease mechanisms; (2) the lack of highly useful diagnostic and prognostic tools; and (3) the unavailability of personalized, targeted therapies for patients with early inflammatory arthritis.