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Follow on Google News | Paid Rheumatoid Arthritis Clinical Trial Now Enrolling at Achieve Clinical Research Near BirminghamAchieve is conducting a multicenter, randomized, single-dose study assessing the pharmacodynamic parameters of an experimental combination therapy in patients with rheumatoid arthritis on stable methotrexate (MTX) treatment.
By: Achieve Clinical Research STUDY DESIGN This is a 6-week, randomized, multicenter, open-label, parallel-group single-dose study to assess the PD and safety of a combination therapy in adults with rheumatoid arthritis who are on a stable dose of MTX (http://www.achieveclinical.com/ After providing informed consent, patients will be assessed for study eligibility at the screening visit (day -14 to day -1). Patients who meet eligibility criteria will undergo day 1/baseline assessments and will be randomized in a 1:1:1:1 ratio to one of four treatment arms. The duration of the study for a patient is approximately 6 weeks, excluding the screening period. BACKGROUND & RATIONALE Rheumatoid arthritis (RA) is a chronic, systemic inflammatory autoimmune disease, primarily targeting the synovial membrane of diarthrodial joints. This process can result in progressive joint destruction (http://www.achieveclinical.com/ Currently, treatment of RA involves the use of nonsteroidal anti-inflammatory drugs (NSAIDs/COX2 inhibitors), glucocorticoids and disease-modifying antirheumatic drugs (DMARDs). Methotrexate (MTX), sulfasalazine, hydroxychloroquine and leflunomide are DMARDs that have been used by rheumatologists for many years (http://www.achieveclinical.com/ PRIMARY OBJECTIVES The primary objective of the study is to describe the PD of hs-CRP, IL-6, sIL-6R, and ANC following a single dose of sarilumab SC or tocilizumab IV in patients with RA, who are on a stable dose of MTX. INCLUSION CRITERIA A patient must meet the following criteria to be eligible for inclusion in the study: Patients with greater than or equal to 3 months of RA as defined by the 2010 revised American College of Rheumatology (ACR) criteria with CRP greater than or equal to 4 mg/L at the screening visit ACR Class I-III functional status, based on the 1991 revised criteria Continuous treatment with MTX – 10 to 25 mg/wk, oral or parenteral, for at least 12 consecutive weeks prior to screening and on a stable dose for at least 8 consecutive weeks prior to screening Willing and able to comply with clinic visits and study-related procedures Provide signed informed consent *Achieve Clinical Research conducts Phase II-IV Clinical Research Studies in Alabama (http://www.achieveclinical.com/ End
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