Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Astellas Pharma Inc
The study drug will be intravenously administered.
Age
20–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject has RA diagnosed according to the 1987 American College of Rheumatology (ACR) criteria or the 2010 ACR/European League Against Rheumatism (EULAR) criteria at least 6 months prior to screening.
Subject meets the 1991 ACR Revised Criteria for the Classification of Global Functional Status in RA Class I, II, or III at screening.
At screening and baseline, subject has active RA as evidenced by both of the following:
Subject meets the criterion for a CRP level (Latex Agglutination method) at screening.
Subject who has continuously received Methotrexate for at least 90 days prior to screening and who is able to continue a stable dose of Methotrexate from at least 28 days prior to screening throughout the study period.
You may not be if
Subject has deviated from the criteria for previous and concomitant treatment before baseline.
Subject has an ongoing infection requiring antibiotics.
Subject is determined to be an inadequate responder to a prior biologic disease modifying antirheumatic drugs (DMARDs) or Janus kinase (JAK) inhibitors.
Subject has participated in previous ASP5094 clinical trial.
Subject has participated in a clinical trial or post-marketing clinical study of another ethical drug or medical device within 12 weeks (84 days).
Subject has another inflammatory arthritis than RA, or any other articular symptom which may affect on joint assessment.
Subject meets any of the criteria for laboratory values at screening.
Subject has a positive T-SPOT or QuantiFERON Gold test within 90 days prior to screening or at screening.
Subject has a history of or concurrent malignant tumor.
Subject has autoimmune disease except for RA or any severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological, or mental illness.
Subject has a history of clinically significant allergy.
Subject has clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening.
Subject has a history of Human Immunodeficiency Virus (HIV) infection.
Subject had surgery within 30 days prior to screening or has a planned elective surgery.
Subject has a wound that is currently healing at baseline.
Clareo Health | A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate
