A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate

• Status: Completed
• Trial end date: 2018-10-16
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP5094 in patients with rheumatoid arthritis (RA) treated with background methotrexate (MTX).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• 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:

• ≥ 6 tender/painful joints (using 68-joint assessment)

• ≥ 6 swollen joints (using 66-joint assessment)

• 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.

Exclusion Criteria:

• 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.