Efficacy and Safety Study of TAS5315 Compared With Placebo in Participants With Rheumatoid Arthritis.

• Status: Completed
• Trial end date: 2020-05-28
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy and safety of TAS5315 in combination with methotrexate in a 12 week or 36 week in participants with rheumatoid arthritis with inadequate response to methotrexate.

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

Details

• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• Have a diagnosis of RA according to 2010 ACR/ EULAR rheumatoid arthritis (RA) classification criteria

• Have been treated with methotrexate (MTX) for at least 90 days prior to screening, and must be on a stable dose between 8 and 16 mg/week for at least 56 days prior to screening.

• Have an inadequate response to MTX

• Have a minimum of 6 swollen and 6 tender joints from 66/68 joint count

• Have hsCRP of ≥ 0.6 mg/dL

Exclusion Criteria:

• Have been treated with conventional synthetic disease-modifying anti-rheumatic drug, except for MTX, within 28 days prior to randomization

• Have an inadequate response to biologic disease-modifying anti-rheumatic drug or Have been treated with 2 biologic treatment

• Have been treated with Janus Kinase inhibitors or other Bruton's Tyrosine Kinase inhibitors

• Have a positive result for hepatitis B surface antigen/antibody, hepatitis B core antibody, hepatitis C virus antibody or human immunodeficiency virus antigen/antibody at screening

• Have been treated with Oral steroids at dose above 10 mg/day of prednisone or prednisone equivalents

• Have a diagnosis of Felty's syndrome

• Have a positive result of the QuantiFERON®-tuberculosis (TB) Gold test or a T-spot ®-TB test at screening

• Have a positive result of β-D-glucan at screening