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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-30

Study Completion Date

2020-05-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TAS5315 low dose group

TAS5315 low dose and Methotrexate as specified

Group Type EXPERIMENTAL

TAS5315 low dose

Intervention Type DRUG

Oral administration for 12 or 36 weeks

TAS5315 high dose group

TAS5315 high dose and Methotrexate as specified

Group Type EXPERIMENTAL

TAS5315 high dose

Intervention Type DRUG

Oral administration for 12 or 36 weeks

Placebo group

Placebo and Methotrexate as specified

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Oral administration for 12 weeks (At Week 12, participants in the placebo group will be assigned to TAS5315 low or high dose group)

Interventions

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TAS5315 low dose

Oral administration for 12 or 36 weeks

Intervention Type DRUG

TAS5315 high dose

Oral administration for 12 or 36 weeks

Intervention Type DRUG

Placebos

Oral administration for 12 weeks (At Week 12, participants in the placebo group will be assigned to TAS5315 low or high dose group)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No