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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

TAS5315 low dose

TAS5315 high dose

Placebos

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Taiho Pharmaceutical Co., Ltd selected site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

TAS5315 low dose group

TAS5315 high dose group

Placebo group

Arm Description

TAS5315 low dose and Methotrexate as specified

TAS5315 high dose and Methotrexate as specified

Placebo and Methotrexate as specified

Outcomes

Primary Outcome Measures

Proportion of participants achieving American College of Rheumatology 20% (ACR20) response

Secondary Outcome Measures

Proportion of participants who achieve ACR20 response

Proportion of participants achieving American College of Rheumatology 50% (ACR50) and American College of Rheumatology 70% (ACR70) response

Proportion of participants who achieve DAS28-hs C-ReactivePprotein (CRP) and DAS28-Erythrocyte Sedimentation Rate (ESR) for remission

Change from baseline in DAS28-CRP and DAS28-ESR score

Proportion of participants who achieve Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) for remission

Change from baseline in CDAI and SDAI score

Change from baseline in patient assessment score of arthritis pain

Change from baseline in patient global assessment score of arthritis

Change from baseline in physician's global assessment score of arthritis

Change from baseline in modified total sharp score

Change from baseline in Anti-cyclic Citrullinated Peptide antibody levels

Change from baseline in rheumatoid factor levels

Maximum observed plasma concentration for TAS5315

Time to reach the maximum plasma concentration for TAS5315

Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for TAS5315

Incidence of adverse events and side effects as safety

Full Information

NCT ID

NCT03605251

First Posted

July 3, 2018

Last Updated

August 14, 2020

Sponsor

Taiho Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03605251

Brief Title

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

Official Title

An Early Phase-II, Randomized, Double-blind, Study of TAS5315 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

August 30, 2018 (Actual)

Primary Completion Date

November 30, 2019 (Actual)

Study Completion Date

May 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taiho Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

91 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TAS5315 low dose group

Arm Type

Experimental

Arm Description

TAS5315 low dose and Methotrexate as specified

Arm Title

TAS5315 high dose group

Arm Type

Experimental

Arm Description

TAS5315 high dose and Methotrexate as specified

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

Placebo and Methotrexate as specified

Intervention Type

Drug

Intervention Name(s)

TAS5315 low dose

Intervention Description

Oral administration for 12 or 36 weeks

Intervention Type

Drug

Intervention Name(s)

TAS5315 high dose

Intervention Description

Oral administration for 12 or 36 weeks

Intervention Type

Drug

Intervention Name(s)

Placebos

Intervention Description

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

Primary Outcome Measure Information:

Title

Proportion of participants achieving American College of Rheumatology 20% (ACR20) response

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Proportion of participants who achieve ACR20 response

Time Frame

Up to Week 36, except for Week 12

Title

Proportion of participants achieving American College of Rheumatology 50% (ACR50) and American College of Rheumatology 70% (ACR70) response

Time Frame

Up to Week 36

Title

Proportion of participants who achieve DAS28-hs C-ReactivePprotein (CRP) and DAS28-Erythrocyte Sedimentation Rate (ESR) for remission

Time Frame

Baseline, Week 12

Title

Change from baseline in DAS28-CRP and DAS28-ESR score

Time Frame

Up to Week 36

Title

Proportion of participants who achieve Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) for remission

Time Frame

Baseline, Week 12

Title

Change from baseline in CDAI and SDAI score

Time Frame

Up to Week 36

Title

Change from baseline in patient assessment score of arthritis pain

Time Frame

Up to Week 36

Title

Change from baseline in patient global assessment score of arthritis

Time Frame

Up to Week 36

Title

Change from baseline in physician's global assessment score of arthritis

Time Frame

Up to Week 36

Title

Change from baseline in modified total sharp score

Time Frame

Baseline, Week 2, 4, 12

Title

Change from baseline in Anti-cyclic Citrullinated Peptide antibody levels

Time Frame

Up to Week 36

Title

Change from baseline in rheumatoid factor levels

Time Frame

Up to Week 36

Title

Maximum observed plasma concentration for TAS5315

Time Frame

Baseline, Week 2, 4, 12

Title

Time to reach the maximum plasma concentration for TAS5315

Time Frame

Baseline, Week 2, 4, 12

Title

Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for TAS5315

Time Frame

Baseline, Week 2, 4, 12

Title

Incidence of adverse events and side effects as safety

Time Frame

Up to Week 36

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Taiho Pharmaceutical Co., Ltd.

Organizational Affiliation

Taiho Pharmaceutical Co., Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Taiho Pharmaceutical Co., Ltd selected site

City

Tokyo

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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