NCT03605251

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P25-P50 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

August 30, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2020

Completed
Last Updated

August 17, 2020

Status Verified

August 1, 2020

Enrollment Period

1.3 years

First QC Date

July 3, 2018

Last Update Submit

August 14, 2020

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

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

    Week 12

Secondary Outcomes (16)

  • Proportion of participants who achieve ACR20 response

    Up to Week 36, except for Week 12

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

    Up to Week 36

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

    Baseline, Week 12

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

    Up to Week 36

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

    Baseline, Week 12

  • +11 more secondary outcomes

Study Arms (3)

TAS5315 low dose group

EXPERIMENTAL

TAS5315 low dose and Methotrexate as specified

Drug: TAS5315 low dose

TAS5315 high dose group

EXPERIMENTAL

TAS5315 high dose and Methotrexate as specified

Drug: TAS5315 high dose

Placebo group

PLACEBO COMPARATOR

Placebo and Methotrexate as specified

Drug: Placebos

Interventions

TAS5315 low doseDRUG

Oral administration for 12 or 36 weeks

TAS5315 low dose group
TAS5315 high doseDRUG

Oral administration for 12 or 36 weeks

TAS5315 high dose group
PlacebosDRUG

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

Placebo group

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taiho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Location

Related Publications (1)

  • Takeuchi T, Tanaka S, Murata M, Tanaka Y. Irreversible covalent Bruton's tyrosine kinase inhibitor, TAS5315 versus placebo in rheumatoid arthritis patients with inadequate response to methotrexate: a randomised, double-blind, phase IIa trial. Ann Rheum Dis. 2023 Aug;82(8):1025-1034. doi: 10.1136/ard-2022-223759. Epub 2023 May 22.

    PMID: 37217273DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Taiho Pharmaceutical Co., Ltd.

    Taiho Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2018

First Posted

July 30, 2018

Study Start

August 30, 2018

Primary Completion

November 30, 2019

Study Completion

May 28, 2020

Last Updated

August 17, 2020

Record last verified: 2020-08

Locations

JP(1)