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
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
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
Sites / Locations
- Taiho Pharmaceutical Co., Ltd selected site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
No
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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