Rheumatoid Arthritis
Conditions
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.
Interventions
DRUGTAS5315 low dose
Oral administration for 12 or 36 weeks
DRUGTAS5315 high dose
Oral administration for 12 or 36 weeks
DRUGPlacebos
Oral administration for 12 weeks (At Week 12, participants in the placebo group will be assigned to TAS5315 low or high dose group)
Sponsors
Taiho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants achieving American College of Rheumatology 20% (ACR20) response | Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Change from baseline in CDAI and SDAI score | Up to Week 36 |
| Change from baseline in patient assessment score of arthritis pain | Up to Week 36 |
| Change from baseline in patient global assessment score of arthritis | Up to Week 36 |
| Proportion of participants who achieve ACR20 response | Up to Week 36, except for Week 12 |
| Change from baseline in modified total sharp score | Baseline, Week 2, 4, 12 |
| Change from baseline in Anti-cyclic Citrullinated Peptide antibody levels | Up to Week 36 |
| Change from baseline in rheumatoid factor levels | Up to Week 36 |
| Maximum observed plasma concentration for TAS5315 | Baseline, Week 2, 4, 12 |
| Time to reach the maximum plasma concentration for TAS5315 | Baseline, Week 2, 4, 12 |
| Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for TAS5315 | Baseline, Week 2, 4, 12 |
| Incidence of adverse events and side effects as safety | Up to Week 36 |
| Change from baseline in physician's global assessment score of arthritis | Up to Week 36 |
Countries
Japan
Outcome results
None listed