Clinical trial NCT03605251: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-07-30
Enrollment: 91
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Proportion of participants achieving American College of Rheumatology 20% (ACR20) response
timeFrame: Week 12
Secondary outcomes:
measure: Proportion of participants who achieve ACR20 response
timeFrame: Up to Week 36, except for Week 12
measure: Proportion of participants achieving American College of Rheumatology 50% (ACR50) and American College of Rheumatology 70% (ACR70) response
timeFrame: Up to Week 36
measure: Proportion of participants who achieve DAS28-hs C-ReactivePprotein (CRP) and DAS28-Erythrocyte Sedimentation Rate (ESR) for remission
timeFrame: Baseline, Week 12
measure: Change from baseline in DAS28-CRP and DAS28-ESR score
timeFrame: Up to Week 36
measure: Proportion of participants who achieve Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) for remission
timeFrame: Baseline, Week 12
measure: Change from baseline in CDAI and SDAI score
timeFrame: Up to Week 36
measure: Change from baseline in patient assessment score of arthritis pain
timeFrame: Up to Week 36
measure: Change from baseline in patient global assessment score of arthritis
timeFrame: Up to Week 36
measure: Change from baseline in physician's global assessment score of arthritis
timeFrame: Up to Week 36
measure: Change from baseline in modified total sharp score
timeFrame: Baseline, Week 2, 4, 12
measure: Change from baseline in Anti-cyclic Citrullinated Peptide antibody levels
timeFrame: Up to Week 36
measure: Change from baseline in rheumatoid factor levels
timeFrame: Up to Week 36
measure: Maximum observed plasma concentration for TAS5315
timeFrame: Baseline, Week 2, 4, 12
measure: Time to reach the maximum plasma concentration for TAS5315
timeFrame: Baseline, Week 2, 4, 12
measure: Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for TAS5315
timeFrame: Baseline, Week 2, 4, 12
measure: Incidence of adverse events and side effects as safety
timeFrame: Up to Week 36
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Taiho Pharmaceutical Co., Ltd selected site
Study officials:
affiliation: Taiho Pharmaceutical Co., Ltd.
name: Taiho Pharmaceutical Co., Ltd.
role: STUDY_DIRECTOR
References: