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

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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: TAS5315 low dose; Drug: TAS5315 high dose; Drug: Placebos

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Taiho Pharmaceutical Co., Ltd selected site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAS5315 low dose group; TAS5315 low dose and Methotrexate as specified	Drug: TAS5315 low dose; Oral administration for 12 or 36 weeks
Experimental: TAS5315 high dose group; TAS5315 high dose and Methotrexate as specified	Drug: TAS5315 high dose; Oral administration for 12 or 36 weeks
Placebo Comparator: Placebo group; Placebo and Methotrexate as specified	Drug: Placebos; Oral administration for 12 weeks (At Week 12, participants in the placebo group will be assigned to TAS5315 low or high dose group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants achieving American College of Rheumatology 20% (ACR20) response	Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
Change from baseline in physician's global assessment score of arthritis	Up to Week 36
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

Collaborators and Investigators

• Sponsor: Taiho Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2018
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): May 28, 2020

Study Registration Dates

• First Submitted: July 3, 2018
• First Submitted That Met QC Criteria: July 20, 2018
• First Posted (Actual): July 30, 2018

Study Record Updates

• Last Update Posted (Actual): August 17, 2020
• Last Update Submitted That Met QC Criteria: August 14, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 10063030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No