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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03605251
• Date of registration: 03/07/2018
• Prospective Registration: Yes
• Primary sponsor: Taiho Pharmaceutical Co., Ltd.
• Public title: Efficacy and Safety Study of TAS5315 Compared With Placebo in Participants With Rheumatoid Arthritis.
• Scientific title: An Early Phase-II, Randomized, Double-blind, Study of TAS5315 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
• Date of first enrolment: August 30, 2018
• Target sample size: 91
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03605251
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Japan

Contacts

• Name: Taiho Pharmaceutical Co., Ltd.
• Affiliation: Taiho Pharmaceutical Co., Ltd.

Key inclusion & exclusion 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 ß-D-glucan at screening



Age minimum: 20 Years
Age maximum: 64 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: TAS5315 low dose

Drug: TAS5315 high dose

Drug: Placebos

Primary Outcome(s)

Proportion of participants achieving American College of Rheumatology 20% (ACR20) response [Time Frame: Week 12]

Secondary Outcome(s)

Change from baseline in Anti-cyclic Citrullinated Peptide antibody levels [Time Frame: Up to Week 36]

Change from baseline in patient assessment score of arthritis pain [Time Frame: Up to Week 36]

Change from baseline in physician's global assessment score of arthritis [Time Frame: Up to Week 36]

Maximum observed plasma concentration for TAS5315 [Time Frame: Baseline, Week 2, 4, 12]

Change from baseline in CDAI and SDAI score [Time Frame: Up to Week 36]

Change from baseline in rheumatoid factor levels [Time Frame: Up to Week 36]

Incidence of adverse events and side effects as safety [Time Frame: Up to Week 36]

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]

Change from baseline in DAS28-CRP and DAS28-ESR score [Time Frame: Up to Week 36]

Time to reach the maximum plasma concentration for TAS5315 [Time Frame: Baseline, Week 2, 4, 12]

Change from baseline in modified total sharp score [Time Frame: Baseline, Week 2, 4, 12]

Change from baseline in patient global assessment score of arthritis [Time Frame: Up to Week 36]

Proportion of participants achieving American College of Rheumatology 50% (ACR50) and American College of Rheumatology 70% (ACR70) response [Time Frame: Up to Week 36]

Proportion of participants who achieve DAS28-hs C-ReactivePprotein (CRP) and DAS28-Erythrocyte Sedimentation Rate (ESR) for remission [Time Frame: Baseline, Week 12]

Proportion of participants who achieve Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) for remission [Time Frame: Baseline, Week 12]

Proportion of participants who achieve ACR20 response [Time Frame: Up to Week 36, except for Week 12]

Secondary ID(s)

10063030

Source(s) of Monetary Support

Please refer to primary and secondary sponsors