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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03605251
• Other study ID #: 10063030
• Status: Completed
• Phase: Phase 2
• Start date: August 30, 2018
• Est. completion date: May 28, 2020

Study information

• Verified date: August 2020
• Source: Taiho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: May 28, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• TAS5315 low dose
Oral administration for 12 or 36 weeks
• TAS5315 high dose
Oral administration for 12 or 36 weeks
• Placebos
Oral administration for 12 weeks (At Week 12, participants in the placebo group will be assigned to TAS5315 low or high dose group)

Locations

Country	Name	City	State
Japan	Taiho Pharmaceutical Co., Ltd selected site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants achieving American College of Rheumatology 20% (ACR20) response		Week 12
Secondary	Proportion of participants who achieve ACR20 response		Up to Week 36, except for Week 12
Secondary	Proportion of participants achieving American College of Rheumatology 50% (ACR50) and American College of Rheumatology 70% (ACR70) response		Up to Week 36
Secondary	Proportion of participants who achieve DAS28-hs C-ReactivePprotein (CRP) and DAS28-Erythrocyte Sedimentation Rate (ESR) for remission		Baseline, Week 12
Secondary	Change from baseline in DAS28-CRP and DAS28-ESR score		Up to Week 36
Secondary	Proportion of participants who achieve Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) for remission		Baseline, Week 12
Secondary	Change from baseline in CDAI and SDAI score		Up to Week 36
Secondary	Change from baseline in patient assessment score of arthritis pain		Up to Week 36
Secondary	Change from baseline in patient global assessment score of arthritis		Up to Week 36
Secondary	Change from baseline in physician's global assessment score of arthritis		Up to Week 36
Secondary	Change from baseline in modified total sharp score		Baseline, Week 2, 4, 12
Secondary	Change from baseline in Anti-cyclic Citrullinated Peptide antibody levels		Up to Week 36
Secondary	Change from baseline in rheumatoid factor levels		Up to Week 36
Secondary	Maximum observed plasma concentration for TAS5315		Baseline, Week 2, 4, 12
Secondary	Time to reach the maximum plasma concentration for TAS5315		Baseline, Week 2, 4, 12
Secondary	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
Secondary	Incidence of adverse events and side effects as safety		Up to Week 36