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Completed

NCT Number: NCT03605251

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Taiho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAS5315 low dose

Drug

Oral administration for 12 or 36 weeks

TAS5315 high dose

Drug

Oral administration for 12 or 36 weeks

Placebos

Drug

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

Primary outcomes

  1. Proportion of participants achieving American College of Rheumatology 20% (ACR20) response

    Time frame: Week 12

Secondary outcomes

  1. Proportion of participants who achieve ACR20 response

    Time frame: Up to Week 36, except for Week 12

  2. Proportion of participants achieving American College of Rheumatology 50% (ACR50) and American College of Rheumatology 70% (ACR70) response

    Time frame: Up to Week 36

  3. Proportion of participants who achieve DAS28-hs C-ReactivePprotein (CRP) and DAS28-Erythrocyte Sedimentation Rate (ESR) for remission

    Time frame: Baseline, Week 12

  4. Change from baseline in DAS28-CRP and DAS28-ESR score

    Time frame: Up to Week 36

  5. Proportion of participants who achieve Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) for remission

    Time frame: Baseline, Week 12

  6. Change from baseline in CDAI and SDAI score

    Time frame: Up to Week 36

  7. Change from baseline in patient assessment score of arthritis pain

    Time frame: Up to Week 36

  8. Change from baseline in patient global assessment score of arthritis

    Time frame: Up to Week 36

  9. Change from baseline in physician's global assessment score of arthritis

    Time frame: Up to Week 36

  10. Change from baseline in modified total sharp score

    Time frame: Baseline, Week 2, 4, 12

  11. Change from baseline in Anti-cyclic Citrullinated Peptide antibody levels

    Time frame: Up to Week 36

  12. Change from baseline in rheumatoid factor levels

    Time frame: Up to Week 36

  13. Maximum observed plasma concentration for TAS5315

    Time frame: Baseline, Week 2, 4, 12

  14. Time to reach the maximum plasma concentration for TAS5315

    Time frame: Baseline, Week 2, 4, 12

  15. 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

  16. Incidence of adverse events and side effects as safety

    Time frame: Up to Week 36

Sponsors and collaborators

Lead sponsor

Taiho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 30, 2018
Registry last updated
Aug 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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