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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223962

Enrollment

Registered

2018-07-02

Start date

2018-08-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rheumatoid arthritis

Interventions

investigational material(s) Generic name etc : TAS5315 INN of investigational material : - Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Have a diagnosis of RA according to 2010 ACR/ EULAR rheumatoid arthritis (RA) classification criteria -Have an inadequate response to MTX

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
efficacy Efficacy	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics Efficacy, safety, PK	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026