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A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate.

A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate.

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220778
Enrollment
Unknown
Registered
2009-07-24
Start date
2009-07-24
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 : T-614 50 mg INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investig

Sponsors

Toyama Chemical Co., Ltd.(Current FUJIFILM Toyama Chemical Co., Ltd.)
Lead Sponsor
Eisai Co., Ltd.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The study population consist of subjects with active RA. Key inclusion criteria are as follows: 1)Patients provided written informed consent and were aged greater or 20 years and less than 70 years old 2)Patients had a diagnosis of active RA for less than 10 years, based on American College of Rheumatology (ACR) criteria.

Exclusion criteria

Exclusion criteria: Key exclusion criteria are as follows: 1)Steinbrocker's class IV. 2)Patients have the complication and anamnesis, different inflammatory joint disease from RA, a malignant tumor, or HIV. 3)Women of childbearing potential who are not practicing a successful method of contraception, or wish to become pregnant.

Design outcomes

Primary

MeasureTime frame
Efficacy and safety Efficacy and safety

Outcome results

None listed

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