A study of Adalimumab in Japanese subjects with Rheumatoid Arthritis

A Phase 3 Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects with Rheumatoid Arthritis

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220724

Enrollment

300

Registered

2009-04-22

Start date

2009-04-22

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 : adalimumab INN of investigational material : adalimumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects who meets the definition of Rheumatoid Arthritis based on the ACR criteria and must be methotrexate or leflunomide naive, and the disease duration must be less than 2 years from diagnosis

Exclusion criteria

Exclusion criteria: History of acute inflammatory joint disease of different origin from rheumatoid arthritis, cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV Previously received anti-TNF therapy anti-IL-6 receptor antibody, CTLA4-Ig, anti-CD20 antibody, cyclophosphamide, cyclosporine, azathioprine or tacrolimus Joint surgery involving joints to be assessed within 8 weeks prior to Screening

Design outcomes

Primary

Measure	Time frame
Change from Baseline in modified Total Sharp Score at Week 26	—

Secondary

Measure	Time frame
ACR20, 50, 70 Evaluation of adverse event, vital sign and laboratory tests	—

Outcome results

None listed

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