A Multi-Center, Open-Labeled Study of Adalimumab in Japanese Subjects with Active Ankylosing Spondylitis

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220558

Enrollment

Registered

2008-05-19

Start date

2008-05-19

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

Ankylosing Spondylitis

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: - Subject who meets the definition of Ankylosing Spondylitis based on the Modified New York Criteria - Subject has a diagnosis of active Ankylosing Spondylitis - Subject has had an inadequate response to or intolerance to one or more nonsteroidal anti-inflammatory drugs

Exclusion criteria

Exclusion criteria: - History of cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV - Previously received anti-TNF therapy - Spinal surgery or joint surgery involving to be assessed within 2 months prior to the Screening

Design outcomes

Primary

Measure	Time frame
Assessment in Ankylosing Spondylitis 20 (ASAS 20)	—

Secondary

Measure	Time frame
ASAS 50 ASAS 70 BASDAI 50 Evaluation of adverse event, vital sign, laboratory tests	—

Outcome results

None listed

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