AMG 162 Phase III study (DESIRABLE study)

A Confirmatory Study of AMG 162 (Denosumab) in Patients with Rheumatoid Arthritis on DMARDs treatment (Phase III)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222228

Enrollment

642

Registered

2013-09-19

Start date

2013-10-29

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 : AMG 162 INN of investigational material : Denosumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Inv

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosed with rheumatoid arthritis according to the American College of Rheumatology (ACR) criteria for rheumatoid arthritis classification (1987 revision) or the 2010 ACR-EULAR (The European League Against Rheumatism) classification criteria for rheumatoid arthritis

Exclusion criteria

Exclusion criteria: Functional class IV according by the ACR revised classification (1991)

Design outcomes

Primary

Measure	Time frame
safety efficacy confirmatory total Sharp score(TSS) modified Sharp method	—

Secondary

Measure	Time frame
efficacy 1: Erosion Score, Joint Space Narrowing score 2: BMD 1: modified Sharp method 2: DXA method	—

Countries

Japan

Outcome results

None listed

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