DRIVE

A Dose-response Study of AMG 162 (Denosumab) in Patients with Rheumatoid Arthritis on Methotrexate (MTX) to Validate Inhibitory Effect on Bone Erosion (Phase II)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221226

Enrollment

320

Registered

2010-09-02

Start date

2010-10-29

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: -Ambulatory outpatients who are diagnosed with rheumatoid arthritis according to the American College of Rheumatology (ACR) criteria for rheumatoid arthritis classification (1987 revision)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
safety efficacy confirmatory Erosion Score modified Sharp	—

Secondary

Measure	Time frame
efficacy pharmacokinetics 1:Total Sharp Score,Joint Space Narrowing score 2:Bone Mineral Density 3:Pharmacokinetics (Serum AMG 162 concentration) 1:modified Sharp 2:DXA	—

Countries

Japan

Outcome results

None listed

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