NCT01973569

AMG 162 (Denosumab) Phase 3 Study (DESIRABLE Study) in Participants With Rheumatoid Arthritis on Disease-modifying Antirheumatic Drugs (DMARDs) Treatment

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 679 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the inhibitory effect of progression, compared with placebo, in joint destruction by AMG 162 administered subcutaneously to rheumatoid arthritis participants.

Detailed description

To evaluate the inhibitory effect of progression, compared with placebo, in joint destruction by AMG 162 administered subcutaneously at a dose of 60 mg every 6 months or every 3 months for 12 months to rheumatoid arthritis participants.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	denosumab	denosumab administered subcutaneously
DRUG	placebo	placebo administered subcutaneously to match denosumab

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-12-01
• Completion: 2017-09-19
• First posted: 2013-10-31
• Last updated: 2020-02-12
• Results posted: 2019-12-13

Locations

1 site across 1 country: Japan