Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatments denosumab, placebo
Phase phase 3
Sponsor Daiichi Sankyo Inc.
Start date October 2013
End date December 2015
Trial size 667 participants
Trial identifier NCT01973569, AMG162-D-J301

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
denosumab administered subcutaneously every 6 months
denosumab AMG 162
denosumab administered subcutaneously
(Experimental)
denosumab administered subcutaneously every 3 months
denosumab AMG 162
denosumab administered subcutaneously
(Placebo Comparator)
placebo administered subcutaneously to match denosumab
placebo
placebo administered subcutaneously to match denosumab

Primary Outcomes

Measure
Change from baseline in Total Sharp Score (TSS) at month 12
time frame: baseline to month 12

Secondary Outcomes

Measure
change form baseline in TSS at month 6
time frame: baseline to month 6
change form baseline in Erosion Score at month 6
time frame: baseline to month 6
change form baseline in Joint Space Narrowing at month 6
time frame: baseline to month 6
change form baseline in Erosion Score at month 12
time frame: baseline to month 12
change form baseline in Joint Space Narrowing at month 12
time frame: baseline to month 12
percent change from baseline in Bone Mineral Density (BMD) at month 12
time frame: baseline to month 12

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title A Confirmatory Study of AMG 162 (Denosumab) in Patients With Rheumatoid Arthritis on DMARDs Treatment (Phase III)
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 patients
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Daiichi Sankyo Inc..