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

Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: denosumab (Drug); placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Daiichi Sankyo Inc.

Official(s) and/or principal investigator(s):
Tsutomu Takeuchi, Prof., Study Director, Affiliation: Division of Rheumatology Department of Internal Medicine, Keio University

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change from baseline in Total Sharp Score (TSS) at month 12

Secondary outcome:

change form baseline in TSS at month 6

change form baseline in Erosion Score at month 6

change form baseline in Joint Space Narrowing at month 6

change form baseline in Erosion Score at month 12

change form baseline in Joint Space Narrowing at month 12

percent change from baseline in Bone Mineral Density (BMD) at month 12

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 patients

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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:

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

Locations and Contacts

Tokyo 162-0054, Japan
Additional Information

Starting date: October 2013
Last updated: December 9, 2014

Page last updated: August 23, 2015

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