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 6change 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
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