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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

679 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-09-19

Brief Summary

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

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Detailed Description

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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

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Denosumab 6 months

denosumab administered subcutaneously every 6 months

Group Type EXPERIMENTAL

denosumab

Intervention Type DRUG

denosumab administered subcutaneously

Denosumab 3 months

denosumab administered subcutaneously every 3 months

Group Type EXPERIMENTAL

denosumab

Intervention Type DRUG

denosumab administered subcutaneously

placebo

placebo administered subcutaneously to match denosumab

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo administered subcutaneously to match denosumab

Interventions

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denosumab

denosumab administered subcutaneously

Intervention Type DRUG

placebo

placebo administered subcutaneously to match denosumab

Intervention Type DRUG

Other Intervention Names

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AMG 162

Eligibility Criteria

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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