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

Daiichi Sankyo

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: denosumab; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01973569

AMG162-D-J301

Details and patient eligibility

About

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

Full 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.

Enrollment: 679 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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679 participants in 3 patient groups, including a placebo group

Denosumab 6 months

Experimental group

Description:

denosumab administered subcutaneously every 6 months

Treatment:

Drug: denosumab

Denosumab 3 months

Experimental group

Description:

denosumab administered subcutaneously every 3 months

Treatment:

Drug: denosumab

placebo

Placebo Comparator group

Description:

placebo administered subcutaneously to match denosumab

Treatment:

Drug: placebo