Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid Arthritis

Amgen

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: denosumab; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00095498

20040144

Details and patient eligibility

About

This study will determine the efficacy, safety, and tolerability of denosumab (AMG 162) in the treatment of Rheumatoid Arthritis (RA).

Enrollment: 227 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of RA.
• All subjects will be required to have been taking a stable dose of methotrexate.
• Active RA at screening defined as greater than or equal to 6 swollen joints.
• The presence of erosive disease

Exclusion criteria

• Received any biologic agent (e.g., Enbrel®, Remicade®, Humira®, Kineret®) or Arava® within 8 weeks before randomization; past use of these agents is allowed.
• Steroid use greater than 15 mg/day.
• Scheduled for surgery or joint replacement in the hands, wrists or feet.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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227 participants in 3 patient groups, including a placebo group

Denosumab 180 mg

Experimental group

Description:

Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.

Treatment:

Drug: denosumab

Denosumab 60 mg

Experimental group

Description:

Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.

Treatment:

Drug: denosumab

Placebo

Placebo Comparator group

Description:

Participants received placebo subcutaneous injections on Day 1 and at Month 6.

Treatment:

Drug: placebo