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

NCT00095498 | Completed Phase 2 Results

• 1 other identifier: 20040144
• Study Type: interventional
• Target: 227
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Rheumatoid Arthritis

Keywords

arthritis; joint pain; Methotrexate

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Rheumatoid Arthritis Erosion Score Measured From MRI Assessments (RA-MRI ES) at Month 6

  Fifteen sites in each wrist and 10 sites in each hand were assessed by a blinded and independent reader. Each site was scored from 0 to 10 (in accordance with the European League Against Rheumatism \[EULAR\]-Outcome Measures in Rheumatology Clinical Trials convention), with each unit increment representing 10% incremental loss of the peripheral 1 cm of articular bone. The Erosion Score is a sum of erosion scores from 50 joint sites in both hands/wrists and ranges from 0 (normal, no erosion) to 500 (worst possible erosion).

  Baseline, Month 6

Secondary Outcomes (139)

• Change From Baseline in Radiographic Total Modified Sharp Score (TSS) at Month 12

  Baseline, Month 12

• Change From Baseline in Radiographic Total Modified Sharp Score (TSS) at Month 6

  Baseline, Month 6

• Change From Baseline in Radiographic Erosion Score at Month 12

  Baseline, Month 12

• Change From Baseline in Radiographic Erosion Score at Month 6

  Baseline, Month 6

• Change From Baseline in Radiographic Joint Space Narrowing Score at Month 12

  Baseline, Month 12

Study Arms (3)

Denosumab 180 mg

EXPERIMENTAL

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

Drug: denosumab

Denosumab 60 mg

EXPERIMENTAL

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

Drug: denosumab

Placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

placebo DRUG

placebo subcutaneous injection

Placebo

denosumab DRUG

For subcutaneous injection

Also known as: AMG 162

Denosumab 180 mg; Denosumab 60 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Related Publications (4)

• Cohen SB, Dore RK, Lane NE, Ory PA, Peterfy CG, Sharp JT, van der Heijde D, Zhou L, Tsuji W, Newmark R; Denosumab Rheumatoid Arthritis Study Group. Denosumab treatment effects on structural damage, bone mineral density, and bone turnover in rheumatoid arthritis: a twelve-month, multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial. Arthritis Rheum. 2008 May;58(5):1299-309. doi: 10.1002/art.23417.

  PMID: 18438830 BACKGROUND

• Deodhar A, Dore RK, Mandel D, Schechtman J, Shergy W, Trapp R, Ory PA, Peterfy CG, Fuerst T, Wang H, Zhou L, Tsuji W, Newmark R. Denosumab-mediated increase in hand bone mineral density associated with decreased progression of bone erosion in rheumatoid arthritis patients. Arthritis Care Res (Hoboken). 2010 Apr;62(4):569-74. doi: 10.1002/acr.20004.

  PMID: 20391513 BACKGROUND

• Dore RK, Cohen SB, Lane NE, Palmer W, Shergy W, Zhou L, Wang H, Tsuji W, Newmark R; Denosumab RA Study Group. Effects of denosumab on bone mineral density and bone turnover in patients with rheumatoid arthritis receiving concurrent glucocorticoids or bisphosphonates. Ann Rheum Dis. 2010 May;69(5):872-5. doi: 10.1136/ard.2009.112920. Epub 2009 Sep 3.

  PMID: 19734132 BACKGROUND

• Sharp JT, Tsuji W, Ory P, Harper-Barek C, Wang H, Newmark R. Denosumab prevents metacarpal shaft cortical bone loss in patients with erosive rheumatoid arthritis. Arthritis Care Res (Hoboken). 2010 Apr;62(4):537-44. doi: 10.1002/acr.20172.

  PMID: 20391509 BACKGROUND

Related Links

• AmgenTrials clinical trials website
• Notice regarding posted summaries of trial results
• To access clinical trial results information click on this link

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis; Arthralgia

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2004
• First Posted: November 8, 2004
• Study Start: August 11, 2004
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: October 25, 2021
• Results First Posted: January 13, 2014

Record last verified: 2021-10