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

NCT ID: NCT00095498

Last Updated: 2021-10-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

227 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-11

Study Completion Date

2007-04-01

Brief Summary

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

Detailed Description

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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

DOUBLE

Participants Investigators

Study Groups

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Denosumab 180 mg

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

Group Type EXPERIMENTAL

denosumab

Intervention Type DRUG

For subcutaneous injection

Denosumab 60 mg

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

Group Type EXPERIMENTAL

denosumab

Intervention Type DRUG

For subcutaneous injection

Placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo subcutaneous injection

Interventions

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placebo

placebo subcutaneous injection

Intervention Type DRUG

denosumab

For subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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AMG 162

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

References

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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.

Reference Type BACKGROUND
PMID: 18438830 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20391513 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19734132 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20391509 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf

Notice regarding posted summaries of trial results

http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_49_AMG_162_20040144.pdf

To access clinical trial results information click on this link

Other Identifiers

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20040144

Identifier Type: -

Identifier Source: org_study_id