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

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ClinicalTrials.gov Identifier: NCT01973569
Recruitment Status : Completed
First Posted : October 31, 2013
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:
To evaluate the inhibitory effect of progression, compared with placebo, in joint destruction by AMG 162 administered subcutaneously to rheumatoid arthritis patients

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: denosumab Drug: placebo Not Applicable

Detailed 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 patients

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 667 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Confirmatory Study of AMG 162 (Denosumab) in Patients With Rheumatoid Arthritis on DMARDs Treatment (Phase III)
Actual Study Start Date : October 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : July 3, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Denosumab

Arm Intervention/treatment
Experimental: Denosumab 6 months
denosumab administered subcutaneously every 6 months
Drug: denosumab
denosumab administered subcutaneously
Other Name: AMG 162

Experimental: Denosumab 3 months
denosumab administered subcutaneously every 3 months
Drug: denosumab
denosumab administered subcutaneously
Other Name: AMG 162

Placebo Comparator: placebo
placebo administered subcutaneously to match denosumab
Drug: placebo
placebo administered subcutaneously to match denosumab




Primary Outcome Measures :
  1. Change from baseline in Total Sharp Score (TSS) at month 12 [ Time Frame: baseline to month 12 ]
    Change from baseline in Total Sharp Score (TSS) from baseline to month 12.


Secondary Outcome Measures :
  1. change form baseline in TSS at month 6 [ Time Frame: baseline to month 6 ]
    Change from baseline in Total Sharp Score (TSS) from baseline to month 6.

  2. change form baseline in Erosion Score at month 6 [ Time Frame: baseline to month 6 ]
    Change from baseline in Erosion Score from baseline to month 6.

  3. change form baseline in Joint Space Narrowing at month 6 [ Time Frame: baseline to month 6 ]
    Change from baseline in Joint Space Narrowing from baseline to month 6.

  4. change form baseline in Erosion Score at month 12 [ Time Frame: baseline to month 12 ]
    Change from baseline in Erosion Score from baseline to month 12.

  5. change form baseline in Joint Space Narrowing at month 12 [ Time Frame: baseline to month 12 ]
    Change from baseline in Joint Space Narrowing from baseline to month 12.

  6. percent change from baseline in Bone Mineral Density (BMD) at month 12 [ Time Frame: baseline to month 12 ]
    percent change from baseline in Bone Mineral Density (BMD) at month 12



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973569


Locations
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Japan
Tokyo, Japan, 162-0054
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Investigators
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Study Director: Tsutomu Takeuchi, Prof. Division of Rheumatology Department of Internal Medicine, Keio University

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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT01973569     History of Changes
Other Study ID Numbers: AMG162-D-J301
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daiichi Sankyo, Inc.:
Rheumatoid Arthritis
Denosumab
RANKL
RANK
AMG 162
joint damage
Developmental Phase III

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Denosumab
Antirheumatic Agents
Bone Density Conservation Agents
Physiological Effects of Drugs