|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT01973569 |
|
Date of registration:
|
25/10/2013 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
AMG 162 (Denosumab) Phase 3 Study (DESIRABLE Study) in Participants With Rheumatoid Arthritis on Disease-modifying Antirheumatic Drugs (DMARDs) Treatment
DESIRABLE |
|
Scientific title:
|
A Confirmatory Study of AMG 162 (Denosumab) in Patients With Rheumatoid Arthritis on DMARDs Treatment (Phase III) |
|
Date of first enrolment:
|
October 2013 |
|
Target sample size:
|
679 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01973569 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Tsutomu Takeuchi, Prof. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Division of Rheumatology Department of Internal Medicine, Keio University |
| | |
|
Key inclusion & exclusion 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)
Age minimum:
20 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Rheumatoid Arthritis
|
|
Intervention(s)
|
|
Drug: placebo
|
|
Drug: denosumab
|
|
Primary Outcome(s)
|
|
Change in Total Sharp Score (TSS) From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo
[Time Frame: baseline to month 12]
|
|
Secondary Outcome(s)
|
|
Change in Joint Space Narrowing From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo
[Time Frame: baseline to month 12]
|
|
Change in Erosion Score From Baseline to Month 6 Following Subcutaneous Administration of Denosumab or Placebo
[Time Frame: baseline to month 6]
|
|
Percent Change in Bone Mineral Density (BMD) From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo
[Time Frame: baseline to month 12]
|
|
Change in Erosion Score From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo
[Time Frame: baseline to month 12]
|
|
Change in Joint Space Narrowing From Baseline to Month 6 Following Subcutaneous Administration of Denosumab or Placebo
[Time Frame: baseline to month 6]
|
|
Change in Total Sharp Score (TSS) From Baseline to Month 6 Following Subcutaneous Administration of Denosumab or Placebo
[Time Frame: baseline to month 6]
|
|
Secondary ID(s)
|
|
AMG162-D-J301
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|