N/A
Completed N=679
AMG 162 (Denosumab) Phase 3 Study (DESIRABLE Study) in Participants With Rheumatoid Arthritis on Disease-modifying Antirheumatic Drugs (DMARDs) Treatment
Source: ClinicalTrials.gov NCT01973569 ↗Enrolled (actual)
679
Serious AEs
7.6%
Results posted
Dec 2019
Primary outcomePrimary: Change in Total Sharp Score (TSS) From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo — 0.99; 0.72; 1.49 score on a scale — p=0.0235
Summary
To evaluate the inhibitory effect of progression, compared with placebo, in joint destruction by AMG 162 administered subcutaneously to rheumatoid arthritis participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Sharp Score (TSS) From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo |
0.99; 0.72; 1.49 | 0.0235 sig |
| SECONDARY Change in Total Sharp Score (TSS) From Baseline to Month 6 Following Subcutaneous Administration of Denosumab or Placebo |
0.62; 0.48; 0.92 | 0.0360 sig |
| SECONDARY Change in Erosion Score From Baseline to Month 6 Following Subcutaneous Administration of Denosumab or Placebo |
0.34; 0.13; 0.58 | 0.1323 |
| SECONDARY Change in Joint Space Narrowing From Baseline to Month 6 Following Subcutaneous Administration of Denosumab or Placebo |
0.28; 0.35; 0.33 | 0.0448 sig |
| SECONDARY Change in Erosion Score From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo |
0.51; 0.22; 0.98 | 0.0104 sig |
| SECONDARY Change in Joint Space Narrowing From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo |
0.48; 0.50; 0.51 | 0.2570 |
| SECONDARY Percent Change in Bone Mineral Density (BMD) From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo |
3.99; 4.88; -1.03 | <0.0001 sig |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT01973569). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.