N/A
Completed N=6,393
Study to Assess the Safety and Efficacy of Etanercept in Patients Treated Over the Long-term in Real-world Clinical Practice, Using Data Collected by the British Society of Rheumatology Biologics Registry
Source: ClinicalTrials.gov NCT01646385 ↗Enrolled (actual)
6,393
Serious AEs
26.4%
Results posted
Aug 2014
Primary outcomePrimary: Crude Incidence Rate of Malignancy — 14.7; 23.9 events per 1000 participant-years — p=0.084
Summary
This study will assess the rates of serious adverse events and death in adult rheumatoid arthritis patients treated with etanercept over the long-term in real-life clinical practice. It will also assess whether there is any difference in the rate of serious adverse events in patients trated with etanercept in comparision to patients treated with conventional disease-modifying anti-rheumatic drugs (DMARDs). The study will in addition quantify the efficacy of etanercept in this population by assessing the rates of important clinical outcomes such as changes in disease activity and disability/functioning.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Crude Incidence Rate of Malignancy |
14.7; 23.9 | 0.084 |
| PRIMARY Crude Incidence Rate of Lymphoproliferative Malignancy (LM) |
1.1; 2.6 | 0.035 sig |
| PRIMARY Crude Incidence Rate of Serious Infections |
35.1; 36.2 | 0.855 |
| PRIMARY Crude Incidence Rate of Other Serious Adverse Events |
20.3; 29.6 | 0.001 sig |
| PRIMARY Crude Incidence Rate of All-Cause Mortality |
12.0; 20.1 | 0.024 sig |
| SECONDARY Percentage of Participants Who Switched to Other Therapy Following Etanercept Discontinuation |
35.3; 18.0 | — |
| SECONDARY Time on Etanercept Therapy |
4.959 | — |
| SECONDARY Disease Activity Score Based on 28-Joints Count (DAS28) at Baseline |
6.6; 5.6 | <0.001 sig |
| SECONDARY Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Year 1, 2, 3, 4, and 5 |
-2.16; -1.42; -2.40; -1.79; -2.55; -1.95 | <0.0001 sig |
| SECONDARY Percentage of Participants With Remission and Low Disease Activity as Assessed by Disease Activity Score Based on 28-Joints Count (DAS28) |
13.0; 12.6; 17.0; 16.2; 20.1; 21.3 | — |
| SECONDARY Time to Remission |
NA; NA | — |
| SECONDARY Health Assessment Questionnaire (HAQ) Score at Baseline |
2.1; 1.7 | <0.001 sig |
| SECONDARY Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Year 1, 2, and 3 |
-0.317; -0.057; -0.309; -0.062; -0.301; -0.064 | <0.001 sig |
| SECONDARY Percentage of Participants With Remission Based on Health Assessment Questionnaire (HAQ) Score |
24.9; 8.4; 23.6; 8.0; 23.9; 7.2 | — |
| SECONDARY Health Assessment Questionnaire (HAQ) Score 6 Months Prior to And 6 Months Post-Switching Etanercept |
2.006; 2.017 | — |
Eligibility Criteria
Inclusion Criteria
- adult
- rheumatoid arthritis
- group 1: initiating etanercept as first biologic therapy
- group 2: DAS28<4.2, biologic naive and treated with non-biologic DMARDs
Exclusion Criteria
- diagnosis of other inflammatory arthritis
Data sourced from ClinicalTrials.gov (NCT01646385). 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.