N/A
Completed N=684
Study Evaluating the Safety and Efficacy of Enbrel (Etanercept) in Japan
Source: ClinicalTrials.gov NCT00503139 ↗Enrolled (actual)
684
Serious AEs
11.4%
Results posted
Feb 2017
Primary outcomePrimary: Number of Participants in Safety Analysis Population of Etanercept — 676; 561; 676; 475 Participants
Summary
The special use-results surveillance is conducted in patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted in the actual setting of use after marketing with the following objectives: 1. To examine the safety of long-term use of Enbrel including the occurrence of malignant tumors. 2. To confirm the efficacy of Enbrel in the long-term use.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants in Safety Analysis Population of Etanercept |
676; 561; 676; 475; 372; 176 | — |
| PRIMARY Number of Participants With Treatment Related Adverse Events of Etanercept |
117; 84; 184; 90; 43; 1 | — |
| PRIMARY Number of Participants With Serious Treatment Related Adverse Events of Etanercept |
12; 17; 29; 24; 13; 0 | — |
| PRIMARY Number of Participants With Unlisted Treatment Related Adverse Events of Etanercept |
16 | — |
| PRIMARY European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (4/Erythrocyte Sedimentation Rate: ESR) |
84.05; 82.51; 79.69; 81.98 | — |
| SECONDARY Modified Health Assessment Questionnaire (mHAQ) Score |
0.82; 0.45; 0.46; 0.45; 0.46 | <0.001 sig |
| SECONDARY Visual Analog Fatigue Scale (VAFS) |
49.1; 26.1; 25.2; 25.3; 26.0 | <0.001 sig |
| SECONDARY European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (3/Erythrocyte Sedimentation Rate: ESR) |
81.80; 81.10; 79.69; 80.42 | — |
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria Patients with rheumatoid arthritis (RA) who fulfill all of the following
- Patients who are refractory to the treatment.
- Patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted.
- Patients without a history of or concurrent malignant tumors.
Exclusion Criteria
Data sourced from ClinicalTrials.gov (NCT00503139). 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.