N/A
Completed N=157
Study With Etanercept Focusing on Remission and Predictability of Remission in Real Life Clinical Practice
Source: ClinicalTrials.gov NCT02202837 ↗Enrolled (actual)
157
Serious AEs
4.5%
Results posted
Dec 2018
Primary outcomePrimary: Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) Less Than (<) 2.6 at Month 6 and Maintained Till Month 12 — 43.4; 30.0 percentage of participants
Summary
Defining Which Remission Criterion at Month 6 Predicts Remission at Month 12 in a Real Life Clinical Practice, in a Cohort of Rheumatoid Arthritis Patients Treated with Etanercept
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) Less Than (<) 2.6 at Month 6 and Maintained Till Month 12 |
43.4; 30.0 | — |
| PRIMARY Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 at Month 6 and Maintained Till Month 12 |
13.7; 22.2 | — |
| PRIMARY Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 at Month 6 and Maintained Till Month 12 |
3.85; 18.2 | — |
| PRIMARY Percentage of Participants With Remission at Month 6 and Maintained Till Month 12 Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Studies) Boolean Criterion |
2.70; 0 | — |
| PRIMARY Percentage of Participants With Remission at Month 6 and Maintained Till Month 12 Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Practice) Boolean Criterion |
11.4; 18.2 | — |
| PRIMARY Percentage of Participants With Remission Based on Seven-Joint Ultrasound (US7) Measurements at Month 6 and Maintained Till Month 12 |
0; 0 | — |
| PRIMARY Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) in Combination With Seven-Joint Ultrasound (US7) Measurement at Month 6 and Maintained Till Month 12 |
0; 0 | — |
| SECONDARY Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) <2.6 at Month 3, 6, 9 and 12 |
50.0; 33.3; 56.6; 60.0; 50.9; 28.6 | — |
| SECONDARY Percentage of Participants With Simplified Disease Activity Index (SDAI) <=3.3 at Month 3, 6, 9 and 12 |
12.7; 12.5; 19.2; 44.4; 28.0; 14.3 | — |
| SECONDARY Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 at Month 3, 6, 9 and 12 |
12.3; 18.2; 7.69; 36.4; 23.2; 0.00 | — |
| SECONDARY Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Studies) Boolean Criterion at Month 3, 6, 9 and 12 |
5.36; 11.1; 6.76; 11.1; 5.88; 0.00 | — |
| SECONDARY Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Practice) Boolean Criterion at Month 3, 6, 9 and 12 |
10.6; 16.7; 16.5; 45.5; 26.3; 25.0 | — |
| SECONDARY Percentage of Participants With no Signs of Ultrasound Synovitis (Ultrasound Remission) at Month 6 and 12 |
0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) in Combination With Seven-Joint Ultrasound (US7) Measurement at Month 6 and Month 12 |
0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Month 6 and 12 |
5.06; 5.32; 2.39; 1.92; 2.36; 1.37 | — |
| SECONDARY Change From Baseline in Simplified Disease Activity Index (SDAI) at Month 6 and 12 |
32.2; 35.83; 21.06; 19.62; 20.30; 12.10 | — |
| SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) at Month 6 and 12 |
31.12; 34.17; 20.06; 15.64; 18.85; 13.20 | — |
| SECONDARY Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12 |
6.21; 9.50; 3.24; 8.36; 3.24; 3.00 | — |
| SECONDARY Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12 |
7.90; 6.50; 6.29; 5.85; 6.90; 0.50 | — |
| SECONDARY Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12 |
2.00; 0.00; 0.50; 0.00; 0.50; 0.00 | — |
| SECONDARY Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12 |
0.67; 0.00; 1.00; 0.00; 1.00; 0.00 | — |
| SECONDARY Change From Baseline in Seven-Joint Ultrasound (US7) Erosion Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12 |
0.67; 5.00; 0.33; 1.50; 0.33; 0.50 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with active RA who start treatment with etanercept according to the prevailing reimbursement criteria and dosing in line with the SmPC.
- First cohort: Etanercept is the first biological product prescribed.
- Second cohort: Etanercept is the second biological product prescribed.
- Capable of understanding and willing to provide signed and dated written, voluntary informed consent before any protocol-specific procedures are performed.
- Eighteen (18) years of age or older at time of consent.
Exclusion Criteria
- History of or current psychiatric illness that would interfere with the subject's ability to comply with protocol requirements or to give informed consent.
Data sourced from ClinicalTrials.gov (NCT02202837). 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.