N/A
Completed N=85
An Observational, Retrospective, Multicenter, National Study for the Monitoring of Subjects Who Participated in the LoadET Clinical Trial
Source: ClinicalTrials.gov NCT01793285 ↗Enrolled (actual)
85
Serious AEs
2.4%
Results posted
Feb 2013
Primary outcomePrimary: Percentage of Participants Who Discontinued Treatment With Etanercept — 41.2 percentage of participants
Summary
Previous studies suggest that an increase in doses of weekly etanercept from 50 mg to 100 mg improves the efficacy of the treatment in patients with cutaneous psoriasis, rheumatoid arthritis, and psoriatic arthritis. In this same line of study, during the 2007 2008 period, we conducted a multicenter, double-blind, 12-week Study (LoadET, 0881A3-102090) comparing the efficacy of etanercept at a standard dose (50 mg/week) versus a double dose (100 mg/week) in subjects with AS refractory to conventional therapy. The interim results of said study do not appear to support the value of doubling the dose of etanercept in the treatment of subjects with AS. Once this study was finalised, the subjects continued to be monitored by their regular physician, who decided on the dose and treatment to follow according to the conditions of standard clinical practice.
The objective of this observational study is to evaluate the course of the disease in the long-term (three years) under the conditions of standard clinical practice, in subjects who had participated in the LoadET study. Therefore, we would like to follow-up on those patients by reviewing their clinical histories for the three-year period between the finalisation of their participation in the LoadET Study (0881A3-102090) and now. This will allow us to assess the efficacy and survival of the drug, as well as the possible appearance of side effects in the three years following the finalisation of the study by comparing the results according to if the subjects had received 50 mg/week or 100 mg/week during the LoadET study (0881A3 102090).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Discontinued Treatment With Etanercept |
41.2 | — |
| SECONDARY Time Between the Onset of Ankylosing Spondylitis Symptoms and First Visit to the Rheumatologist |
6.35 | — |
| SECONDARY Time to Diagnosis of Ankylosing Spondylitis |
7.53 | — |
| SECONDARY Number of Participants Who Received Non-pharmacological Treatment |
3 | — |
| SECONDARY Number of Participants Who Received Pharmacological Treatment |
55; 15; 7; 26 | — |
| SECONDARY Patient Global Assessment (PtGA) of Disease Activity Score |
1.70; 2.00; 2.00; 1.40 | — |
| SECONDARY Bath Ankylosing Spondylitis Functional Index (BASFI) |
26.00; 23.10; 23.00; 24.05 | — |
| SECONDARY Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) |
9.90; 10.60; 10.50; 9.30 | — |
| SECONDARY Spinal Pain as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) |
2.20; 2.90; 3.00; 2.00 | — |
| SECONDARY Fatigue as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) |
1.70; 2.00; 1.50; 2.00 | — |
| SECONDARY Modified Schober's Test |
17.75; 13.00; 11.00; 15.45 | — |
| SECONDARY Occiput-to-wall Distance |
0.00; 0.00; 2.00; 0.00 | — |
| SECONDARY Chest Expansion Measurement |
98.00; 98.13; 96.25; 101.00; 100.50; 86.00 | — |
| SECONDARY C-reactive Protein (CRP) |
0.27; 0.25; 0.47; 0.40 | — |
| SECONDARY Erythrocyte Sedimentation Rate (ESR) |
2.00; 4.00; 4.00; 6.00 | — |
| SECONDARY Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels |
189.50; 53.00; 77.00; 191.00; 58.00; 89.50 | — |
| SECONDARY Time to Treatment Discontinuation With Etanercept |
3.56 | — |
Eligibility Criteria
Inclusion Criteria
- AS patients who had previously participated in the LoadET study (0881A3-102090).
- Subjects who completed the LoadET Study.
- Patients who grant their informed consent
Exclusion Criteria
- Patients who participated in the LoadET study but who discontinued treatment and, therefore, did not complete the study.
- Patients without standard follow-up by the physician since the end of the study.
Data sourced from ClinicalTrials.gov (NCT01793285). 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.