An Observational, Retrospective, Multicenter, National Study for the Monitoring of Subjects Who Participated in the LoadET Clinical Trial

Study Overview
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Brief Summary
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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).

Detailed Description
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Given that this is a follow-up study of subjects who participated in the LoadET study (0881A3-102090), we have planned the inclusion of all subjects who completed said study, that is, 97 of the 108 subjects in the LoadET study.

Official Title
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Retrospective, Multicentric, National, Observational Study, to Follow-up the Patients Who Participated in the Loadet Study (RELOADET Study)

Conditions
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Ankylosing Spondylitis

Intervention / Treatment
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* Drug: ETANERCEPT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ETANERCEPT|During the LoadET study (0881A3-102090), subjects were treated with etanercept 100 mg versus 50 mg weekly. After completing this study, the subjects were allowed to continue the treatment with etanercept 50 mg weekly, etanercept 100 mg weekly, another drug, or abandoned medication at the discretion of their physician. This is a non-interventional study in which historic data will be collected retrospectively from the patient's clinical history. During the historical period covered in the Study, patients would have received the treatment and the medical care that their treating physicians considered appropriate under the conditions of standard clinical practice.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Discontinued Treatment With Etanercept | Participants who discontinued etanercept following 3 years after finalization of LoadET study 0881A3-102090 (NCT00873730) due to any of these reason were reported: adverse events, failure in therapeutic response, disease remission and discontinued for other causes. | Baseline up to Year 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Between the Onset of Ankylosing Spondylitis Symptoms and First Visit to the Rheumatologist | Time passed since the ankylosing spondylitis symptoms started until the participant arrived for the first time to visit the rheumatologist was reported. Ankylosing spondylitis symptoms may include pain, stiffness, axial manifestations, and enthesitis etc. | Baseline | 
| Time to Diagnosis of Ankylosing Spondylitis | Time to first diagnosis of alkylosing spondylitis was reported. | Baseline | 
| Number of Participants Who Received Non-pharmacological Treatment | Participants who received any non-pharmacological treatment (participant education, regular exercises and physical therapy) in the 3 years since the last LoadET study 0881A3-102090 (NCT00873730) visit were reported. | Baseline up to Year 3 | 
| Number of Participants Who Received Pharmacological Treatment | Participants who received any pharmacological treatment (non-steroidal anti-inflammatory drugs [NSAIDs], disease-modifying antirheumatic drugs [DMARDs], corticosteroids and other treatments including anti-tumor necrosis factor-alpha [TNFalpha] or other biological agents etc.) in the 3 years since the last LoadET study 0881A3-102090 (NCT00873730) visit were reported. | Baseline up to Year 3 | 
| Patient Global Assessment (PtGA) of Disease Activity Score | Participants disease activity assessed using a 100 millimeter (mm) Visual Analog Scale (VAS), ranging from 0 = very good to 100 = very bad. | Baseline, Year 1, 2, 3 | 
| Bath Ankylosing Spondylitis Functional Index (BASFI) | BASFI is a validated self-assessment tool that determines the degree of functional limitation in ankylosing spondylitis. Utilizing a VAS of 0-10, 0 = easy, 10 = impossible, participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a sum of the scores of the 10 questions, final score ranged from 0-100, where higher score referred to higher impairment in the functional ability. | Baseline, Year 1, 2, 3 | 
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | BASDAI is a validated self-assessment tool used to determine disease activity in participant with ankylosing spondylitis. Utilizing a VAS of 0-10, 0=none and 10=very severe participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score is a sum of the individual assessments. Final score ranged from 0-60, higher score indicates higher disease activity. | Baseline, Year 1, 2, 3 | 
| Spinal Pain as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Participant's spinal pain - was assessed by answering question 2 of BASDAI on a 0 to10 VAS; participants were asked: How would you describe the overall level of ankylosing spondylitis neck, back or hip pain you have had? 0 =none and 10 =very severe. | Baseline, Year 1, 2, 3 | 
| Fatigue as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Participant's fatigue was assessed by answering question 1 of BASDAI on a 0 to 10 VAS; participants were asked: How would you describe the overall level of fatigue/tiredness you have experienced? 0=none and 10=very severe. | Baseline, Year 1, 2, 3 | 
| Modified Schober's Test | Measurement in centimeters (cm) of the distance between marks originally placed while the participant was standing erect 10 cm above and 5 cm below the midpoint of a line that joints the posterior superior iliac spines. Distance between marks was re-measured (in cm rounded to the nearest 0.1 cm) with participant maximally bend forward, knees fully extended, with spine in full flexion. The measurement of two attempts was made. | Baseline, Year 1, 2, 3 | 
| Occiput-to-wall Distance | Occiput-to-wall distance: distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight. The distance between the occiput and the wall was measured in cm (rounded to the nearest 0.1 cm), in two attempts. | Baseline, Year 1, 2, 3 | 
| Chest Expansion Measurement | Chest expansion, measured in cm (rounded to the nearest 0.1 cm), is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation. The measurement of two attempts was made. | Baseline, Year 1, 2, 3 | 
| C-reactive Protein (CRP) | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. | Baseline, Year 1, 2, 3 | 
| Erythrocyte Sedimentation Rate (ESR) | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation. | Baseline, Year 1, 2, 3 | 
| Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels | Lipid profile included following parameters: Total Cholesterol (TC), high-density lipoprotein (HDL) and triglycerides (TGs). | Baseline, Year 1, 2, 3 | 
| Time to Treatment Discontinuation With Etanercept | Time to treatment discontinuation with etanercept was assessed retrospectively at Year 3 for participants who did not discontinue treatment at the end of previous LoadET study 0881A3-102090 (NCT00873730). It was defined as time from first dose of etanercept received in the previous LoadET study 0881A3-102090 (NCT00873730) to last dose of etanercept. | Year 3 |