Clinical trial NCT01793285: An Observational, Retrospective, Multicenter, National Study for the Monitoring of Subjects Who Participated in the LoadET Clinical Trial
Official title: Retrospective, Multicentric, National, Observational Study, to Follow-up the Patients Who Participated in the Loadet Study (RELOADET Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ankylosing Spondylitis subjects who were treated with ETN when participating in the previous LoadET study (0881A3-102090)

Brief 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).

Detailed description: 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.

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.

Primary outcomes:
measure: Percentage of Participants Who Discontinued Treatment With Etanercept
timeFrame: Baseline up to Year 3
Secondary outcomes:
measure: Time Between the Onset of Ankylosing Spondylitis Symptoms and First Visit to the Rheumatologist
timeFrame: Baseline
measure: Time to Diagnosis of Ankylosing Spondylitis
timeFrame: Baseline
measure: Number of Participants Who Received Non-pharmacological Treatment
timeFrame: Baseline up to Year 3
measure: Number of Participants Who Received Pharmacological Treatment
timeFrame: Baseline up to Year 3
measure: Patient Global Assessment (PtGA) of Disease Activity Score
timeFrame: Baseline, Year 1, 2, 3
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: Baseline, Year 1, 2, 3
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Baseline, Year 1, 2, 3
measure: Spinal Pain as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Baseline, Year 1, 2, 3
measure: Fatigue as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Baseline, Year 1, 2, 3
measure: Modified Schober's Test
timeFrame: Baseline, Year 1, 2, 3
measure: Occiput-to-wall Distance
timeFrame: Baseline, Year 1, 2, 3
measure: Chest Expansion Measurement
timeFrame: Baseline, Year 1, 2, 3
measure: C-reactive Protein (CRP)
timeFrame: Baseline, Year 1, 2, 3
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: Baseline, Year 1, 2, 3
measure: Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels
timeFrame: Baseline, Year 1, 2, 3
measure: Time to Treatment Discontinuation With Etanercept
timeFrame: Year 3
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Pfizer Investigational Site
state: Alcorcón
city: Sabadell
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Murcia
country: Spain
facility: Pfizer Investigational Site
state: El Palmar
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
state: Hospitalet de Llobregat
city: Madrid
country: Spain
facility: Pfizer Investigational Site
state: Majadahonda
city: A Coruña
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Córdoba
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Oviedo
country: Spain
facility: Pfizer Investigational Site
city: Oviedo
country: Spain
facility: Pfizer Investigational Site
city: Pamplona_Iruña_
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: