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

NCT ID: NCT01793285

Last Updated: 2013-02-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 85 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-02-29

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.

Conditions

Ankylosing Spondylitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Investigational Site

Madrid, Alcorcón, Spain

Pfizer Investigational Site

Sabadell, Barcelona, Spain

Pfizer Investigational Site

Murcia, El Palmar, Spain

Pfizer Investigational Site

Barcelona, Hospitalet de Llobregat, Spain

Pfizer Investigational Site

Madrid, Madrid, Spain

Pfizer Investigational Site

Madrid, Madrid, Spain

Pfizer Investigational Site

Madrid, Majadahonda, Spain

Pfizer Investigational Site

A Coruña, , Spain

Pfizer Investigational Site

Barcelona, , Spain

Pfizer Investigational Site

Córdoba, , Spain

Pfizer Investigational Site

Oviedo, , Spain

Pfizer Investigational Site

Oviedo, , Spain

Pfizer Investigational Site

Pamplona_Iruña_, , Spain

Pfizer Investigational Site

Seville, , Spain

Pfizer Investigational Site

Valencia, , Spain

Countries

Spain

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1801136&StudyName=An%20Observational%2C%20Retrospective%2C%20Multicenter%2C%20National%20Study%20for%20the%20Monitoring%20of%20Subjects%20Who%20Participated%20in%20the%20LoadET%20Clinical%20Tr

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Other Identifiers

RELOADET

Identifier Type: -

Identifier Source: secondary_id

B1801136

Identifier Type: -

Identifier Source: org_study_id