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

NCT01793285

Last updated date
Study Location
Pfizer Investigational Site
Madrid, Alcorcón, 28922, Spain
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ankylosing Spondylitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title 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)
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Ankylosing Spondylitis subjects who were treated with ETN when participating in the previous LoadET study (0881A3-102090)
Condition Ankylosing Spondylitis
Intervention 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.

Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 14, 2013)
85
Original Actual Enrollment Same as current
Actual Study Completion Date February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT01793285
Other Study ID Numbers B1801136
RELOADET
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2013