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

NCT01793285 | Completed Results

• 2 other identifiers: B1801136RELOADET
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 15

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).

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Time Between the Onset of Ankylosing Spondylitis Symptoms and First Visit to the Rheumatologist

  Baseline

• Time to Diagnosis of Ankylosing Spondylitis

  Baseline

• Number of Participants Who Received Non-pharmacological Treatment

  Baseline up to Year 3

• Number of Participants Who Received Pharmacological Treatment

  Baseline up to Year 3

• Patient Global Assessment (PtGA) of Disease Activity Score

  Baseline, Year 1, 2, 3

Interventions

ETANERCEPT DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ankylosing Spondylitis subjects who were treated with ETN when participating in the previous LoadET study (0881A3-102090)

You may qualify if:

• AS patients who had previously participated in the LoadET study (0881A3-102090).
• Subjects who completed the LoadET Study.
• Patients who grant their informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (15)

Pfizer Investigational Site

Madrid, Alcorcón, 28922, Spain

Location

Pfizer Investigational Site

Sabadell, Barcelona, 08208, Spain

Location

Pfizer Investigational Site

Murcia, El Palmar, 20120, Spain

Location

Pfizer Investigational Site

Barcelona, Hospitalet de Llobregat, 08907, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28007, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, Spain

Location

Pfizer Investigational Site

Madrid, Majadahonda, 28222, Spain

Location

Pfizer Investigational Site

A Coruña, 15006, Spain

Location

Pfizer Investigational Site

Barcelona, 08036, Spain

Location

Pfizer Investigational Site

Córdoba, 14004, Spain

Location

Pfizer Investigational Site

Oviedo, 30012, Spain

Location

Pfizer Investigational Site

Oviedo, 33006, Spain

Location

Pfizer Investigational Site

Pamplona_Iruña_, 31004, Spain

Location

Pfizer Investigational Site

Seville, 41009, Spain

Location

Pfizer Investigational Site

Valencia, 46017, Spain

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2013
• First Posted: February 15, 2013
• Study Start: December 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 15, 2013
• Results First Posted: February 15, 2013

Record last verified: 2013-02

Locations

ES (15)