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Trial record 1 of 1 for:    NCT01793285
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An Observational, Retrospective, Multicenter, National Study for the Monitoring of Subjects Who Participated in the LoadET Clinical Trial (RELOADET)

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ClinicalTrials.gov Identifier: NCT01793285
Recruitment Status : Completed
First Posted : February 15, 2013
Results First Posted : February 15, 2013
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date January 30, 2013
First Posted Date February 15, 2013
Results First Submitted Date February 14, 2013
Results First Posted Date February 15, 2013
Last Update Posted Date February 15, 2013
Study Start Date December 2010
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 14, 2013)
Percentage of Participants Who Discontinued Treatment With Etanercept [ Time Frame: Baseline up to Year 3 ]
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 14, 2013)
  • Time Between the Onset of Ankylosing Spondylitis Symptoms and First Visit to the Rheumatologist [ Time Frame: Baseline ]
    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.
  • Time to Diagnosis of Ankylosing Spondylitis [ Time Frame: Baseline ]
    Time to first diagnosis of alkylosing spondylitis was reported.
  • Number of Participants Who Received Non-pharmacological Treatment [ Time Frame: Baseline up to Year 3 ]
    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.
  • Number of Participants Who Received Pharmacological Treatment [ Time Frame: Baseline up to Year 3 ]
    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.
  • Patient Global Assessment (PtGA) of Disease Activity Score [ Time Frame: Baseline, Year 1, 2, 3 ]
    Participants disease activity assessed using a 100 millimeter (mm) Visual Analog Scale (VAS), ranging from 0 = very good to 100 = very bad.
  • Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: Baseline, Year 1, 2, 3 ]
    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.
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Baseline, Year 1, 2, 3 ]
    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.
  • Spinal Pain as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Baseline, Year 1, 2, 3 ]
    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.
  • Fatigue as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Baseline, Year 1, 2, 3 ]
    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.
  • Modified Schober's Test [ Time Frame: Baseline, Year 1, 2, 3 ]
    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.
  • Occiput-to-wall Distance [ Time Frame: Baseline, Year 1, 2, 3 ]
    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.
  • Chest Expansion Measurement [ Time Frame: Baseline, Year 1, 2, 3 ]
    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.
  • C-reactive Protein (CRP) [ Time Frame: Baseline, Year 1, 2, 3 ]
    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.
  • Erythrocyte Sedimentation Rate (ESR) [ Time Frame: Baseline, Year 1, 2, 3 ]
    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.
  • Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels [ Time Frame: Baseline, Year 1, 2, 3 ]
    Lipid profile included following parameters: Total Cholesterol (TC), high-density lipoprotein (HDL) and triglycerides (TGs).
  • Time to Treatment Discontinuation With Etanercept [ Time Frame: Year 3 ]
    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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
PRS Account Pfizer
Verification Date February 2013