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Clinical Trials/NCT01856569
NCT01856569
Completed
Not Applicable

Assial - Anti Tnf Treatment In Ankylosing Spondylitis: An Observational Cohort Study In Italy

Pfizer17 sites in 1 country152 target enrollmentJuly 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ankylosing Spondylitis
Sponsor
Pfizer
Enrollment
152
Locations
17
Primary Endpoint
Percentage of Participants With Unchanged First Line Anti-TNF Treatment Up to Month 18
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Observe in real life adherence therapy and time to switch in ankylosing spondylitis patients with predominant assial involvement with 4 anti-TNF.

Detailed Description

retrospective and prospective 150

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
November 2015
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Pfizer
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • retrospective:12 months at least first anti-TNF therapy prospective: at maximum 6 months observation AS patients with axial involvement

Exclusion Criteria

  • patients in other AS studies involved

Outcomes

Primary Outcomes

Percentage of Participants With Unchanged First Line Anti-TNF Treatment Up to Month 18

Time Frame: Baseline up to Month 18

First line anti-TNF treatment included adalimumab, etanercept, golimumab and infliximab. In this outcome, percentage of participants who were taking any one of the first line anti-TNF treatment at baseline and maintained the same up to Month 18 without any change in prescription, were reported.

Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 18

Time Frame: Baseline, Month 18

BASDAI was a validated self-assessment tool used to determine disease activity in participants with AS. Utilizing a numerical rating scale (NRS) of 0-10 (0 = no problem to 10 = worst problem) participants answered 6 questions measuring symptoms of AS (spinal pain, fatigue, joint pain or swelling, areas of localized tenderness, morning stiffness duration and severity). The BASDAI total score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score was then divided by 5. BASDAI=Q1+Q2+Q3+Q4+\[Q5+Q6/2\]/5. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity.

Percentage of Participants With Unchanged First Line Anti-TNF Treatment In State of Low Disease Activity

Time Frame: Month 12, 18

Low disease activity was defined as a BASDAI score of less than or equal to (\<=) 2. BASDAI was a validated self-assessment tool used to determine disease activity in participants with AS. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity. In this outcome, percentage of participants with unchanged first line anti-TNF drug (nor dose neither frequency, but drug only) in the state of low disease activity, during the specified time points were reported.

Secondary Outcomes

  • Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Month 18(Month 18)
  • C Reactive Protein Level at Baseline(Baseline)
  • Erythrocyte Sedimentation Rate at Baseline(Baseline)

Study Sites (17)

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