Assial - Anti Tnf Treatment in Ankylosing Spondylitis: an Observational Cohort Study in Italy (ASSIAL)
|ClinicalTrials.gov Identifier: NCT01856569|
Recruitment Status : Completed
First Posted : May 17, 2013
Results First Posted : March 9, 2017
Last Update Posted : March 9, 2017
|Condition or disease||Intervention/treatment|
|Ankylosing Spondylitis||Other: no intervention|
|Study Type :||Observational|
|Actual Enrollment :||152 participants|
|Official Title:||Assial - Anti Tnf Treatment In Ankylosing Spondylitis: An Observational Cohort Study In Italy|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||November 2015|
Other: no intervention
in real life of drug,dosage,frequency and duration
Other Name: adherence of therapy,switching,combo therapy
- 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.
- Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Month 18 [ Time Frame: Month 18 ]ASQoL was a disease-specific questionnaire that assessed the impact of AS on participant's quality of life (QoL). It consisted of 18 questions to be completed by the participant. Each question was answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). Scores of each individual question was summed to give a total score that ranges from 0 (good QoL) to 18 (poor QoL), where lower scores indicated good quality of life. Data for this outcome was planned to be reported separately for switchers (participants who switched to a second anti-TNF drug during observation period) and non-switchers (participants who did not switched to a second anti-TNF drug during observation period).
- C Reactive Protein Level at Baseline [ Time Frame: Baseline ]C reactive protein was measured from blood samples as a marker for inflammation. Higher levels were indicative of more inflammation.
- Erythrocyte Sedimentation Rate at Baseline [ Time Frame: Baseline ]Erythrocyte sedimentation rate was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeter per hour (mm/h).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856569
|Study Director:||Pfizer CT.gov Call Center||Pfizer|