Assial - Anti Tnf Treatment in Ankylosing Spondylitis: an Observational Cohort Study in Italy

Completed

Conditions: Ankylosing Spondylitis

Interventions: Other: no intervention

Registration Number: NCT01856569

Lead Sponsor: Pfizer

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 152

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
observational	no intervention	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Unchanged First Line Anti-TNF Treatment Up to Month 18	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	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	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 Outcome Measures

Name	Time	Method
Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Month 18	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	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	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).

Trial Locations

Locations (17): Unita Operativa Semplice di Reumatologia
🇮🇹
Catania, CT, Italy
U.O.S. Reumatologia - Azienda Ospedaliera Universitaria Policlinico Sant'Orsola-Malpighi
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Bologna, Italy
Piazzale Spedali Civili
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Brescia, Italy
Policlinico Di Cagliari, Dipartimento Di Scienze Mediche
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Cagliari, Italy
Arcispedale Sant'Anna
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Ferrara, Italy
Ospedale Ortopedico G. Pini
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Milano, Italy
Via Torregalli, 3
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Firenze, Italy
Policlinico Universitario, II Universita
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Napoli, Italy
Fondazione San Raffaele del Monte Tabor
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Milano, Italy
Policlinico Universitario
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Udine, Italy
Policlinico Universitario P. Giaconne
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Palermo, Italy
Divisione di Reumatologia
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Palermo, Italy
Azienda USL 4 di Prato
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Prato, Italy
Università Campus Bio-Medico di Roma- Policlinico Universitario Campus Bio-medico di Roma
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Roma, Italy
Policlinico Umberto I
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Roma, Italy
Ospedale Mauriziano Umberto I
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Torino, Italy
Ospedale Borgo Trento - Clinica Reumatologica
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Verona, Italy