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NCT01856569 Clinical Trial

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

Ankylosing Spondylitis Clinical Trial

— ASSIAL  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01856569
Other study ID # B1801362
Secondary ID B1801362
Status Completed
Phase N/A
First received May 14, 2013
Last updated January 8, 2016
Start date July 2013
Est. completion date December 2015

Study information
Verified date January 2016
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial Summary

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

Description:

retrospective and prospective 150

Recruitment information / eligibility
Status Completed
Enrollment 152
Est. completion date December 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

patients in other AS studies involved

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

Intervention

Other:
• no intervention
in real life of drug,dosage,frequency and duration

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

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10. 12-18 months No
Primary Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10. month 18 No
Secondary Ankylosing Spondylitis Quality of Life (ASQoL) Score ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a participant with Ankylosing Spondylitis (AS): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL). 12-18 months No
Secondary Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a participant with Ankylosing Spondylitis (AS): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL). month 18 No
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