Clinical trial NCT01856569: Assial - Anti Tnf Treatment in Ankylosing Spondylitis: an Observational Cohort Study in Italy
Official title: Assial - Anti Tnf Treatment In Ankylosing Spondylitis: An Observational Cohort Study In Italy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-05-17
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: ankylosing spondylitis

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

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

Primary outcomes:
measure: Percentage of Participants With Unchanged First Line Anti-TNF Treatment Up to Month 18
timeFrame: Baseline up to Month 18
measure: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 18
timeFrame: Baseline, Month 18
measure: Percentage of Participants With Unchanged First Line Anti-TNF Treatment In State of Low Disease Activity
timeFrame: Month 12, 18
Secondary outcomes:
measure: Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Month 18
timeFrame: Month 18
measure: C Reactive Protein Level at Baseline
timeFrame: Baseline
measure: Erythrocyte Sedimentation Rate at Baseline
timeFrame: Baseline
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Unita Operativa Semplice di Reumatologia
state: CT
city: Bologna
country: Italy
facility: U.O.S. Reumatologia - Azienda Ospedaliera Universitaria Policlinico Sant'Orsola-Malpighi
city: Brescia
country: Italy
facility: Piazzale Spedali Civili
city: Cagliari
country: Italy
facility: Policlinico Di Cagliari, Dipartimento Di Scienze Mediche
city: Ferrara
country: Italy
facility: Arcispedale Sant'Anna
city: Firenze
country: Italy
facility: Via Torregalli, 3
city: Milano
country: Italy
facility: Ospedale Ortopedico G. Pini
city: Milano
country: Italy
facility: Fondazione San Raffaele del Monte Tabor
city: Napoli
country: Italy
facility: Policlinico Universitario, II Universita
city: Padova
country: Italy
facility: Policlinico Universitario
city: Palermo
country: Italy
facility: Divisione di Reumatologia
city: Palermo
country: Italy
facility: Policlinico Universitario P. Giaconne
city: Prato
country: Italy
facility: Azienda USL 4 di Prato
city: Roma
country: Italy
facility: Università Campus Bio-Medico di Roma- Policlinico Universitario Campus Bio-medico di Roma
city: Roma
country: Italy
facility: Policlinico Umberto I
city: Torino
country: Italy
facility: Ospedale Mauriziano Umberto I
city: Udine
country: Italy
facility: Policlinico Universitario
city: Verona
country: Italy
facility: Ospedale Borgo Trento - Clinica Reumatologica
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: