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

Last updated on November 13, 2019

FOR MORE INFORMATION
Study Location
Unita Operativa Semplice di Reumatologia
Catania, CT, 95100 Italy
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ankylosing Spondylitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

patients in other AS studies involved

NCT01856569
Pfizer
Completed
Assial - Anti Tnf Treatment in Ankylosing Spondylitis: an Observational Cohort Study in Italy

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Descriptive Information
Brief TitleAssial - Anti Tnf Treatment in Ankylosing Spondylitis: an Observational Cohort Study in Italy
Official TitleAssial - Anti Tnf Treatment In Ankylosing Spondylitis: An Observational Cohort Study In Italy
Brief SummaryObserve in real life adherence therapy and time to switch in ankylosing spondylitis patients with predominant assial involvement with 4 anti-TNF.
Detailed Descriptionretrospective and prospective 150
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Other
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study Populationankylosing spondylitis
ConditionAnkylosing Spondylitis
InterventionOther: no intervention
in real life of drug,dosage,frequency and duration
Other Name: adherence of therapy,switching,combo therapy
Study Groups/Cohortsobservational
Intervention: Other: no intervention
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: January 8, 2016)
152
Original Estimated Enrollment
 (submitted: May 14, 2013)
150
Actual Study Completion DateNovember 2015
Actual Primary Completion DateOctober 2015   (Final data collection date for primary outcome measure)
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

Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesItaly
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01856569
Other Study ID NumbersB1801362
B1801362
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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