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

NCT01856569

Last updated date
Study Location
Unita Operativa Semplice di Reumatologia
Catania, CT, 95100, Italy
Contact
1-800-718-1021

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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

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Advanced Information
Descriptive Information
Brief Title 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
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population ankylosing spondylitis
Condition Ankylosing Spondylitis
Intervention Other: no intervention
in real life of drug,dosage,frequency and duration
Other Name: adherence of therapy,switching,combo therapy
Study Groups/Cohorts observational
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 Status Completed
Actual Enrollment
 (submitted: January 8, 2016)
152
Original Estimated Enrollment
 (submitted: May 14, 2013)
150
Actual Study Completion Date November 2015
Actual Primary Completion Date October 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
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT01856569
Other Study ID Numbers B1801362
B1801362
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2017