Assial - Anti Tnf Treatment in Ankylosing Spondylitis: an Observational Cohort Study in Italy
NCT01856569
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retrospective:12 months at least first anti-TNF therapy prospective: at maximum 6 months observation AS patients with axial involvement
patients in other AS studies involved
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Descriptive Information | ||||
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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 | 152 | |||
Original Estimated Enrollment | 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 |
| |||
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 |
| |||
PRS Account | Pfizer | |||
Verification Date | January 2017 |