Observe in real life adherence therapy and time to switch in ankylosing spondylitis patients with predominant assial involvement with 4 anti-TNF.
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
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| 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 | 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 | |||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
