Assial - Anti Tnf Treatment in Ankylosing Spondylitis: an Observational Cohort Study in Italy
NCT01856569
Last updated date
ABOUT THIS STUDY
Observe in real life adherence therapy and time to switch in ankylosing spondylitis patients
with predominant assial involvement with 4 anti-TNF.
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
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
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 | 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 | |||