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

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ClinicalTrials.gov Identifier: NCT01856569
Recruitment Status : Completed
First Posted : May 17, 2013
Results First Posted : March 9, 2017
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
Observe in real life adherence therapy and time to switch in ankylosing spondylitis patients with predominant assial involvement with 4 anti-TNF.

Condition or disease Intervention/treatment
Ankylosing Spondylitis Other: no intervention

Detailed Description:
retrospective and prospective 150

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Study Type : Observational
Actual Enrollment : 152 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Assial - Anti Tnf Treatment In Ankylosing Spondylitis: An Observational Cohort Study In Italy
Study Start Date : July 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
observational Other: no intervention
in real life of drug,dosage,frequency and duration
Other Name: adherence of therapy,switching,combo therapy




Primary Outcome Measures :
  1. Percentage of Participants With Unchanged First Line Anti-TNF Treatment Up to Month 18 [ Time Frame: Baseline up to Month 18 ]
    First line anti-TNF treatment included adalimumab, etanercept, golimumab and infliximab. In this outcome, percentage of participants who were taking any one of the first line anti-TNF treatment at baseline and maintained the same up to Month 18 without any change in prescription, were reported.

  2. Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 18 [ Time Frame: Baseline, Month 18 ]
    BASDAI was a validated self-assessment tool used to determine disease activity in participants with AS. Utilizing a numerical rating scale (NRS) of 0-10 (0 = no problem to 10 = worst problem) participants answered 6 questions measuring symptoms of AS (spinal pain, fatigue, joint pain or swelling, areas of localized tenderness, morning stiffness duration and severity). The BASDAI total score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score was then divided by 5. BASDAI=Q1+Q2+Q3+Q4+[Q5+Q6/2]/5. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity.

  3. Percentage of Participants With Unchanged First Line Anti-TNF Treatment In State of Low Disease Activity [ Time Frame: Month 12, 18 ]
    Low disease activity was defined as a BASDAI score of less than or equal to (<=) 2. BASDAI was a validated self-assessment tool used to determine disease activity in participants with AS. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity. In this outcome, percentage of participants with unchanged first line anti-TNF drug (nor dose neither frequency, but drug only) in the state of low disease activity, during the specified time points were reported.


Secondary Outcome Measures :
  1. Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Month 18 [ Time Frame: Month 18 ]
    ASQoL was a disease-specific questionnaire that assessed the impact of AS on participant's quality of life (QoL). It consisted of 18 questions to be completed by the participant. Each question was answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). Scores of each individual question was summed to give a total score that ranges from 0 (good QoL) to 18 (poor QoL), where lower scores indicated good quality of life. Data for this outcome was planned to be reported separately for switchers (participants who switched to a second anti-TNF drug during observation period) and non-switchers (participants who did not switched to a second anti-TNF drug during observation period).

  2. C Reactive Protein Level at Baseline [ Time Frame: Baseline ]
    C reactive protein was measured from blood samples as a marker for inflammation. Higher levels were indicative of more inflammation.

  3. Erythrocyte Sedimentation Rate at Baseline [ Time Frame: Baseline ]
    Erythrocyte sedimentation rate was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeter per hour (mm/h).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
ankylosing spondylitis
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856569


Locations
Show Show 18 study locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01856569    
Other Study ID Numbers: B1801362
B1801362
First Posted: May 17, 2013    Key Record Dates
Results First Posted: March 9, 2017
Last Update Posted: March 9, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis