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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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Other
Condition Ankylosing Spondylitis
Intervention Other: no intervention
Enrollment 152

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Anti-Tumor Necrosis Factor (Anti-TNF)
Hide Arm/Group Description Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
Period Title: Overall Study
Started 152
Full Analysis Set 144
Completed 139
Not Completed 13
Reason Not Completed
Other             1
Changed Site/Structure             1
Lost to Follow-up             3
Did not met inclusion criteria             8
Arm/Group Title Anti-Tumor Necrosis Factor (Anti-TNF)
Hide Arm/Group Description Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
Overall Number of Baseline Participants 144
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all participants who met the inclusion criteria.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 144 participants
41.85  (12.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 144 participants
Female
53
  36.8%
Male
91
  63.2%
1.Primary Outcome
Title Percentage of Participants With Unchanged First Line Anti-TNF Treatment Up to Month 18
Hide Description 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.
Time Frame Baseline up to Month 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who met the inclusion criteria.
Arm/Group Title Anti-Tumor Necrosis Factor (Anti-TNF)
Hide Arm/Group Description:
Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
Overall Number of Participants Analyzed 144
Measure Type: Number
Unit of Measure: percentage of participants
85.42
2.Primary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 18
Hide Description 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.
Time Frame Baseline, Month 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who met the inclusion criteria. Here, number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.
Arm/Group Title Anti-Tumor Necrosis Factor (Anti-TNF)
Hide Arm/Group Description:
Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
Overall Number of Participants Analyzed 113
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.84  (2.41)
3.Primary Outcome
Title Percentage of Participants With Unchanged First Line Anti-TNF Treatment In State of Low Disease Activity
Hide Description 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.
Time Frame Month 12, 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who met the inclusion criteria. Here, "n" signifies number of participants evaluable for each time point.
Arm/Group Title Anti-Tumor Necrosis Factor (Anti-TNF)
Hide Arm/Group Description:
Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
Overall Number of Participants Analyzed 144
Measure Type: Number
Unit of Measure: percentage of participants
Month 12 (n=65) 60.19
Month 18 (n=73) 61.86
4.Secondary Outcome
Title Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Month 18
Hide Description 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).
Time Frame Month 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who met the inclusion criteria. Here, "n" signifies number of participants evaluable each specified category.
Arm/Group Title Anti-Tumor Necrosis Factor (Anti-TNF)
Hide Arm/Group Description:
Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
Overall Number of Participants Analyzed 144
Mean (Standard Deviation)
Unit of Measure: units on a scale
Switchers (n= 21) 5.4  (4.7)
Non-switchers (n= 123) 3.0  (4.2)
5.Secondary Outcome
Title C Reactive Protein Level at Baseline
Hide Description C reactive protein was measured from blood samples as a marker for inflammation. Higher levels were indicative of more inflammation.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who met the inclusion criteria. Here, number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.
Arm/Group Title Anti-Tumor Necrosis Factor (Anti-TNF)
Hide Arm/Group Description:
Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
Overall Number of Participants Analyzed 141
Mean (Standard Deviation)
Unit of Measure: milligram per liter
5.91  (10.53)
6.Secondary Outcome
Title Erythrocyte Sedimentation Rate at Baseline
Hide Description 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).
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who met the inclusion criteria.
Arm/Group Title Anti-Tumor Necrosis Factor (Anti-TNF)
Hide Arm/Group Description:
Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
Overall Number of Participants Analyzed 144
Mean (Standard Deviation)
Unit of Measure: millimeter per hour
25.91  (19.64)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Anti-Tumor Necrosis Factor (Anti-TNF)
Hide Arm/Group Description Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
All-Cause Mortality
Anti-Tumor Necrosis Factor (Anti-TNF)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Anti-Tumor Necrosis Factor (Anti-TNF)
Affected / at Risk (%)
Total   0/144 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Anti-Tumor Necrosis Factor (Anti-TNF)
Affected / at Risk (%)
Total   28/144 (19.44%) 
Gastrointestinal disorders   
Gastroenteritis viral * 1  2/144 (1.39%) 
Diarrhoea * 1  1/144 (0.69%) 
Diarrhoea haemorrhagic * 1  1/144 (0.69%) 
Abdominal pain * 1  1/144 (0.69%) 
Enteritis * 1  1/144 (0.69%) 
General disorders   
Injection site erythema * 1  3/144 (2.08%) 
Chest pain * 1  1/144 (0.69%) 
Infusion site urticaria * 1  1/144 (0.69%) 
Hepatobiliary disorders   
Hypertransaminasaemia * 1  1/144 (0.69%) 
Immune system disorders   
Hypersensitivity * 1  1/144 (0.69%) 
Infections and infestations   
Conjunctivitis viral * 1  1/144 (0.69%) 
Folliculitis * 1  1/144 (0.69%) 
Oral herpes * 1  1/144 (0.69%) 
Upper respiratory tract infection * 1  1/144 (0.69%) 
Respiratory tract infection * 1  1/144 (0.69%) 
Fungal infection * 1  1/144 (0.69%) 
Sinusitis * 1  1/144 (0.69%) 
Urethritis * 1  1/144 (0.69%) 
Urinary tract infection * 1  1/144 (0.69%) 
Injury, poisoning and procedural complications   
Spinal column injury * 1  1/144 (0.69%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/144 (0.69%) 
Arthritis * 1  1/144 (0.69%) 
Nervous system disorders   
Migraine * 1  1/144 (0.69%) 
Cervicobrachial syndrome * 1  1/144 (0.69%) 
Pregnancy, puerperium and perinatal conditions   
Abortion spontaneous * 1  1/144 (0.69%) 
Pregnancy * 1  1/144 (0.69%) 
Respiratory, thoracic and mediastinal disorders   
Bronchitis * 1  2/144 (1.39%) 
Sleep apnoea syndrome * 1  1/144 (0.69%) 
Cough * 1  1/144 (0.69%) 
Skin and subcutaneous tissue disorders   
Urticaria * 1  2/144 (1.39%) 
Skin lesion * 1  1/144 (0.69%) 
Pustular psoriasis * 1  1/144 (0.69%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v19.0
Data for change from baseline in ASQoL score was not collected as per change in planned analyses.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01856569     History of Changes
Other Study ID Numbers: B1801362
B1801362
First Submitted: May 14, 2013
First Posted: May 17, 2013
Results First Submitted: January 19, 2017
Results First Posted: March 9, 2017
Last Update Posted: March 9, 2017