Trial Outcomes & Findings for Assial - Anti Tnf Treatment in Ankylosing Spondylitis: an Observational Cohort Study in Italy (NCT NCT01856569)
NCT ID: NCT01856569
Last Updated: 2017-03-09
Results Overview
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.
COMPLETED
152 participants
Baseline up to Month 18
2017-03-09
Participant Flow
Participant milestones
| Measure |
Anti-Tumor Necrosis Factor (Anti-TNF)
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.
|
|---|---|
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Overall Study
STARTED
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152
|
|
Overall Study
Full Analysis Set
|
144
|
|
Overall Study
COMPLETED
|
139
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Anti-Tumor Necrosis Factor (Anti-TNF)
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.
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|---|---|
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Overall Study
Other
|
1
|
|
Overall Study
Changed Site/Structure
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Did not met inclusion criteria
|
8
|
Baseline Characteristics
Assial - Anti Tnf Treatment in Ankylosing Spondylitis: an Observational Cohort Study in Italy
Baseline characteristics by cohort
| Measure |
Anti-Tumor Necrosis Factor (Anti-TNF)
n=144 Participants
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.
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|---|---|
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Age, Continuous
|
41.85 years
STANDARD_DEVIATION 12.46 • n=5 Participants
|
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Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
91 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 18Population: FAS included all participants who met the inclusion criteria.
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.
Outcome measures
| Measure |
Anti-Tumor Necrosis Factor (Anti-TNF)
n=144 Participants
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.
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|---|---|
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Percentage of Participants With Unchanged First Line Anti-TNF Treatment Up to Month 18
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85.42 percentage of participants
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PRIMARY outcome
Timeframe: Baseline, Month 18Population: FAS included all participants who met the inclusion criteria. Here, number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Anti-Tumor Necrosis Factor (Anti-TNF)
n=113 Participants
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.
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|---|---|
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Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 18
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3.84 units on a scale
Standard Deviation 2.41
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PRIMARY outcome
Timeframe: Month 12, 18Population: FAS included all participants who met the inclusion criteria. Here, "n" signifies number of participants evaluable for each time point.
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.
Outcome measures
| Measure |
Anti-Tumor Necrosis Factor (Anti-TNF)
n=144 Participants
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.
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|---|---|
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Percentage of Participants With Unchanged First Line Anti-TNF Treatment In State of Low Disease Activity
Month 12 (n=65)
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60.19 percentage of participants
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Percentage of Participants With Unchanged First Line Anti-TNF Treatment In State of Low Disease Activity
Month 18 (n=73)
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61.86 percentage of participants
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SECONDARY outcome
Timeframe: Month 18Population: FAS included all participants who met the inclusion criteria. Here, "n" signifies number of participants evaluable each specified category.
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).
Outcome measures
| Measure |
Anti-Tumor Necrosis Factor (Anti-TNF)
n=144 Participants
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.
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|---|---|
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Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Month 18
Switchers (n= 21)
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5.4 units on a scale
Standard Deviation 4.7
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Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Month 18
Non-switchers (n= 123)
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3.0 units on a scale
Standard Deviation 4.2
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SECONDARY outcome
Timeframe: BaselinePopulation: FAS included all participants who met the inclusion criteria. Here, number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.
C reactive protein was measured from blood samples as a marker for inflammation. Higher levels were indicative of more inflammation.
Outcome measures
| Measure |
Anti-Tumor Necrosis Factor (Anti-TNF)
n=141 Participants
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.
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|---|---|
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C Reactive Protein Level at Baseline
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5.91 milligram per liter
Standard Deviation 10.53
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SECONDARY outcome
Timeframe: BaselinePopulation: FAS included all participants who met the inclusion criteria.
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).
Outcome measures
| Measure |
Anti-Tumor Necrosis Factor (Anti-TNF)
n=144 Participants
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.
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|---|---|
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Erythrocyte Sedimentation Rate at Baseline
|
25.91 millimeter per hour
Standard Deviation 19.64
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Adverse Events
Anti-Tumor Necrosis Factor (Anti-TNF)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Anti-Tumor Necrosis Factor (Anti-TNF)
n=144 participants at risk
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.
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Bronchitis
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1.4%
2/144
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.69%
1/144
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.69%
1/144
|
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Gastrointestinal disorders
Gastroenteritis viral
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1.4%
2/144
|
|
Gastrointestinal disorders
Diarrhoea
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0.69%
1/144
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
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0.69%
1/144
|
|
Gastrointestinal disorders
Abdominal pain
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0.69%
1/144
|
|
Gastrointestinal disorders
Enteritis
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0.69%
1/144
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
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0.69%
1/144
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
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0.69%
1/144
|
|
Immune system disorders
Hypersensitivity
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0.69%
1/144
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.69%
1/144
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.69%
1/144
|
|
Nervous system disorders
Migraine
|
0.69%
1/144
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.69%
1/144
|
|
General disorders
Injection site erythema
|
2.1%
3/144
|
|
General disorders
Chest pain
|
0.69%
1/144
|
|
General disorders
Infusion site urticaria
|
0.69%
1/144
|
|
Infections and infestations
Conjunctivitis viral
|
0.69%
1/144
|
|
Infections and infestations
Folliculitis
|
0.69%
1/144
|
|
Infections and infestations
Oral herpes
|
0.69%
1/144
|
|
Infections and infestations
Upper respiratory tract infection
|
0.69%
1/144
|
|
Infections and infestations
Respiratory tract infection
|
0.69%
1/144
|
|
Infections and infestations
Fungal infection
|
0.69%
1/144
|
|
Infections and infestations
Sinusitis
|
0.69%
1/144
|
|
Infections and infestations
Urethritis
|
0.69%
1/144
|
|
Infections and infestations
Urinary tract infection
|
0.69%
1/144
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.69%
1/144
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.4%
2/144
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.69%
1/144
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.69%
1/144
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.69%
1/144
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER