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| ID | Type | Description | Link |
|---|---|---|---|
| B1801362 |
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Observe in real life adherence therapy and time to switch in ankylosing spondylitis patients with predominant assial involvement with 4 anti-TNF.
retrospective and prospective 150
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| observational |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention | Other | in real life of drug,dosage,frequency and duration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Unchanged First Line Anti-TNF Treatment 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. | Baseline up to Month 18 |
| Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at 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. | Baseline, Month 18 |
| Percentage of Participants With Unchanged First Line Anti-TNF Treatment In State of Low Disease Activity | 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. | Month 12, 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at 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). |
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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
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ankylosing spondylitis
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unita Operativa Semplice di Reumatologia | Catania | CT | 95100 | Italy | ||
| Arcispedale Sant'Anna |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full analysis set (FAS) included all participants who met the inclusion criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Unchanged First Line Anti-TNF Treatment 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. | FAS included all participants who met the inclusion criteria. | Posted | Number | percentage of participants | Baseline up to Month 18 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
Data for change from baseline in ASQoL score was not collected as per change in planned analyses.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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| Month 18 |
| C Reactive Protein Level at Baseline | C reactive protein was measured from blood samples as a marker for inflammation. Higher levels were indicative of more inflammation. | Baseline |
| Erythrocyte Sedimentation Rate at 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). | Baseline |
| Ferrara |
| Italy |
| 44100 |
| Italy |
| U.O.S. Reumatologia - Azienda Ospedaliera Universitaria Policlinico Sant'Orsola-Malpighi | Bologna | 40138 | Italy |
| Piazzale Spedali Civili | Brescia | 125128 | Italy |
| Policlinico Di Cagliari, Dipartimento Di Scienze Mediche | Cagliari | 09100 | Italy |
| Via Torregalli, 3 | Florence | 50143 | Italy |
| Ospedale Ortopedico G. Pini | Milan | 20122 | Italy |
| Fondazione San Raffaele del Monte Tabor | Milan | 20132 | Italy |
| Policlinico Universitario, II Universita | Naples | 80131 | Italy |
| Policlinico Universitario | Padova | 35128 | Italy |
| Divisione di Reumatologia | Palermo | 90134 | Italy |
| Policlinico Universitario P. Giaconne | Palermo | 90146 | Italy |
| Azienda USL 4 di Prato | Prato | Italy |
| Università Campus Bio-Medico di Roma- Policlinico Universitario Campus Bio-medico di Roma | Roma | 00128 | Italy |
| Policlinico Umberto I | Roma | Italy |
| Ospedale Mauriziano Umberto I | Torino | 10128 | Italy |
| Policlinico Universitario | Udine | 33100 | Italy |
| Ospedale Borgo Trento - Clinica Reumatologica | Verona | 37126 | Italy |
| Did not met inclusion criteria |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at 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. | FAS included all participants who met the inclusion criteria. Here, number of participants analyzed (N) signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 18 |
|
|
|
| Primary | Percentage of Participants With Unchanged First Line Anti-TNF Treatment In State of Low Disease Activity | 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. | FAS included all participants who met the inclusion criteria. Here, "n" signifies number of participants evaluable for each time point. | Posted | Number | percentage of participants | Month 12, 18 |
|
|
|
| Secondary | Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at 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). | FAS included all participants who met the inclusion criteria. Here, "n" signifies number of participants evaluable each specified category. | Posted | Mean | Standard Deviation | units on a scale | Month 18 |
|
|
|
| Secondary | C Reactive Protein Level at Baseline | C reactive protein was measured from blood samples as a marker for inflammation. Higher levels were indicative of more inflammation. | FAS included all participants who met the inclusion criteria. Here, number of participants analyzed (N) signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | milligram per liter | Baseline |
|
|
|
| Secondary | Erythrocyte Sedimentation Rate at 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). | FAS included all participants who met the inclusion criteria. | Posted | Mean | Standard Deviation | millimeter per hour | Baseline |
|
|
|
| 0 |
| 144 |
| 28 |
| 144 |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Gastroenteritis viral | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA v19.0 | Non-systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA v19.0 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Infusion site urticaria | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Conjunctivitis viral | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Urethritis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Spinal column injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
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.
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |