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| ID | Type | Description | Link |
|---|---|---|---|
| B1801100 |
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The objective of this observational study is to determine the incidence of response in patients with predictive factors of major clinical response in active ankylosing spondylitis (AS) in patients who start anti-tumor necrosis factor (anti-TNF) therapy and correlate these findings in patients who switch from one to another anti-TNF due to inefficacy under usual clinical practice conditions in Spain.
A sample size of 240 patients, 120 of them exposed and 120 not exposed to factors of response. Sample will be obtain from all the consecutive patients attending the rheumatology settings included in the study who fulfill the inclusion criteria
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Patients diagnosed with active AS who start anti-TNF therapy according to standard clinical practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment switching | Other | If the patients do not response to first AntiTNF treatment, Investigator can switch to another anti TNF.Spanish Guidelines will be provided to the investigators, which recommend stopping biologics if there is an inadequate response after 16w of therapy and switch to another biologic. Responsive patients to the first anti-TNF who continue with this first anti-TNF adjusting dose treatment according to the Spanish guidelines or investigator criteria. The doses for each Anti TNF will be done following specific SmPc and under Investiagtor criteria |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Clinical Response | Assessment of clinical response was as per investigator's discretion. Investigators were provided with the final consensus document of the Spanish Society for Rheumatology (SER) for the biological treatment of spondyloarthropathies as a guide for defining active AS, the indication of treatment with biological therapy and the assessment of response to it. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With High Probability of Response and no Response Who Received Second Anti-TNF Treatment | High probability of response=participants who met at least 3 of 5 criteria at start of treatment:C-reactive Protein (CRP) >15 mg/Liter (mg/L);time from onset of disease <10 years;total spinal pain >30 millimeter (mm), mean score on 100 mm visual numeric scale (VNS) for nocturnal, total spinal pain;Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >4 centimeter (cm), mean score on 10 cm VNS for discomfort, pain, fatigue;Bath Ankylosing Spondylitis Functional index (BASFI) <4.5 cm, mean score on 10 cm VNS evaluating functional capacity. Assessment of response was per investigator. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with active ankylosing spondylitis treated in rheumatology units
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Madrid | Madrid | 28006 | Spain |
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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 Agents | Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study and if no response was observed, treatment was changed as per investigator's discretion in Phase 2 of the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 |
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| Between Phase 1 and Phase 2 |
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| Phase 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Anti-tumor Necrosis Factor Agents (Evaluable Population) | Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-TNF agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week, in Phase 1 of the study and who were eligible for the analysis. |
| Units | Counts |
|---|---|
| Participants |
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| 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 a Clinical Response | Assessment of clinical response was as per investigator's discretion. Investigators were provided with the final consensus document of the Spanish Society for Rheumatology (SER) for the biological treatment of spondyloarthropathies as a guide for defining active AS, the indication of treatment with biological therapy and the assessment of response to it. | Analysis population included all participants enrolled in the study who gave their consent, satisfied all evaluation criteria and had information available at Week 16 after starting the first anti-TNF treatment (Phase 1). | Posted | Number | 95% Confidence Interval | percentage of participants | Week 16 |
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 Agents | Participants with active AS who were prescribed with an anti-TNF agent, either etanercept 50 mg once weekly or 25 mg twice weekly s.c. or infliximab infusion 5 mg/kg body weight IV at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study and if no response was observed, treatment was changed as per investigator's discretion in Phase 2 of the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tonsillar neoplasm | General disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | General disorders | MedDRA | Non-systematic Assessment |
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| 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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| ID | Term |
|---|---|
| D000085582 | Treatment Switching |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Week 32 |
| Percentage of Participants With Low Probability of Response and no Response Who Received Second Anti-TNF Treatment | Low probability of response = participants who met no more than 2 of 5 criteria at time of treatment start: CRP > 15 mg/L; time from onset of disease less than < 10 years; total spinal pain > 30 mm, measured as mean score on 100 mm VNS (higher score=more severe pain) for nocturnal and total spinal pain; BASDAI > 4 cm, measured as mean score on 10 cm VNS (higher score=more severe state) for discomfort, pain and fatigue; BASFI < 4.5 cm; measured as mean score on 10 cm VNS (higher score=less functionality) evaluating functional capacity. Assessment of response was as per investigator's criteria. | Week 32 |
| Percentage of Participants With Low Probability of Response and a Clinical Response at Week 16 | Low probability of response = participants who met no more than 2 of 5 criteria at time of treatment start: CRP > 15 mg/L; time from onset of disease less than < 10 years; total spinal pain > 30 mm, measured as mean score on 100 mm VNS (higher score=more severe pain) for nocturnal and total spinal pain; BASDAI > 4 cm, measured as mean score on 10 cm VNS (higher score=more severe state) for discomfort, pain and fatigue; BASFI < 4.5 cm; measured as mean score on 10 cm VNS (higher score=less functionality) evaluating functional capacity. Assessment of response was as per investigator's criteria. | Week 16 |
| Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16 | ASAS measures symptomatic improvement in ankylosing spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40 percent (%) improvement from baseline and an absolute change of greater than or equal to (>=) 2 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for >= 3 domains, and no worsening in remaining domain. | Week 16 |
| Percentage of Participants Who Switched to Another Anti-TNF Treatment Due to Lack of Efficacy | Week 16 |
| Percentage of Participants With ASAS 40 Response Who Started Second Anti-TNF Treatment and Were Treated for at Least 16 Weeks | ASAS measures symptomatic improvement in ankylosing spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change of greater than or equal to (>=) 2 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for >= 3 domains, and no worsening in remaining domain. | Week 32 |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Percentage of Participants With High Probability of Response and no Response Who Received Second Anti-TNF Treatment | High probability of response=participants who met at least 3 of 5 criteria at start of treatment:C-reactive Protein (CRP) >15 mg/Liter (mg/L);time from onset of disease <10 years;total spinal pain >30 millimeter (mm), mean score on 100 mm visual numeric scale (VNS) for nocturnal, total spinal pain;Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >4 centimeter (cm), mean score on 10 cm VNS for discomfort, pain, fatigue;Bath Ankylosing Spondylitis Functional index (BASFI) <4.5 cm, mean score on 10 cm VNS evaluating functional capacity. Assessment of response was per investigator. | Analysis population included all participants with an inadequate response, 16 weeks after starting the first anti-TNF treatment as determined by the investigator and who received second anti-TNF treatment for at least 16 weeks (Phase 2). | Posted | Number | 95% Confidence Interval | percentage of participants | Week 32 |
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|
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| Secondary | Percentage of Participants With Low Probability of Response and no Response Who Received Second Anti-TNF Treatment | Low probability of response = participants who met no more than 2 of 5 criteria at time of treatment start: CRP > 15 mg/L; time from onset of disease less than < 10 years; total spinal pain > 30 mm, measured as mean score on 100 mm VNS (higher score=more severe pain) for nocturnal and total spinal pain; BASDAI > 4 cm, measured as mean score on 10 cm VNS (higher score=more severe state) for discomfort, pain and fatigue; BASFI < 4.5 cm; measured as mean score on 10 cm VNS (higher score=less functionality) evaluating functional capacity. Assessment of response was as per investigator's criteria. | Data was not analyzed as no participant met the criteria for low probability of response in phase 2 of the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 32 |
|
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| Secondary | Percentage of Participants With Low Probability of Response and a Clinical Response at Week 16 | Low probability of response = participants who met no more than 2 of 5 criteria at time of treatment start: CRP > 15 mg/L; time from onset of disease less than < 10 years; total spinal pain > 30 mm, measured as mean score on 100 mm VNS (higher score=more severe pain) for nocturnal and total spinal pain; BASDAI > 4 cm, measured as mean score on 10 cm VNS (higher score=more severe state) for discomfort, pain and fatigue; BASFI < 4.5 cm; measured as mean score on 10 cm VNS (higher score=less functionality) evaluating functional capacity. Assessment of response was as per investigator's criteria. | Analysis population included all participants enrolled in study who gave their consent, satisfied all evaluation criteria and had information available at Week 16 after starting first anti-TNF treatment (Phase 1). N (number of participants analyzed) signifies those participants who had low probability of response and were evaluable for the measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 16 |
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|
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| Secondary | Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16 | ASAS measures symptomatic improvement in ankylosing spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40 percent (%) improvement from baseline and an absolute change of greater than or equal to (>=) 2 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for >= 3 domains, and no worsening in remaining domain. | Analysis population included all participants enrolled in the study who gave their consent, satisfied all evaluation criteria and had information available at Week 16 after starting the first anti-TNF treatment (Phase 1). | Posted | Number | 95% Confidence Interval | percentage of participants | Week 16 |
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|
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| Secondary | Percentage of Participants Who Switched to Another Anti-TNF Treatment Due to Lack of Efficacy | Analysis population included all participants enrolled in the study who gave their consent, satisfied all evaluation criteria and had information available at Week 16 after starting the first anti-TNF treatment (Phase 1). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 16 |
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|
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| Secondary | Percentage of Participants With ASAS 40 Response Who Started Second Anti-TNF Treatment and Were Treated for at Least 16 Weeks | ASAS measures symptomatic improvement in ankylosing spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change of greater than or equal to (>=) 2 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for >= 3 domains, and no worsening in remaining domain. | Analysis population included all participants with an inadequate response, 16 weeks after starting the first anti-TNF treatment as determined by ASAS 40 and who received second anti-TNF treatment for at least 16 weeks (Phase 2). | Posted | Number | percentage of participants | Week 32 |
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| 1 |
| 132 |
| 9 |
| 132 |
| Injection site reaction | General disorders | MedDRA | Non-systematic Assessment |
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| Gastroenteritis viral | General disorders | MedDRA | Non-systematic Assessment |
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| Diarrhoea and vomiting | General disorders | MedDRA | Non-systematic Assessment |
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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 |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |