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| ID | Type | Description | Link |
|---|---|---|---|
| B1801095 |
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This observational study will be a documentation of the prescribing and administration practices of Enbrel® and their impact on ankylosing spondylitis patients outcome in a real life setting.
The study population will be described using standard descriptive statistics for demographic, clinical, medical, characteristics, as well as for standard health-related quality of life and functional disability questionnaires .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group Enbrel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enbrel | Drug | The patients will be treated in accordance with the requirements of the labeling of Enbrel® in Austria. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment. To record complete dosing information, initial dose will be documented at baseline and any change will be documented with date, dose and reason at the subsequent visits. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving BASDAI 40 Response at Week 24 | BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10. Participants who achieved a decrease of 40 percent or more from baseline to the following visits are called as responders. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in BASDAI at Week 12 and 24 | BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10. |
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Inclusion Criteria:
Exclusion Criteria:
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The patient cohort in this non-interventional study will reflect the kind of patients seen in routine clinical practice and will not be specifically pre-selected as it is the case in clinical studies.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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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 | Etanercept | Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits. |
| 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 Achieving BASDAI 40 Response at Week 24 | BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10. Participants who achieved a decrease of 40 percent or more from baseline to the following visits are called as responders. | Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point | Posted | Number | Percentage of participants | Week 24 |
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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 | Etanercept | Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site hypersensitivity | General disorders | MedDRA 13.1 | 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 |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| Baseline, Week 12 and Week 24 |
| Change From Baseline in the BASFI at Weeks 12 and 24 | BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions. | Baseline, Week 12 and Week 24 |
| Participant's Global Assessment Visual Analog Scale at Weeks 12 and 24 | Measured using a 100mm VAS ranging from 0=very good to 100=very bad. | Week 12 and Week 24 |
| Physician's Global Assessment Visual Analog Scale at Weeks 12 and 24 | Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm= no disease activity. | Week 12 and Week 24 |
| Mean Duration of Morning Stiffness | Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes (24h x 60 minutes) was recorded). | Week 12 and Week 24 |
| Change From Baseline in ASQoL at Week 12 and Week 24 | ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL). | Baseline, Week 12 and Week 24 |
| Percentage of Participants Without Enthesitis | Week 12 and Week 24 |
| Percentage of Participants Without Peripheral Arthritis | Week 12 and Week 24 |
| Mean Occiput-to-wall Distance at Week 12 and Week 24 | Week 12 and Week 24 |
| Spine Agility Function by Schober Test | Schober test determines agility of lumbar spine. It measures participant's ability to flex the lower back. Examiner makes a mark at fifth lumbar vertebra (L5); places 1 finger 5 cm below and another 10 cm above the mark. Participant is asked to touch the toes. Examiner measures the increase in distance between 2 fingers. | Week 12 and Week 24 |
| Spine Agility Function by Ott Test | The Ott index determines the agility of the thoracic spine. | Week 12 and Week 24 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at baseline | BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. Number of participants analyzed for BASDAI (n)= 84 | Mean | Standard Deviation | units on a scale |
|
| Bath Ankylosing Spondylitis Functional Index (BASFI) at baseline | BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 =impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. Number of participants analyzed for BASFI (n)= 83 | Mean | Standard Deviation | Units on a scale |
|
| Participant's Global Assessment Visual Analog Scale at baseline | Measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad. Number of participants analyzed for Participant's Global Assessment VAS (n)= 84 | Mean | Standard Deviation | Units on a scale |
|
| Physician's Global Assessment Visual Analog Scale at baseline | Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity. | Mean | Standard Deviation | mm |
|
| Duration of morning stiffness at baseline | Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes. Number of participants analyzed for morning stiffness (n)= 80 | Mean | Standard Deviation | minutes |
|
| Ankylosing Spondylitis Quality of Life Scale (ASQoL) at baseline | ASQoL is a questionnaire consisting of 18 statements, related to mobility, self-care, usual activities, pain/discomfort and anxiety/depression, relevant to the physical and mental conditions of the participant with AS, to assess disease-specific quality of life. Score range: 0 (good)-18 (poor). Number of participants analyzed for ASQoL (n)= 77 | Mean | Standard Deviation | Units on a scale |
|
| Percentage of Participants Without Enthesitis | Number of participants analyzed for Enthesitis (n)= 87 | Number | Percentage of Participants |
|
| Percentage of Participants Without Peripheral Arthritis | Number of participants analyzed for Peripheral Arthritis (n)= 87 | Number | Percentage of Participants |
|
| Occiput-to-wall distance | Number of participants analyzed for occiput-to-wall distance (n)= 67 | Mean | Standard Deviation | centimeter (cm) |
|
| Spine agility function by Schober test | Schober test determines agility of lumbar spine. It measures participant's ability to flex lower back. Examiner makes mark at fifth lumbar vertebra (L5); places 1 finger 5 cm below and another 10 cm above the mark. Participant is asked to touch toes. Examiner measures increase in distance between 2 fingers. Number of participants analyzed (n)= 58. | Mean | Standard Deviation | cm |
|
| Spine agility function by Ott test | The Ott index determines the agility of the thoracic spine. Number of participants analyzed for Ott test (n)= 48 | Mean | Standard Deviation | cm |
|
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| Secondary | Change From Baseline in BASDAI at Week 12 and 24 | BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10. | Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 and Week 24 |
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|
| Secondary | Change From Baseline in the BASFI at Weeks 12 and 24 | BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions. | Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 12 and Week 24 |
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| Secondary | Participant's Global Assessment Visual Analog Scale at Weeks 12 and 24 | Measured using a 100mm VAS ranging from 0=very good to 100=very bad. | Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point. | Posted | Mean | Standard Deviation | Units on a scale | Week 12 and Week 24 |
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| Secondary | Physician's Global Assessment Visual Analog Scale at Weeks 12 and 24 | Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm= no disease activity. | Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point. | Posted | Mean | Standard Deviation | mm | Week 12 and Week 24 |
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| Secondary | Mean Duration of Morning Stiffness | Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes (24h x 60 minutes) was recorded). | Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point. | Posted | Mean | Standard Deviation | minutes | Week 12 and Week 24 |
|
|
|
| Secondary | Change From Baseline in ASQoL at Week 12 and Week 24 | ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL). | Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 12 and Week 24 |
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| Secondary | Percentage of Participants Without Enthesitis | Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point. | Posted | Number | Percentage of Participants | Week 12 and Week 24 |
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| Secondary | Percentage of Participants Without Peripheral Arthritis | Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point. | Posted | Number | Percentage of Participants | Week 12 and Week 24 |
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| Secondary | Mean Occiput-to-wall Distance at Week 12 and Week 24 | Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point | Posted | Mean | Standard Deviation | cm | Week 12 and Week 24 |
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| Secondary | Spine Agility Function by Schober Test | Schober test determines agility of lumbar spine. It measures participant's ability to flex the lower back. Examiner makes a mark at fifth lumbar vertebra (L5); places 1 finger 5 cm below and another 10 cm above the mark. Participant is asked to touch the toes. Examiner measures the increase in distance between 2 fingers. | Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point | Posted | Mean | Standard Deviation | cm | Week 12 and Week 24 |
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| Secondary | Spine Agility Function by Ott Test | The Ott index determines the agility of the thoracic spine. | Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point | Posted | Mean | Standard Deviation | cm | Week 12 and Week 24 |
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|
| 0 |
| 89 |
| 3 |
| 89 |
| Injection site erythema | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA 13.1 | 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 |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |