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| ID | Type | Description | Link |
|---|---|---|---|
| BEFLEX |
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With the new reimbursement criteria, we want:
To describe the average treatment duration of patients with Enbrel expressed as a number of weeks/year.
To describe the number of patients who receive continuous treatment To describe the number of patients who receive intermittent treatment To describe the number of weeks off treatment
100 patients will be followed for at least 1 year
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plaque psoriasis patients | Plaque psoriasis patients treated with Enbrel after the approval of the new belgian reimbursement criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enbrel treatment | Other | Enbrel SC 50mg once weekly or 25mg twice weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Weeks of Etanercept Treatment | Average duration of time in weeks for treatment with etanercept was reported. | Baseline up to end of study (90 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Weeks of Off-Treatment | Total duration of time in weeks for which participants discontinued etanercept treatment was reported. | Baseline up to end of study (90 weeks) |
| Psoriasis Area and Severity Index (PASI) Score |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Received Continuous Treatment | Number of participants who were treated continuously with etanercept without any treatment discontinuation as per dermatologist's discretion was reported. | Baseline up to end of study (90 weeks) |
| Number of Participants Who Received Intermittent Treatment |
Inclusion Criteria:
Exclusion Criteria:
N/A
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All subjects enrolled should meet the usual prescribing criteria for Enbrel as per local reimbursement criteria and should be entered into the study at the investigator's discretion. It is requested to include patients in a consecutive manner as much as possible.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herestraat 49 | Leuven | 3000 | Belgium |
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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 who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist's discretion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist's discretion. |
| 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 | Number of Weeks of Etanercept Treatment | Average duration of time in weeks for treatment with etanercept was reported. | Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. | Posted | Mean | Standard Deviation | weeks | Baseline up to end of study (90 weeks) |
|
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Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
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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 who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist's discretion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystolithiasis | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphocytosis | Blood and lymphatic system disorders | MedDRA 15.0 | 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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Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, and legs. For each section, percent (%) area of skin involved was estimated: 0 = 0%, 1 = less than (<) 10%, 2 = 10 to <30%, 3 = 30 to <50%, 4 = 50 to <70%, 5= 70 to <90%, 6 = 90 to 100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0 = none to 4 = maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.
| Start and end of cycle 1, 2, 3 |
| Percentage of Body Surface Area (BSA) Affected by Psoriasis | Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)]. The total BSA affected was the summation of individual regions affected. | Start and end of cycle 1, 2, 3 |
| Number of Participants With Reasons for Treatmant Discontinuation | Number of participants who discontinued etanercept before completing the study was reported. | Baseline up to end of study (90 weeks) |
Number of participants who received etanercept treatment in cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation was reported. |
| Baseline up to end of study (90 weeks) |
| Lack of Efficacy |
|
| Non-compliance |
|
| Withdrawal by Subject |
|
| Participant's weight too high for dose |
|
| Worsening of psoriasis |
|
| Other |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Number of Weeks of Off-Treatment | Total duration of time in weeks for which participants discontinued etanercept treatment was reported. | Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Mean | Standard Deviation | weeks | Baseline up to end of study (90 weeks) |
|
|
|
| Secondary | Psoriasis Area and Severity Index (PASI) Score | Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, and legs. For each section, percent (%) area of skin involved was estimated: 0 = 0%, 1 = less than (<) 10%, 2 = 10 to <30%, 3 = 30 to <50%, 4 = 50 to <70%, 5= 70 to <90%, 6 = 90 to 100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0 = none to 4 = maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. | Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. 'N' (number of participants analyzed) signifies participants evaluable for this measure; 'n' signifies participants evaluable for this measure at specified time points. | Posted | Mean | Standard Deviation | units on a scale | Start and end of cycle 1, 2, 3 |
|
|
|
| Secondary | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)]. The total BSA affected was the summation of individual regions affected. | Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. 'N' (number of participants analyzed) signifies participants evaluable for this measure; 'n' signifies participants evaluable for this measure at specified time points. | Posted | Mean | Standard Deviation | percentage of BSA | Start and end of cycle 1, 2, 3 |
|
|
|
| Secondary | Number of Participants With Reasons for Treatmant Discontinuation | Number of participants who discontinued etanercept before completing the study was reported. | Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. | Posted | Number | participants | Baseline up to end of study (90 weeks) |
|
|
|
| Other Pre-specified | Number of Participants Who Received Continuous Treatment | Number of participants who were treated continuously with etanercept without any treatment discontinuation as per dermatologist's discretion was reported. | Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Number | participants | Baseline up to end of study (90 weeks) |
|
|
|
| Other Pre-specified | Number of Participants Who Received Intermittent Treatment | Number of participants who received etanercept treatment in cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation was reported. | Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Number | participants | Baseline up to end of study (90 weeks) |
|
|
|
| 7 |
| 138 |
| 28 |
| 138 |
| Obesity and surgery | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Paget's disease | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
|
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
|
| Respiratory tract infection viral | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Intervertebral disc operation | Surgical and medical procedures | MedDRA 15.0 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Functional digestive disorders, not elsewhere classified | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Leg edema | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Face edema | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Hepatic dysfunction NOS | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Allergic reaction | Immune system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Rhinopharyngitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Weight loss | Investigations | MedDRA 15.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Cluster headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Influenza | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Respiratory infection | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Keratoacanthoma | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Ankle ulcer | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Furuncle | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Plastic operation on nose | Surgical and medical procedures | MedDRA 15.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Blood pressure high | Vascular disorders | MedDRA 15.0 | 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.
| Title | Measurements |
|---|---|
|
| End of Cycle 2 (n=87) |
|
| Start of Cycle 3 (n=81) |
|
| End of Cycle 3 (n=25) |
|
| Title | Measurements |
|---|---|
|
| End of Cycle 2 (n=84) |
|
| Start of Cycle 3 (n=78) |
|
| End of Cycle 3 (n=28) |
|
| Title | Measurements |
|---|---|
|
| Non-compliance |
|
| Withdrawal by Subject |
|
| Participant's weight too high for dose |
|
| Worsening of Psoriasis |
|
| Unspecified |
|