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The purpose of this study is to evaluate the use of etanercept as a replacement therapy for ciclosporin in patients with plaque psoriasis.
The purpose of this study is to evaluate the efficacy and safety of etanercept as a replacement therapy for ciclosporin in patients with moderate to severe plaque psoriasis who have achieved an adequate response with ciclosporin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etanercept | Experimental | Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin. |
|
| placebo | Placebo Comparator | Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | Etanercept 50 mg QW initiated during taper of ciclosporin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo) | PASI score: range: 0 (none) to 72 (maximum). Body was divided into head, upper extremities, trunk and lower extremities; each area score was combined for final PASI. For each section, percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: (erythema, induration, and desquamation); scale: 0 (none) to 4 (maximum). Final PASI= sum of severity parameters for each section times area score times weight of section (head: 0.1, upper extremities: 0.2, trunk: 0.3, lower extremities: 0.4). Change = PASI at Week 24 - PASI at baseline. | Randomization to Week 24. |
| Measure | Description | Time Frame |
|---|---|---|
| PASI Area Under the Curve (AUC) Between Randomization and Week 24 | PASI AUC = Area under the curve from randomization (Week 6) to Week 24. | Randomization to Week 24. |
| Change From Randomization in PGA Score to Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24682319 | Derived | Micali G, Wilsmann-Theis D, Mallbris L, Gallo G, Marino V, Brault Y, Germain JM. Etanercept reduces symptoms and severity of psoriasis after cessation of cyclosporine therapy: results of the SCORE study. Acta Derm Venereol. 2015 Jan;95(1):57-61. doi: 10.2340/00015555-1845. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin. |
| FG001 | Etanercept | Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin. |
| BG001 | Etanercept | Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin. |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | PASI Area Under the Curve (AUC) Between Randomization and Week 24 | PASI AUC = Area under the curve from randomization (Week 6) to Week 24. | ITT population: included all randomized participants. n equals number of participants with evaluable data. | Posted | Mean | Standard Error | scores on a scale * weeks | Randomization to Week 24. |
|
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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 | Placebo | Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
Not provided
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| Placebo | Other | Randomized to placebo during taper of ciclosporin |
|
PGA score is based on dermatologist's assessment of disease averaged over all lesions. Overall lesions were graded for individual scores of induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Change = PGA at Week 24 - PGA at baseline.
| Randomization to Week 24. |
| Relapse (Loss of 50% Improvement in PASI) During the 24 Weeks After Randomization | Relapse was defined as the loss of 50% improvement in PASI. | Randomization to Week 24. |
| Probability of Being Relapse Free During the 24 Weeks After Randomization | Relapse was defined as loss of 50% improvement in PASI. The time to relapse was estimated using a Kaplan-Meier analysis. | Randomization to Week 24. |
| Percent (%) Change of PASI Score From Randomization to Week 24 | Percent improvement in PASI score was calculated from Week 6 to Week 24. | Randomization to Week 24. |
| Change From Randomization in DLQI to Week 24 | DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst). | Randomization to Week 24. |
| DLQI at Each Visit From Baseline | DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10 item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst). | Baseline to Week 24. |
| Percentage of Rebound Effects | Rebound effects was defined as worsening of psoriasis to 125% of the baseline PASI or appearance of psoriasis variants such as erythrodermic or pustular psoriasis within 12 weeks of discontinuation of therapy. | Baseline to Week 24. |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Other reasons |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| PASI score | Psoriasis Area and Severity Index (PASI) score: range: 0 (none) to 72 (maximum). Body was divided into head, upper extremities, trunk and lower extremities; each area score was combined for final PASI. For each section, percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: (erythema, induration, and desquamation); scale: 0 (none) to 4 (maximum). Final PASI= sum of severity parameters for each section times area score times weight of section (head: 0.1, upper extremities: 0.2, trunk: 0.3, lower extremities: 0.4). | Mean | Standard Deviation | units on scale |
|
| PGA | Physician Global Assessment (PGA) score is based on dermatologist's assessment of disease averaged over all lesions. Overall lesions were graded for individual scores of induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. | Mean | Standard Deviation | units on scale |
|
| DLQI score | Dermatology Life Quality Index (DLQI) is the dermatology-specific quality of life measure used for psoriatic population. The 10 item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst). | Mean | Standard Deviation | units on scale |
|
|
|
|
| Secondary | Change From Randomization in PGA Score to Week 24 | PGA score is based on dermatologist's assessment of disease averaged over all lesions. Overall lesions were graded for individual scores of induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Change = PGA at Week 24 - PGA at baseline. | ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure. | Posted | Mean | 95% Confidence Interval | scores on a scale | Randomization to Week 24. |
|
|
|
|
| Secondary | Relapse (Loss of 50% Improvement in PASI) During the 24 Weeks After Randomization | Relapse was defined as the loss of 50% improvement in PASI. | ITT population: that included all randomized participants. n equals number of participants with evaluable data for this outcome measure. | Posted | Number | Percentage of participants | Randomization to Week 24. |
|
|
|
|
| Secondary | Probability of Being Relapse Free During the 24 Weeks After Randomization | Relapse was defined as loss of 50% improvement in PASI. The time to relapse was estimated using a Kaplan-Meier analysis. | ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure. | Posted | Number | probability of relapse free | Randomization to Week 24. |
|
|
|
|
| Primary | Change From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo) | PASI score: range: 0 (none) to 72 (maximum). Body was divided into head, upper extremities, trunk and lower extremities; each area score was combined for final PASI. For each section, percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: (erythema, induration, and desquamation); scale: 0 (none) to 4 (maximum). Final PASI= sum of severity parameters for each section times area score times weight of section (head: 0.1, upper extremities: 0.2, trunk: 0.3, lower extremities: 0.4). Change = PASI at Week 24 - PASI at baseline. | Intent-To-Treat (ITT) population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure. | Posted | Mean | 95% Confidence Interval | scores on a scale | Randomization to Week 24. |
|
|
|
|
| Secondary | Percent (%) Change of PASI Score From Randomization to Week 24 | Percent improvement in PASI score was calculated from Week 6 to Week 24. | ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure. | Posted | Mean | 95% Confidence Interval | percent change | Randomization to Week 24. |
|
|
|
|
| Secondary | Change From Randomization in DLQI to Week 24 | DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst). | ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure. | Posted | Mean | 95% Confidence Interval | scores on a scale | Randomization to Week 24. |
|
|
|
|
| Secondary | DLQI at Each Visit From Baseline | DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10 item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst). | ITT population: included all randomized participants. n equals number of participants with evaluable data | Posted | Mean | Standard Error | scores on a scale | Baseline to Week 24. |
|
|
|
|
| Secondary | Percentage of Rebound Effects | Rebound effects was defined as worsening of psoriasis to 125% of the baseline PASI or appearance of psoriasis variants such as erythrodermic or pustular psoriasis within 12 weeks of discontinuation of therapy. | ITT population: included all randomized participants.n equals number of participants with evaluable data for this outcome measure. | Posted | Number | percentage of participants | Baseline to Week 24. |
|
|
|
|
| 1 |
| 62 |
| 48 |
| 62 |
| EG001 | Etanercept | Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin. | 2 | 58 | 43 | 58 |
| Tonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Oedema peripheral | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Inborn error of bilirubin metabolism | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
|
| Odontogenic cyst | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Vitreous detachment | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Anal pruritus | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Diarrhoea infectious | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Dysentery | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Gingival disorder | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Gingival hyperplasia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Gingival hypertrophy | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Throat irritation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA | Non-systematic Assessment |
|
| Feeling of body temperature change | General disorders | MedDRA | Non-systematic Assessment |
|
| Hyperpyrexia | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection site anaesthesia | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA | Non-systematic Assessment |
|
| Localised oedema | General disorders | MedDRA | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
|
| Ascariasis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Asymptomatic bacteriuria | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Escherichia urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Superinfection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Tinea cruris | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood cholesterol abnormal | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood magnesium decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Sensation of heaviness | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Hyperaesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Insomnia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Sensory disturbance | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Vertigo | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Somatoform disorder | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Cystitis | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Renovascular hypertension | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Alopecia effluvium | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Folliculitis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Hair disorder | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Herpes simplex | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Hypertrichosis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Injection site dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Injection site rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
|
| Tooth repair | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Essential hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Migraine with aura | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Secondary hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Systolic hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Venous injury | Vascular disorders | MedDRA | 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.
| 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 |
| Week 12 |
|
| Week 16 |
|
| Week 20 |
|
| Week 24 |
|
| Week 6 (n= 8, 3) |
|
| Week 8 (n= 58, 55) |
|
| Week 10 (n= 56, 54) |
|
| Week 12 (n= 52, 54) |
|
| Week 16 (n= 44, 48) |
|
| Week 20 (n= 29, 44) |
|
| Week 24 (n= 20, 40) |
|
| Analysis from baseline to Week 4. | mixed model of ANCOVA | Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate. | 0.41 | P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05. | Mean Difference (Final Values) | -1.1 | Standard Error of the Mean | 1.3 | 2-Sided | 95 | -3.6 | 1.5 | No | Superiority or Other |
| Analysis from baseline to Week 6. | mixed model of ANCOVA | Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate. | 0.844 | P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05. | Mean Difference (Final Values) | -0.4 | Standard Error of the Mean | 2.2 | 2-Sided | 95 | -4.8 | 3.9 | No | Superiority or Other |
| Analysis from baseline to Week 8. | mixed model of ANCOVA | Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate. | 0.968 | P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05. | Mean Difference (Final Values) | 0.0 | Standard Error of the Mean | 0.9 | 2-Sided | 95 | -1.8 | 1.8 | No | Superiority or Other |
| Analysis from baseline to Week 10. | mixed model of ANCOVA | Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate. | 0.441 | P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05. | Mean Difference (Final Values) | 0.7 | Standard Error of the Mean | 0.9 | 2-Sided | 95 | -1.1 | 2.5 | No | Superiority or Other |
| Analysis from baseline to Week 12. | mixed model of ANCOVA | Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate. | 0.3 | P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05. | Mean Difference (Final Values) | 1.0 | Standard Error of the Mean | 0.9 | 2-Sided | 95 | -0.9 | 2.8 | No | Superiority or Other |
| Analysis from baseline to Week 16. | mixed model of ANCOVA | Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate. | 0.008 | P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05. | Mean Difference (Final Values) | 2.6 | Standard Error of the Mean | 1.0 | 2-Sided | 95 | 0.7 | 4.5 | No | Superiority or Other |
| Analysis from baseline to Week 20. | mixed model of ANCOVA | Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate. | 0.005 | P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05. | Mean Difference (Final Values) | 3.0 | Standard Error of the Mean | 1.0 | 2-Sided | 95 | 0.9 | 5.0 | No | Superiority or Other |
| Analysis from baseline to Week 24. | mixed model of ANCOVA | Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate. | 0.031 | P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05. | Mean Difference (Final Values) | 2.4 | Standard Error of the Mean | 1.1 | 2-Sided | 95 | 0.2 | 4.6 | No | Superiority or Other |