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The objective of this investigation is to identify the following problems and questions with respect to the safety and efficacy of Enbrel during the post-marketing period as required by Korea Food and Drug Administration (KFDA)'s regulation.
This investigation spanned 3 different studies, 0881A-101575 (alias B1801105) NCT00195403, 0881A-102018 (alias B1801112) NCT00195416 and 0881A-102212 (alias B1801113). All studies have been combined into this record.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | Etanercept 25mg Injection, 2 times/week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious AE (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Unexpected AEs were reported as yes or no at the investigator's determination based on current country product label. | Baseline up to Day 832 |
| Change From Baseline in Physician Global Assessment (PGA) of Disease Status at Month 3 | PGA of disease activity was measured on a 0 to 10 centimeter (cm) Visual Analog Scale (VAS), with 0 cm = no disease activity and 10 cm = worst disease activity possible. | Baseline, Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Number of Joints With Tenderness, Pain, Limitation of Motion or Swelling at Month 3 and 9 | Assessment of 68 joints: joints classified as either tender or not tender, pain or no pain, with limitation of motion or no limitation of motion, swollen or not swollen. An increase from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. |
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Inclusion Criteria
Rheumatoid Arthritis
Psoriatic Arthritis
- Active and progressive psoriatic arthritis (PsA) in adults who do not respond adequately to previous DMARDs
Exclusion Criteria
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Primary care clinic, secondary and tertiary medical centers
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyunggi-do | 463-712 | South Korea | ||||
Total of 1016 case report forms were retrieved, of these 2 were double registered. Out of 1014 participants, 16 were enrolled prior to the agreement date of the study and therefore excluded from the safety analysis population (998). Three participants had missing efficacy assessments (efficacy population = 995).
Results for three unique protocols 0881A-101575 (NCT00195403), 0881A-102018 (NCT00195416), and 0881A-102212 (protocol not registered) were summarized in a single clinical study report.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept | Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety population included all participants who received at least (>=) 1 dose of study medication and had the safety assessment through appropriate follow-up.
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly. |
| 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 Participants With Adverse Events (AEs) | Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious AE (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Unexpected AEs were reported as yes or no at the investigator's determination based on current country product label. | Safety population included all participants who received >= 1 dose of study medication and had the safety assessment through appropriate follow-up. | Posted | Number | participants | Baseline up to Day 832 |
|
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All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
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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 rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | WHO-ART | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Itching | Skin and subcutaneous tissue disorders | WHO-ART | 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 |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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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, Month 3, 9 |
| Seoul |
| 120-752 |
| South Korea |
| Seoul | 133-792 | South Korea |
| Seoul | 137-807 | South Korea |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Primary diagnosis | Number | participants |
|
|
|
| Primary | Change From Baseline in Physician Global Assessment (PGA) of Disease Status at Month 3 | PGA of disease activity was measured on a 0 to 10 centimeter (cm) Visual Analog Scale (VAS), with 0 cm = no disease activity and 10 cm = worst disease activity possible. | Efficacy population included all participants who received >=1 dose of study medication and had the efficacy assessment within 14 days after the final administration. | Posted | Mean | Standard Deviation | cm | Baseline, Month 3 |
|
|
|
|
| Secondary | Change From Baseline in Number of Joints With Tenderness, Pain, Limitation of Motion or Swelling at Month 3 and 9 | Assessment of 68 joints: joints classified as either tender or not tender, pain or no pain, with limitation of motion or no limitation of motion, swollen or not swollen. An increase from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. | Efficacy population included all participants who received >=1 dose of study medication and had the efficacy assessment within 14 days after the final administration. 'N' (number of participants analyzed) = participants who were evaluable for this measure. Data for Month 9 was not analyzed because there were not enough participants for analysis. | Posted | Mean | Standard Deviation | joints | Baseline, Month 3, 9 |
|
|
|
|
| 3 |
| 998 |
| 142 |
| 998 |
| Gastroenteritis | Gastrointestinal disorders | WHO-ART | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | WHO-ART | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | WHO-ART | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | WHO-ART | Non-systematic Assessment |
|
| Macular rash | Skin and subcutaneous tissue disorders | WHO-ART | Non-systematic Assessment |
|
| Verruca vulgatis | Skin and subcutaneous tissue disorders | WHO-ART | Non-systematic Assessment |
|
| Folliculitis | Skin and subcutaneous tissue disorders | WHO-ART | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | WHO-ART | Non-systematic Assessment |
|
| Burn | Skin and subcutaneous tissue disorders | WHO-ART | Non-systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | WHO-ART | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | WHO-ART | Non-systematic Assessment |
|
| Sputum increased | Respiratory, thoracic and mediastinal disorders | WHO-ART | Non-systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | WHO-ART | Non-systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | WHO-ART | Non-systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | WHO-ART | Non-systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | WHO-ART | Non-systematic Assessment |
|
| Rhinitis | Respiratory, thoracic and mediastinal disorders | WHO-ART | Non-systematic Assessment |
|
| Injection site itching | General disorders | WHO-ART | Non-systematic Assessment |
|
| Injection site erythema | General disorders | WHO-ART | Non-systematic Assessment |
|
| Injection site reaction | General disorders | WHO-ART | Non-systematic Assessment |
|
| Injection site edema | General disorders | WHO-ART | Non-systematic Assessment |
|
| Injection site pain | General disorders | WHO-ART | Non-systematic Assessment |
|
| Cellulitis | General disorders | WHO-ART | Non-systematic Assessment |
|
| Injection site burning sensation | General disorders | WHO-ART | Non-systematic Assessment |
|
| Headache | General disorders | WHO-ART | Non-systematic Assessment |
|
| Edema | General disorders | WHO-ART | Non-systematic Assessment |
|
| Facial flushing | General disorders | WHO-ART | Non-systematic Assessment |
|
| Fever | General disorders | WHO-ART | Non-systematic Assessment |
|
| Chest pain | General disorders | WHO-ART | Non-systematic Assessment |
|
| Facial edema | General disorders | WHO-ART | Non-systematic Assessment |
|
| Asthenia | General disorders | WHO-ART | Non-systematic Assessment |
|
| Chills | General disorders | WHO-ART | Non-systematic Assessment |
|
| Fatigue | General disorders | WHO-ART | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | WHO-ART | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | WHO-ART | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | WHO-ART | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | WHO-ART | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | WHO-ART | Non-systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | WHO-ART | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | WHO-ART | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | WHO-ART | Non-systematic Assessment |
|
| Increased Serum Glutamic Pyruvate Transaminase | Hepatobiliary disorders | WHO-ART | Non-systematic Assessment |
|
| Increased Serum Glutamic-oxaloacetic Transminase | Hepatobiliary disorders | WHO-ART | Non-systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | WHO-ART | Non-systematic Assessment |
|
| Infection | Infections and infestations | WHO-ART | Non-systematic Assessment |
|
| Infection, aggravated | Infections and infestations | WHO-ART | Non-systematic Assessment |
|
| Tuberculosis, bones and joints | Infections and infestations | WHO-ART | Non-systematic Assessment |
|
| Abscess, pulmonary | Infections and infestations | WHO-ART | Non-systematic Assessment |
|
| Ear discharge | Infections and infestations | WHO-ART | Non-systematic Assessment |
|
| Shock, septic | Infections and infestations | WHO-ART | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | WHO-ART | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | WHO-ART | Non-systematic Assessment |
|
| Back pain aggravated | Musculoskeletal and connective tissue disorders | WHO-ART | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | WHO-ART | Non-systematic Assessment |
|
| Thirst | Metabolism and nutrition disorders | WHO-ART | Non-systematic Assessment |
|
| Weight decrease | Metabolism and nutrition disorders | WHO-ART | Non-systematic Assessment |
|
| Weight increase | Metabolism and nutrition disorders | WHO-ART | Non-systematic Assessment |
|
| Auto-antibody response | General disorders | WHO-ART | Non-systematic Assessment |
|
| Uveitis | Eye disorders | WHO-ART | Non-systematic Assessment |
|
| Xerophthalmia | Eye disorders | WHO-ART | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | WHO-ART | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | WHO-ART | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | WHO-ART | Non-systematic Assessment |
|
| Blood pressure high | General disorders | WHO-ART | Non-systematic Assessment |
|
| Lymph nodes enlarged | Blood and lymphatic system disorders | WHO-ART | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | WHO-ART | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | WHO-ART | Non-systematic Assessment |
|
| Azotemia | Renal and urinary disorders | WHO-ART | Non-systematic Assessment |
|
| Palpitation | General disorders | WHO-ART | 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.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| 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 |