Not provided
Not provided
Not provided
Not provided
Not provided
See termination reason in detailed description.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label, multicenter and observational study in China, which is designed to record the data of RA & AS patients within 52 weeks after rheumatologists decided to prescribe etanercept, and evaluate the safety and efficacy of the treatment. All eligible subjects agreed to be recruited in the study and can withdraw anytime if they choose so.
Patients with RA or AS are typically managed by rheumatologists. As this study seeks to record the data of RA & AS patient in etanercept and evaluate the safety and efficacy of the treatment, patients will be recruited from Rheumatic department. Rheumatologist will be asked to build up the database for RA & AS patient surveillance prospectively in outpatient dept, which benefits for the patient treatment outcomes evaluation and clinical management.
The primary objective of this non-interventional study is to evaluate the safety of etanercept in Chinese RA and AS subjects. Total of 600 subjects (300 RA subjects and 300 AS subjects) will be enrolled in the study. If the true rate of an adverse event is no less than 0.5%, with sample size of 600 subjects, this study will have 95% probability to detect at least one occurrence of the adverse event. The study prematurely discontinued on January 15, 2013 due to slow enrollment and low adherence of etanercept. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RA, AS | Rheumatoid arthritis patients Ankylosing spondylitis patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enbrel | Drug | 25mg biweekly or 50mg per week, subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had Any Adverse Events (AEs) During 24 Weeks | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | First day of receiving etanercept through 24 weeks |
| Number of Participants Who Had Any AEs During 52 Weeks | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | First day of receiving etanercept through 52 weeks |
| Number of Participants Who Had Any Serious Adverse Events (SAEs) During 24 Weeks | An SAE was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Informed consent or signed data privacy statement through 24 weeks |
| Number of Participants Who Had Any SAEs During 52 Weeks | An SAE was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Informed consent or signed data privacy statement through 52 weeks |
| Number of Participants With AEs Per System Organ Class During 24 Weeks | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with multiple AEs within a category (system organ class) were counted once within the category. |
| Measure | Description | Time Frame |
|---|---|---|
| Physician's Global Assessment of Disease Activity | Physicians indicated on a 0-100 millimeters (mm) visual analogue scale (VAS) to assess the activity of the participant's disease according to the participant's clinical condition, with 0 meaning no disease activity (disease inactive) and 100 meaning extreme disease activity (disease extremely active). | Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
outpatient RA and AS patients in China
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daping Hospital | Chongqing | Chongqing Municipality | 400038 | China | ||
| Fujian Provincial Hospital |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Rheumatoid Arthritis [RA] | Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks |
| FG001 | Ankylosing Spondylitis [AS] | Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline participants were all enrolled participants who received at least 1 dose of etanercept.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rheumatoid Arthritis [RA] | Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks |
| BG001 | Ankylosing Spondylitis [AS] |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 Who Had Any Adverse Events (AEs) During 24 Weeks | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | All enrolled participants who received at least 1 dose of etanercept. | Posted | Number | Participants | First day of receiving etanercept through 24 weeks |
|
First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement.
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rheumatoid Arthritis [RA] | Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uveitis | Eye disorders | MedDRA 16.0 | 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 |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic 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
Not provided
Not provided
Not provided
Not provided
| First day of receiving etanercept through 24 weeks |
| Number of Participants With AEs Per System Organ Class During 52 Weeks | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with multiple AEs within a category (system organ class) were counted once within the category. | First day of receiving etanercept through 52 weeks |
| Participant's Global Assessment (PtGA) of Disease Activity | Participants placed a vertical line on a 0-100 mm VAS to indicate the magnitude of their global disease activity, with 0 meaning no disease activity (disease inactive) and 100 meaning extreme disease activity (disease extremely active). | Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 |
| VAS Score for Pain | Participants placed a mark on a 0-100 mm VAS to indicate the magnitude of pain, with 0 meaning no pain and 100 meaning the most severe pain. | Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 |
| Number of Participants With Treatment Adherence Rate of 1), <50 Percents (%), 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120% | Treatment adherence rate was calculated using the following formula: [Actual dosing/expected dosing on the basis of approved product label] × 100%. Counts of participants by 6 levels of treatment adherence rate: 1), <50%, 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120%. | First day of receiving etanercept up to Week 52 |
| Evaluate the Association Between Participant's Age and Treatment Adherence Rate | Participants were allocated to 5 groups by age as 10 years separately: <20 years, >=20 and <30 years, >=30 and <40 years, >=40 and <50 years, >50 years. The number of participants with treatment adherence rate 1), <50%, 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120% were provided for each age group described above. | First day of receiving etanercept up to Week 52 |
| Number of Participants With Any Abnormal Laboratory Test Results | Number of participants with any abnormal laboratory test results, criteria for abnormalities were complete blood count (CBC) including hemoglobin (<0.8*lower limit of normal[LLN]), mean corpuscular volume (MCV, <0.9*LLN or >1.1*upper limit of normal[ULN]), hematocrit (<0.8*LLN), red blood cell count (<0.8*LLN), platelets (<0.5*LLN or >1.75*ULN), white blood cell count (<0.6*LLN or >1.5*ULN), lymphocytes (<0.8*LLN or >1.2*ULN), neutrophils (<0.8*LLN or >1.2*ULN), basophil (>1.2*ULN), eosinophil (>1.2*ULN), and monocytes (>1.2*ULN); ESR (>1.5*ULN); aspartate aminotransferase (AST,>3.0*ULN); alanine aminotransferase (ALT,>3.0*ULN); blood urea nitrogen (BUN,>1.3*ULN); and creatinine (CRE,>1.3*ULN). | Baseline (Week 0) up to Week 52 |
| Tender Joint Count (TJC) for RA Participants | TJC (28 joints) include the joints of shoulders, elbows, wrists, metacarpophalangeal (MCP), proximal interphalangeal (PIP), and the knees. The joints were assessed for tenderness using the following scale: Present (1), Absent (2), Not Done (3), Not Applicable (4). Artificial joints were not assessed. | Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 |
| Swollen Joint Count (SJC) for RA Participants | SJC (28 joints) include the joints of shoulders, elbows, wrists, MCP, PIP, and the knees. The joints were assessed for swelling using the following scale: Present (1), Absent (2), Not Done (3), Not Applicable (4). Artificial joints were not assessed. | Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 |
| Disease Activity Score (DAS) Based on 28-joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity on a 0-100 mm VAS: DAS28-4 (ESR)=0.56*square root(TJC 28 joints) + 0.28*square root(SJC 28 joints) + 0.70*ln(ESR) + 0.014*PtGA. DAS28-4 (ESR) above 5.1 indicated high disease activity whereas a DAS28-4 (ESR) below 3.2 indicated low disease activity. | Baseline (Week 0), Week 2, Week 4, Week 12, Week 52 |
| Number of RA Participants Had DAS28-4 (ESR) Improvement | Counts of participants had good, moderate and no response to treatment with etanercept. Good response was present DAS28-4 (ESR) <=3.2, DAS28-4 (ESR) improvement from baseline >1.2. Moderate response was 1) present DAS28-4 (ESR) >3.2 and <=5.1, DAS28-4 (ESR) improvement from baseline >1.2, or >0.6 and <=1.2; 2) present DAS28-4 (ESR) <=3.2, DAS28-4 (ESR) improvement from baseline >0.6 and <=1.2; or 3) present DAS28-4 (ESR) >5.1, DAS28-4 (ESR) improvement from baseline > 1.2. No response was 1) DAS28-4 (ESR) improvement from baseline <=0.6 regardless present DAS28-4 (ESR), or 2) present DAS28-4 (ESR) >5.1, DAS28-4 (ESR) improvement from baseline >0.6 and <=1.2. | Week 2, Week 4, Week 8, Week 12, Week 36, Week 52 |
| Number of RA Participants Had Remission of Disease | Counts of participants had remission of disease. Remission of disease was defined by a DAS28-4 (ESR) <2.6. | Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 36, Week 52 |
| Fuzhou |
| Fujian |
| 350001 |
| China |
| Lanzhou University Second Hospital | Lanzhou | Gansu | 730030 | China |
| The First Affiliated Hospital of Guangzhou University of Chinese Medicine | Guangzhou | Guangdong | 510405 | China |
| No. 199 | Haerbin | Heilongjiang | 150001 | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | 410011 | China |
| The First Affiliated Hospital of Baotou Medical College | Baotou | Inner Mongolia | 014010 | China |
| Jiangsu Province Hospital/Department of Rheumatology | Nanjing | Jiangsu | 210029 | China |
| Affiliated Hospital of Nantong University | Nantong | Jiangsu | 226001 | China |
| The Second Hospital of Shanxi Medical University | Taiyuan | Shanxi | 030001 | China |
| Si Chuan Huaxi Hospital/Rheumatology Department | Chengdu | Sichuan | 610041 | China |
| Baotou Central Hospital | Baotou | China |
| Shanghai Changning Guanghua Integrative Medicine Hospital | Beijing | 200052 | China |
| Shanghai Jiaotong University Affiliated Third People's Hospital | Shanghai | 201900 | China |
| Xinjiang Uygur Autonomous Region People's Hospital | Ürümqi | 830001 | China |
| Lost to Follow-up |
|
| Did not meet entrance criteria |
|
| Study terminated by sponsor |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Other |
|
| Screen failure |
|
Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Number of Participants Who Had Any AEs During 52 Weeks | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | All enrolled participants who received at least 1 dose of etanercept. | Posted | Number | Participants | First day of receiving etanercept through 52 weeks |
|
|
|
| Primary | Number of Participants Who Had Any Serious Adverse Events (SAEs) During 24 Weeks | An SAE was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | All enrolled participants who received at least 1 dose of etanercept. | Posted | Number | Participants | Informed consent or signed data privacy statement through 24 weeks |
|
|
|
| Primary | Number of Participants Who Had Any SAEs During 52 Weeks | An SAE was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | All enrolled participants who received at least 1 dose of etanercept. | Posted | Number | Participants | Informed consent or signed data privacy statement through 52 weeks |
|
|
|
| Primary | Number of Participants With AEs Per System Organ Class During 24 Weeks | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with multiple AEs within a category (system organ class) were counted once within the category. | All enrolled participants who received at least 1 dose of etanercept. | Posted | Number | Participants | First day of receiving etanercept through 24 weeks |
|
|
|
| Primary | Number of Participants With AEs Per System Organ Class During 52 Weeks | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with multiple AEs within a category (system organ class) were counted once within the category. | All enrolled participants who received at least 1 dose of etanercept. | Posted | Number | Participants | First day of receiving etanercept through 52 weeks |
|
|
|
| Secondary | Physician's Global Assessment of Disease Activity | Physicians indicated on a 0-100 millimeters (mm) visual analogue scale (VAS) to assess the activity of the participant's disease according to the participant's clinical condition, with 0 meaning no disease activity (disease inactive) and 100 meaning extreme disease activity (disease extremely active). | All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for physician's global assessment of disease activity. n=number of evaluable participants at the corresponding visit. | Posted | Mean | Standard Deviation | mm | Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Participant's Global Assessment (PtGA) of Disease Activity | Participants placed a vertical line on a 0-100 mm VAS to indicate the magnitude of their global disease activity, with 0 meaning no disease activity (disease inactive) and 100 meaning extreme disease activity (disease extremely active). | All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for PtGA of disease activity. n=number of evaluable participants at the corresponding visit. | Posted | Mean | Standard Deviation | mm | Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | VAS Score for Pain | Participants placed a mark on a 0-100 mm VAS to indicate the magnitude of pain, with 0 meaning no pain and 100 meaning the most severe pain. | All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for pain. n=number of evaluable participants at the corresponding visit. | Posted | Mean | Standard Deviation | mm | Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Number of Participants With Treatment Adherence Rate of 1), <50 Percents (%), 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120% | Treatment adherence rate was calculated using the following formula: [Actual dosing/expected dosing on the basis of approved product label] × 100%. Counts of participants by 6 levels of treatment adherence rate: 1), <50%, 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120%. | All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for treatment adherence rate; those participants with partial dosing dates were excluded. | Posted | Number | Participants | First day of receiving etanercept up to Week 52 |
|
|
|
| Secondary | Evaluate the Association Between Participant's Age and Treatment Adherence Rate | Participants were allocated to 5 groups by age as 10 years separately: <20 years, >=20 and <30 years, >=30 and <40 years, >=40 and <50 years, >50 years. The number of participants with treatment adherence rate 1), <50%, 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120% were provided for each age group described above. | All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for treatment adherence rate; those participants with partial dosing dates were excluded. n=number of evaluable participants at the corresponding age group. | Posted | Number | Participants | First day of receiving etanercept up to Week 52 |
|
|
|
| Secondary | Number of Participants With Any Abnormal Laboratory Test Results | Number of participants with any abnormal laboratory test results, criteria for abnormalities were complete blood count (CBC) including hemoglobin (<0.8*lower limit of normal[LLN]), mean corpuscular volume (MCV, <0.9*LLN or >1.1*upper limit of normal[ULN]), hematocrit (<0.8*LLN), red blood cell count (<0.8*LLN), platelets (<0.5*LLN or >1.75*ULN), white blood cell count (<0.6*LLN or >1.5*ULN), lymphocytes (<0.8*LLN or >1.2*ULN), neutrophils (<0.8*LLN or >1.2*ULN), basophil (>1.2*ULN), eosinophil (>1.2*ULN), and monocytes (>1.2*ULN); ESR (>1.5*ULN); aspartate aminotransferase (AST,>3.0*ULN); alanine aminotransferase (ALT,>3.0*ULN); blood urea nitrogen (BUN,>1.3*ULN); and creatinine (CRE,>1.3*ULN). | All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for laboratory test abnormalities. | Posted | Number | Participants | Baseline (Week 0) up to Week 52 |
|
|
|
| Secondary | Tender Joint Count (TJC) for RA Participants | TJC (28 joints) include the joints of shoulders, elbows, wrists, metacarpophalangeal (MCP), proximal interphalangeal (PIP), and the knees. The joints were assessed for tenderness using the following scale: Present (1), Absent (2), Not Done (3), Not Applicable (4). Artificial joints were not assessed. | All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were RA participants who were evaluated for TJC. n=number of evaluable participants at the corresponding visit. | Posted | Mean | Standard Deviation | Joints | Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Swollen Joint Count (SJC) for RA Participants | SJC (28 joints) include the joints of shoulders, elbows, wrists, MCP, PIP, and the knees. The joints were assessed for swelling using the following scale: Present (1), Absent (2), Not Done (3), Not Applicable (4). Artificial joints were not assessed. | All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were RA participants who were evaluated for SJC. n=number of evaluable participants at the corresponding visit. | Posted | Mean | Standard Deviation | Joints | Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Disease Activity Score (DAS) Based on 28-joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity on a 0-100 mm VAS: DAS28-4 (ESR)=0.56*square root(TJC 28 joints) + 0.28*square root(SJC 28 joints) + 0.70*ln(ESR) + 0.014*PtGA. DAS28-4 (ESR) above 5.1 indicated high disease activity whereas a DAS28-4 (ESR) below 3.2 indicated low disease activity. | All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were RA participants who were evaluated for DAS28-4 (ESR). n=number of evaluable participants at the corresponding visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0), Week 2, Week 4, Week 12, Week 52 |
|
|
|
| Secondary | Number of RA Participants Had DAS28-4 (ESR) Improvement | Counts of participants had good, moderate and no response to treatment with etanercept. Good response was present DAS28-4 (ESR) <=3.2, DAS28-4 (ESR) improvement from baseline >1.2. Moderate response was 1) present DAS28-4 (ESR) >3.2 and <=5.1, DAS28-4 (ESR) improvement from baseline >1.2, or >0.6 and <=1.2; 2) present DAS28-4 (ESR) <=3.2, DAS28-4 (ESR) improvement from baseline >0.6 and <=1.2; or 3) present DAS28-4 (ESR) >5.1, DAS28-4 (ESR) improvement from baseline > 1.2. No response was 1) DAS28-4 (ESR) improvement from baseline <=0.6 regardless present DAS28-4 (ESR), or 2) present DAS28-4 (ESR) >5.1, DAS28-4 (ESR) improvement from baseline >0.6 and <=1.2. | All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for DAS28-4 (ESR) improvement. n=number of evaluable participants at the corresponding visit. | Posted | Number | Participants | Week 2, Week 4, Week 8, Week 12, Week 36, Week 52 |
|
|
|
| Secondary | Number of RA Participants Had Remission of Disease | Counts of participants had remission of disease. Remission of disease was defined by a DAS28-4 (ESR) <2.6. | All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for DAS28-4 (ESR). n=number of evaluable participants at the corresponding visit. | Posted | Number | Participants | Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 36, Week 52 |
|
|
|
| 0 |
| 69 |
| 8 |
| 69 |
| EG001 | Ankylosing Spondylitis [AS] | Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks | 0 | 90 | 9 | 90 |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Irritability | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
|
| Alanine aminotransferase | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Alanine aminotransferase abnormal | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | 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.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D000844 | Ankylosis |
| 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 |
| General disorders+administration site conditions |
|
| Hepatobiliary disorders |
|
| Infections and infestations |
|
| Investigations |
|
| Metabolism and nutrition disorders |
|
| Musculoskeletal and connective tissue disorders |
|
| Skin and subcutaneous tissue disorders |
|
| General disorders+administration site conditions |
|
| Hepatobiliary disorders |
|
| Infections and infestations |
|
| Investigations |
|
| Metabolism and nutrition disorders |
|
| Musculoskeletal and connective tissue disorders |
|
| Skin and subcutaneous tissue disorders |
|
| Week 4, n=35,61 |
|
| Week 8, n=24,47 |
|
| Week 12, n=16,34 |
|
| Week 24, n=7,18 |
|
| Week 36, n=2,13 |
|
| Week 52, n=3,6 |
|
| Week 4, n=35, 60 |
|
| Week 8, n=23, 47 |
|
| Week 12, n=16,33 |
|
| Week 24, n=7,18 |
|
| Week 36, n=2,12 |
|
| Week 52, n=3,6 |
|
| Week 4, n=35,60 |
|
| Week 8, n=23,47 |
|
| Week 12, n=16,34 |
|
| Week 24, n=7,18 |
|
| Week 36, n=2,13 |
|
| Week 48, n=3,6 |
|
| >=70% and <80% |
|
| >=80% and <100% |
|
| >=100% and <120% |
|
| >=120% |
|
| <20 years (>=70% and <80%), n=3,15 |
|
| <20 years (>=80% and <100%), n=3,15 |
|
| <20 years (>=100% and <120%), n=3,15 |
|
| <20 years (>=120%), n=3,15 |
|
| >=20 and <30 years (<50%), n=3,26 |
|
| >=20 and <30 years (>=50% and <70%), n=3,26 |
|
| >=20 and <30 years (>=70% and <80%), n=3,26 |
|
| >=20 and <30 years (>=80% and <100%), n=3,26 |
|
| >=20 and <30 years (>=100% and <120%), n=3,26 |
|
| >=20 and <30 years (>=120%), n=3,26 |
|
| >=30 and <40 years (<50%), n=7,21 |
|
| >=30 and <40 years (>=50% and <70%), n=7,21 |
|
| >=30 and <40 years (>=70% and <80%), n=7,21 |
|
| >=30 and <40 years (>=80% and <100%), n=7,21 |
|
| >=30 and <40 years (>=100% and <120%), n=7,21 |
|
| >=30 and <40 years (>=120%), n=7,21 |
|
| >=40 and <50 years (<50%), n=22,17 |
|
| >=40 and <50 years (>=50% and <70%), n=22,17 |
|
| >=40 and <50 years (>=70% and <80%), n=22,17 |
|
| >=40 and <50 years (>=80% and <100%), n=22,17 |
|
| >=40 and <50 years (>=100% and <120%), n=22,17 |
|
| >=40 and <50 years (>=120%), n=22,17 |
|
| >50 years (<50%), n=34,9 |
|
| >50 years (>=50% and <70%), n=34,9 |
|
| >50 years (>=70% and <80%), n=34,9 |
|
| >50 years (>=80% and <100%), n=34,9 |
|
| >50 years (>=100% and <120%), n=34,9 |
|
| >50 years (>=120%), n=34,9 |
|
| Title | Measurements |
|---|---|
|
| Week 8, n=22 |
|
| Week 12, n=17 |
|
| Week 24, n=6 |
|
| Week 36, n=2 |
|
| Week 52, n=3 |
|
| Title | Measurements |
|---|---|
|
| Week 8, n=22 |
|
| Week 12, n=17 |
|
| Week 24, n=6 |
|
| Week 36, n=2 |
|
| Week 52, n=3 |
|
| Title | Measurements |
|---|---|
|
| Week 8, n=1 |
|
| Week 12, n=8 |
|
| Week 36, n=1 |
|
| Week 52, n=2 |
|
| Title | Measurements |
|---|---|
|
| Good response (Week 4), n=16 |
|
| Moderate response (Week 4), n=16 |
|
| No response (Week 4), n=16 |
|
| Good response (Week 8), n=1 |
|
| Moderate response (Week 8), n=1 |
|
| No response (Week 8), n=1 |
|
| Good response (Week 12), n=7 |
|
| Moderate response (Week 12), n=7 |
|
| No response (Week 12), n=7 |
|
| Good response (Week 36), n=1 |
|
| Moderate response (Week 36), n=1 |
|
| No response (Week 36), n=1 |
|
| Good response (Week 52), n=1 |
|
| Moderate response (Week 52), n=1 |
|
| No response (Week 52), n=1 |
|
| Title | Measurements |
|---|---|
|
| Week 8, n=1 |
|
| Week 12, n=8 |
|
| Week 36, n=1 |
|
| Week 52, n=2 |
|