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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004569-16 | EudraCT Number |
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Open-label immunogenicity, safety and efficacy study of etanercept manufactured using the high capacity process. Descriptive results will be provided however a formal hypothesis will not be tested in this trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ETN 50mg QW | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etanercept | Biological | 50mg subcutaneous, once weekly, 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Positive Etanercept Anti-Drug Antibody (ADA) Status at Week 12 | Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized. | Week 12 |
| Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status at Week 24 | Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized. | Week 24 |
| Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status: Throughout Study Treatment | Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized. | Baseline up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Positive Etanercept Neutralizing Anti-Drug Antibody Status: Throughout Study Treatment | Percentage of participants with positive Etanercept neutralizing anti-drug antibodies were summarized. | Baseline (Day 1) up to Week 24 |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MHAT Plovdiv | Plovdiv | 4000 | Bulgaria | |||
| DCC "Aleksandrovska" EOOD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30451655 | Derived | Polak P, Peric P, Louw I, Gaylord SM, Williams T, Becker JC, Pedersen R, Korth-Bradley J, Vlahos B. A single-arm, open-label study to assess the immunogenicity, safety, and efficacy of etanercept manufactured using the serum-free, high-capacity manufacturing process administered to patients with rheumatoid arthritis. Eur J Rheumatol. 2019 Jan;6(1):23-28. doi: 10.5152/eurjrheum.2018.18078. |
| 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 with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was 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. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. |
| Baseline (Day 1) up to Week 28 (Follow-up) |
| Number of Participants With Investigator-Identified Serious Infections | Infection was considered as serious by investigator for any of the following outcomes: death; life-threatening; required initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity or congenital anomaly/birth defect. | Baseline (Day 1) up to Week 28 (Follow-up) |
| Number of Participants With Injection Site Reactions | Injection site reactions included injection site erythema, swelling, pain and warmth. | Baseline (Day 1) up to Week 28 (Follow-up) |
| Number of Participants With Grade 3 and 4 Clinical Laboratory Abnormalities | Laboratory abnormalities(national cancer institute toxicity criteria version 4.0),Grade 3:neutrophil (greater than or equal to[>=]0.5,less than[<]1.0 10^9/L),lymphocyte (<0.5 10^9/L),hemoglobin (Hb) (<80,>=65 gram per liter [g/L]),platelet(<50.0,>=25.0 10^9/L),white blood count(WBC) (<2.0, >=1.0 10^9/L);alkaline phosphatase (AP),aspartate aminotransferase(AST),alanine aminotransferase(ALT) (greater than[>]5.0*upper range [UR], <=20.0*UR unit per liter[U/L]);bilirubin(>1.5*UR, less than or equal to[<=]3.0*UR micromole per liter[mcmol/L]);creatinine(>3.0*UR, <=6.0*UR mcmol/L);albumin (<20.0 g/L),urea(>3.0*UR, <=4.0*UR g/L);potassium (K)-high,low (>6.0,<=7.0or<3.0,>=2.5 mcmol/L); sodium(Na)-high,low(>155, <=160 or <130, >=120 mcmol/L)and Grade 4: neutrophil(<0.5 10^9/L),Hb (<65 g/L);platelet (<25.0 10^9/L); WBC(<1.0 10^9/L);AP,AST,ALT(>20.0*UR U/L);bilirubin(>3.0*UR mcmol/L);creatinine (>6.0*UR mcmol/L);urea (>4.0*UR g/L);K-high,low (>7.0or<2.5 mcmol/L);Na-high, low (>160or<120 mcmol/L). | Baseline (Day 1) up to Week 28 (Follow-up) |
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | ACR20 responder: participants with 20 percent (%) improvement in tender and swollen 28-joint counts and 20% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR20 response were reported. | Week 4, 12, 24 |
| Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | ACR50 responder: participants with 50% improvement in tender and swollen 28-joint counts and 50% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR50 response were reported. | Week 4, 12, 24 |
| Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | ACR70 responder: participants with 70% improvement in tender and swollen 28-joint counts and 70% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR70 response were reported. | Week 4, 12, 24 |
| Change From Baseline in Disease Activity Scale Based on 28 Joint Count Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 4, 12 and 24 | DAS28: measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from number of swollen joints (SJC) and tender joints (TJC ) using the 28 joints count, erythrocyte sedimentation rate (millimeter per hour [mm/hour]) and participant's general health visual analog scale assessment (scores: 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (ESR) score: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (ESR) less than (<) 2.6= remission, <3.2= low disease activity, greater than or equal to (>=) 3.2 to 5.1= moderate disease activity and >5.1= high disease activity. | Baseline, Week 4, 12, 24 |
| Change From Baseline in Disease Activity Scale Based on 28 Joint Count C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 4, 12 and 24 | DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from the number of swollen joints and tender joints using the 28 joints count, C-Reactive protein (milligram per liter [mg/L]) and participant's general health visual analog scale assessment (scores ranging 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (CRP) less than (<) 2.6= remission, <3.2= low disease activity, greater than or equal to (>=) 3.2 to 5.1= moderate disease activity and >5.1= high disease activity. | Baseline, Week 4, 12, 24 |
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 4, 12 and 24 | HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each item scored on 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities. | Baseline, Week 4, 12, 24 |
| Sofia |
| 1431 |
| Bulgaria |
| UMHAT "Sv. Ivan Rilski" EAD, Sofia | Sofia | 1612 | Bulgaria |
| Medical Center - "New rehabilitation center" EOOD | Stara Zagora | 6000 | Bulgaria |
| Chc Rijeka | Rijeka | 51000 | Croatia |
| Medicinski Centar Kuna Peric | Zagreb | 10000 | Croatia |
| Centrum für innovative Diagnostik und Therapie | Frankfurt am Main | Hesse | 60528 | Germany |
| Rheumaforschung - Studienambulanz Dr. Wassenberg | Ratingen | North Rhine-Westphalia | 40882 | Germany |
| Schlosspark-Klinik, Innere Medizin II, Rheumatologie | Berlin | 14059 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Immunologisches Zentrum Vogelsang-Gommern GmbH | Vogelsang-Gommern | 39245 | Germany |
| Rheumatology Department | Rion Patras | Achaia | 26500 | Greece |
| University Hospital of Heraklion | Heraklion | Crete | 71110 | Greece |
| Rheumatology Unit | Thessaloniki | 56429 | Greece |
| Qualiclinic Kft. | Budapest | 1036 | Hungary |
| Pest Megyei Flor Ferenc Korhaz | Kistarcsa | 2143 | Hungary |
| Szabolcs-Szatmar-Bereg megyei | Nyíregyháza | 4400 | Hungary |
| Krakowskie Centrum Medyczne sp. Z.O.O | Krakow | 31-501 | Poland |
| NZOZ Lecznica MAK-MED s.c. | Nadarzyn | 05-830 | Poland |
| Prywatna Praktyka Lekarska Prof. UM dr hab.med. Pawel Hrycaj | Poznan | 61-397 | Poland |
| Reumatika-Centrum Reumatologii | Warsaw | 02-691 | Poland |
| Institute of Rheumatology | Belgrade | Beograd | 11000 | Serbia |
| Reumatologicka ambulancia | Bratislava | 841 04 | Slovakia |
| AAGS, s.r.o. | Dunajská Streda | 929 01 | Slovakia |
| Reumatologicka ambulancia, MUDr. Zuzana Cizmarikova, s.r.o. | Poprad | 058 01 | Slovakia |
| REUMEX s.r.o. | Rimavská Sobota | 979 01 | Slovakia |
| REUMA-GLOBAL s.r.o. | Trnava | 917 01 | Slovakia |
| Reumatologicka ambulancia | Žilina | 010 01 | Slovakia |
| Panorama Medical Centre | Panorama | Cape Town | 7500 | South Africa |
| Wits Clinical Research CMJAH Clinical Trial Site | Parktown | Johannesburg | 2193 | South Africa |
| St. Augustines Hospital | Durban/Berea | KwaZulu-Natal | 4001 | South Africa |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Safety population included all participants who had taken at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Positive Etanercept Anti-Drug Antibody (ADA) Status at Week 12 | Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized. | Analysis set included all participants who had taken at least 1 dose of study medication and had at least 1 Etanercept anti-drug antibody evaluation. Here, "Number of Participants Analyzed" (N) signifies number of participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12 |
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| Primary | Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status at Week 24 | Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized. | Analysis set included all participants who had taken at least 1 dose of study medication and had at least 1 Etanercept anti-drug antibody evaluation. Here, "N" signifies number of participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 24 |
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| Secondary | Percentage of Participants With Positive Etanercept Neutralizing Anti-Drug Antibody Status: Throughout Study Treatment | Percentage of participants with positive Etanercept neutralizing anti-drug antibodies were summarized. | Analysis set included all participants who had taken at least 1 dose of study medication and had at least 1 Etanercept anti-drug antibody evaluation. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (Day 1) up to Week 24 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was 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. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. | Safety population included all participants who had taken at least 1 dose of study medication. | Posted | Number | participants | Baseline (Day 1) up to Week 28 (Follow-up) |
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| Secondary | Number of Participants With Investigator-Identified Serious Infections | Infection was considered as serious by investigator for any of the following outcomes: death; life-threatening; required initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity or congenital anomaly/birth defect. | Safety population included all participants who had taken at least 1 dose of study medication. | Posted | Number | participants | Baseline (Day 1) up to Week 28 (Follow-up) |
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| Secondary | Number of Participants With Injection Site Reactions | Injection site reactions included injection site erythema, swelling, pain and warmth. | Safety population included all participants who had taken at least 1 dose of study medication. | Posted | Number | participants | Baseline (Day 1) up to Week 28 (Follow-up) |
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| Secondary | Number of Participants With Grade 3 and 4 Clinical Laboratory Abnormalities | Laboratory abnormalities(national cancer institute toxicity criteria version 4.0),Grade 3:neutrophil (greater than or equal to[>=]0.5,less than[<]1.0 10^9/L),lymphocyte (<0.5 10^9/L),hemoglobin (Hb) (<80,>=65 gram per liter [g/L]),platelet(<50.0,>=25.0 10^9/L),white blood count(WBC) (<2.0, >=1.0 10^9/L);alkaline phosphatase (AP),aspartate aminotransferase(AST),alanine aminotransferase(ALT) (greater than[>]5.0*upper range [UR], <=20.0*UR unit per liter[U/L]);bilirubin(>1.5*UR, less than or equal to[<=]3.0*UR micromole per liter[mcmol/L]);creatinine(>3.0*UR, <=6.0*UR mcmol/L);albumin (<20.0 g/L),urea(>3.0*UR, <=4.0*UR g/L);potassium (K)-high,low (>6.0,<=7.0or<3.0,>=2.5 mcmol/L); sodium(Na)-high,low(>155, <=160 or <130, >=120 mcmol/L)and Grade 4: neutrophil(<0.5 10^9/L),Hb (<65 g/L);platelet (<25.0 10^9/L); WBC(<1.0 10^9/L);AP,AST,ALT(>20.0*UR U/L);bilirubin(>3.0*UR mcmol/L);creatinine (>6.0*UR mcmol/L);urea (>4.0*UR g/L);K-high,low (>7.0or<2.5 mcmol/L);Na-high, low (>160or<120 mcmol/L). | Safety population included all participants who had taken at least 1 dose of study medication. | Posted | Number | participants | Baseline (Day 1) up to Week 28 (Follow-up) |
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| Secondary | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | ACR20 responder: participants with 20 percent (%) improvement in tender and swollen 28-joint counts and 20% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR20 response were reported. | Modified intent-to-treat (mITT) population included all participants who had taken at least 1 dose of study medication. Here, "n" signifies number of participants who were evaluable for specified time points. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4, 12, 24 |
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| Secondary | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | ACR50 responder: participants with 50% improvement in tender and swollen 28-joint counts and 50% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR50 response were reported. | mITT population included all participants who had taken at least 1 dose of study medication. Here, "n" signifies number of participants who were evaluable for specified time points. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4, 12, 24 |
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| Secondary | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | ACR70 responder: participants with 70% improvement in tender and swollen 28-joint counts and 70% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR70 response were reported. | mITT population included all participants who had taken at least 1 dose of study medication. Here, "n" signifies number of participants who were evaluable for specified time points. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4, 12, 24 |
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| Secondary | Change From Baseline in Disease Activity Scale Based on 28 Joint Count Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 4, 12 and 24 | DAS28: measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from number of swollen joints (SJC) and tender joints (TJC ) using the 28 joints count, erythrocyte sedimentation rate (millimeter per hour [mm/hour]) and participant's general health visual analog scale assessment (scores: 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (ESR) score: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (ESR) less than (<) 2.6= remission, <3.2= low disease activity, greater than or equal to (>=) 3.2 to 5.1= moderate disease activity and >5.1= high disease activity. | mITT population included all participants who had taken at least 1 dose of study medication. Here, "n" signifies number of participants who were evaluable for specified time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 4, 12, 24 |
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| Secondary | Change From Baseline in Disease Activity Scale Based on 28 Joint Count C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 4, 12 and 24 | DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from the number of swollen joints and tender joints using the 28 joints count, C-Reactive protein (milligram per liter [mg/L]) and participant's general health visual analog scale assessment (scores ranging 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (CRP) less than (<) 2.6= remission, <3.2= low disease activity, greater than or equal to (>=) 3.2 to 5.1= moderate disease activity and >5.1= high disease activity. | mITT population included all participants who had taken at least 1 dose of study medication. Here, "n" signifies number of participants who were evaluable for specified time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 4, 12, 24 |
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| Secondary | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 4, 12 and 24 | HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each item scored on 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities. | mITT population included all participants who had taken at least 1 dose of study medication. Here, "n" signifies number of participants who were evaluable for specified time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 4, 12, 24 |
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| Primary | Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status: Throughout Study Treatment | Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized. | Analysis set included all participants who had taken at least 1 dose of study medication and had at least 1 Etanercept anti-drug antibody evaluation. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to Week 24 |
|
|
Baseline (Day 1) up to Week 28 (follow-up)
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious 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 | Etanercept | Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28. | 9 | 187 | 85 | 187 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Metatarsalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Injection site nodule | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Injection site urticaria | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Injection site vesicles | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Hepatic cyst | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Asymptomatic bacteriuria | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Genitourinary tract infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Blood pressure diastolic abnormal | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Vitamin D decreased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Joint instability | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Impulsive behaviour | Psychiatric disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Amenorrhoea | Reproductive system and breast disorders | MedDRA 19.0 | Non-systematic Assessment | This event was gender specific. |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA 19.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.0 | 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 | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| 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 |
Not provided
Not provided
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