Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ANTIBODY-RA | Other Identifier | Alias Study Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to examine the relationship between anti-drug antibodies, serum drug concentrations, and clinical response for rheumatoid arthritis patients being treated with etanercept, adalimumab or infliximab.
cross-sectional Population will be selected through convenience sampling. Patients sequentially visiting the rheumatology clinic for routine care who are receiving etanercept, adalimumab, or infliximab for between 6 and 24 months will be evaluated for eligibility and interest in participation. A maximum of 200 patients per treatment will be enrolled.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etanercept | Participants currently receiving etanercept treatment in a clinical setting for a minimum of 6 months and maximum of 24 months prior to study assessment visit. |
| |
| adalimumab | Participants currently receiving adalimumab treatment in a clinical setting for a minimum of 6 months and maximum of 24 months prior to study assessment visit. |
| |
| infliximab | Participants currently receiving infliximab treatment in a clinical setting for a minimum of 6 months and maximum of 24 months prior to study assessment visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention | Other |
|
| |
| no intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept Versus Those Treated With Monoclonal Antibodies (Adalimumab or Infliximab). | Percentage of participants positive for antidrug antibodies among those treated with etanercept versus those treated with monoclonal antibodies (adalimumab or infliximab) was determined. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Low Disease Activity (LDA) (DAS28 ESR Score ≤ 3.2) Among Those Who Are Antidrug Antibody Positive Versus Negative (All Patients Receiving Etanercept, Adalimumab, or Infliximab Combined). | Percentage of participants with Low Disease Activity (LDA) (Disease Activity Score based on a 28-joint count [DAS28] Erythrocyte sedimentation rate [ESR] score ≤3.2) among those who are antidrug antibody positive versus negative (all participants receiving etanercept, adalimumab, or infliximab combined). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Population will be selected from patients seen in a rheumatology clinical setting who currently treated with etanercept, adalimumab or infliximab for rheumatoid arthritis
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Arthritis & Rheumatology | Glendale | Arizona | 85304 | United States | ||
| Arizona Arthritis & Rheumatology Associates, P. C. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29480357 | Derived | Bassiouni H, Spargo CE, Vlahos B, Jones HE, Pedersen R, Shirazy K. Maintenance of Remission with Etanercept-DMARD Combination Therapy Compared with DMARDs Alone in African and Middle Eastern Patients with Active Rheumatoid Arthritis. Rheumatol Ther. 2018 Jun;5(1):149-158. doi: 10.1007/s40744-018-0094-6. Epub 2018 Feb 26. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Participants treated with one of the three targeted therapies were enrolled using interactive response technology to assure data for approximately 200 participants were included for each RA treatment.
This is a multicenter, non-interventional (NI) study conducted to evaluate data collected from a cross sectional population of participants with rheumatoid arthritis (RA) who received treatment with etanercept, adalimumab, or infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept | Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit. |
| FG001 | Adalimumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
|
|
| no intervention | Other |
|
|
| 1 day |
| Serum Trough Drug Concentrations for Etanercept, Adalimumab, and Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | Serum trough drug concentrations for etanercept, adalimumab, and infliximab compared between participants who are antidrug antibody positive versus negative. Units of measurement for Serum trough drug concentration is µg/mL. | 1 day |
| Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept, Adalimumab, or Infliximab. | Percentage of participants positive for antidrug antibodies among those treated with etanercept, adalimumab, or infliximab were determined. | 1 Day |
| The Clinical Disease Activity Index (CDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | The CDAI total scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative. CDAI = Disease activity score (DAS) 28 prorated Swollen Joint Count (0-28) + DAS 28 prorated Tender Joint Count (0-28) + Physician's Global Assessment (0-10) + Subject's Global Assessment (0-10). The total score range is 0-76. Score interpretation: Remission ≤ 2.8; Low Disease Activity CDAI > 2.8 and ≤ 10; Moderate Disease Activity CDAI > 10 and ≤ 22; High Disease Activity CDAI > 22. | 1 Day |
| The Simplified Disease Activity Index (SDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | The SDAI Total Scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative. SDAI = DAS 28 prorated Swollen Joint Count (0-28) + DAS 28 prorated Tender Joint Count (0-28) + Physician's Global Assessment (0-10) + Subject's Global Assessment (0-10) + C-reactive protein (CRP) (in mg/dL). The total score range is 0-86. Score interpretation: Remission SDAI ≤ 3.3; Low Disease Activity SDAI > 3.3 and ≤ 11; Moderate Disease Activity SDAI > 11 and ≤ 26; High Disease Activity SDAI > 26. | 1 day |
| Disease Activity Score Based on a 28-joint Count (DAS28), Calculated With Erythrocyte Sedimentation Rate for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | The DAS28 assessment is a derived measurement with differential weight given to each component. DAS28 will be calculated twice, utilizing first ESR, and then CRP as the acute phase reactant: 1) DAS28-ESR = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln ESR) + 0.014 GH, where GH=subject general health VAS (0-100 mm). 2) DAS28-4 CRP = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen count) + 0.36 (ln CRP+1) + 0.014 GH + 0.96, where GH=subject general health VAS (0- 100 mm), higher scores were indicative of a worse outcome. The specific components of the DAS28 assessment that were used in this study are: Tender/Painful Joint Count (28), Swollen Joint Count (28), ESR/CRP, and Subject's General Health VAS assessment. | 1 day |
| Disease Activity Score, 28 Joint Count, Calculated With C-reactive Protein (DAS28-CRP) for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | The DAS28 assessment is a derived measurement with differential weight given to each component. DAS28 will be calculated twice, utilizing first ESR, and then CRP as the acute phase reactant: 1) DAS28-ESR = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln ESR) + 0.014 GH, where GH=subject general health VAS (0 100 mm). 2) DAS28-4 CRP = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen count) + 0.36 (ln CRP+1) + 0.014 GH + 0.96, where GH=subject general health VAS (0-100 mm), higher scores were indicative of a worse outcome. The specific components of the DAS28 assessment that were used in this study are: Tender/Painful Joint Count (28), Swollen Joint Count (28), ESR/CRP, and Subject's General Health VAS assessment. | 1 day |
| Health Assessment Questionnaire-Disability Index (HAQ DI) Scores for for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | The HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question in the questionnaire, the level of difficulty is scored from 0 to 3 with 0 representing "no difficulty," 1 as "some difficulty," 2 as "much difficulty," and 3 as "unable to do." Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. The total score range for the HAQ-DI scale, minimum score was 0 (best), maximum score was 3 (worst). | 1 day |
| Percentage of HAQ DI (<=0.5) Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | HAQ DI (<=0.5) scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative. | 1 day |
| Correlation of Antidrug Antibody Titers With Efficacy Measures. | Correlation of antidrug antibody titers with efficacy measures analysed using Spearman correlation coefficient. | 1 day |
| Correlation of Antidrug Antibody Titers With Trough Drug Concentration. | Correlation of antidrug antibody titers with trough drug concentration analysed using Spearman correlation coefficient. | 1 day |
| Mesa |
| Arizona |
| 85202 |
| United States |
| Arizona Arthritis & Rheumatology | Phoenix | Arizona | 85032 | United States |
| Arizona Arthritis and Rheumatology Research, PLLC | Phoenix | Arizona | 85032 | United States |
| Arizona Arthritis & Rheumatology Research | Sun City | Arizona | 85351 | United States |
| Mercy Clinic Hot Springs Communities | Hot Springs | Arkansas | 71913 | United States |
| Sutter Institute for Medical Research | Sacramento | California | 95816 | United States |
| Arthritis Care Center, Incorporated | San Jose | California | 95035 | United States |
| Rheumatology Consultants of Delaware dba Delaware Arthritis | Lewes | Delaware | 19958 | United States |
| Omega Research Consultants, LLC | DeBary | Florida | 32713 | United States |
| Center for Rheumatology, Immunology, and Arthritis | Fort Lauderdale | Florida | 33309 | United States |
| Florida Medical Research | Gainesville | Florida | 32607 | United States |
| Arthritis and Rheumatic Care Center | South Miami | Florida | 33143 | United States |
| Health Point Medical Group, Inc. | Tampa | Florida | 33614 | United States |
| Northeast Georgia Diagnostic Clinic, LLC | Gainesville | Georgia | 30501 | United States |
| Via Christi Hospitals Wichita, Inc. | Wichita | Kansas | 67214 | United States |
| Rheumatology Associates of Baltimore | Baltimore | Maryland | 21286 | United States |
| Phase III Clinical Research | Fall River | Massachusetts | 02720 | United States |
| David S. Rosenberg, M.D | Florissant | Missouri | 63031 | United States |
| Dr Melvin Albert Churchill Jr | Lincoln | Nebraska | 68516 | United States |
| Prospect Medical Offices | Midland Park | New Jersey | 07432 | United States |
| Advanced Arthritis Care Center | Brooklyn | New York | 11235 | United States |
| Prem C.Chatpar, M.D., LLC | Plainview | New York | 11803 | United States |
| Box Arthritis and Rheumatology | Charlotte | North Carolina | 28210 | United States |
| Clinical Research Center of Reading, LLC | Wyomissing | Pennsylvania | 19610 | United States |
| Low Country Rheumatology, PA | North Charleston | South Carolina | 29406 | United States |
| Comprehensive Rheumatology Care | Hendersonville | Tennessee | 37075 | United States |
| Elizabeth Marini Simpson | Hixon | Tennessee | 37343 | United States |
| Austin Regional Clinic | Austin | Texas | 78731 | United States |
| Accurate Clinical Research | Houston | Texas | 77084 | United States |
| Clinical Research Institute of Houston | Houston | Texas | 77090 | United States |
| Spring Clinical Research | Tomball | Texas | 77375 | United States |
| Center for Arthritis and Rheumatic Diseases, P.C. | Chesapeake | Virginia | 23320 | United States |
| Arthritis Northwest, PLLC | Spokane | Washington | 99204 | United States |
| Hospital Británico de Buenos Aires | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1280AEB | Argentina |
| Sociedad Italiana de Beneficencia en Buenos Aires (Hospital Italiano de Buenos Aires) | Ciudad Autónoma de Buenos Aires / Buenos Aires | Buenos Aires / Argentina | C1181ACH | Argentina |
| Instituto de Asistencia Reumatológica Integral I.A.R.I | San Fernando | Buenos Aires / Argentina | 1646 | Argentina |
| Clínica Adventista Belgrano | Ciudad Autónoma de Buenos Aires / Buenos Aires | Ciudad Autónoma de Buenos Aires / Buenos Aires /Argentina. | C1430EGF | Argentina |
| CIER, centro de investigaciones en enfermedades reumáticas (Razón social: ARIES MEDICA S.R.L.) | Ciudad de Buenos Aires / Buenos Aires | Ciudad de Buenos Aires, Buenos Aires, Argentina | C1055AAF | Argentina |
| Sociedad Española de Beneficiencia y Mutualidad Hospital español de Mendoza | Godoy Cruz | Mendoza / Argentina | M5501AAJ | Argentina |
| DIM Clinica Privada | Ramos Mejía | Ramos Mejía / Buenos Aires / Argentina | B1704ETD | Argentina |
| Centro Integral de Reumatología S.R.L. | S.M. de Tucumán / Tucumán | S.M. de Tucumán / Tucumán / Argentina. | 4000 | Argentina |
| C.E.R - Centro Polivalente de Asistencia e Investigación Clínica propiedad de CER SAN JUAN S.R.L. | San Juan | San Juan / San Juan / Buenos Aires | J5402DIL | Argentina |
| Instituto CAICI SRL. | Rosario | Santa Fe / Argentina | S2000PBJ | Argentina |
| I.N.Ne.L S.R.L. (Instituto de Neurología y Neurorrehabilitación del Litoral S.R.L.) | Santa Fe | Santa Fé / Argentina | S3000ASL | Argentina |
| Southern Clinical Research Pty Ltd | Sandy Bay, Hobart | Tasmania | 7000 | Australia |
| MHAT Burgas | Burgas | 8000 | Bulgaria |
| DCC Sveti Pantaleimon OOD | Pleven | 5800 | Bulgaria |
| MHAT Kaspela EOOD | Plovdiv | 4000 | Bulgaria |
| UMHAT "Sv.Ivan Rilski" | Sofia | 1612 | Bulgaria |
| Cukurova Universitesi Tip Fakultesi Balcalı Hastanesi | Adana | 01030 | Turkey (Türkiye) |
| Hacettepe Universitesi Tip Fakultesi Hastanesi | Ankara | 06100 | Turkey (Türkiye) |
| Ataturk Universitesi Yakutiye Egitim ve Arastirma Hastanesi | Erzurum | 25240 | Turkey (Türkiye) |
| Osmangazi Universitesi Tıp Fakultesi Hastanesi | Eskişehir | 26480 | Turkey (Türkiye) |
Participants who had received treatment with Adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
| FG002 | Infliximab | Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The full analysis set (FAS) composed of participants who had diagnosis of RA and who received treatment with etanercept, adalimumab, or infliximab for a minimum of 6 months and a maximum of 24 months prior to the study visit. Data was not collected or analyzed on participants who entered the study but did not complete based on not meeting criteria.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit. |
| BG001 | Adalimumab | Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit. |
| BG002 | Infliximab | Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 Positive for Antidrug Antibodies Among Those Treated With Etanercept Versus Those Treated With Monoclonal Antibodies (Adalimumab or Infliximab). | Percentage of participants positive for antidrug antibodies among those treated with etanercept versus those treated with monoclonal antibodies (adalimumab or infliximab) was determined. | FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit. | Posted | Number | Percentage of participants | 1 day |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Low Disease Activity (LDA) (DAS28 ESR Score ≤ 3.2) Among Those Who Are Antidrug Antibody Positive Versus Negative (All Patients Receiving Etanercept, Adalimumab, or Infliximab Combined). | Percentage of participants with Low Disease Activity (LDA) (Disease Activity Score based on a 28-joint count [DAS28] Erythrocyte sedimentation rate [ESR] score ≤3.2) among those who are antidrug antibody positive versus negative (all participants receiving etanercept, adalimumab, or infliximab combined). | FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit. | Posted | Number | percentage of participants | 1 day |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum Trough Drug Concentrations for Etanercept, Adalimumab, and Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | Serum trough drug concentrations for etanercept, adalimumab, and infliximab compared between participants who are antidrug antibody positive versus negative. Units of measurement for Serum trough drug concentration is µg/mL. | FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit. | Posted | Mean | Standard Deviation | µg/mL | 1 day |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept, Adalimumab, or Infliximab. | Percentage of participants positive for antidrug antibodies among those treated with etanercept, adalimumab, or infliximab were determined. | FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit. | Posted | Number | Percentage of participants | 1 Day |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Clinical Disease Activity Index (CDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | The CDAI total scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative. CDAI = Disease activity score (DAS) 28 prorated Swollen Joint Count (0-28) + DAS 28 prorated Tender Joint Count (0-28) + Physician's Global Assessment (0-10) + Subject's Global Assessment (0-10). The total score range is 0-76. Score interpretation: Remission ≤ 2.8; Low Disease Activity CDAI > 2.8 and ≤ 10; Moderate Disease Activity CDAI > 10 and ≤ 22; High Disease Activity CDAI > 22. | FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit. | Posted | Mean | Standard Deviation | units on a scale | 1 Day |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Simplified Disease Activity Index (SDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | The SDAI Total Scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative. SDAI = DAS 28 prorated Swollen Joint Count (0-28) + DAS 28 prorated Tender Joint Count (0-28) + Physician's Global Assessment (0-10) + Subject's Global Assessment (0-10) + C-reactive protein (CRP) (in mg/dL). The total score range is 0-86. Score interpretation: Remission SDAI ≤ 3.3; Low Disease Activity SDAI > 3.3 and ≤ 11; Moderate Disease Activity SDAI > 11 and ≤ 26; High Disease Activity SDAI > 26. | FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit. | Posted | Mean | Standard Deviation | units on a scale | 1 day |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Activity Score Based on a 28-joint Count (DAS28), Calculated With Erythrocyte Sedimentation Rate for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | The DAS28 assessment is a derived measurement with differential weight given to each component. DAS28 will be calculated twice, utilizing first ESR, and then CRP as the acute phase reactant: 1) DAS28-ESR = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln ESR) + 0.014 GH, where GH=subject general health VAS (0-100 mm). 2) DAS28-4 CRP = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen count) + 0.36 (ln CRP+1) + 0.014 GH + 0.96, where GH=subject general health VAS (0- 100 mm), higher scores were indicative of a worse outcome. The specific components of the DAS28 assessment that were used in this study are: Tender/Painful Joint Count (28), Swollen Joint Count (28), ESR/CRP, and Subject's General Health VAS assessment. | FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit. | Posted | Mean | Standard Deviation | Units on a scale | 1 day |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Activity Score, 28 Joint Count, Calculated With C-reactive Protein (DAS28-CRP) for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | The DAS28 assessment is a derived measurement with differential weight given to each component. DAS28 will be calculated twice, utilizing first ESR, and then CRP as the acute phase reactant: 1) DAS28-ESR = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln ESR) + 0.014 GH, where GH=subject general health VAS (0 100 mm). 2) DAS28-4 CRP = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen count) + 0.36 (ln CRP+1) + 0.014 GH + 0.96, where GH=subject general health VAS (0-100 mm), higher scores were indicative of a worse outcome. The specific components of the DAS28 assessment that were used in this study are: Tender/Painful Joint Count (28), Swollen Joint Count (28), ESR/CRP, and Subject's General Health VAS assessment. | FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit. | Posted | Mean | Standard Deviation | Units on a scale | 1 day |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Health Assessment Questionnaire-Disability Index (HAQ DI) Scores for for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | The HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question in the questionnaire, the level of difficulty is scored from 0 to 3 with 0 representing "no difficulty," 1 as "some difficulty," 2 as "much difficulty," and 3 as "unable to do." Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. The total score range for the HAQ-DI scale, minimum score was 0 (best), maximum score was 3 (worst). | FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit. | Posted | Mean | Standard Deviation | Units on a scale | 1 day |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of HAQ DI (<=0.5) Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | HAQ DI (<=0.5) scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative. | FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit. | Posted | Number | percentage of participants | 1 day |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Correlation of Antidrug Antibody Titers With Efficacy Measures. | Correlation of antidrug antibody titers with efficacy measures analysed using Spearman correlation coefficient. | FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit. No participants for etanercept arm were antibody positive, therefore there is no correlation to report. | Posted | Number | Correlation coefficient | 1 day |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Correlation of Antidrug Antibody Titers With Trough Drug Concentration. | Correlation of antidrug antibody titers with trough drug concentration analysed using Spearman correlation coefficient. | FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit. No participants for etanercept arm were antibody positive, therefore there is no correlation to report. | Posted | Number | Correlation coefficient | 1 day |
|
From the signing of the informed consent until the follow-up visit (+28 days) following the assessment visit.
Not provided
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 who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit. | 1 | 200 | 5 | 200 | ||
| EG001 | Adalimumab | Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit. | 0 | 199 | 4 | 199 | ||
| EG002 | Infliximab | Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit. | 1 | 196 | 11 | 196 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal Failure | Renal and urinary disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Blood Count Abnormal | Investigations | MedDRA 17.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Injection Site Reaction | General disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Clostridium Difficile Colitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Oesophageal Candidiasis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Blood Pressure Increased | Investigations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Synovial Cyst | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1 | 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 |
| D000068879 | Adalimumab |
| D000069285 | Infliximab |
| 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 |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
Not provided
Not provided
| Male |
|
| No |
| Superiority or Other |
| Counts |
|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Infliximab |
Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit. |
|
|
| Infliximab |
Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit. |
|
|
Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
| OG002 | Infliximab | Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit. |
|
|
Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
| OG002 | Infliximab | Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit. |
|
|
| OG002 | Infliximab | Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|