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| ID | Type | Description | Link |
|---|---|---|---|
| ICON 9002/010 | |||
| 2011-002896-40 | EudraCT Number |
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In this study, patients with moderate to severe rheumatoid arthritis who are being treated with methotrexate will receive 2 intravenous treatments with either PF-05280586 or Rituxan (Rituximab) or MabThera (Rituximab). During the course of the study, the effects of the drugs will be assessed by sampling the levels of drug in the blood, blood cell counts, and by comparing these levels among the different treatments. Safety, tolerability and immunologic response also will be evaluated throughout.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - PF-05280586 | Experimental |
| |
| B - Rituximab EU | Active Comparator |
| |
| C- Rituximab-US | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05280586 | Biological | 1000 mg, IV on days 1 and 15 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Serum Concentration (Cmax) of Rituximab | Cmax is the peak serum concentration of study drug (rituximab) after a dose has been administered. | Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion |
| AUC 0-inf of Rituximab | The AUC 0-inf refers to the concentration in serum of the drug over time. It represents the total drug exposure over time, from time 0 (the point of drug administration) extrapolated to infinity. | Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Rituximab AUC From Time 0 to 2 Weeks (AUC 0-2wk) | The AUC 0-2wk refers to the concentration in serum of the drug over time. It represents the total drug exposure over time, from time 0 (the point of drug administration) to 2 weeks after drug administration. | Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion |
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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 |
|---|---|---|---|---|---|---|
| University of Alabama at Bermingham | Birmingham | Alabama | 35249 | United States | ||
| University of Alabama at Birmingham - Arthritis Clinical Intervention Program (ACIP) SRC 076 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27530379 | Derived | Williams JH, Hutmacher MM, Zierhut ML, Becker JC, Gumbiner B, Spencer-Green G, Melia LA, Liao KH, Suster M, Yin D, Li R, Meng X. Comparative assessment of clinical response in patients with rheumatoid arthritis between PF-05280586, a proposed rituximab biosimilar, and rituximab. Br J Clin Pharmacol. 2016 Dec;82(6):1568-1579. doi: 10.1111/bcp.13094. Epub 2016 Sep 22. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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This was a multinational, randomized, double-blind, controlled trial in participants with active rheumatoid arthritis (RA) on a background of methotrexate (MTX). The study was conducted at 56 centres in 10 countries. There were a total of 220 participants enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab-Pfizer | Participants received intravenous (IV) rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 milligram [mg] methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg per week (mg/week) (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| MabThera |
| Biological |
1000 mg, IV on days 1 and 15 |
|
| Rituxan | Biological | 1000 mg, IV on days 1 and 15 |
|
| Rituximab AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUC 0-T) | The AUC 0-T refers to the concentration in serum of the drug over time. It represents the total drug exposure over time, from time 0 (the point of drug administration) to the last measured concentration at time T. | Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion |
| CD19+ B-cell Count AUC From Time 0 to the Last Measurement at Time T (AUC 0-T,B-cell) | The AUC 0-T,B-cell refers to the concentration in serum of B-cells. It represents the total B-cells over time from time 0 (the point of drug administration) to the last measurement taken at time T. | Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT) |
| Minimum Post-Baseline CD19+ B-cell Count (/uL) | The lowest CD19+ B-cell count measured in a participant's blood post-baseline. | Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT) |
| Time to Minimum Post-Baseline CD19+ B-cell Count (Weeks) | The amount of time in weeks from baseline to the lowest observed CD19+ B-cell count. | Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT) |
| Duration of B-cell Depletion (τB-cell) (Days) | The τB-cell is defined as the time interval over which the B-cell count was <0.3 cells/uL or the detection limit. | Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT) |
| Percentage of Participants With CD19+ B-cell Count Recovery | The percentage of participants with CD19+ B-cell counts which fell to <50% of Baseline value during treatment and which recovered to ≥50% of Baseline value at End of Treatment. | Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 |
| Area Under the CD19+ B-cell Count Concentration-time Profile (AUC 0-T, B-cell) | The AUC 0-T, B-cell refers to the CD19+ B-cell count over time. It represents the total B-cells over time, from time 0 (the point of drug administration) to the last measured count at time T. | Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT) |
| Baseline and Change From Baseline in Circulating Immunoglobulin-M (IgM) by Visit (Grams Per Liter (g/L]) | The level of IgM in serum at Baseline and the change from Baseline at each subsequent visit. | Baseline and Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21 and 25 (EOT) |
| Percent (%) Change From Baseline in Circulating IgM by Visit (g/L) | The percentage change from Baseline in circulating IgM by visit. | Baseline and Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21 and 25 |
| Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response by Visit | ACR20 response: greater than or equal to (≥)20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). Non-responder imputation categorized participants as having a non-response if they did not have data available at a visit due to missing data or study discontinuation. Participants who rolled over to the extension study were not included in the non-responder imputation from that point on. | Weeks 3, 5, 9, 13, 17, 21 and 25 |
| Percentage of Participants With ACR 70% Improvement (ACR70) Response by Visit | ACR70 response: ≥70% improvement in tender joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. Non-responder imputation categorized participants as having a non-response if they did not have data available at a visit due to missing data or study discontinuation. Participantss who rolled over to the extension study were not included in the non-responder imputation from that point on. | Weeks 3, 5, 9, 13, 17, 21 and 25 (EOT) |
| Percentage of Participants With ACR 50% Improvement (ACR50) Response by Visit | ACR50 response: ≥50% improvement in tender joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. Non-responder imputation categorized participants as having a non-response if they did not have data available at a visit due to missing data or study discontinuation. Participants who rolled over to the extension study were not included in the non-responder imputation from that point on. | Weeks 3, 5, 9, 13, 17, 21 and 25 |
| Percentage of Participants by Anti-drug Antibody (ADA) Status | Presence of anti-rituximab antibodies in blood. Participants with a positive antibody status at any time during the study were defined as having overall positive antibody status; participants with a negative antibody status throughout the study were defined as having overall negative antibody status. | Days 1 up to Day 169. |
| Percentage of Participants With Neutralizing Antibody (NAb) in Participants With a Positive ADA by Visit | Day 1 up to Day 169 |
| Change From Baseline in Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (DAS28-CRP) | DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP less than or equal to (≤)3.2 implied low disease activity, DAS28-CRP greater than (>)3.2 to ≤5.1 implied moderate to high disease activity, and DAS28-CRP less than (<)2.6 implied remission. | Baseline and Weeks 3, 5, 9, 13, 17, 21 and 25 |
| Percent Change From Baseline in DAS28-CRP by Visit | DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP less than or equal to (≤)3.2 implied low disease activity, DAS28-CRP greater than (>)3.2 to ≤5.1 implied moderate to high disease activity, and DAS28-CRP less than (<)2.6 implied remission. | Baseline and Weeks 3, 5, 9, 13, 17, 21 and 25 |
| Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on Disease Activity Score Based on 28-Joint Count (DAS28) by Visit | The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6, or change from baseline >0.6 and ≤1.2 with DAS28 >5.1. | Weeks 3, 5, 9, 13, 17, 21 and 25 |
| Percentage of Participants With Moderate EULAR Response Based on Disease Activity Score Based on DAS28 by Visit | The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6, or change from baseline >0.6 and ≤1.2 with DAS28 >5.1. | Weeks 3, 5, 9, 13, 17, 21 and 25 |
| Percentage of Participants With No EULAR Response Based on DAS28 by Visit | The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6, or change from baseline >0.6 and ≤1.2 with DAS28 >5.1. | Weeks 3, 5, 9, 13, 17, 21 and 25 |
| Percentage of Participants With Low Disease Activity Score (DAS <=3.2) by Visit | DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity. p-value of 9999 indicates p-value is not applicable. | Weeks 3, 5, 9, 13, 17, 21 and 25 |
| Percentage of Participants With DAS Remission (DAS <2.6) by Visit | DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP <2.6 implied remission. p-value of 9999 indicates p-value is not applicable. | Weeks 3, 5, 9, 13, 17, 21 and 25 |
| Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Visit | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. 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 0-3 where 0 = least difficulty and 3 = extreme difficulty. | Baseline, Week 3, 5, 9, 13, 17, 21 and 25 |
| Percent Change From Baseline in HAQ-DI Score by Visit | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. 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 0-3 where 0 = least difficulty and 3 = extreme difficulty. | Baseline, Week 3, 5, 9, 13, 17, 21 and 25 |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| Rheumatology Associates of North Alabama, PC | Huntsville | Alabama | 35801 | United States |
| ArthroCare, Arthritis Care & Research, PC | Gilbert | Arizona | 85234 | United States |
| Mercy Clinic Hot Springs Communities | Hot Springs | Arkansas | 71913 | United States |
| UCLA David Geffen School of Medicine | Los Angeles | California | 90095-1670 | United States |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | United States |
| Desert Medical Advances | Palm Desert | California | 92260 | United States |
| Advances In Medicine | Rancho Mirage | California | 92270 | United States |
| New England Research Assoc. LLC | Trumbull | Connecticut | 06611 | United States |
| Arthritis Associates | Orlando | Florida | 32804 | United States |
| University of South Florida - College of Medicine, Frank and Carol Morsani Center | Tampa | Florida | 33612 | United States |
| Loyola Center for Health at Burr Ridge | Burr Ridge | Illinois | 60527 | United States |
| Loyola Medical Medical Center Outpatient Center | Maywood | Illinois | 60153 | United States |
| Loyola University Medical Center Pharmacy | Maywood | Illinois | 60153 | United States |
| Illinois Bone and Joint Institute | Morton Grove | Illinois | 60053 | United States |
| Loyola Center for health at Oakbrook Terrace North | Oakbrook Terrace | Illinois | 60181 | United States |
| Bluegrass Community Research, Inc. | Lexington | Kentucky | 40504 | United States |
| Klein & Associates, M.D., P.A. | Cumberland | Maryland | 21502 | United States |
| Klein & Associates, M.D., P.A. | Hagerstown | Maryland | 21740 | United States |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01605 | United States |
| UMass Memorial Medical Center - Memorial Campus | Worcester | Massachusetts | 01605 | United States |
| UMass Memorial Medical Center-Rheumatology Center-Memorial Campus | Worcester | Massachusetts | 01605 | United States |
| Bronson Internal Medicine & Rheumatology | Battle Creek | Michigan | 49015 | United States |
| Rheumatology/Arthritis Center | Lansing | Michigan | 48910 | United States |
| University Of Nevada School Of Medicine | Las Vegas | Nevada | 89102 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| North Shore-LIJ Health System - Division of Rheumatology and Allergy-Clinical Immunology | Great Neck | New York | 11021 | United States |
| Box Arthritis & Rheumatology of the Carolinas, PLLC | Charlotte | North Carolina | 28210 | United States |
| Hickory Family Practice Associates | Hickory | North Carolina | 28601 | United States |
| PMG Research of Hickory, LLC - PI's Main Office (Subject visit, IP Storage, Infusion, & Lab Draws) | Hickory | North Carolina | 28602 | United States |
| PMG Research of Hickory | Hickory | North Carolina | 28602 | United States |
| Cincinnati Rheumatic Disease Study Group, Inc. | Cincinnati | Ohio | 45219 | United States |
| Health Research of Oklahoma | Oklahoma City | Oklahoma | 73103 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| The Arthritis Group | Philadelphia | Pennsylvania | 19152 | United States |
| Clinical Research Center of Reading, LLP | Wyomissing | Pennsylvania | 19610 | United States |
| Arthritis Associates, PLLC | Hixson | Tennessee | 37343 | United States |
| Arthritis Clinic | Jackson | Tennessee | 38305 | United States |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | United States |
| Metroplex Clinical Research Center | Dallas | Texas | 75231 | United States |
| Center For Clinical Trials Of Houston | Houston | Texas | 77004 | United States |
| Southwest Rheumatology Research LLC. | Mesquite | Texas | 75150 | United States |
| Rheumatology Research Unit | Maroochydore | Queensland | 4558 | Australia |
| The Queen Elizabeth Hospital, Department of Rheumatology | Woodville South | South Australia | 5011 | Australia |
| St. Vincent's Hospital (Melbourne) | Fitzroy | Victoria | 03065 | Australia |
| Pharmacie Matte et Petit | Québec | Quebec | G1V 3M7 | Canada |
| Centre de Rhumatologie St-Louis | Québec | Quebec | G1W 4R4 | Canada |
| Centre de Rhumatologie de l'Est du Quebec | Rimouski | Quebec | G5L 8W1 | Canada |
| Clinique Medicale du Phare | Rimouski | Quebec | G5L IJ5 | Canada |
| Centre de Recherche Musculo-Squelettique | Trois-Rivières | Quebec | G8Z 1Y2 | Canada |
| Clinica Medellin S.A Sede Centro | Medellín | Antioquia | Colombia |
| Mix Supplier S.A | Medellín | Antioquia | Colombia |
| Rodrigo Botero S.A.S. | Medellín | Antioquia | Colombia |
| Cediul S.A. | Barranquilla | Atlántico | Colombia |
| Centro de Reumatologia y Ortopedia | Barranquilla | Atlántico | Colombia |
| Clinica Bonnadona - Prevenir S.A. | Barranquilla | Atlántico | Colombia |
| Clinica de la Costa Ltdz. | Barranquilla | Atlántico | Colombia |
| IPS Centro Integral de Reumatologia del Cairbe, CIRCARIBE S.A.S. | Barranquilla | Atlántico | Colombia |
| Sabbag Radiologos Ltda. | Barranquilla | Atlántico | Colombia |
| Cerid S.A. | Barranquilla, Colombia | Atlántico | Colombia |
| Congregacion de las Hemanas Franciscanas Misioneras de Maria Auxiliadora - Clinica La Asuncion | Barranquilla, Colombia | Atlántico | Colombia |
| IPS Clinica General del Norte S.A. | Barranquilla, Colombia | Atlántico | Colombia |
| Schlosspark-Klinik GMBH, Internal Medicine II | Berlin | 14059 | Germany |
| The Chaim Sheba Medical Center Department of Internal Medicine B | Ramat Gan | 52621 | Israel |
| Cliditer, S.A. de C.V. | México | D.F. | 06700 | Mexico |
| Private Office | Guadalajara | Jalisco | 06726 | Mexico |
| Centro De Investigacion Y Atencion Integral Durango CIAID | Durango | 34270 | Mexico |
| Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C. | San Luis Potosí City | 78200 | Mexico |
| LLC CDCR "Healthy Joints" | Novosibirsk | Novosibirsk Oblast | 630091 | Russia |
| GBUZ City Clinical Hospital #7 | Kazan' | Tatarstan Republic | 420103 | Russia |
| State Institution of Healthcare "Regional Clinical Hospital for Wars' Veterans" | Kemerovo | 650000 | Russia |
| State Budgetary Institution of Healthcare of Nizhegorodskiy Region | Nizhny Novgorod | 603005 | Russia |
| St. Petersburg state Healthcare lnstitution 'Clinical Rheumatology Hospital No25 | Saint Petersburg | 190068 | Russia |
| Llc Ava-Peter | Saint Petersburg | 191014 | Russia |
| State Institute of Healthcare Samara Regional Clinical Hospital named after M.I.Kalinin | Samara | 443095 | Russia |
| Regional State Budget Institution of Healthcare "Tomsk Regional Clinical Hospital" | Tomsk | 634063 | Russia |
| Panorama Medical Centre | Panorama | CAPE TOWN | 7500 | South Africa |
| Dr. Jan Fourie Medical Centre | Dundee | KwaZulu-Natal | 3000 | South Africa |
| Bexley Wing - St. James's University Hospital | Leeds | UK | LS9 7TF | United Kingdom |
| Pharmacy Department, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust | Leeds | LS1 3EX | United Kingdom |
| "The University of Leeds, | Leeds | LS7 4SA | United Kingdom |
| Pharmacy Dispensing - Bexley Wing - St. James's University Hospital | Leeds | LS9 7TF | United Kingdom |
| Whipps Cross University Hospital | London | E11 1NR | United Kingdom |
| FG001 | Rituximab-European Union (EU) | Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
| FG002 | Rituximab-US | Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Modified intent-to-treat (mITT) population included all participants who were randomized and received at least 1 dose of study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab-Pfizer | Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
| BG001 | Rituximab-EU | Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
| BG002 | Rituximab-US | Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Maximum Serum Concentration (Cmax) of Rituximab | Cmax is the peak serum concentration of study drug (rituximab) after a dose has been administered. | Per protocol (PP) population: all participants who were randomized, received the full doses of the assigned study treatment, and had no major protocol violations that could impact the pharmacokinetic (PK) analysis. Exclusions from the PP population were based on a blinded data review by the Medical Monitor and Clinical Pharmacologist. | Posted | Mean | Standard Deviation | micrograms per milliliter | Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion |
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| Primary | AUC 0-inf of Rituximab | The AUC 0-inf refers to the concentration in serum of the drug over time. It represents the total drug exposure over time, from time 0 (the point of drug administration) extrapolated to infinity. | PP population. "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | ug*hr/mL | Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion |
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| Secondary | Rituximab AUC From Time 0 to 2 Weeks (AUC 0-2wk) | The AUC 0-2wk refers to the concentration in serum of the drug over time. It represents the total drug exposure over time, from time 0 (the point of drug administration) to 2 weeks after drug administration. | PP population. | Posted | Mean | Standard Deviation | ug*hr/mL | Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion |
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| Secondary | Rituximab AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUC 0-T) | The AUC 0-T refers to the concentration in serum of the drug over time. It represents the total drug exposure over time, from time 0 (the point of drug administration) to the last measured concentration at time T. | PP population. | Posted | Mean | Standard Deviation | ug*hr/mL | Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion |
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| Secondary | CD19+ B-cell Count AUC From Time 0 to the Last Measurement at Time T (AUC 0-T,B-cell) | The AUC 0-T,B-cell refers to the concentration in serum of B-cells. It represents the total B-cells over time from time 0 (the point of drug administration) to the last measurement taken at time T. | mITT population. "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | cells*day/mL | Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT) |
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| Secondary | Minimum Post-Baseline CD19+ B-cell Count (/uL) | The lowest CD19+ B-cell count measured in a participant's blood post-baseline. | mITT population. "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | cells/uL | Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT) |
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| Secondary | Time to Minimum Post-Baseline CD19+ B-cell Count (Weeks) | The amount of time in weeks from baseline to the lowest observed CD19+ B-cell count. | mITT population. "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | weeks | Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT) |
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| Secondary | Duration of B-cell Depletion (τB-cell) (Days) | The τB-cell is defined as the time interval over which the B-cell count was <0.3 cells/uL or the detection limit. | mITT population. "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | days | Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT) |
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| Secondary | Percentage of Participants With CD19+ B-cell Count Recovery | The percentage of participants with CD19+ B-cell counts which fell to <50% of Baseline value during treatment and which recovered to ≥50% of Baseline value at End of Treatment. | mITT population. "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. | Posted | Number | Percentage of participants | Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 |
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| Secondary | Area Under the CD19+ B-cell Count Concentration-time Profile (AUC 0-T, B-cell) | The AUC 0-T, B-cell refers to the CD19+ B-cell count over time. It represents the total B-cells over time, from time 0 (the point of drug administration) to the last measured count at time T. | mITT population. "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | cells*day/uL | Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT) |
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| Secondary | Baseline and Change From Baseline in Circulating Immunoglobulin-M (IgM) by Visit (Grams Per Liter (g/L]) | The level of IgM in serum at Baseline and the change from Baseline at each subsequent visit. | mITT population. "Number Analyzed" = participants evaluable at specified time points. | Posted | Mean | Standard Deviation | g/L | Baseline and Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21 and 25 (EOT) |
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| Secondary | Percent (%) Change From Baseline in Circulating IgM by Visit (g/L) | The percentage change from Baseline in circulating IgM by visit. | mITT population. "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. "Number Analyzed" = participants evaluable at specified time points. | Posted | Mean | Standard Deviation | percent change | Baseline and Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21 and 25 |
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| Secondary | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response by Visit | ACR20 response: greater than or equal to (≥)20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). Non-responder imputation categorized participants as having a non-response if they did not have data available at a visit due to missing data or study discontinuation. Participants who rolled over to the extension study were not included in the non-responder imputation from that point on. | mITT population. "Number Analyzed" = participants evaluable at specified time points. | Posted | Number | Percentage of participants | Weeks 3, 5, 9, 13, 17, 21 and 25 |
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| Secondary | Percentage of Participants With ACR 70% Improvement (ACR70) Response by Visit | ACR70 response: ≥70% improvement in tender joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. Non-responder imputation categorized participants as having a non-response if they did not have data available at a visit due to missing data or study discontinuation. Participantss who rolled over to the extension study were not included in the non-responder imputation from that point on. | mITT population. "Number Analyzed" = participants evaluable at specified time points. | Posted | Number | Percentage of participants | Weeks 3, 5, 9, 13, 17, 21 and 25 (EOT) |
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| Secondary | Percentage of Participants With ACR 50% Improvement (ACR50) Response by Visit | ACR50 response: ≥50% improvement in tender joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. Non-responder imputation categorized participants as having a non-response if they did not have data available at a visit due to missing data or study discontinuation. Participants who rolled over to the extension study were not included in the non-responder imputation from that point on. | mITT population. "Number Analyzed" = participants evaluable at specified time points. | Posted | Number | Percentage of Participants | Weeks 3, 5, 9, 13, 17, 21 and 25 |
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| Secondary | Percentage of Participants by Anti-drug Antibody (ADA) Status | Presence of anti-rituximab antibodies in blood. Participants with a positive antibody status at any time during the study were defined as having overall positive antibody status; participants with a negative antibody status throughout the study were defined as having overall negative antibody status. | mITT population. | Posted | Number | Percentage of participants | Days 1 up to Day 169. |
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| Secondary | Percentage of Participants With Neutralizing Antibody (NAb) in Participants With a Positive ADA by Visit | mITT population. Only participants with a positive ADA status were included in the analysis. | Posted | Number | Percentage of participants | Day 1 up to Day 169 |
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| Secondary | Change From Baseline in Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (DAS28-CRP) | DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP less than or equal to (≤)3.2 implied low disease activity, DAS28-CRP greater than (>)3.2 to ≤5.1 implied moderate to high disease activity, and DAS28-CRP less than (<)2.6 implied remission. | mITT population. "Number Analyzed" = participants evaluable at specified time points. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Weeks 3, 5, 9, 13, 17, 21 and 25 |
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| Secondary | Percent Change From Baseline in DAS28-CRP by Visit | DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP less than or equal to (≤)3.2 implied low disease activity, DAS28-CRP greater than (>)3.2 to ≤5.1 implied moderate to high disease activity, and DAS28-CRP less than (<)2.6 implied remission. | mITT population. "Number Analyzed" = participants evaluable at specified time points. | Posted | Mean | Standard Deviation | Percent change | Baseline and Weeks 3, 5, 9, 13, 17, 21 and 25 |
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| Secondary | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on Disease Activity Score Based on 28-Joint Count (DAS28) by Visit | The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6, or change from baseline >0.6 and ≤1.2 with DAS28 >5.1. | mITT population. "Number Analyzed" = participants evaluable at specified time points. | Posted | Number | Percentage of participants | Weeks 3, 5, 9, 13, 17, 21 and 25 |
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| Secondary | Percentage of Participants With Moderate EULAR Response Based on Disease Activity Score Based on DAS28 by Visit | The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6, or change from baseline >0.6 and ≤1.2 with DAS28 >5.1. | mITT population. "Number Analyzed" = participants evaluable at specified time points. | Posted | Number | Percentage of participants | Weeks 3, 5, 9, 13, 17, 21 and 25 |
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| Secondary | Percentage of Participants With No EULAR Response Based on DAS28 by Visit | The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6, or change from baseline >0.6 and ≤1.2 with DAS28 >5.1. | mITT population. "Number Analyzed" = participants evaluable at specified time points. | Posted | Number | Percentage of Participants | Weeks 3, 5, 9, 13, 17, 21 and 25 |
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| Secondary | Percentage of Participants With Low Disease Activity Score (DAS <=3.2) by Visit | DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity. p-value of 9999 indicates p-value is not applicable. | mITT population. "Number Analyzed" = participants evaluable at specified time points. | Posted | Number | Percentage of participants | Weeks 3, 5, 9, 13, 17, 21 and 25 |
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| Secondary | Percentage of Participants With DAS Remission (DAS <2.6) by Visit | DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP <2.6 implied remission. p-value of 9999 indicates p-value is not applicable. | mITT population. "Number Analyzed" = participants evaluable at specified time points. | Posted | Number | Percentage of participants | Weeks 3, 5, 9, 13, 17, 21 and 25 |
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| Secondary | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Visit | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. 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 0-3 where 0 = least difficulty and 3 = extreme difficulty. | mITT population. "Number Analyzed" = participants evaluable at specified time points. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 3, 5, 9, 13, 17, 21 and 25 |
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| Secondary | Percent Change From Baseline in HAQ-DI Score by Visit | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. 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 0-3 where 0 = least difficulty and 3 = extreme difficulty. | mITT population. "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. "Number Analyzed" = participants evaluable at specified time points. | Posted | Mean | Standard Deviation | Percentage change | Baseline, Week 3, 5, 9, 13, 17, 21 and 25 |
|
Adverse events (AEs) were collected for 28 days after the last administration of study drug or, in the case of incomplete B-cell count recovery, for up to 1 year after Study Day 1.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant 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 | Rituximab-Pfizer | Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. | 5 | 73 | 49 | 73 | ||
| EG001 | Rituximab-EU | Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. | 1 | 74 | 40 | 74 | ||
| EG002 | Rituximab-US | Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. | 4 | 73 | 45 | 73 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Bone neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Intentional self-injury | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Joint instability | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Muscle atrophy | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
| |
| Benign neoplasm of thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Venous insufficiency | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Ear disorder | Ear and labyrinth disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Ear pruritus | Ear and labyrinth disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Abnormal sensation in eye | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Eye haemorrhage | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Eyelid pain | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Lip swelling | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Lip ulceration | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Tongue ulceration | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Inflammation | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Local swelling | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Tachycardia paroxysmal | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Infected bites | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| Muscle contusion | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| Underdose | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Mood swings | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Campbell de Morgan spots | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Rash vesicular | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 17.0 | 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 |
| 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 |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation. | Test-to-reference ratio: adjusted means | 106.62 | 2-Sided | 90 | 97.65 | 116.41 | Rituximab-Pfizer is the numerator. | Equivalence | PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC 0-inf are within the 80.00% to 125.00% range. |
| A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation. | Test-to-reference ratio: adjusted means | 100.90 | 2-Sided | 90 | 92.38 | 110.20 | Rituximab-EU is the numerator. | Equivalence | PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC 0-inf are within the 80.00% to 125.00% range. |
| OG002 | Rituximab-US | Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
|
|
|
| OG002 | Rituximab-US | Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
|
|
|
| OG002 | Rituximab-US | Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
|
|
|
| OG002 | Rituximab-US | Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
|
|
| Rituximab-US |
Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
|
|
| Rituximab-US |
Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
|
|
| OG002 |
| Rituximab-US |
Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
|
|
| OG002 | Rituximab-US | Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
|
|
| OG002 | Rituximab-US | Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
|
|
| OG002 |
| Rituximab-US |
Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
|
|
| OG002 | Rituximab-US | Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
|
|
Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
| OG002 | Rituximab-US | Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
|
|
| OG002 | Rituximab-US | Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
|
|
| OG002 | Rituximab-US | Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
|
|
| OG002 | Rituximab-US | Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
|
|
Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
|
|
| OG002 | Rituximab-US | Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
|
|
| OG002 | Rituximab-US | Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
|
|
| OG002 | Rituximab-US | Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
|
|
| OG002 | Rituximab-US | Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
|
|
| OG002 | Rituximab-US | Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
|
|
| OG002 | Rituximab-US | Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
|
|
|
| OG002 | Rituximab-US | Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
|
|
|
| OG002 | Rituximab-US | Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
|
|
| OG002 | Rituximab-US | Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. |
|
|