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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018375-22 |
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This randomized, double-blind, parallel group study compares the efficacy and safety of subcutaneous (sc) versus intravenous (iv) administration of tocilizumab in participants with moderate to severe active rheumatoid arthritis. Participants were randomized to receive either tocilizumab 162 mg sc weekly plus iv placebo every 4 weeks, or tocilizumab 8 mg/kg iv every 4 weeks plus sc placebo weekly during the double-blind period from baseline to Week 24. The double-blind period was followed by a 72-week open-label treatment with some switching of sc and iv administration. No placebo was administered in the open-label phase. Participants continued on their stable dose of disease-modifying antirheumatic drugs (DMARDs) throughout the study. Anticipated time on study treatment was 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocilizumab SC | Experimental | Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study. |
|
| Tocilizumab IV | Experimental | Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study. |
|
| Tocilizumab SC Then Tocilizumab IV | Experimental | Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tocilizumab SC | Drug | Tocilizumab supplied in a single-use pre-filled syringe, with a needle safety device, delivering 162 mg/0.9 mL solution for subcutaneous injection once a week. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR20) Response at Week 24 | ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein [CRP] or Erythrocyte Sedimentation Rate [ESR]). | Baseline, 24 weeks |
| Percentage of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Assessments | Baseline to up to 3 months after last dose of study drug (approximately up to 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR50) Response at Week 24 | ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein or Erythrocyte Sedimentation Rate). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | 35801 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26056119 | Derived | Burmester GR, Rubbert-Roth A, Cantagrel A, Hall S, Leszczynski P, Feldman D, Rangaraj MJ, Roane G, Ludivico C, Bao M, Rowell L, Davies C, Mysler EF. Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA). Ann Rheum Dis. 2016 Jan;75(1):68-74. doi: 10.1136/annrheumdis-2015-207281. Epub 2015 Jun 8. |
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A total of 1262 participants at 209 centers in 25 countries were randomized into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tocilizumab SC | Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 24 Weeks Double Blind Period |
|
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| Tocilizumab IV Then Tocilizumab SC | Experimental | Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study. |
|
|
| tocilizumab IV | Drug | Tocilizumab supplied in vials as a sterile solution for 8 mg/kg intravenous infusion every 4 weeks. |
|
|
| placebo to tocilizumab SC | Drug | Placebo tocilizumab supplied as a single-use pre-filled syringe with a needle safety device, delivering 0.9 mL sodium chloride for subcutaneous injection once a week for 24 weeks in the double-blind period. |
|
| placebo to tocilizumab IV | Drug | Placebo to tocilizumab supplied as a solution in 10 mL vials containing polysorbate 80 and sucrose in water for infusion every 4 weeks for a total of 24 weeks in the double-blind period. |
|
| Disease-modifying antirheumatic drugs (DMARDs) | Drug | stable dose as prescribed |
|
| Baseline, 24 weeks |
| Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR70) Response at Week 24 | ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein or Erythrocyte Sedimentation Rate). | Baseline, 24 weeks |
| Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 24 | The DAS28 (ESR) score is a measure of the subject's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity VAS where left side of the line 0=no disease activity to right side of the line 100=extreme disease activity and ESR. DAS28-(ESR) total scores range from 0 - 10. Remission is defined as achieving a DAS28-ESR score of less than 2.6. | Week 24 |
| Percentage of Participants Achieving a Decrease of ≥ 0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24 | The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a participant completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A decrease indicates improvement. | Baseline, 24 Weeks |
| Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 24 | The percentage of participants who withdrew from the study because they were not responding to treatment with the study drug. | 24 Weeks |
| Percentage of Participants With American College of Rheumatology Criteria (ACR20, ACR50, ACR70) at Week 97 | ACR20, ACR50 and ACR70: ≥20%, ≥50% and ≥70% reduction from baseline for both TJC68 and SJC66, as well as for 3 of 5 additional ACR variables: Patient's Assessment of Pain in last 24 hours using a Visual Analog Scale (VAS) (0=no pain and 100=unbearable pain); Patient's and Physician's Global Assessment of Disease Activity in last 24 hours using a VAS (0=no disease activity and100=maximum disease activity); Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either CRP or ESR). CRP was used for calculation of ACR. If missing, ESR was used. LOCF was used for missing joint counts, no imputation for other ACR components. | Week 97 |
| Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 97 | The DAS28 (ESR) score is a measure of the subject's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity VAS where left side of the line 0=no disease activity to right side of the line 100=extreme disease activity and ESR. DAS28-(ESR) total scores range from 0 - 10. Remission is defined as achieving a DAS28-ESR score of less than 2.6. LOCF used for tender and swollen joint counts, no imputation used for ESR and Patient's Global Assessment of Disease Activity VAS. | Week 97 |
| Percentage of Participants Achieving a Decrease of ≥0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 97 | The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A decrease indicates improvement. No imputation of missing scores was made other than for missing baseline scores, for which last score prior to baseline will be carried forward. For participants who prematurely withdrew, data collected at withdrawal visit was used and data thereafter is missing. | Baseline, Week 97 |
| Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 97 | The percentage of participants who withdrew from the study because they were not responding to treatment with the study drug. | Week 97 |
| Area Under the Serum Concentration Curve of Tocilizumab After First SC Injection or IV Infusion | Week 0: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after first dose |
| Area Under the Serum Concentration Curve of Tocilizumab at Steady State for SC and IV Treatment | Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose. |
| Minimum Serum Concentration (Cmin) of Tocilizumab | Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose |
| Maximum Serum Concentration (Cmax) of Tocilizumab | Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose |
| Time to Maximum Serum Concentration (Tmax) of Tocilizumab | Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose |
| Change From Baseline in Serum Interleukin-6 (IL-6) Concentration at Week 25 | Baseline, Week 25 |
| Change From Baseline in Serum Soluble Interleukin-6 Receptor (sIL-6R) Concentration at Week 97 | Baseline, Week 97 |
| Percentage of Participants Who Developed Antibodies To Tocilizumab at Week 97 | Week 97 |
| Tuscaloosa |
| Alabama |
| 35406 |
| United States |
| Tucson | Arizona | 85704 | United States |
| Tucson | Arizona | 85712 | United States |
| Long Beach | California | 90806 | United States |
| Los Angeles | California | 90048 | United States |
| Upland | California | 91786 | United States |
| Van Nuys | California | 91405 | United States |
| Denver | Colorado | 80230-7127 | United States |
| Bridgeport | Connecticut | 06606 | United States |
| Delray Beach | Florida | 33484 | United States |
| Miami | Florida | 33133 | United States |
| Ocala | Florida | 34474 | United States |
| Orlando | Florida | 32806 | United States |
| Palm Harbor | Florida | 34684 | United States |
| Pinellas Park | Florida | 33782 | United States |
| South Miami | Florida | 33143 | United States |
| Tampa | Florida | 33614 | United States |
| Coeur d'Alene | Idaho | 83814 | United States |
| Morton Grove | Illinois | 60053 | United States |
| Wichita | Kansas | 67208 | United States |
| Monroe | Louisiana | 71203 | United States |
| Petoskey | Michigan | 49770 | United States |
| Saint Claire Shores | Michigan | 48081 | United States |
| Eagan | Minnesota | 55121 | United States |
| Florissant | Missouri | 63031 | United States |
| St Louis | Missouri | 63117 | United States |
| St Louis | Missouri | 63131 | United States |
| Lebanon | New Hampshire | 03756 | United States |
| Clifton | New Jersey | 07012 | United States |
| Manalapan | New Jersey | 07726 | United States |
| Voorhees Township | New Jersey | 08043 | United States |
| Albuquerque | New Mexico | 87102 | United States |
| Albany | New York | 12206 | United States |
| Binghamton | New York | 13905 | United States |
| Orchard Park | New York | 14127 | United States |
| Asheville | North Carolina | 28803 | United States |
| Raleigh | North Carolina | 27609 | United States |
| Wilmington | North Carolina | 28401 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Toledo | Ohio | 43623 | United States |
| Oklahoma City | Oklahoma | 73103 | United States |
| Tulsa | Oklahoma | 74135 | United States |
| Bethlehem | Pennsylvania | 18015 | United States |
| Charleston | South Carolina | 29406 | United States |
| Charleston | South Carolina | 29407 | United States |
| Knoxville | Tennessee | 37909 | United States |
| Memphis | Tennessee | 38119 | United States |
| Houston | Texas | 77004 | United States |
| San Antonio | Texas | 78217 | United States |
| Olympia | Washington | 98502 | United States |
| Seattle | Washington | 98122 | United States |
| Spokane | Washington | 99204 | United States |
| Wenatchee | Washington | 98801 | United States |
| Buenos Aires | B1878DVB | Argentina |
| Buenos Aires | C1015ABO | Argentina |
| Buenos Aires | C1428DQG | Argentina |
| Rosario | S2000PBJ | Argentina |
| Adelaide | 5011 | Australia |
| Adelaide | 5041 | Australia |
| Clayton | 3168 | Australia |
| Geelong | 3220 | Australia |
| Hobart | 7000 | Australia |
| Malvern East | 3145 | Australia |
| Maroochydore | 4558 | Australia |
| New Lambton | 2305 | Australia |
| Curitiba | 80060-240 | Brazil |
| Goiânia | 74110010 | Brazil |
| Juiz de Fora | 36010-570 | Brazil |
| Porto Alegre | 90035-903 | Brazil |
| Porto Alegre | 90610-000 | Brazil |
| São Paulo | 04039-000 | Brazil |
| São Paulo | 05403-000 | Brazil |
| São Paulo | 4037003 | Brazil |
| Sofia | 1606 | Bulgaria |
| Sofia | 1612 | Bulgaria |
| Sofia | 1784 | Bulgaria |
| Edmonton | Alberta | T5H 3V9 | Canada |
| Kelowna | British Columbia | V1Y 3G8 | Canada |
| Vancouver | British Columbia | V5Z 1L7 | Canada |
| St. John's | Newfoundland and Labrador | A1A 5E8 | Canada |
| St. John's | Newfoundland and Labrador | A1C 5B8 | Canada |
| Hamilton | Ontario | L8N 1Y2 | Canada |
| Hamilton | Ontario | L8N 2B6 | Canada |
| Kitchener | Ontario | N2M 5N6 | Canada |
| Ottawa | Ontario | K1Y 4G2 | Canada |
| St. Catharines | Ontario | L2N 7E4 | Canada |
| Windsor | Ontario | N8X 5A6 | Canada |
| Montreal | Quebec | H2L 1S6 | Canada |
| Québec | Quebec | G1V 3M7 | Canada |
| Rimouski | Quebec | G5L 3W1 | Canada |
| Sainte-Foy | Quebec | G1W 4R4 | Canada |
| Trois-Rivières | Quebec | G8Z 1Y2 | Canada |
| Saskatoon | Saskatchewan | S7K 0H6 | Canada |
| Barranquilla | Colombia |
| Bogotá | Colombia |
| Bordeaux | 33076 | France |
| Le Mans | 72037 | France |
| Marseille | 13285 | France |
| Montpellier | 34295 | France |
| Nantes | 44035 | France |
| Paris | 75679 | France |
| Strasbourg | 67098 | France |
| Toulouse | 31059 | France |
| Bad Bramstedt | 24576 | Germany |
| Berlin | 10117 | Germany |
| Berlin | 14059 | Germany |
| Cologne | 50924 | Germany |
| Dresden | 01067 | Germany |
| Essen | 45239 | Germany |
| Freiburg im Breisgau | 79106 | Germany |
| Gommern | 39245 | Germany |
| Heidelberg | 69120 | Germany |
| Herne | 44652 | Germany |
| Hildesheim | 31134 | Germany |
| Ludwigshafen | 67063 | Germany |
| Osnabrück | 49074 | Germany |
| Ratingen | 40882 | Germany |
| Rostock | 18059 | Germany |
| Würzburg | 97080 | Germany |
| Guatemala City | 01010 | Guatemala |
| Guatemala City | 01015 | Guatemala |
| Hong Kong | 852 | Hong Kong |
| Hong Kong | Hong Kong |
| Arenzano | 16011 | Italy |
| Bergamo | 24128 | Italy |
| Catania | 95124 | Italy |
| Cona (ferrara) | 44124 | Italy |
| Genova | 16132 | Italy |
| Naples | 80131 | Italy |
| Pavia | 27100 | Italy |
| Pisa | 56100 | Italy |
| Potenza | 85100 | Italy |
| Reggio Emilia | 42100 | Italy |
| Udine | 33100 | Italy |
| Varese | 21100 | Italy |
| Klaipėda | 92288 | Lithuania |
| Šiauliai | 76231 | Lithuania |
| Vilnius | LT-08661 | Lithuania |
| Culiacán | 80000 | Mexico |
| Guadalajara | 44629 | Mexico |
| Guadalajara | 44690 | Mexico |
| León | 37000 | Mexico |
| Mexico Ctiy | 07760 | Mexico |
| Mérida | 97000 | Mexico |
| Miexico City | 06700 | Mexico |
| Morelia | 58070 | Mexico |
| Obregón | 85000 | Mexico |
| Querétaro | 76178 | Mexico |
| Saltillo | 25000 | Mexico |
| Torreón | 27000 | Mexico |
| Auckland | 2025 | New Zealand |
| Hamilton | 3240 | New Zealand |
| Tauranga | 3112 | New Zealand |
| Wellington | 6035 | New Zealand |
| Lima | 01 | Peru |
| Lima | LIMA 14 | Peru |
| Lima | Lima 41 | Peru |
| Cebu | 6000 | Philippines |
| Manila | 1000 | Philippines |
| Quezon | 1102 | Philippines |
| Bialystok | 15-351 | Poland |
| Lublin | 20-954 | Poland |
| Poznan | 60-218 | Poland |
| Warsaw | 01-157 | Poland |
| Ponce | 00716 | Puerto Rico |
| Bucharest | 011172 | Romania |
| Bucharest | 020475 | Romania |
| Bucharest | 020983 | Romania |
| Iași | 700661 | Romania |
| Moscow | 115522 | Russia |
| Moscow | 119991 | Russia |
| Novosibirsk | 630099 | Russia |
| Novosibirsk | 630117 | Russia |
| Ryazan | 390026 | Russia |
| Saint Petersburg | 190068 | Russia |
| Ulyanovsk | 432600 | Russia |
| Yaroslavl | 150030 | Russia |
| Yaroslavl | 150062 | Russia |
| Singapore | 119074 | Singapore |
| Cape Town | 7500 | South Africa |
| Durban | 4001 | South Africa |
| Parktown | 2000 | South Africa |
| Port Elizabeth | 6045 | South Africa |
| Stellenbosch | 7600 | South Africa |
| A Coruña | 15006 | Spain |
| Barakaldo | 48903 | Spain |
| Bilbao | 48013 | Spain |
| Madrid | 28007 | Spain |
| Madrid | 28046 | Spain |
| Málaga | 29010 | Spain |
| Mérida | 97500 | Spain |
| San Cristóbal de La Laguna | 38320 | Spain |
| Santander | 39008 | Spain |
| Santiago de Compostela | 15706 | Spain |
| Seville | 41009 | Spain |
| Torrelavega | 39300 | Spain |
| Valencia | 46009 | Spain |
| Bangkok | 10400 | Thailand |
| Bangkok | 10700 | Thailand |
| Chiang Mai | 50200 | Thailand |
| Khon Kaen | 40002 | Thailand |
| Cambridge | CB2 2QQ | United Kingdom |
| Cannock | WS11 5XY | United Kingdom |
| Coventry | CV2 2DX | United Kingdom |
| Eastbourne | BN21 2UD | United Kingdom |
| Exeter | EX2 5DW | United Kingdom |
| Harrogate | HG2 7SX | United Kingdom |
| Ipswich | IP4 5PD | United Kingdom |
| London | E11 1NR | United Kingdom |
| Metropolitan Borough of Wirral | CH49 5PE | United Kingdom |
| Middlesbrough | TS4 3BW | United Kingdom |
| Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Northampton | NN1 5BD | United Kingdom |
| Nottingham | NG7 2UH | United Kingdom |
| Westcliffe-on-sea | SS0 0RY | United Kingdom |
| FG001 | Tocilizumab IV | Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study. |
| FG002 | Tocilizumab SC Then Tocilizumab IV | Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study. |
| FG003 | Tocilizumab IV Then Tocilizumab SC | Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study. |
| Per Protocol Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| 72 Weeks Open Label Extension |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tocilizumab SC | Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study. |
| BG001 | Tocilizumab IV | Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study. |
| BG002 | 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 Achieving an American College of Rheumatology Criteria (ACR20) Response at Week 24 | ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein [CRP] or Erythrocyte Sedimentation Rate [ESR]). | Per Protocol Population included all randomized participants who received study drug and had no major protocol violations. Last Observation Carried Forward was used for missing joint counts, no imputation for other ACR components. CRP will be used primarily for calculation of the ACR response. If missing, the ESR will be used for that participant. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, 24 weeks |
|
|
| ||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Assessments | The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms. | Posted | Number | percentage of participants | Baseline to up to 3 months after last dose of study drug (approximately up to 2 years) |
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| Secondary | Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR50) Response at Week 24 | ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein or Erythrocyte Sedimentation Rate). | Per Protocol Population included all randomized participants who received study drug and had no major protocol violations. Last Observation Carried Forward was used for missing joint counts, no imputation for other ACR components. CRP will be used primarily for calculation of the ACR response. If missing, the ESR will be used for that participant. | Posted | Number | Percentage of participants | Baseline, 24 weeks |
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| Secondary | Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR70) Response at Week 24 | ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein or Erythrocyte Sedimentation Rate). | Per Protocol Population included all randomized participants who received study drug and had no major protocol violations. Last Observation Carried Forward was used for missing joint counts, no imputation for other ACR components. CRP will be used primarily for calculation of the ACR response. If missing, the ESR will be used for that participant. | Posted | Number | Percentage of participants | Baseline, 24 weeks |
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| Secondary | Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 24 | The DAS28 (ESR) score is a measure of the subject's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity VAS where left side of the line 0=no disease activity to right side of the line 100=extreme disease activity and ESR. DAS28-(ESR) total scores range from 0 - 10. Remission is defined as achieving a DAS28-ESR score of less than 2.6. | Participants from the Per Protocol Population (randomized participants who received study drug and had no major protocol violations) with data available for analysis. Missing SJC and TJC will be imputed using the last post-baseline value for the patient (LOCF). No imputation for missing ESR or patient's global assessment of disease activity. | Posted | Number | Percentage of participants | Week 24 |
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| Secondary | Percentage of Participants Achieving a Decrease of ≥ 0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24 | The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a participant completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A decrease indicates improvement. | Participants from the Per Protocol Population (all randomized participants who received study drug and had no major protocol violations) with data available for analysis. No imputation of missing scores will be made other than for missing baseline scores, for which last score prior to defined protocol baseline time window will be carried forward. | Posted | Number | Percentage of participants | Baseline, 24 Weeks |
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| Secondary | Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 24 | The percentage of participants who withdrew from the study because they were not responding to treatment with the study drug. | Per Protocol Population included all randomized participants who received study drug and had no major protocol violations. | Posted | Number | Percentage of participants | 24 Weeks |
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| Secondary | Percentage of Participants With American College of Rheumatology Criteria (ACR20, ACR50, ACR70) at Week 97 | ACR20, ACR50 and ACR70: ≥20%, ≥50% and ≥70% reduction from baseline for both TJC68 and SJC66, as well as for 3 of 5 additional ACR variables: Patient's Assessment of Pain in last 24 hours using a Visual Analog Scale (VAS) (0=no pain and 100=unbearable pain); Patient's and Physician's Global Assessment of Disease Activity in last 24 hours using a VAS (0=no disease activity and100=maximum disease activity); Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either CRP or ESR). CRP was used for calculation of ACR. If missing, ESR was used. LOCF was used for missing joint counts, no imputation for other ACR components. | Re-Randomized Intent-to-Treat Population (ITT Population) included all participants who completed double blind period and were re-randomized at Week 24, received at least 1 dose of study drug. Here, number of participants analyzed is the participants for whom parameter was collected. | Posted | Number | percentage of participants | Week 97 |
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| Secondary | Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 97 | The DAS28 (ESR) score is a measure of the subject's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity VAS where left side of the line 0=no disease activity to right side of the line 100=extreme disease activity and ESR. DAS28-(ESR) total scores range from 0 - 10. Remission is defined as achieving a DAS28-ESR score of less than 2.6. LOCF used for tender and swollen joint counts, no imputation used for ESR and Patient's Global Assessment of Disease Activity VAS. | ITT Population included all participants who completed double blind period and were re-randomized at Week 24 and received at least one dose of study drug. If ESR=0 then ESR=1 is substituted into the DAS28 calculation to enable a non-missing DAS28 score. Here, number of participants analyzed is the participants for whom parameter was collected. | Posted | Number | percentage of participants | Week 97 |
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| Secondary | Percentage of Participants Achieving a Decrease of ≥0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 97 | The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A decrease indicates improvement. No imputation of missing scores was made other than for missing baseline scores, for which last score prior to baseline will be carried forward. For participants who prematurely withdrew, data collected at withdrawal visit was used and data thereafter is missing. | ITT Population included all participants who completed double blind period and were re-randomized at Week 24 and received at least one dose of study drug. Here, number of participants analyzed is the participants for whom parameter was collected. | Posted | Number | percentage of participants | Baseline, Week 97 |
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| Secondary | Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 97 | The percentage of participants who withdrew from the study because they were not responding to treatment with the study drug. | ITT Population included all participants who completed double blind period and were re-randomized at Week 24 and received at least one dose of study drug. | Posted | Number | percentage of participants | Week 97 |
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| Secondary | Area Under the Serum Concentration Curve of Tocilizumab After First SC Injection or IV Infusion | Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the pharmacokinetic analysis (PK) analysis. Here, number of participants analyzed who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | microgram*hour/milliliter (mcg*hr/mL) | Week 0: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after first dose |
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| Secondary | Area Under the Serum Concentration Curve of Tocilizumab at Steady State for SC and IV Treatment | Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the pharmacokinetic analysis (PK) analysis. Here, number of participants analyzed who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | μg*hr/mL | Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose. |
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| Secondary | Minimum Serum Concentration (Cmin) of Tocilizumab | Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the PK analysis. Here, number of participants analyzed who were evaluable for this outcome measure and 'n' indicates number of participants who were evaluated at specified time point. | Posted | Mean | Standard Deviation | micrgram/milliliter (mcg/mL) | Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose |
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| Secondary | Maximum Serum Concentration (Cmax) of Tocilizumab | Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the PK analysis. Here, number of participants analyzed who were evaluable for this outcome measure and 'n' indicates number of participants who were evaluated at specified time point. | Posted | Mean | Standard Deviation | mcg/mL | Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose |
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| Secondary | Time to Maximum Serum Concentration (Tmax) of Tocilizumab | Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the PK analysis. Here, number of participants analyzed who were evaluable for this outcome measure and 'n' indicates number of participants who were evaluated at specified time point. | Posted | Median | Full Range | hour (hr) | Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose |
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| Secondary | Change From Baseline in Serum Interleukin-6 (IL-6) Concentration at Week 25 | The ITT-PK population includes all participants who were eligible for the ITT population and provided at least 1 evaluable PK sample in the double blind or open label periods. Here, number of participants analyzed who were evaluable for this outcome measure and 'n' indicates number of participants who were evaluated at specified time point. | Posted | Mean | Standard Deviation | picogram/milliliter (pg/mL) | Baseline, Week 25 |
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| Secondary | Change From Baseline in Serum Soluble Interleukin-6 Receptor (sIL-6R) Concentration at Week 97 | The ITT-PK population includes all participants who were eligible for the ITT population and provided at least 1 evaluable PK sample in the double blind or open label periods. Here, number of participants analyzed who were evaluable for this outcome measure and 'n' indicates number of participants who were evaluated at specified time point. | Posted | Mean | Standard Deviation | nanogram/milliliter (ng/mL) | Baseline, Week 97 |
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| Secondary | Percentage of Participants Who Developed Antibodies To Tocilizumab at Week 97 | The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Here, 'n' indicates number of subjects in the safety population tested by screening assay at any time point. | Posted | Number | percentage of participants | Week 97 |
|
Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
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 | Tocilizumab SC | Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study. | 88 | 631 | 488 | 631 | ||
| EG001 | Tocilizumab IV | Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study. | 80 | 631 | 430 | 631 | ||
| EG002 | Tocilizumab SC Then Tocilizumab IV | Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study. | 6 | 48 | 29 | 48 | ||
| EG003 | Tocilizumab IV Then Tocilizumab SC | Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study. | 21 | 186 | 118 | 186 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Bursitis infective | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Bone tuberculosis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Burkholderia pseudomallei infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Dacryocystitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Muscle abscess | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pericolic abscess | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pharyngeal abscess | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pyelonephritis chronic | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Renal abscess | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Retroperitoneal abscess | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Whipple's disease | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Carotid artery thrombosis | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cerebellar ischaemia | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cerebrovascular insufficiency | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Transient global amnesia | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Adrenal gland injury | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Anastomotic ulcer haemorrhage | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Chillblains | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Hepatic haematoma | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Pulmonary contusion | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Synovial rupture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Brain neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Cervix carcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Endometrial adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Gastrointestinal tract adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Lentigo maligna | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Morton's neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Parathyroid tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Schwannoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Lumbar hernia | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Megacolon | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cardiac valve disease | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Sphincter of oddi dysfunction | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Amyloidosis | Immune system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Device dislocation | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Ischaemic ulcer | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pelvic floor muscle weakness | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (16.0) | Systematic Assessment |
| |
| Imminent abortion | Pregnancy, puerperium and perinatal conditions | MedDRA (16.0) | Systematic Assessment |
| |
| Hydrocele | Congenital, familial and genetic disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Amaurosis | Eye disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (16.0) | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-LaRoche | 800-821-8590 |
| 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 |
|---|---|
| C502936 | tocilizumab |
| D018501 | Antirheumatic Agents |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided
| Subject/legal Guardian Decision |
|
| Insufficient Therapeutic Response |
|
| Lost to Follow-up |
|
| Physician Decision to Withdraw Subject |
|
| Pregnancy |
|
| Other |
|
| Protocol Violation |
|
| Adverse Event |
|
| Anaphylaxis or Hypersensitivity Reaction |
|
| Death |
|
| Male |
|
| OG002 | Tocilizumab SC Then Tocilizumab IV | Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study. |
| OG003 | Tocilizumab IV Then Tocilizumab SC | Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study. |
|
|
| OG001 | Tocilizumab IV | Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study. |
|
|
| OG001 | Tocilizumab IV | Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study. |
|
|
|
|
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study. |
|
|
| Participants |
|
|
| OG001 | Tocilizumab IV | Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study. |
| OG002 | Tocilizumab SC Then Tocilizumab IV | Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study. |
| OG003 | Tocilizumab IV Then Tocilizumab SC | Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study. |
|
|
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study. |
| OG002 | Tocilizumab SC Then Tocilizumab IV | Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study. |
| OG003 | Tocilizumab IV Then Tocilizumab SC | Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study. |
|
|
| OG001 | Tocilizumab IV | Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study. |
| OG002 | Tocilizumab SC Then Tocilizumab IV | Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study. |
| OG003 | Tocilizumab IV Then Tocilizumab SC | Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study. |
|
|
| Tocilizumab SC Then Tocilizumab IV |
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study. |
| OG003 | Tocilizumab IV Then Tocilizumab SC | Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study. |
|
|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| OG002 |
| Tocilizumab SC Then Tocilizumab IV |
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study. |
| OG003 | Tocilizumab IV Then Tocilizumab SC | Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study. |
|
|
| OG002 |
| Tocilizumab SC Then Tocilizumab IV |
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study. |
| OG003 | Tocilizumab IV Then Tocilizumab SC | Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study. |
|
|
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study. |
| OG003 | Tocilizumab IV Then Tocilizumab SC | Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study. |
|
|