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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000424-28 | EudraCT Number |
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This study will assess the efficacy and safety of tocilizumab compared with placebo in participants with SSc across approximately 120 planned global study sites. The study will consist of a 48-week, double-blind, placebo-controlled period followed by a 48-week open-label treatment period. Participants will be assigned, in a 1:1 ratio, to double-blind treatment with active tocilizumab or matching placebo. In the open-label period, eligible participants from either arm may receive active tocilizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double-Blind Placebo | Placebo Comparator | Participants will receive double-blind matching placebo from Baseline to Week 47. Participants may then receive open-label tocilizumab from Weeks 48 to 96. |
|
| Double-Blind Tocilizumab | Experimental | Participants will receive double-blind tocilizumab from Baseline to Week 47. Participants may then receive open-label tocilizumab from Weeks 48 to 96. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Participants will receive matching placebo subcutaneous (SC) injections once weekly for 48 weeks of double-blind treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Modified Rodnan Skin Score (mRSS) During Double-blind Period | The efficacy of TCZ vs placebo is evaluated in terms of in mean change in mRSS. Skin thickness will be assessed by palpation and rated using an mRSS that ranges from 0 (normal) to 3 (severe skin thickening) across 17 different body sites. The total score is the sum of the individual skin scores from all of these sites and ranges from 0 to 51 units. | From baseline to week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Greater Than or Equal to (>/=) 20%, 40%, or 60% Improvement in mRSS During Double-blind Period | The proportion of participants with threshold improvements in mRSS at Week 48 relative to baseline. | From Baseline to Week 48 |
| Change From Baseline in Percent Predicted FVC (ppFVC) During Double-blind Period |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TriWest Research Associates, LLC | El Cajon | California | 92020 | United States | ||
| St. Joseph's Heritage Healthcare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37228011 | Derived | Ghuman A, Khanna D, Lin CJF, Furst DE, Raghu G, Martinez FJ, Zucchetto M, Huang S, Jennings A, Nihtyanova SI, Denton CP. Prognostic and predictive markers of systemic sclerosis-associated interstitial lung disease in a clinical trial and long-term observational cohort. Rheumatology (Oxford). 2024 Feb 1;63(2):472-481. doi: 10.1093/rheumatology/kead234. | |
| 34851799 |
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Overall 212 participants were randomized on to the study, 107 to the placebo arm and 105 to the tocilizumab arm. One participant in placebo arm withdrew consent prior to receiving any treatment and one participant in the tocilizumab arm was withdrawn due to randomization error prior to receiving any treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Double-Blind Placebo, Then Open Label Tocilizumab | Participants received double-blind matching placebo from Baseline to Week 48. Participants then received open-label tocilizumab from Weeks 48 to 96. |
| FG001 | Double-Blind Tocilizumab, Then Open Label Tocilizumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double Blind Period |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 23, 2018 | Mar 13, 2019 |
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| Tocilizumab | Drug | Participants will receive 162 mg SC tocilizumab once weekly for 48 weeks of double-blind treatment. The same regimen will be given to all eligible participants for 48 weeks of open-label treatment. |
|
FVC is pulmonary function test and will be conducted as per the study Pulmonary Function Manual, which is based on the American Thoracic Society/European Respiratory Society (ATS/ERS) Consensus Statement. FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Patients perform three to eight exhalations into a spirometer with the highest value recorded. |
| Baseline to week 48 |
| Change in Forced Vital Capacity (FVC) During Double-blind Period | FVC is pulmonary function test and will be conducted as per the study Pulmonary Function Manual, which is based on the American Thoracic Society/European Respiratory Society (ATS/ERS) Consensus Statement. FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Patients perform three to eight exhalations into a spirometer with the highest value recorded. | From Baseline to Week 48 |
| Change in Health Assessment Questionnaire Disability Index (HAQ-DI) Score During Double-blind Period | The Health Assessment Questionnaire Disability Index (HAQ-DI) consists of 20 questions referring to eight component sets consisting of dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each item is scored on a 4-point scale from 0 to 3: 0 = Without any difficulty; 1 = With some difficulty; 2 = With much difficulty; 3 = Unable to do. Overall score was computed as the sum of component set scores and divided by the number of component sets answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. The total score indicates the patient's self-assessed level of disability. This outcome measure represents the change in mean score from baseline. A negative change from baseline indicates improvement. | From Baseline to Week 48 |
| Change in Patient Global Assessment Score During Double-blind Period | The Patient's Global Assessment represents the patient's overall assessment of current SSc status on a 100-mm horizontal visual analogue scale (VAS), ranging from 0 on the extreme left end of the scale indicating "has no effect at all" (symptom free), and 100 on the extreme right end indicating "worst possible effect." | From Baseline to Week 48 |
| Change in Physician Global Assessment Score During Double-blind Period | The Physician's Global Assessment is to be completed on the basis of examination and overall assessment of the patient. The physician's assessment of the patient's SSc status will be scored on a 100-mm horizontal visual analogue scale (VAS), ranging from 0 on the extreme left end of the scale indicating "has no effect at all" (symptom free), and 100 on the extreme right end indicating "worst possible effect." | From Baseline to Week 48 |
| Time to Treatment Failure According to mRSS, FVC, or Protocol-Specified Event During Double-blind Period | Time to treatment failure is defined as the time from randomization to the time of death, decline in percent-predicted FVC > 10% relative to baseline, > 20% increase in mRSS and an increase in mRSS of equal to or more than 5 points, or occurrence of a predefined SSc-related complication as adjudicated by the Clinical Adjudication Committee (whichever occurs first) during the 48-week double-blind treatment period. The median TTF was not estimable and is not presented for either treatment arm because of the low number of patients with events at Week 48. | From Baseline to Week 48 |
| Summary of Adverse Events During Double-blind Period | Summary of key safety results including Adverse Events of Special Interest (AESI). All adverse events categorized according to MedDRA version 20.1. NMSC = Non-Melanoma Skin Cancer | From Baseline until Week 48 |
| Incidence and Severity of Adverse Events During Double-blind Period | Adverse events listed according to MedDRA version 20.1 preferred terms and severity grade. | From Baseline until Week 48 |
| Number of Participants With Adverse Events Leading to Death During Double-blind Period | Reason of death is coded using MedDRA 20.1 | From Baseline up to Week 48 |
| Frequency of Serious Systemic Sclerosis (SSC) Related Complications During Double-blind Period | Adverse event terms coded using MedDRA 20.1. Includes only those serious events adjudicated as SSC-related complications by an independent external committee. | From Baseline up to Week 48 |
| Incidence of Haematology and Hepatic Laboratory Parameters During Double-blind Period | A laboratory event occurred if the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade for a post-baseline laboratory measurement increased from baseline. | From Baseline up to Week 48 |
| Percentage of Participants With Change in Digital Ulcer Count During Double-blind Period | A digital ulcer is defined as an ulcer at or distal to the MCP joint on either the dorsal or volar surface, with loss of surface epithelialization. This does not include fissures, cracks, or calcium extrusions from calcinosis cutis. The number of fingers (0-10) with digital ulcers and the number of digital (or finger) ulcers will be counted and recorded by the investigator. | From Baseline to Week 48 |
| Percentage of Participants With Positive Anti-Tocilizumab Assay Result at Baseline | Incidence of anti-Tocilizumab at baseline | Baseline |
| Percentage of Participants With Positive Anti-Tocilizumab Assay Post-Baseline up to Week 48 | Incidence of anti-Tocilizumab antibodies during the study relative to the prevalence of anti-Tocilizumab antibodies at baseline. Samples that are positive for anti-TCZ in the screening assay will be further analyzed by a confirmation assay to confirm specificity. If the confirmation assay is positive, two additional tests will be performed: a neutralizing assay for the ability to inhibit the activity of TCZ and a test for anti -TCZ of the IgE isotype. | Double-blind period (up to Week 48) |
| Correlation Between Anti-Tocilizumab Antibody Status and Outcome Measures Pertaining to the Efficacy, Safety, and Pharmacokinetics of Tocilizumab | Pre-specified analysis of the relationship between Anti-Tocilizumab Antibody status and safety, efficacy, and PK endpoints were not analyzed via subgroup analyses as there was only 1 patient with ADA-positive status. | Baseline; during Weeks 8, 16, 24, 36, 48, 96, and/or at treatment discontinuation (up to 96 weeks); and 8 weeks after treatment discontinuation (up to 104 weeks overall) |
| Erythrocyte Sedimentation Rate (ESR), Mean, From Baseline to Week 48 | Erythrocyte Sedimentation Rate (ESR) levels predose at baseline and at subsequent time points after initiation of study drug. | From Predose up to Week 48 |
| Erythrocyte Sedimentation Rate (ESR), Median, From Baseline to Week 48 | Erythrocyte Sedimentation Rate (ESR) levels predose at baseline and at subsequent time points after initiation of study drug. | From Baseline to Week 48 |
| Serum Interleukin (IL)-6 Level, Mean, From Baseline to Week 48 | Serum Interleukin (IL)-6 levels predose at baseline and at subsequent time points after initiation of study drug. | From Baseline to Week 48 |
| Serum Interleukin (IL)-6 Level, Median, From Baseline to Week 48 | Serum Interleukin (IL)-6 levels predose at baseline and at subsequent time points after initiation of study drug. | From Baseline to Week 48 |
| Serum Interleukin (IL)-6 Level, Mean Change From Baseline to Week 48 | Serum Interleukin (IL)-6 levels predose at baseline and at subsequent time points after initiation of study drug. | From Baseline to Week 48 |
| Serum Interleukin (IL)-6 Level, Median Change From Baseline to Week 48 | Serum Interleukin (IL)-6 levels predose at baseline and at subsequent time points after initiation of study drug. | From Baseline to Week 48 |
| Serum Soluble Interleukin (IL)-6 Receptor Level, Mean, From Baseline to Week 48 | Serum soluble Interleukin (IL)-6 receptor levels predose at baseline and at subsequent time points after initiation of study drug. | From Baseline to Week 48 |
| Serum Soluble Interleukin (IL)-6 Receptor Level, Median, From Baseline to Week 48 | Serum soluble Interleukin (IL)-6 receptor levels predose at baseline and at subsequent time points after initiation of study drug. | From Baseline to Week 48 |
| Serum Soluble Interleukin (IL)-6 Receptor Level, Mean Change From Baseline to Week 48 | Serum soluble Interleukin (IL)-6 receptor levels predose at baseline and at subsequent time points after initiation of study drug. | From Baseline to Week 48 |
| Serum Soluble Interleukin (IL)-6 Receptor Level, Median Change From Baseline to Week 48 | Serum soluble Interleukin (IL)-6 receptor levels predose at baseline and at subsequent time points after initiation of study drug. | From Baseline to Week 48 |
| Serum C-Reactive Protein (CRP) Level, Mean, From Baseline to Week 48 | Serum C-Reactive Protein (CRP) levels predose at baseline and at subsequent time points after initiation of study drug. | From Baseline up to Week 48 |
| Serum C-Reactive Protein (CRP) Level, Median, From Baseline to Week 48 | Serum C-Reactive Protein (CRP) levels predose at baseline and at subsequent time points after initiation of study drug. | From Baseline up to Week 48 |
| Serum Tocilizumab Concentration, Mean, From Baseline to Week 48 | Predose observed serum TCZ concentration at baseline and at specified timepoints thereafter | From Baseline to Week 48 |
| Serum Tocilizumab Concentration, Median, From Baseline to Week 48 | Predose observed serum TCZ concentration at baseline and at specified timepoints thereafter | From Baseline to Week 48 |
| Correlation Between Low Serum Tocilizumab Exposure and Mean Modified Rodnan Skin Score (mRSS) From Baseline to Week 48 | In order to characterize exposure-efficacy relationships, mRSS scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml. | From Baseline to Week 48 |
| Correlation Between Low Serum Tocilizumab Exposure and Median Modified Rodnan Skin Score (mRSS) From Baseline to Week 48 | In order to characterize exposure-efficacy relationships, mRSS scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml. | From Baseline to Week 48 |
| Correlation Between Medium Serum Tocilizumab Exposure and Mean Modified Rodnan Skin Score (mRSS) From Baseline to Week 48 | In order to characterize exposure-efficacy relationships, mRSS scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml. | From Baseline to Week 48 |
| Correlation Between Medium Serum Tocilizumab Exposure and Median Modified Rodnan Skin Score (mRSS) From Baseline to Week 48 | In order to characterize exposure-efficacy relationships, mRSS scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml. | From Baseline to Week 48 |
| Correlation Between High Serum Tocilizumab Exposure and Mean Modified Rodnan Skin Score (mRSS) From Baseline to Week 48 | In order to characterize exposure-efficacy relationships, mRSS scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml. | From Baseline to Week 48 |
| Correlation Between High Serum Tocilizumab Exposure and Median Modified Rodnan Skin Score (mRSS) From Baseline to Week 48 | In order to characterize exposure-efficacy relationships, mRSS scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml. | From Baseline to Week 48 |
| Change in Mean Modified Rodnan Skin Score (mRSS) at Low, Medium and High Serum Tocilizumab Exposure From Baseline to Week 48 | In order to characterize exposure-efficacy relationships, mRSS scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml. | From Baseline to Week 48 |
| Change in Median Modified Rodnan Skin Score (mRSS), at Low, Medium and High Serum Tocilizumab Exposure From Baseline to Week 48 | In order to characterize exposure-efficacy relationships, mRSS scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml. | From Baseline to Week 48 |
| Change in Mean Percent Predicted Forced Vital Capacity (ppFVC), at Low, Medium and High Serum Tocilizumab Exposure From Baseline to Week 48 | In order to characterize exposure-efficacy relationships, ppFVC scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml. | From Baseline to Week 48 |
| Change in Median Percent Predicted Forced Vital Capacity (ppFVC), at Low, Medium and High Serum Tocilizumab Exposure From Baseline to Week 48 | In order to characterize exposure-efficacy relationships, ppFVC scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml. | From Baseline to Week 48 |
| Summary of Adverse Events Up to Week 96 | Summary of key safety results including Adverse Events of Special Interest (AESI). All adverse events categorized according to MedDRA version 21.1. NMSC = Non-Melanoma Skin Cancer | Up to Week 96 |
| Incidence and Severity of Adverse Events Up to Week 96 | Adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) severity grade: 1 = mild, 2 = moderate, 3 = severe and/or requiring medical intervention but not life-threatening, 4 = life-threatening consequences, and 5 = death. | Up to Week 96 |
| Number of Participants With Adverse Events Leading to Death Up to Week 96 | Up to Week 96 |
| Percentage of Participants With Change in Digital Ulcer Count at Week 96 | A digital ulcer is defined as an ulcer at or distal to the MCP joint on either the dorsal or volar surface, with loss of surface epithelialization. This does not include fissures, cracks, or calcium extrusions from calcinosis cutis. The number of fingers (0-10) with digital ulcers and the number of digital (or finger) ulcers will be counted and recorded by the investigator. | From Baseline to Week 96 |
| Percentage of Participants With Positive Anti-Tocilizumab Assay Post-Baseline From Week 48 to 96 | Reported were the percentage of participants with post-baseline treatment-induced anti-TCZ antibodies. Positive samples underwent additional analyses: a neutralizing assay for the ability to inhibit the activity of TCZ and a test for anti -TCZ of the IgE isotype. | Open-label period from Week 48 to 96 |
| Erythrocyte Sedimentation Rate (ESR) Up to Week 96 | Erythrocyte Sedimentation Rate (ESR) levels predose at baseline and at subsequent time points after initiation of study drug. | Up to Week 96 |
| Serum Interleukin (IL)-6 Level, Mean, From Baseline to Week 96 | Serum Interleukin (IL)-6 levels predose at baseline and at subsequent time points after initiation of study drug. | Up to Week 96 |
| Serum Soluble Interleukin (IL)-6 Receptor Level, Mean, Up to Week 96 | Serum Soluble Interleukin (IL)-6 receptor levels predose at baseline and at subsequent time points after initiation of study drug. | Up to Week 96 |
| Serum C-Reactive Protein (CRP) Level, Mean, Up to Week 96 | Serum C-Reactive Protein (CRP) levels predose at baseline and at subsequent time points after initiation of study drug. | From Baseline up to Week 96 |
| Serum Tocilizumab Concentration, Mean, Up to Week 96 | Predose observed serum TCZ concentration at baseline and at specified timepoints thereafter | Up to Week 96 |
| Fullerton |
| California |
| 92835 |
| United States |
| Univ of Calif., Los Angeles; Rheumatology | Los Angeles | California | 90025 | United States |
| Arthritis Associates of Southern California | Los Angeles | California | 90045 | United States |
| Georgetown Uni. Hosp.; Rheumatology, Immunology and Allergy Dept. | Washington D.C. | District of Columbia | 20007 | United States |
| Rheumatology Assoc. of S. Florida - Clinical Research Center | Boca Raton | Florida | 33486 | United States |
| Millenium Research | Ormond Beach | Florida | 32174 | United States |
| Boston Univ Med Center - AC | Boston | Massachusetts | 02118 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109-0934 | United States |
| West Michigan Rheumatology, PLLC | Grand Rapids | Michigan | 49546 | United States |
| Joint & Muscle Research Institute | Charlotte | North Carolina | 28204 | United States |
| Arthritis and Rheumatology; Center of Oklahoma PLLC | Oklahoma City | Oklahoma | 73103 | United States |
| Thomas Jefferson Uni ; Division of Rheumatology | Philadelphia | Pennsylvania | 19131 | United States |
| Clinical Research Center of Reading | Wyomissing | Pennsylvania | 19610 | United States |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | United States |
| Metroplex Clinical Research | Dallas | Texas | 75231 | United States |
| Organizacion Medica de Investigacion | Buenos Aires | C1015ABO | Argentina |
| Hospital Britanico; Haematology | Buenos Aires | C1280AEB | Argentina |
| Sanatorio Parque S.A. | Rosario, Santa FE | S2000DSV | Argentina |
| Centro de Investigaciones Reumatologicas Tucuman | San Miguel de Tucumán | 4000 | Argentina |
| UZ Gent | Ghent | 9000 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| MHAT Kaspela; Rheumatology | Plovdiv | 4002 | Bulgaria |
| MHAT-Plovdiv AD; Reumatology Department | Plovdiv | 4003 | Bulgaria |
| MHAT St.Ivan Rilski; Rheumtology Department | Sofia | 1612 | Bulgaria |
| MHAT Sv.Ivan Rilski; Clinic of Rheumatology | Sofia | 1612 | Bulgaria |
| St. Paul's Hospital University of British Colambia Division of Hematology | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Mount Sinai Hospital; Rebecca Macdonald Centre For Arthritis & Autoimmune Disease | Toronto | Ontario | M5G 1X5 | Canada |
| Aarhus Universitetshospital Skejby, Hud- og Kønssygdomme | Aarhus N | 8200 | Denmark |
| Bispebjerg Hospital, Dermatologisk afdeling | København NV | 2400 | Denmark |
| Hopital Claude Huriez; Internal Medicine | Lille | 59037 | France |
| Asklepios Kllinikum Bad Abbach; Klinik für Rheumatologie und Klinische Immunologie | Bad Abbach | 93077 | Germany |
| Kerckhoff-Klinik; Rheumatologie&klin.Immunologie | Bad Nauheim | 61231 | Germany |
| Universitätsklinikum Dresden; Technische Universität Dresden; Rheumatologie, Innere Medizin III | Dresden | 01307 | Germany |
| Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV | München | 80336 | Germany |
| Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II | Tübingen | 72076 | Germany |
| Laiko General Hospital; Dept. of Pathophysiology-Uni of Athens | Athens | 115 27 | Greece |
| University Hospital of Patras; Rheumatology | Pátrai | 265 04 | Greece |
| National Institute of Rheumatology and Physiology | Budapest | 1023 | Hungary |
| Pécsi Tudományegyetem Klinikai Központ: Immunológiai és Reumatológiai Klinika | Pécs | 7632 | Hungary |
| Policlinico Universitario-II Università di Napoli; Reumatologia | Naples | Campania | 80131 | Italy |
| Uni ' Cattolica Del Sacro Cuore; Facoltà Di Medicina E Chirurgia A.Gemelli-Clinica Reumatologica | Rome | Lazio | 00168 | Italy |
| Ospedale Maggiore Policlinico; Unità Operativa Complessa di Allergologia e Immunologia Clinica | Milan | Lombardy | 20122 | Italy |
| Ospedale Careggi Villa Monnatessa ; Sezione Di Reumatologia | Florence | Tuscany | 50139 | Italy |
| Gunma University Hospital | Gunma | 371-8511 | Japan |
| Sapporo Medical University Hospital | Hokkaido | 060-8543 | Japan |
| Hokkaido University Hospital | Hokkaido | 060-8648 | Japan |
| Kanazawa University Hospital | Ishikawa | 920-8641 | Japan |
| St. Marianna University School of Medicine Hospital | Kanagawa | 216-8511 | Japan |
| Hospital of the University of Occupational and Environmental Health,Japan | Kitakyushu-shi | 807-8556 | Japan |
| Kumamoto University Hospital | Kumamoto | 860-8556 | Japan |
| Tohoku University Hospital | Miyagi | 980-8574 | Japan |
| Osaka University Hospital | Osaka | 565-0871 | Japan |
| Nippon Medical School Hospital | Tokyo | 113-8603 | Japan |
| The University of Tokyo Hospital | Tokyo | 113-8655 | Japan |
| Klaipeda University Hospital; Department of Rheumatology | Klaipėda | LT - 92288 | Lithuania |
| Vilnius University Hospital Santariskiu Clinic Public Insti | Vilnius | 08661 | Lithuania |
| Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán | Mexico City | Tlalpan 14000 | Mexico |
| Unidad De Enfermedades; Cronico Degenerativas, SC. | México | 44620 | Mexico |
| Cliditer SA de CV | Miexico City | 06700 | Mexico |
| Academisch Ziekenhuis Leiden; Dept of Rheumatology | Leiden | 2333 ZA | Netherlands |
| Szpital Uniwersytecki; nr 2 im. Dr J. Biziela; Klinika Reumatologii i Ukladowych Chorob | Bydgoszcz | 85-168 | Poland |
| Uniwersyteckie Centrum Kliniczne; Klinika Chorob Wewnetrznych, Chorob Tkanki Łacznej i Geriatrii | Gdansk | 80-952 | Poland |
| Gornoslaskie Centrum Medyczne | Katowice | 40-635 | Poland |
| Szpital Specjalistyczny im Jozefa Dietla; Centrum Reumatologii, Immunologii i Rehabilitacji, I Oddzi | Krakow | 31-121 | Poland |
| SPSK NR 4; Reumatologii i Ukladowych Chorob Tkanki | Lublin | 20-954 | Poland |
| Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher | Warsaw | 02-637 | Poland |
| Hospital Garcia de Orta; Servico de Reumatologia | Almada | 2801-951 | Portugal |
| Hospital Prof. Dr. Fernando Fonseca; Medicina IV | Amadora | 3814-501 | Portugal |
| Puerto Rico Clinical & Translational Research Consortium | San Juan | 00936-5067 | Puerto Rico |
| Cantacuzino Hospital; Department of Internal Medicine and Rheumatology | Bucharest | 020475 | Romania |
| Spitalul Judetean Cluj; Sectia de Reumatologie | Cluj-Napoca | 400006 | Romania |
| Hospital de la Santa Creu i Sant Pau; Servicio de Medicina Interna/Reumatologia | Barcelona | 08025 | Spain |
| Hospital Universitario Vall d'Hebron; Servicio de Medicina Interna | Barcelona | 08035 | Spain |
| Hospital General Universitario Gregorio Marañon; Servicio de Reumatología | Madrid | 28007 | Spain |
| Universitätsspital Basel; Rheumatologische Poliklinik | Basel | 4031 | Switzerland |
| Universitätsspital Zürich; Klinik für Rheumatologie | Zurich | 8091 | Switzerland |
| Queen Elizabeth Hospital; Rheumatology Dept. | Birmingham | B15 2TH | United Kingdom |
| Western General Hospital | Edinburgh | EH4 2XU | United Kingdom |
| Chapel Allerton Hospital; Leeds Institution of Rheumatology Medicine | Leeds | LS7 4SA | United Kingdom |
| Uni Hospital Aintree; Academic Rheumatology Unit | Liverpool | L9 7AL | United Kingdom |
| Royal Free Hospital; Department of Rheumatology | London | NW3 2QG | United Kingdom |
| Freeman Hospital; Musculoskeletal Unit | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Khanna D, Lin CJF, Furst DE, Wagner B, Zucchetto M, Raghu G, Martinez FJ, Goldin J, Siegel J, Denton CP. Long-Term Safety and Efficacy of Tocilizumab in Early Systemic Sclerosis-Interstitial Lung Disease: Open-Label Extension of a Phase 3 Randomized Controlled Trial. Am J Respir Crit Care Med. 2022 Mar 15;205(6):674-684. doi: 10.1164/rccm.202103-0714OC. |
| 33538094 | Derived | Roofeh D, Lin CJF, Goldin J, Kim GH, Furst DE, Denton CP, Huang S, Khanna D; focuSSced Investigators. Tocilizumab Prevents Progression of Early Systemic Sclerosis-Associated Interstitial Lung Disease. Arthritis Rheumatol. 2021 Jul;73(7):1301-1310. doi: 10.1002/art.41668. Epub 2021 May 25. |
| 33294861 | Derived | Gao X, Jia G, Guttman A, DePianto DJ, Morshead KB, Sun KH, Ramamoorthi N, Vander Heiden JA, Modrusan Z, Wolters PJ, Jahreis A, Arron JR, Khanna D, Ramalingam TR. Osteopontin Links Myeloid Activation and Disease Progression in Systemic Sclerosis. Cell Rep Med. 2020 Nov 17;1(8):100140. doi: 10.1016/j.xcrm.2020.100140. eCollection 2020 Nov 17. |
| 32866440 | Derived | Khanna D, Lin CJF, Furst DE, Goldin J, Kim G, Kuwana M, Allanore Y, Matucci-Cerinic M, Distler O, Shima Y, van Laar JM, Spotswood H, Wagner B, Siegel J, Jahreis A, Denton CP; focuSSced investigators. Tocilizumab in systemic sclerosis: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2020 Oct;8(10):963-974. doi: 10.1016/S2213-2600(20)30318-0. Epub 2020 Aug 28. |
Participants received double-blind tocilizumab from Baseline to Week 48. Participants then received open-label tocilizumab from Weeks 48 to 96. |
| COMPLETED |
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| NOT COMPLETED |
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| Open Label Period |
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The analysis was conducted on the safety population, i.e. all randomized patients who received at least one dose of study drug and provided data from at least one post dose safety assessment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Double-Blind Placebo, Then Tocilizumab Open Label | Participants received double-blind matching placebo from Baseline to Week 48. Participants then received open-label tocilizumab from Weeks 48 to 96. |
| BG001 | Double-Blind Tocilizumab, Then Tocilizumab Open Label | Participants received double-blind tocilizumab from Baseline to Week 48. Participants then received open-label tocilizumab from Weeks 48 to 96. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in Modified Rodnan Skin Score (mRSS) During Double-blind Period | The efficacy of TCZ vs placebo is evaluated in terms of in mean change in mRSS. Skin thickness will be assessed by palpation and rated using an mRSS that ranges from 0 (normal) to 3 (severe skin thickening) across 17 different body sites. The total score is the sum of the individual skin scores from all of these sites and ranges from 0 to 51 units. | The analysis was conducted in the Intent-to-treat (ITT) population, i.e. all patients who were randomized and received any study drug. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | From baseline to week 48 |
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| Secondary | Percentage of Participants With Greater Than or Equal to (>/=) 20%, 40%, or 60% Improvement in mRSS During Double-blind Period | The proportion of participants with threshold improvements in mRSS at Week 48 relative to baseline. | The analysis was conducted in the Intent-to-treat (ITT) population, i.e. all patients who were randomized and received any study drug. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From Baseline to Week 48 |
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| Secondary | Change From Baseline in Percent Predicted FVC (ppFVC) During Double-blind Period | FVC is pulmonary function test and will be conducted as per the study Pulmonary Function Manual, which is based on the American Thoracic Society/European Respiratory Society (ATS/ERS) Consensus Statement. FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Patients perform three to eight exhalations into a spirometer with the highest value recorded. | The analysis was conducted in the Intent-to-treat (ITT) population, i.e. all patients who were randomized and received any study drug. | Posted | Median | 95% Confidence Interval | Percent Predicted FVC | Baseline to week 48 |
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| Secondary | Change in Forced Vital Capacity (FVC) During Double-blind Period | FVC is pulmonary function test and will be conducted as per the study Pulmonary Function Manual, which is based on the American Thoracic Society/European Respiratory Society (ATS/ERS) Consensus Statement. FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Patients perform three to eight exhalations into a spirometer with the highest value recorded. | The analysis was conducted in the Intent-to-treat (ITT) population, i.e. all patients who were randomized and received any study drug. | Posted | Least Squares Mean | 95% Confidence Interval | Liters of air | From Baseline to Week 48 |
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| Secondary | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) Score During Double-blind Period | The Health Assessment Questionnaire Disability Index (HAQ-DI) consists of 20 questions referring to eight component sets consisting of dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each item is scored on a 4-point scale from 0 to 3: 0 = Without any difficulty; 1 = With some difficulty; 2 = With much difficulty; 3 = Unable to do. Overall score was computed as the sum of component set scores and divided by the number of component sets answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. The total score indicates the patient's self-assessed level of disability. This outcome measure represents the change in mean score from baseline. A negative change from baseline indicates improvement. | The analysis was conducted in the Intent-to-treat (ITT) population, i.e. all patients who were randomized and received any study drug. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a Scale | From Baseline to Week 48 |
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| Secondary | Change in Patient Global Assessment Score During Double-blind Period | The Patient's Global Assessment represents the patient's overall assessment of current SSc status on a 100-mm horizontal visual analogue scale (VAS), ranging from 0 on the extreme left end of the scale indicating "has no effect at all" (symptom free), and 100 on the extreme right end indicating "worst possible effect." | The analysis was conducted in the Intent-to-treat (ITT) population, i.e. all patients who were randomized and received any study drug. | Posted | Least Squares Mean | 95% Confidence Interval | mm | From Baseline to Week 48 |
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| Secondary | Change in Physician Global Assessment Score During Double-blind Period | The Physician's Global Assessment is to be completed on the basis of examination and overall assessment of the patient. The physician's assessment of the patient's SSc status will be scored on a 100-mm horizontal visual analogue scale (VAS), ranging from 0 on the extreme left end of the scale indicating "has no effect at all" (symptom free), and 100 on the extreme right end indicating "worst possible effect." | The analysis was conducted in the Intent-to-treat (ITT) population, i.e. all patients who were randomized and received any study drug. | Posted | Least Squares Mean | 95% Confidence Interval | mm | From Baseline to Week 48 |
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| Secondary | Time to Treatment Failure According to mRSS, FVC, or Protocol-Specified Event During Double-blind Period | Time to treatment failure is defined as the time from randomization to the time of death, decline in percent-predicted FVC > 10% relative to baseline, > 20% increase in mRSS and an increase in mRSS of equal to or more than 5 points, or occurrence of a predefined SSc-related complication as adjudicated by the Clinical Adjudication Committee (whichever occurs first) during the 48-week double-blind treatment period. The median TTF was not estimable and is not presented for either treatment arm because of the low number of patients with events at Week 48. | The analysis was conducted in the Intent-to-treat (ITT) population, i.e. all patients who were randomized and received any study drug. | Posted | Median | 95% Confidence Interval | months | From Baseline to Week 48 |
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| Secondary | Summary of Adverse Events During Double-blind Period | Summary of key safety results including Adverse Events of Special Interest (AESI). All adverse events categorized according to MedDRA version 20.1. NMSC = Non-Melanoma Skin Cancer | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Number | Percentage of Participants | From Baseline until Week 48 |
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| Secondary | Incidence and Severity of Adverse Events During Double-blind Period | Adverse events listed according to MedDRA version 20.1 preferred terms and severity grade. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Number | Number of participants | From Baseline until Week 48 |
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| Secondary | Number of Participants With Adverse Events Leading to Death During Double-blind Period | Reason of death is coded using MedDRA 20.1 | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Number | Number of participants | From Baseline up to Week 48 |
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| Secondary | Frequency of Serious Systemic Sclerosis (SSC) Related Complications During Double-blind Period | Adverse event terms coded using MedDRA 20.1. Includes only those serious events adjudicated as SSC-related complications by an independent external committee. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Number | Number of Participants | From Baseline up to Week 48 |
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| Secondary | Incidence of Haematology and Hepatic Laboratory Parameters During Double-blind Period | A laboratory event occurred if the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade for a post-baseline laboratory measurement increased from baseline. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Number | Number of Participants | From Baseline up to Week 48 |
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| Secondary | Percentage of Participants With Change in Digital Ulcer Count During Double-blind Period | A digital ulcer is defined as an ulcer at or distal to the MCP joint on either the dorsal or volar surface, with loss of surface epithelialization. This does not include fissures, cracks, or calcium extrusions from calcinosis cutis. The number of fingers (0-10) with digital ulcers and the number of digital (or finger) ulcers will be counted and recorded by the investigator. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Number | Percentage of participants | From Baseline to Week 48 |
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| Secondary | Percentage of Participants With Positive Anti-Tocilizumab Assay Result at Baseline | Incidence of anti-Tocilizumab at baseline | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Number | Percentage of Participants | Baseline |
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| Secondary | Percentage of Participants With Positive Anti-Tocilizumab Assay Post-Baseline up to Week 48 | Incidence of anti-Tocilizumab antibodies during the study relative to the prevalence of anti-Tocilizumab antibodies at baseline. Samples that are positive for anti-TCZ in the screening assay will be further analyzed by a confirmation assay to confirm specificity. If the confirmation assay is positive, two additional tests will be performed: a neutralizing assay for the ability to inhibit the activity of TCZ and a test for anti -TCZ of the IgE isotype. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Number | Percentage of Participants | Double-blind period (up to Week 48) |
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| Secondary | Correlation Between Anti-Tocilizumab Antibody Status and Outcome Measures Pertaining to the Efficacy, Safety, and Pharmacokinetics of Tocilizumab | Pre-specified analysis of the relationship between Anti-Tocilizumab Antibody status and safety, efficacy, and PK endpoints were not analyzed via subgroup analyses as there was only 1 patient with ADA-positive status. | Posted | Median | Full Range | Units on a scale | Baseline; during Weeks 8, 16, 24, 36, 48, 96, and/or at treatment discontinuation (up to 96 weeks); and 8 weeks after treatment discontinuation (up to 104 weeks overall) |
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| Secondary | Erythrocyte Sedimentation Rate (ESR), Mean, From Baseline to Week 48 | Erythrocyte Sedimentation Rate (ESR) levels predose at baseline and at subsequent time points after initiation of study drug. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Mean | Standard Deviation | mm/hr | From Predose up to Week 48 |
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| Secondary | Erythrocyte Sedimentation Rate (ESR), Median, From Baseline to Week 48 | Erythrocyte Sedimentation Rate (ESR) levels predose at baseline and at subsequent time points after initiation of study drug. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Median | Inter-Quartile Range | mm/hr | From Baseline to Week 48 |
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| Secondary | Serum Interleukin (IL)-6 Level, Mean, From Baseline to Week 48 | Serum Interleukin (IL)-6 levels predose at baseline and at subsequent time points after initiation of study drug. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Mean | Standard Deviation | pg/mL | From Baseline to Week 48 |
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| Secondary | Serum Interleukin (IL)-6 Level, Median, From Baseline to Week 48 | Serum Interleukin (IL)-6 levels predose at baseline and at subsequent time points after initiation of study drug. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Median | Full Range | pg/mL | From Baseline to Week 48 |
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| Secondary | Serum Interleukin (IL)-6 Level, Mean Change From Baseline to Week 48 | Serum Interleukin (IL)-6 levels predose at baseline and at subsequent time points after initiation of study drug. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Mean | Standard Deviation | pg/mL | From Baseline to Week 48 |
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| Secondary | Serum Interleukin (IL)-6 Level, Median Change From Baseline to Week 48 | Serum Interleukin (IL)-6 levels predose at baseline and at subsequent time points after initiation of study drug. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Median | Full Range | pg/mL | From Baseline to Week 48 |
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| Secondary | Serum Soluble Interleukin (IL)-6 Receptor Level, Mean, From Baseline to Week 48 | Serum soluble Interleukin (IL)-6 receptor levels predose at baseline and at subsequent time points after initiation of study drug. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Mean | Standard Deviation | ng/mL | From Baseline to Week 48 |
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| Secondary | Serum Soluble Interleukin (IL)-6 Receptor Level, Median, From Baseline to Week 48 | Serum soluble Interleukin (IL)-6 receptor levels predose at baseline and at subsequent time points after initiation of study drug. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Median | Full Range | ng/mL | From Baseline to Week 48 |
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| Secondary | Serum Soluble Interleukin (IL)-6 Receptor Level, Mean Change From Baseline to Week 48 | Serum soluble Interleukin (IL)-6 receptor levels predose at baseline and at subsequent time points after initiation of study drug. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Mean | Standard Deviation | ng/mL | From Baseline to Week 48 |
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| Secondary | Serum Soluble Interleukin (IL)-6 Receptor Level, Median Change From Baseline to Week 48 | Serum soluble Interleukin (IL)-6 receptor levels predose at baseline and at subsequent time points after initiation of study drug. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Median | Full Range | ng/mL | From Baseline to Week 48 |
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| Secondary | Serum C-Reactive Protein (CRP) Level, Mean, From Baseline to Week 48 | Serum C-Reactive Protein (CRP) levels predose at baseline and at subsequent time points after initiation of study drug. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Mean | Standard Deviation | mg/L | From Baseline up to Week 48 |
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| Secondary | Serum C-Reactive Protein (CRP) Level, Median, From Baseline to Week 48 | Serum C-Reactive Protein (CRP) levels predose at baseline and at subsequent time points after initiation of study drug. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Median | Inter-Quartile Range | mg/L | From Baseline up to Week 48 |
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| Secondary | Serum Tocilizumab Concentration, Mean, From Baseline to Week 48 | Predose observed serum TCZ concentration at baseline and at specified timepoints thereafter | The PK population includes all patients who received at least one TCZ injection and had at least one PK sample with detectable results. | Posted | Mean | Standard Deviation | ug/mL | From Baseline to Week 48 |
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| Secondary | Serum Tocilizumab Concentration, Median, From Baseline to Week 48 | Predose observed serum TCZ concentration at baseline and at specified timepoints thereafter | The PK population includes all patients who received at least one TCZ injection and had at least one PK sample with detectable results. | Posted | Median | Full Range | ug/mL | From Baseline to Week 48 |
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| Secondary | Correlation Between Low Serum Tocilizumab Exposure and Mean Modified Rodnan Skin Score (mRSS) From Baseline to Week 48 | In order to characterize exposure-efficacy relationships, mRSS scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Mean | Standard Deviation | Units on a scale | From Baseline to Week 48 |
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| Secondary | Correlation Between Low Serum Tocilizumab Exposure and Median Modified Rodnan Skin Score (mRSS) From Baseline to Week 48 | In order to characterize exposure-efficacy relationships, mRSS scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Median | Full Range | Units on a scale | From Baseline to Week 48 |
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| Secondary | Correlation Between Medium Serum Tocilizumab Exposure and Mean Modified Rodnan Skin Score (mRSS) From Baseline to Week 48 | In order to characterize exposure-efficacy relationships, mRSS scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Mean | Standard Deviation | Units on a scale | From Baseline to Week 48 |
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| Secondary | Correlation Between Medium Serum Tocilizumab Exposure and Median Modified Rodnan Skin Score (mRSS) From Baseline to Week 48 | In order to characterize exposure-efficacy relationships, mRSS scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Median | Full Range | Units on a scale | From Baseline to Week 48 |
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| Secondary | Correlation Between High Serum Tocilizumab Exposure and Mean Modified Rodnan Skin Score (mRSS) From Baseline to Week 48 | In order to characterize exposure-efficacy relationships, mRSS scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Mean | Standard Deviation | Units on a scale | From Baseline to Week 48 |
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| Secondary | Correlation Between High Serum Tocilizumab Exposure and Median Modified Rodnan Skin Score (mRSS) From Baseline to Week 48 | In order to characterize exposure-efficacy relationships, mRSS scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Median | Full Range | Units on a scale | From Baseline to Week 48 |
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| Secondary | Change in Mean Modified Rodnan Skin Score (mRSS) at Low, Medium and High Serum Tocilizumab Exposure From Baseline to Week 48 | In order to characterize exposure-efficacy relationships, mRSS scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Mean | Standard Deviation | Units on a scale | From Baseline to Week 48 |
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| Secondary | Change in Median Modified Rodnan Skin Score (mRSS), at Low, Medium and High Serum Tocilizumab Exposure From Baseline to Week 48 | In order to characterize exposure-efficacy relationships, mRSS scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Median | Full Range | Units on a scale | From Baseline to Week 48 |
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| Secondary | Change in Mean Percent Predicted Forced Vital Capacity (ppFVC), at Low, Medium and High Serum Tocilizumab Exposure From Baseline to Week 48 | In order to characterize exposure-efficacy relationships, ppFVC scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Mean | Standard Deviation | Percent | From Baseline to Week 48 |
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| Secondary | Change in Median Percent Predicted Forced Vital Capacity (ppFVC), at Low, Medium and High Serum Tocilizumab Exposure From Baseline to Week 48 | In order to characterize exposure-efficacy relationships, ppFVC scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Median | Full Range | Percent | From Baseline to Week 48 |
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| Secondary | Summary of Adverse Events Up to Week 96 | Summary of key safety results including Adverse Events of Special Interest (AESI). All adverse events categorized according to MedDRA version 21.1. NMSC = Non-Melanoma Skin Cancer | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Number | Percentage of participants | Up to Week 96 |
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| Secondary | Incidence and Severity of Adverse Events Up to Week 96 | Adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) severity grade: 1 = mild, 2 = moderate, 3 = severe and/or requiring medical intervention but not life-threatening, 4 = life-threatening consequences, and 5 = death. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Number | Number of participants | Up to Week 96 |
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| Secondary | Number of Participants With Adverse Events Leading to Death Up to Week 96 | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Number | Number of participants | Up to Week 96 |
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| Secondary | Percentage of Participants With Change in Digital Ulcer Count at Week 96 | A digital ulcer is defined as an ulcer at or distal to the MCP joint on either the dorsal or volar surface, with loss of surface epithelialization. This does not include fissures, cracks, or calcium extrusions from calcinosis cutis. The number of fingers (0-10) with digital ulcers and the number of digital (or finger) ulcers will be counted and recorded by the investigator. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Number | Percentage of participants | From Baseline to Week 96 |
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| Secondary | Percentage of Participants With Positive Anti-Tocilizumab Assay Post-Baseline From Week 48 to 96 | Reported were the percentage of participants with post-baseline treatment-induced anti-TCZ antibodies. Positive samples underwent additional analyses: a neutralizing assay for the ability to inhibit the activity of TCZ and a test for anti -TCZ of the IgE isotype. | Safety population: received at least one dose of study drug and provide data from at least one post dose safety assessment. Only samples from the Double Blind TCZ, then Open Label TCZ were measured by the lab after week 48. Data for the Double Blind Period were reported at the time of Primary Results disclosure up to Week 48. | Posted | Number | Percentage of Participants | Open-label period from Week 48 to 96 |
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| Secondary | Erythrocyte Sedimentation Rate (ESR) Up to Week 96 | Erythrocyte Sedimentation Rate (ESR) levels predose at baseline and at subsequent time points after initiation of study drug. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Mean | Standard Deviation | mm/hr | Up to Week 96 |
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| Secondary | Serum Interleukin (IL)-6 Level, Mean, From Baseline to Week 96 | Serum Interleukin (IL)-6 levels predose at baseline and at subsequent time points after initiation of study drug. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Mean | Standard Deviation | pg/mL | Up to Week 96 |
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| Secondary | Serum Soluble Interleukin (IL)-6 Receptor Level, Mean, Up to Week 96 | Serum Soluble Interleukin (IL)-6 receptor levels predose at baseline and at subsequent time points after initiation of study drug. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Mean | Standard Deviation | ng/mL | Up to Week 96 |
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| Secondary | Serum C-Reactive Protein (CRP) Level, Mean, Up to Week 96 | Serum C-Reactive Protein (CRP) levels predose at baseline and at subsequent time points after initiation of study drug. | The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment. | Posted | Mean | Standard Deviation | mg/L | From Baseline up to Week 96 |
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| Secondary | Serum Tocilizumab Concentration, Mean, Up to Week 96 | Predose observed serum TCZ concentration at baseline and at specified timepoints thereafter | The PK population included all participants who received at least one TCZ injection and had at least one PK sample with detectable results. Only samples from the Double Blind TCZ, then Open Label TCZ were measured by the lab after week 48. Data for the Double Blind Period were reported at the time of Primary Results disclosure up to Week 48. | Posted | Mean | Standard Deviation | ug/mL | Up to Week 96 |
|
|
Up to Week 96
The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.
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 | Double-Blind Placebo | Participants received double-blind matching placebo from Baseline to Week 48. Participants may then receive open-label tocilizumab from Weeks 48 to 96. | 3 | 106 | 18 | 106 | 59 | 106 |
| EG001 | Double-Blind Tocilizumab | Participants received double-blind tocilizumab from Baseline to Week 48. Participants may then receive open-label tocilizumab from Weeks 48 to 96. | 1 | 104 | 13 | 104 | 60 | 104 |
| EG002 | Placebo, Then Tocilizumab Open Label | Participants who received placebo during the double blind period from Baseline to Week 48, received tocilizumab from Week 48 to Week 96. | 1 | 89 | 7 | 89 | 46 | 89 |
| EG003 | Tocilizumab, Then Tocilizumab Open Label | Participants who received tocilizumab during the double blind period from Baseline to Week 48, received tocilizumab from Week 48 to Week 96. | 1 | 92 | 10 | 92 | 28 | 92 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA MEGALOBLASTIC | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| LYMPHADENOPATHY MEDIASTINAL | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| ARRHYTHMIA | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| CARDIAC FAILURE CHRONIC | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| CARDIAC TAMPONADE | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| CONGESTIVE CARDIOMYOPATHY | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| MICROVASCULAR CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| MYOCARDITIS | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| RETINAL VEIN THROMBOSIS | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| GASTRITIS EROSIVE | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| ILEUS PARALYTIC | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| RECTAL PROLAPSE | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| INFECTED SKIN ULCER | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| INFECTIVE TENOSYNOVITIS | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| OTITIS MEDIA | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| PELVIC INFLAMMATORY DISEASE | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| PYELONEPHRITIS CHRONIC | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| SOFT TISSUE INFECTION | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| LIMB TRAUMATIC AMPUTATION | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| SPINAL CORD INJURY | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| DIABETIC KETOACIDOSIS | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| JOINT STIFFNESS | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| SCLERODERMA | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| TENDONITIS | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| TENOSYNOVITIS | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| TRIGGER FINGER | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| B-CELL LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| BENIGN BONE NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| LUNG ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| BRAIN INJURY | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| ADJUSTMENT DISORDER | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| SCLERODERMA RENAL CRISIS | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| PULMONARY HYPERTENSION | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| DIGITAL PITTING SCAR | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| ECCHYMOSIS | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA 21.1 | 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 | Hoffmann-La Roche | 1-800-821-8590 | genentech@druginfo.com |
| SAP_001.pdf |
| Prot | Yes | No | No | Study Protocol | May 5, 2017 | Apr 2, 2019 | Prot_002.pdf |
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C502936 | tocilizumab |
Not provided
Not provided
Not provided
| Lost to Follow-up |
|
| Other |
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| Withdrawal by Subject |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Units | Counts |
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| Participants |
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Participants who received tocilizumab during the double blind period from Baseline to Week 48, received tocilizumab from Week 48 to Week 96. |
|
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| OG003 |
| Tocilizumab, Then Tocilizumab Open Label |
Participants who received tocilizumab during the double blind period from Baseline to Week 48, received tocilizumab from Week 48 to Week 96. |
|
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| OG003 | Tocilizumab, Then Tocilizumab Open Label | Participants who received tocilizumab during the double blind period from Baseline to Week 48, received tocilizumab from Week 48 to Week 96. |
|
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|
Participants who received tocilizumab during the double blind period from Baseline to Week 48, received tocilizumab from Week 48 to Week 96. |
|
|
Participants who received tocilizumab during the double blind period from Baseline to Week 48, received tocilizumab from Week 48 to Week 96. |
|
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Participants who received tocilizumab during the double blind period from Baseline to Week 48, received tocilizumab from Week 48 to Week 96. |
|
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Participants who received tocilizumab during the double blind period from Baseline to Week 48, received tocilizumab from Week 48 to Week 96. |
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