Systemic Sclerosis Clinical Trial
— focuSScedOfficial title:
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Tocilizumab Versus Placebo in Patients With Systemic Sclerosis
Verified date | March 2020 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 212 |
Est. completion date | February 4, 2019 |
Est. primary completion date | January 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of SSc according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria, meeting criteria for active disease and with total disease duration of less than or equal to (</=) 60 months - mRSS of 10-35 units, inclusive - Agreement to remain abstinent or use an effective contraceptive method among males and females with childbearing potential Exclusion Criteria: - Pregnant or lactating females - Major surgery within 8 weeks prior to screening - Scleroderma limited to the face or areas distal to the elbows or knees - Rheumatic autoimmune disease other than SSc - Immunization with a live or attenuated vaccine within 4 weeks prior to Baseline - Known hypersensitivity to human, humanized, or murine monoclonal antibodies - Moderately severe nervous system, renal, endocrine, pulmonary, cardiovascular, or gastrointestinal (GI) disease not related to SSc, including diverticulitis or ulcerative lower GI disorders, or myocardial infarction (MI) within 6 months prior to screening - Active or significant history of infection, including treatment with intravenous (IV) antibiotics within 4 weeks or oral antibiotics within 2 weeks prior to screening - Significant history of tuberculosis (TB) - Primary or secondary immunodeficiency - Malignant disease, with the exception of excised/cured local basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix - History of drug or alcohol abuse |
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital Britanico; Haematology | Buenos Aires | |
Argentina | Organizacion Medica de Investigacion | Buenos Aires | |
Argentina | Sanatorio Parque S.A. | Rosario, Santa FE | |
Argentina | Centro de Investigaciones Reumatologicas Tucuman | Tucuman | |
Belgium | UZ Gent | Gent | |
Belgium | UZ Leuven Gasthuisberg | Leuven | |
Bulgaria | MHAT Kaspela; Rheumatology | Plovdiv | |
Bulgaria | MHAT-Plovdiv AD; Reumatology Department | Plovdiv | |
Bulgaria | MHAT St.Ivan Rilski; Rheumtology Department | Sofia | |
Bulgaria | MHAT Sv.Ivan Rilski; Clinic of Rheumatology | Sofia | |
Canada | Mount Sinai Hospital; Rebecca Macdonald Centre For Arthritis & Autoimmune Disease | Toronto | Ontario |
Canada | St. Paul's Hospital University of British Colambia Division of Hematology | Vancouver | British Columbia |
Denmark | Aarhus Universitetshospital Skejby, Hud- og Kønssygdomme | Aarhus N | |
Denmark | Bispebjerg Hospital, Dermatologisk afdeling | København NV | |
France | Hopital Claude Huriez; Internal Medicine | Lille | |
Germany | Asklepios Kllinikum Bad Abbach; Klinik für Rheumatologie und Klinische Immunologie | Bad Abbach | |
Germany | Kerckhoff-Klinik; Rheumatologie&klin.Immunologie | Bad Nauheim | |
Germany | Universitätsklinikum Dresden; Technische Universität Dresden; Rheumatologie, Innere Medizin III | Dresden | |
Germany | Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV | München | |
Germany | Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II | Tübingen | |
Greece | Laiko General Hospital; Dept. of Pathophysiology-Uni of Athens | Athens | |
Greece | University Hospital of Patras; Rheumatology | Patras | |
Hungary | National Institute of Rheumatology and Physiology | Budapest | |
Hungary | Pécsi Tudományegyetem Klinikai Központ: Immunológiai és Reumatológiai Klinika | Pécs | |
Italy | Ospedale Careggi Villa Monnatessa ; Sezione Di Reumatologia | Firenze | Toscana |
Italy | Ospedale Maggiore Policlinico; Unità Operativa Complessa di Allergologia e Immunologia Clinica | Milano | Lombardia |
Italy | Policlinico Universitario-II Università di Napoli; Reumatologia | Napoli | Campania |
Italy | Uni ' Cattolica Del Sacro Cuore; Facoltà Di Medicina E Chirurgia A.Gemelli-Clinica Reumatologica | Roma | Lazio |
Japan | Gunma University Hospital | Gunma | |
Japan | Hokkaido University Hospital | Hokkaido | |
Japan | Sapporo Medical University Hospital | Hokkaido | |
Japan | Kanazawa University Hospital | Ishikawa | |
Japan | St. Marianna University School of Medicine Hospital | Kanagawa | |
Japan | Hospital of the University of Occupational and Environmental Health,Japan | Kitakyushu-shi | |
Japan | Kumamoto University Hospital | Kumamoto | |
Japan | Tohoku University Hospital | Miyagi | |
Japan | Osaka University Hospital | Osaka | |
Japan | Nippon Medical School Hospital | Tokyo | |
Japan | The University of Tokyo Hospital | Tokyo | |
Lithuania | Klaipeda University Hospital; Department of Rheumatology | Klaipeda | |
Lithuania | Vilnius University Hospital Santariskiu Clinic Public Insti | Vilnius | |
Mexico | Unidad De Enfermedades; Cronico Degenerativas, SC. | Mexico | |
Mexico | Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán | Mexico City | |
Mexico | Cliditer SA de CV | Miexico City | |
Netherlands | Academisch Ziekenhuis Leiden; Dept of Rheumatology | Leiden | |
Poland | Szpital Uniwersytecki; nr 2 im. Dr J. Biziela; Klinika Reumatologii i Ukladowych Chorob | Bydgoszcz | |
Poland | Uniwersyteckie Centrum Kliniczne; Klinika Chorob Wewnetrznych, Chorob Tkanki Lacznej i Geriatrii | Gdansk | |
Poland | Gornoslaskie Centrum Medyczne | Katowice | |
Poland | Szpital Specjalistyczny im Jozefa Dietla; Centrum Reumatologii, Immunologii i Rehabilitacji, I Oddzi | Krakow | |
Poland | SPSK NR 4; Reumatologii i Ukladowych Chorob Tkanki | Lublin | |
Poland | Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher | Warszawa | |
Portugal | Hospital Garcia de Orta; Servico de Reumatologia | Almada | |
Portugal | Hospital Prof. Dr. Fernando Fonseca; Medicina IV | Amadora | |
Puerto Rico | Puerto Rico Clinical & Translational Research Consortium | San Juan | |
Romania | Cantacuzino Hospital; Department of Internal Medicine and Rheumatology | Bucharest | |
Romania | Spitalul Judetean Cluj; Sectia de Reumatologie | Cluj-napoca | |
Spain | Hospital de la Santa Creu i Sant Pau; Servicio de Medicina Interna/Reumatologia | Barcelona | |
Spain | Hospital Universitario Vall d'Hebron; Servicio de Medicina Interna | Barcelona | |
Spain | Hospital General Universitario Gregorio Marañon; Servicio de Reumatología | Madrid | |
Switzerland | Universitätsspital Basel; Rheumatologische Poliklinik | Basel | |
Switzerland | Universitätsspital Zürich; Klinik für Rheumatologie | Zürich | |
United Kingdom | Queen Elizabeth Hospital; Rheumatology Dept. | Birmingham | |
United Kingdom | Western General Hospital | Edinburgh | |
United Kingdom | Chapel Allerton Hospital; Leeds Institution of Rheumatology Medicine | Leeds | |
United Kingdom | Uni Hospital Aintree; Academic Rheumatology Unit | Liverpool | |
United Kingdom | Royal Free Hospital; Department of Rheumatology | London | |
United Kingdom | Freeman Hospital; Musculoskeletal Unit | Newcastle Upon Tyne | |
United States | University of Michigan | Ann Arbor | Michigan |
United States | Rheumatology Assoc. of S. Florida - Clinical Research Center | Boca Raton | Florida |
United States | Boston Univ Med Center - AC | Boston | Massachusetts |
United States | Joint & Muscle Research Institute | Charlotte | North Carolina |
United States | Metroplex Clinical Research | Dallas | Texas |
United States | TriWest Research Associates, LLC | El Cajon | California |
United States | St. Joseph's Heritage Healthcare | Fullerton | California |
United States | West Michigan Rheumatology, PLLC | Grand Rapids | Michigan |
United States | West Tennessee Research Institute | Jackson | Tennessee |
United States | Arthritis Associates of Southern California | Los Angeles | California |
United States | Univ of Calif., Los Angeles; Rheumatology | Los Angeles | California |
United States | Arthritis and Rheumatology; Center of Oklahoma PLLC | Oklahoma City | Oklahoma |
United States | Millenium Research | Ormond Beach | Florida |
United States | Thomas Jefferson Uni ; Division of Rheumatology | Philadelphia | Pennsylvania |
United States | Georgetown Uni. Hosp.; Rheumatology, Immunology and Allergy Dept. | Washington | District of Columbia |
United States | Clinical Research Center of Reading | Wyomissing | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United States, Argentina, Belgium, Bulgaria, Canada, Denmark, France, Germany, Greece, Hungary, Italy, Japan, Lithuania, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Spain, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | From baseline to week 48 | |
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. | From Baseline to Week 48 | |
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. | Baseline to week 48 | |
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. | From Baseline to Week 48 | |
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. | From Baseline to Week 48 | |
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." | From Baseline to Week 48 | |
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." | From Baseline to Week 48 | |
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. | From Baseline to Week 48 | |
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 | From Baseline until Week 48 | |
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. | From Baseline until Week 48 | |
Secondary | 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 | |
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. | From Baseline up to Week 48 | |
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. | From Baseline up to Week 48 | |
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. | From Baseline to Week 48 | |
Secondary | Percentage of Participants With Positive Anti-Tocilizumab Assay Result at Baseline | Incidence of anti-Tocilizumab at baseline | Baseline | |
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. | Double-blind period (up to Week 48) | |
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. | 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) | |
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. | From Predose up to Week 48 | |
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. | From Baseline to Week 48 | |
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. | From Baseline to Week 48 | |
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. | From Baseline to Week 48 | |
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. | From Baseline to Week 48 | |
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. | From Baseline to Week 48 | |
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. | From Baseline to Week 48 | |
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. | From Baseline to Week 48 | |
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. | From Baseline to Week 48 | |
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. | From Baseline to Week 48 | |
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. | From Baseline up to Week 48 | |
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. | From Baseline up to Week 48 | |
Secondary | 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 | |
Secondary | 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 | |
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. | From Baseline to Week 48 | |
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. | From Baseline to Week 48 | |
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. | From Baseline to Week 48 | |
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. | From Baseline to Week 48 | |
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. | From Baseline to Week 48 | |
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. | From Baseline to Week 48 | |
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. | From Baseline to Week 48 | |
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. | From Baseline to Week 48 | |
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. | From Baseline to Week 48 | |
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. | From Baseline to Week 48 | |
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 | Up to Week 96 | |
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. | Up to Week 96 | |
Secondary | Number of Participants With Adverse Events Leading to Death Up to Week 96 | Up to Week 96 | ||
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. | From Baseline to Week 96 | |
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. | Open-label period from Week 48 to 96 | |
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. | Up to Week 96 | |
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. | Up to Week 96 | |
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. | Up to Week 96 | |
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. | From Baseline up to Week 96 | |
Secondary | Serum Tocilizumab Concentration, Mean, Up to Week 96 | Predose observed serum TCZ concentration at baseline and at specified timepoints thereafter | Up to Week 96 |
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