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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02453256
Other study ID # WA29767
Secondary ID 2015-000424-28
Status Completed
Phase Phase 3
First received
Last updated
Start date November 20, 2015
Est. completion date February 4, 2019

Study information

Verified date March 2020
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
Placebo
Participants will receive matching placebo subcutaneous (SC) injections once weekly for 48 weeks of double-blind treatment.
Tocilizumab
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

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, 

Outcome

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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