A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc) (focuSSced)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02453256

Recruitment Status : Completed

First Posted : May 25, 2015

Results First Posted : April 3, 2019

Last Update Posted : March 9, 2020

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Systemic Sclerosis	Drug: Placebo Drug: Tocilizumab	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	212 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official 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
Actual Study Start Date :	November 20, 2015
Actual Primary Completion Date :	January 15, 2018
Actual Study Completion Date :	February 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Systemic scleroderma

MedlinePlus related topics: Scleroderma

Drug Information available for: Tocilizumab

Genetic and Rare Diseases Information Center resources: Systemic Scleroderma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Double-Blind Placebo Participants will receive double-blind matching placebo from Baseline to Week 47. Participants may then receive open-label tocilizumab from Weeks 48 to 96.	Drug: Placebo Participants will receive matching placebo subcutaneous (SC) injections once weekly for 48 weeks of double-blind treatment. Drug: 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.
Experimental: Double-Blind Tocilizumab Participants will receive double-blind tocilizumab from Baseline to Week 47. Participants may then receive open-label tocilizumab from Weeks 48 to 96.	Drug: 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.

Outcome Measures

Primary Outcome Measures :

Change in Modified Rodnan Skin Score (mRSS) During Double-blind Period [ Time Frame: From baseline to week 48 ]
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.

Secondary Outcome Measures :

Percentage of Participants With Greater Than or Equal to (>/=) 20%, 40%, or 60% Improvement in mRSS During Double-blind Period [ Time Frame: From Baseline to Week 48 ]
The proportion of participants with threshold improvements in mRSS at Week 48 relative to baseline.
Change From Baseline in Percent Predicted FVC (ppFVC) During Double-blind Period [ Time Frame: Baseline to week 48 ]
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.
Change in Forced Vital Capacity (FVC) During Double-blind Period [ Time Frame: From Baseline to Week 48 ]
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.
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) Score During Double-blind Period [ Time Frame: From Baseline to Week 48 ]
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.
Change in Patient Global Assessment Score During Double-blind Period [ Time Frame: From Baseline to Week 48 ]
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."
Change in Physician Global Assessment Score During Double-blind Period [ Time Frame: From Baseline to Week 48 ]
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."
Time to Treatment Failure According to mRSS, FVC, or Protocol-Specified Event During Double-blind Period [ Time Frame: From Baseline to Week 48 ]
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.
Summary of Adverse Events During Double-blind Period [ Time Frame: From Baseline until Week 48 ]
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
Incidence and Severity of Adverse Events During Double-blind Period [ Time Frame: From Baseline until Week 48 ]
Adverse events listed according to MedDRA version 20.1 preferred terms and severity grade.
Number of Participants With Adverse Events Leading to Death During Double-blind Period [ Time Frame: From Baseline up to Week 48 ]
Reason of death is coded using MedDRA 20.1
Frequency of Serious Systemic Sclerosis (SSC) Related Complications During Double-blind Period [ Time Frame: From Baseline up to Week 48 ]
Adverse event terms coded using MedDRA 20.1. Includes only those serious events adjudicated as SSC-related complications by an independent external committee.
Incidence of Haematology and Hepatic Laboratory Parameters During Double-blind Period [ Time Frame: From Baseline up to Week 48 ]
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.
Percentage of Participants With Change in Digital Ulcer Count During Double-blind Period [ Time Frame: From Baseline to Week 48 ]
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.
Percentage of Participants With Positive Anti-Tocilizumab Assay Result at Baseline [ Time Frame: Baseline ]
Incidence of anti-Tocilizumab at baseline
Percentage of Participants With Positive Anti-Tocilizumab Assay Post-Baseline up to Week 48 [ Time Frame: Double-blind period (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.
Correlation Between Anti-Tocilizumab Antibody Status and Outcome Measures Pertaining to the Efficacy, Safety, and Pharmacokinetics of Tocilizumab [ Time Frame: 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) ]
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.
Erythrocyte Sedimentation Rate (ESR), Mean, From Baseline to Week 48 [ Time Frame: From Predose up to Week 48 ]
Erythrocyte Sedimentation Rate (ESR) levels predose at baseline and at subsequent time points after initiation of study drug.
Erythrocyte Sedimentation Rate (ESR), Median, From Baseline to Week 48 [ Time Frame: From Baseline to Week 48 ]
Erythrocyte Sedimentation Rate (ESR) levels predose at baseline and at subsequent time points after initiation of study drug.
Serum Interleukin (IL)-6 Level, Mean, From Baseline to Week 48 [ Time Frame: From Baseline to Week 48 ]
Serum Interleukin (IL)-6 levels predose at baseline and at subsequent time points after initiation of study drug.
Serum Interleukin (IL)-6 Level, Median, From Baseline to Week 48 [ Time Frame: From Baseline to Week 48 ]
Serum Interleukin (IL)-6 levels predose at baseline and at subsequent time points after initiation of study drug.
Serum Interleukin (IL)-6 Level, Mean Change From Baseline to Week 48 [ Time Frame: From Baseline to Week 48 ]
Serum Interleukin (IL)-6 levels predose at baseline and at subsequent time points after initiation of study drug.
Serum Interleukin (IL)-6 Level, Median Change From Baseline to Week 48 [ Time Frame: From Baseline to Week 48 ]
Serum Interleukin (IL)-6 levels predose at baseline and at subsequent time points after initiation of study drug.
Serum Soluble Interleukin (IL)-6 Receptor Level, Mean, From Baseline to Week 48 [ Time Frame: 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.
Serum Soluble Interleukin (IL)-6 Receptor Level, Median, From Baseline to Week 48 [ Time Frame: 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.
Serum Soluble Interleukin (IL)-6 Receptor Level, Mean Change From Baseline to Week 48 [ Time Frame: 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.
Serum Soluble Interleukin (IL)-6 Receptor Level, Median Change From Baseline to Week 48 [ Time Frame: 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.
Serum C-Reactive Protein (CRP) Level, Mean, From Baseline to Week 48 [ Time Frame: From Baseline up to Week 48 ]
Serum C-Reactive Protein (CRP) levels predose at baseline and at subsequent time points after initiation of study drug.
Serum C-Reactive Protein (CRP) Level, Median, From Baseline to Week 48 [ Time Frame: From Baseline up to Week 48 ]
Serum C-Reactive Protein (CRP) levels predose at baseline and at subsequent time points after initiation of study drug.
Serum Tocilizumab Concentration, Mean, From Baseline to Week 48 [ Time Frame: From Baseline to Week 48 ]
Predose observed serum TCZ concentration at baseline and at specified timepoints thereafter
Serum Tocilizumab Concentration, Median, From Baseline to Week 48 [ Time Frame: From Baseline to Week 48 ]
Predose observed serum TCZ concentration at baseline and at specified timepoints thereafter
Correlation Between Low Serum Tocilizumab Exposure and Mean Modified Rodnan Skin Score (mRSS) From Baseline to Week 48 [ Time Frame: 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.
Correlation Between Low Serum Tocilizumab Exposure and Median Modified Rodnan Skin Score (mRSS) From Baseline to Week 48 [ Time Frame: 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.
Correlation Between Medium Serum Tocilizumab Exposure and Mean Modified Rodnan Skin Score (mRSS) From Baseline to Week 48 [ Time Frame: 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.
Correlation Between Medium Serum Tocilizumab Exposure and Median Modified Rodnan Skin Score (mRSS) From Baseline to Week 48 [ Time Frame: 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.
Correlation Between High Serum Tocilizumab Exposure and Mean Modified Rodnan Skin Score (mRSS) From Baseline to Week 48 [ Time Frame: 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.
Correlation Between High Serum Tocilizumab Exposure and Median Modified Rodnan Skin Score (mRSS) From Baseline to Week 48 [ Time Frame: 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.
Change in Mean Modified Rodnan Skin Score (mRSS) at Low, Medium and High Serum Tocilizumab Exposure From Baseline to Week 48 [ Time Frame: 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.
Change in Median Modified Rodnan Skin Score (mRSS), at Low, Medium and High Serum Tocilizumab Exposure From Baseline to Week 48 [ Time Frame: 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.
Change in Mean Percent Predicted Forced Vital Capacity (ppFVC), at Low, Medium and High Serum Tocilizumab Exposure From Baseline to Week 48 [ Time Frame: 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.
Change in Median Percent Predicted Forced Vital Capacity (ppFVC), at Low, Medium and High Serum Tocilizumab Exposure From Baseline to Week 48 [ Time Frame: 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.
Summary of Adverse Events Up to Week 96 [ Time Frame: 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
Incidence and Severity of Adverse Events Up to Week 96 [ Time Frame: 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.
Number of Participants With Adverse Events Leading to Death Up to Week 96 [ Time Frame: Up to Week 96 ]
Percentage of Participants With Change in Digital Ulcer Count at Week 96 [ Time Frame: From Baseline to 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.
Percentage of Participants With Positive Anti-Tocilizumab Assay Post-Baseline From Week 48 to 96 [ Time Frame: Open-label period 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.
Erythrocyte Sedimentation Rate (ESR) Up to Week 96 [ Time Frame: Up to Week 96 ]
Erythrocyte Sedimentation Rate (ESR) levels predose at baseline and at subsequent time points after initiation of study drug.
Serum Interleukin (IL)-6 Level, Mean, From Baseline to Week 96 [ Time Frame: Up to Week 96 ]
Serum Interleukin (IL)-6 levels predose at baseline and at subsequent time points after initiation of study drug.
Serum Soluble Interleukin (IL)-6 Receptor Level, Mean, Up to Week 96 [ Time Frame: Up to Week 96 ]
Serum Soluble Interleukin (IL)-6 receptor levels predose at baseline and at subsequent time points after initiation of study drug.
Serum C-Reactive Protein (CRP) Level, Mean, Up to Week 96 [ Time Frame: From Baseline up to Week 96 ]
Serum C-Reactive Protein (CRP) levels predose at baseline and at subsequent time points after initiation of study drug.
Serum Tocilizumab Concentration, Mean, Up to Week 96 [ Time Frame: Up to Week 96 ]
Predose observed serum TCZ concentration at baseline and at specified timepoints thereafter

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02453256

Locations

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United States, California
TriWest Research Associates, LLC
El Cajon, California, United States, 92020
St. Joseph's Heritage Healthcare
Fullerton, California, United States, 92835
Univ of Calif., Los Angeles; Rheumatology
Los Angeles, California, United States, 90025
Arthritis Associates of Southern California
Los Angeles, California, United States, 90045
United States, District of Columbia
Georgetown Uni. Hosp.; Rheumatology, Immunology and Allergy Dept.
Washington, District of Columbia, United States, 20007
United States, Florida
Rheumatology Assoc. of S. Florida - Clinical Research Center
Boca Raton, Florida, United States, 33486
Millenium Research
Ormond Beach, Florida, United States, 32174
United States, Massachusetts
Boston Univ Med Center - AC
Boston, Massachusetts, United States, 02118
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-0934
West Michigan Rheumatology, PLLC
Grand Rapids, Michigan, United States, 49546
United States, North Carolina
Joint & Muscle Research Institute
Charlotte, North Carolina, United States, 28204
United States, Oklahoma
Arthritis and Rheumatology; Center of Oklahoma PLLC
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Thomas Jefferson Uni ; Division of Rheumatology
Philadelphia, Pennsylvania, United States, 19131
Clinical Research Center of Reading
Wyomissing, Pennsylvania, United States, 19610
United States, Tennessee
West Tennessee Research Institute
Jackson, Tennessee, United States, 38305
United States, Texas
Metroplex Clinical Research
Dallas, Texas, United States, 75231
Argentina
Organizacion Medica de Investigacion
Buenos Aires, Argentina, C1015ABO
Hospital Britanico; Haematology
Buenos Aires, Argentina, C1280AEB
Sanatorio Parque S.A.
Rosario, Santa FE, Argentina, S2000DSV
Centro de Investigaciones Reumatologicas Tucuman
Tucuman, Argentina, 4000
Belgium
UZ Gent
Gent, Belgium, 9000
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
Bulgaria
MHAT Kaspela; Rheumatology
Plovdiv, Bulgaria, 4002
MHAT-Plovdiv AD; Reumatology Department
Plovdiv, Bulgaria, 4003
MHAT St.Ivan Rilski; Rheumtology Department
Sofia, Bulgaria, 1612
MHAT Sv.Ivan Rilski; Clinic of Rheumatology
Sofia, Bulgaria, 1612
Canada, British Columbia
St. Paul's Hospital University of British Colambia Division of Hematology
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
Mount Sinai Hospital; Rebecca Macdonald Centre For Arthritis & Autoimmune Disease
Toronto, Ontario, Canada, M5G 1X5
Denmark
Aarhus Universitetshospital Skejby, Hud- og Kønssygdomme
Aarhus N, Denmark, 8200
Bispebjerg Hospital, Dermatologisk afdeling
København NV, Denmark, 2400
France
Hopital Claude Huriez; Internal Medicine
Lille, France, 59037
Germany
Asklepios Kllinikum Bad Abbach; Klinik für Rheumatologie und Klinische Immunologie
Bad Abbach, Germany, 93077
Kerckhoff-Klinik; Rheumatologie&klin.Immunologie
Bad Nauheim, Germany, 61231
Universitätsklinikum Dresden; Technische Universität Dresden; Rheumatologie, Innere Medizin III
Dresden, Germany, 01307
Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV
München, Germany, 80336
Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II
Tübingen, Germany, 72076
Greece
Laiko General Hospital; Dept. of Pathophysiology-Uni of Athens
Athens, Greece, 115 27
University Hospital of Patras; Rheumatology
Patras, Greece, 265 04
Hungary
National Institute of Rheumatology and Physiology
Budapest, Hungary, 1023
Pécsi Tudományegyetem Klinikai Központ: Immunológiai és Reumatológiai Klinika
Pécs, Hungary, 7632
Italy
Policlinico Universitario-II Università di Napoli; Reumatologia
Napoli, Campania, Italy, 80131
Uni ' Cattolica Del Sacro Cuore; Facoltà Di Medicina E Chirurgia A.Gemelli-Clinica Reumatologica
Roma, Lazio, Italy, 00168
Ospedale Maggiore Policlinico; Unità Operativa Complessa di Allergologia e Immunologia Clinica
Milano, Lombardia, Italy, 20122
Ospedale Careggi Villa Monnatessa ; Sezione Di Reumatologia
Firenze, Toscana, Italy, 50139
Japan
Gunma University Hospital
Gunma, Japan, 371-8511
Sapporo Medical University Hospital
Hokkaido, Japan, 060-8543
Hokkaido University Hospital
Hokkaido, Japan, 060-8648
Kanazawa University Hospital
Ishikawa, Japan, 920-8641
St. Marianna University School of Medicine Hospital
Kanagawa, Japan, 216-8511
Hospital of the University of Occupational and Environmental Health,Japan
Kitakyushu-shi, Japan, 807-8556
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Tohoku University Hospital
Miyagi, Japan, 980-8574
Osaka University Hospital
Osaka, Japan, 565-0871
Nippon Medical School Hospital
Tokyo, Japan, 113-8603
The University of Tokyo Hospital
Tokyo, Japan, 113-8655
Lithuania
Klaipeda University Hospital; Department of Rheumatology
Klaipeda, Lithuania, LT - 92288
Vilnius University Hospital Santariskiu Clinic Public Insti
Vilnius, Lithuania, 08661
Mexico
Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán
Mexico City, Mexico, Tlalpan 14000
Unidad De Enfermedades; Cronico Degenerativas, SC.
Mexico, Mexico, 44620
Cliditer SA de CV
Miexico City, Mexico, 06700
Netherlands
Academisch Ziekenhuis Leiden; Dept of Rheumatology
Leiden, Netherlands, 2333 ZA
Poland
Szpital Uniwersytecki; nr 2 im. Dr J. Biziela; Klinika Reumatologii i Ukladowych Chorob
Bydgoszcz, Poland, 85-168
Uniwersyteckie Centrum Kliniczne; Klinika Chorob Wewnetrznych, Chorob Tkanki Łacznej i Geriatrii
Gdansk, Poland, 80-952
Gornoslaskie Centrum Medyczne
Katowice, Poland, 40-635
Szpital Specjalistyczny im Jozefa Dietla; Centrum Reumatologii, Immunologii i Rehabilitacji, I Oddzi
Krakow, Poland, 31-121
SPSK NR 4; Reumatologii i Ukladowych Chorob Tkanki
Lublin, Poland, 20-954
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher
Warszawa, Poland, 02-637
Portugal
Hospital Garcia de Orta; Servico de Reumatologia
Almada, Portugal, 2801-951
Hospital Prof. Dr. Fernando Fonseca; Medicina IV
Amadora, Portugal, 3814-501
Puerto Rico
Puerto Rico Clinical & Translational Research Consortium
San Juan, Puerto Rico, 00936-5067
Romania
Cantacuzino Hospital; Department of Internal Medicine and Rheumatology
Bucharest, Romania, 020475
Spitalul Judetean Cluj; Sectia de Reumatologie
Cluj-napoca, Romania, 400006
Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Medicina Interna/Reumatologia
Barcelona, Spain, 08025
Hospital Universitario Vall d'Hebron; Servicio de Medicina Interna
Barcelona, Spain, 08035
Hospital General Universitario Gregorio Marañon; Servicio de Reumatología
Madrid, Spain, 28007
Switzerland
Universitätsspital Basel; Rheumatologische Poliklinik
Basel, Switzerland, 4031
Universitätsspital Zürich; Klinik für Rheumatologie
Zürich, Switzerland, 8091
United Kingdom
Queen Elizabeth Hospital; Rheumatology Dept.
Birmingham, United Kingdom, B15 2TH
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Chapel Allerton Hospital; Leeds Institution of Rheumatology Medicine
Leeds, United Kingdom, LS7 4SA
Uni Hospital Aintree; Academic Rheumatology Unit
Liverpool, United Kingdom, L9 7AL
Royal Free Hospital; Department of Rheumatology
London, United Kingdom, NW3 2QG
Freeman Hospital; Musculoskeletal Unit
Newcastle Upon Tyne, United Kingdom, NE7 7DN

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

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Study Director:	Clinical Trials	Hoffmann-La Roche

Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:

Statistical Analysis Plan [PDF] January 23, 2018

Study Protocol [PDF] May 5, 2017

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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. Erratum In: Lancet Respir Med. 2020 Oct;8(10):e75. Lancet Respir Med. 2021 Mar;9(3):e29.

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Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT02453256
Other Study ID Numbers:	WA29767 2015-000424-28 ( EudraCT Number )
First Posted:	May 25, 2015 Key Record Dates
Results First Posted:	April 3, 2019
Last Update Posted:	March 9, 2020
Last Verified:	March 2020

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Scleroderma, Systemic Scleroderma, Diffuse Sclerosis	Pathologic Processes Connective Tissue Diseases Skin Diseases

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