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

March 5, 2020 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
212

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From baseline to week 48

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
From Baseline to Week 48
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.
Baseline to week 48
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.
From Baseline to Week 48
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.
From Baseline to Week 48
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."
From Baseline to Week 48
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."
From Baseline to Week 48
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.
From Baseline to 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
From Baseline until Week 48
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.
From Baseline until Week 48
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
From Baseline up to Week 48
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.
From Baseline up to Week 48
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.
From Baseline up to Week 48
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.
From Baseline to Week 48
Percentage of Participants With Positive Anti-Tocilizumab Assay Result at Baseline
Time Frame: Baseline
Incidence of anti-Tocilizumab at baseline
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.
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
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.
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
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.
From Predose up to Week 48
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.
From Baseline to Week 48
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.
From Baseline to Week 48
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.
From Baseline to Week 48
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.
From Baseline to Week 48
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.
From Baseline to Week 48
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.
From Baseline to Week 48
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.
From Baseline to Week 48
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.
From Baseline to Week 48
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.
From Baseline to Week 48
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.
From Baseline up to Week 48
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.
From Baseline up to Week 48
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
From Baseline to Week 48
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
From Baseline to Week 48
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.
From Baseline to Week 48
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.
From Baseline to Week 48
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.
From Baseline to Week 48
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.
From Baseline to Week 48
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.
From Baseline to Week 48
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.
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
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.
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
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.
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
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.
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
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.
From Baseline to Week 48
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
Up to Week 96
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.
Up to Week 96
Number of Participants With Adverse Events Leading to Death Up to Week 96
Time Frame: Up to Week 96
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.
From Baseline to Week 96
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.
Open-label period from Week 48 to 96
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.
Up to Week 96
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.
Up to Week 96
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.
Up to Week 96
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.
From Baseline up to Week 96
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
Up to Week 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 4, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WA29767
  • 2015-000424-28 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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