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Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)

Primary Purpose

Diffuse Cutaneous Systemic Sclerosis

Status
Withdrawn
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
IgPro10
Placebo
Sponsored by
CSL Behring
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Cutaneous Systemic Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Age ≥18 years (male or female) at time of providing written informed consent
  • Documented diagnosis of SSc according to ACR / EULAR criteria 2013
  • mRSS ≥ 15 and ≤ 45
  • Disease duration ≤ 5 years defined as the time from the first non-Raynaud's phenomenon manifestation
  • Subjects within first 18 months of disease duration from first non-Raynaud's phenomenon manifestation.

Exclusion Criteria:

  • Primary rheumatic autoimmune disease other than dcSSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, mixed connective tissue disorder, polymyositis, and dermatomyositis, as determined by the investigator Note: Subjects with fibromyalgia, secondary Sjogren's syndrome, and scleroderma-associated myopathy or myositis at Screening are not excluded
  • Positive anti-centromere autoantibodies at Screening
  • Evidence of severe chronic kidney disease with estimated glomerular filtration rate < 45 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation) or receiving dialysis. Additionally, subjects with current confirmed diagnosis of diabetes mellitus and requiring medication, with eGFR < 90 mL/min/1.73m2 will be excluded from the study.
  • History of documented thrombotic episode eg, PE, DVT, myocardial infarction, thromboembolic stroke at any time Note: past superficial thrombophlebitis more than two years from Screening is not exclusionary
  • Documented thrombophilic abnormalities including blood hyperviscosity, protein S or protein C deficiency, anti-thrombin-3 deficiency, plasminogen deficiency, antiphospholipid syndrome, Factor V Leiden mutation, dysfibrinogenemia, or prothrombin G20210A mutation
  • Greater than 3 specified current risk factors for TEEs (documented and currents conditions): atrial fibrillation, coronary disease, diabetes mellitus, dyslipidemia, hypertension, obesity (Body Mass Index ≥ 30 kg/m2), recent significant trauma, and immobility (wheelchair-bound or bedridden)
  • Ongoing active serious infection at Screening (including, but not limited to, pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess)
  • Malignancy in the past 2 years, except for non-melanoma skin cancer, cervical carcinoma in situ, or other in situ cancer if it has been excised and treated within in the past year
  • Known hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total urine protein concentration > 0.2 g/L)
  • Known IgA deficiency or serum IgA level < 5% lower limit of normal

Sites / Locations

  • Mayo Clinic Arizona - Scottsdale
  • Pacific Arthritis Care Center
  • University of California
  • Stanford University Medical Center
  • University of Colorado
  • Lombardi Cancer Center-Georgetown University
  • Alliance for Multispecialty Research
  • Heartland Research Associates, LLC
  • Louisiana State University Health Sciences Center
  • John Hopkins Bayview Medical Center
  • Boston University Amyloidosis Center
  • University of Michigan Health System
  • Rutgers Clinical Research Center
  • Northwell Health
  • Hospital For Special Surgery
  • Cleveland Clinic - Taussig Cancer Center
  • Altoona Center For Research
  • University of Pennsylvania - Perelman Center
  • Medical University of South Carolina
  • The University Of Texas Medical School At Houston (Utms)
  • APRILLUS Asistencia e Investigacion Clinica
  • Hospital Italiano de Buenos Aires
  • Hospital Militar Central
  • Sanatorio Parque S.A y Consultorios Externos Asociados
  • John Hunter Hospital / Autoimmune Resource and Research Centre
  • PARC Clinical Research
  • UZ Gent
  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
  • Mount Sinai Hospital, The Rebecca Macdonald Centre For Arthritis
  • CHU de Caen
  • CHRU de Lille Hopital Huriez
  • Internal Medicine, Nantes University Hospital
  • Assistance Publique - Hopitaux de Paris (AP-HP)
  • CHU de Rennes-Hopital Sud
  • Centre Hospitalier Universitaire de Rouen-Hopital
  • CHU Hautepierre
  • Kerckhoff Klinik GmbH, Abteilung für Rheumatologie und Klinische Immunologie Rheumatologie
  • Charite - Universitaetsmedizin Berlin - Campus Charite Mitte
  • Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
  • Universitaetsklinikum Freiburg- Klinik fuer Rheumatologie und Klinische Immunologie
  • University Hospital of Cologne
  • Universitaetsmedizin der Johannes Gutenberg
  • University Hospital Of Tuebingen
  • Universitaetsklinikum Ulm
  • Hospital St. Josef
  • Universita degli Study di Ancona
  • Universita Degli Studi Di Bari Aldo Moro
  • Universita degli Studi Di Brescia
  • Universita degli Studi Firenze
  • UOC Immunoreumatologia
  • Azienda Ospedaliera Gaetano Pini
  • Modena University
  • Universita degli Studi di Napoli Federico II
  • IRCCS Policlinico San Matteo
  • Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza
  • Centro de Investigacion y Tratamiento Reumatologico S.C.
  • Centro Integral en Reumatologia, SA de CV
  • Centro De Estudios De Investigation Basica Y Clinica S.C
  • Cliditer, S.A. DE C.V.
  • Instituto Nacional De Ciencias Medicas Y Nutricion
  • Centro de Alta Especialidad en Reumatologia
  • Uniwersytecki Szpital Kliniczny W Bialymstoku
  • University Clinical Centre, Medical University of Gdansk
  • Samodzielny Publiczny Szpital Kliniczny
  • Klinika Dermatologii Szpital im. Dzieciątka Jezus
  • Klinika i Poliklinika Układowych Chorób Tkanki Łącznej Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
  • Complejo Hospitalario Universitario A Coruna
  • Hospital Universitari Materno Infantil Vall Dhebron
  • Hospital de la Santa Creu i Sant Pau
  • Hospital General Universitario Gregorio Maranon
  • Hospital Univ 12 de Octubre
  • Hospital Infanta Luisa Quirónsalud
  • Hospital Universitari Dr.Peset
  • Cantonal Hospital St. Gallen - Klinik fuer Rheumatologie
  • Countess of Chester Hospital
  • Chapel Allerton Hospital
  • Royal Free Hospital-Royal Free London NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IgPro10

Placebo

Arm Description

10% liquid formulation of human immunoglobulin for intravenous use

0.5% human albumin solution stabilized with 250 mmol/L L-proline

Outcomes

Primary Outcome Measures

Response on American College of Rheumatology Combined Response Index in Diffuse Systemic Sclerosis (ACR CRISS) score in IgPro10 vs Placebo

Secondary Outcome Measures

Proportion of subjects meeting cardiopulmonary or renal failure criteria in ACR CRISS Step 1 events
Proportion of responders (ACR CRISS > 0.6)
Mean change from Baseline in Modified Rodnan Skin Score (mRSS)
Mean change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)
Mean change from Baseline in Forced Vital Capacity (FVC)% predicted
Mean change from Baseline in diffusing capacity of lung for carbon monoxide (DLCO)% predicted
Mean change from Baseline in Physician Global Assessment (MDGA)
MDGA evaluates the overall impact of SSc on the participant as assessed by the physician on a 11-point Numeric rating scale scale from 0 (excellent) to 10 (extremely poor)
Mean change from Baseline in Patient Global Assessment (PGA)
PGA evaluates the overall impact of SSc on the participant as assessed by the physician on a 11-point Numeric rating scale scale from 0 (excellent) to 10 (extremely poor)
Mean change from Baseline in UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract 2.0 (UCLA SCTC GIT 2.0) total score and subscale
This survey consists of 34 questions and items are scored on a scale of 0 (better health) to 3 (worse health). Scores are combined to form total score.
Mean change from Baseline in Scleroderma Skin Patient Reported Outcome (SSPRO) score in IgPro10 vs Placebo
Proportion of responders in mRSS
Response is decrease of mRSS ≥ 5 points and change of ≥ 25% from Baseline in IgPro10 vs Placebo
Time to treatment failure (time from first infusion to time of first event) in IgPro10 vs Placebo
Treatment failure - defined as occurrence of SSc associated complications in ACR CRISS step 1 events, digital ischemia (requiring hospitalization for IV prostacyclin, surgical intervention or amputation), serious gastrointestinal events (events requiring parenteral nutrition due to SSc -such as total parenteral nutrition or enteral nutrition), all-cause mortality
Proportion of subjects with events at Week 48 in IgPro10 vs Placebo
Events defined as occurrence of SSc associated complications in ACR CRISS step 1 events, digital ischemia (requiring hospitalization for IV prostacyclin, surgical intervention or amputation), serious gastrointestinal events (events requiring parenteral nutrition due to SSc -such as total parenteral nutrition or enteral nutrition), all -cause mortality
Mean change from Baseline in Cochin Hand Function Scale in IgPro10 vs Placebo
Mean change from Baseline in Scleroderma Health Assessment Questionnaire (SHAQ) score in IgPro10 vs Placebo
Mean change from baseline in muscle strength as measured by Manual Muscle Testing 8 (MMT) in IgPro10 vs Placebo
Number of subjects with adverse events (AEs) including any AEs, treatment-emergent AEs (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs)
Percentage of subjects with AEs, TEAEs, SAEs, AESIs
Concentration of serum trough IgG levels at Baseline and prior to first infusion
Mean change from Baseline in Modified Rodnan skin score (mRSS)
Mean change from Baseline in Patient global assessment (PGA)
Proportion of responders (ACR CRISS > 0.6)
Mean change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)
Mean change from Baseline in Forced Vital Capacity (FVC)% predicted
Mean change from Baseline in diffusing capacity of lung for carbon monoxide (DLCO)% predicted
Mean change from Baseline in Physician Global Assessment (MDGA)
Number of subjects with adverse events (AEs) including any AEs, treatment-emergent AEs (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs)
Percentage of subjects with AEs, TEAEs, SAEs, AESIs

Full Information

First Posted
October 14, 2019
Last Updated
November 16, 2020
Sponsor
CSL Behring
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1. Study Identification

Unique Protocol Identification Number
NCT04138485
Brief Title
Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)
Official Title
A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults With Systemic Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Due to business reasons, not safety issues
Study Start Date
December 20, 2019 (Actual)
Primary Completion Date
September 16, 2020 (Actual)
Study Completion Date
September 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Behring

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized, multicenter, double-blind (DB), placebo controlled, phase 2 study will evaluate the efficacy and safety of IgPro10. The DB Treatment Period will be followed by a 24-week Open-label (OL) Treatment Period. Eligible subjects will be randomized at Baseline in a 2:1 ratio of treatment IgPro10 or placebo in the DB Treatment Period. All subjects who enter OL Treatment Period will receive IgPro10.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Cutaneous Systemic Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IgPro10
Arm Type
Experimental
Arm Description
10% liquid formulation of human immunoglobulin for intravenous use
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.5% human albumin solution stabilized with 250 mmol/L L-proline
Intervention Type
Biological
Intervention Name(s)
IgPro10
Other Intervention Name(s)
Human normal immunoglobulin
Intervention Description
10% liquid formulation of human immunoglobulin for IVIG
Intervention Type
Biological
Intervention Name(s)
Placebo
Other Intervention Name(s)
Albumin
Intervention Description
0.5% human albumin solution stabilized with 250 mmol/L L-proline
Primary Outcome Measure Information:
Title
Response on American College of Rheumatology Combined Response Index in Diffuse Systemic Sclerosis (ACR CRISS) score in IgPro10 vs Placebo
Time Frame
Over 48 weeks
Secondary Outcome Measure Information:
Title
Proportion of subjects meeting cardiopulmonary or renal failure criteria in ACR CRISS Step 1 events
Time Frame
Over 48 weeks
Title
Proportion of responders (ACR CRISS > 0.6)
Time Frame
Over 48 weeks
Title
Mean change from Baseline in Modified Rodnan Skin Score (mRSS)
Time Frame
Baseline and over48 weeks
Title
Mean change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time Frame
Baseline and over 48 weeks
Title
Mean change from Baseline in Forced Vital Capacity (FVC)% predicted
Time Frame
Baseline and over 48 weeks
Title
Mean change from Baseline in diffusing capacity of lung for carbon monoxide (DLCO)% predicted
Time Frame
Baseline and over 48 weeks
Title
Mean change from Baseline in Physician Global Assessment (MDGA)
Description
MDGA evaluates the overall impact of SSc on the participant as assessed by the physician on a 11-point Numeric rating scale scale from 0 (excellent) to 10 (extremely poor)
Time Frame
Baseline and over 48 weeks
Title
Mean change from Baseline in Patient Global Assessment (PGA)
Description
PGA evaluates the overall impact of SSc on the participant as assessed by the physician on a 11-point Numeric rating scale scale from 0 (excellent) to 10 (extremely poor)
Time Frame
Baseline and over 48 weeks
Title
Mean change from Baseline in UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract 2.0 (UCLA SCTC GIT 2.0) total score and subscale
Description
This survey consists of 34 questions and items are scored on a scale of 0 (better health) to 3 (worse health). Scores are combined to form total score.
Time Frame
Baseline and over 48 weeks
Title
Mean change from Baseline in Scleroderma Skin Patient Reported Outcome (SSPRO) score in IgPro10 vs Placebo
Time Frame
Baseline and up to 48 weeks
Title
Proportion of responders in mRSS
Description
Response is decrease of mRSS ≥ 5 points and change of ≥ 25% from Baseline in IgPro10 vs Placebo
Time Frame
Up to 48 weeks
Title
Time to treatment failure (time from first infusion to time of first event) in IgPro10 vs Placebo
Description
Treatment failure - defined as occurrence of SSc associated complications in ACR CRISS step 1 events, digital ischemia (requiring hospitalization for IV prostacyclin, surgical intervention or amputation), serious gastrointestinal events (events requiring parenteral nutrition due to SSc -such as total parenteral nutrition or enteral nutrition), all-cause mortality
Time Frame
Over 48 weeks
Title
Proportion of subjects with events at Week 48 in IgPro10 vs Placebo
Description
Events defined as occurrence of SSc associated complications in ACR CRISS step 1 events, digital ischemia (requiring hospitalization for IV prostacyclin, surgical intervention or amputation), serious gastrointestinal events (events requiring parenteral nutrition due to SSc -such as total parenteral nutrition or enteral nutrition), all -cause mortality
Time Frame
Over 48 weeks
Title
Mean change from Baseline in Cochin Hand Function Scale in IgPro10 vs Placebo
Time Frame
Baseline and over 48 weeks
Title
Mean change from Baseline in Scleroderma Health Assessment Questionnaire (SHAQ) score in IgPro10 vs Placebo
Time Frame
Baseline and over 48 weeks
Title
Mean change from baseline in muscle strength as measured by Manual Muscle Testing 8 (MMT) in IgPro10 vs Placebo
Time Frame
Baseline and over 48 weeks
Title
Number of subjects with adverse events (AEs) including any AEs, treatment-emergent AEs (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs)
Time Frame
Over 48 weeks
Title
Percentage of subjects with AEs, TEAEs, SAEs, AESIs
Time Frame
Over 48 weeks
Title
Concentration of serum trough IgG levels at Baseline and prior to first infusion
Time Frame
Baseline and up to 72 weeks
Title
Mean change from Baseline in Modified Rodnan skin score (mRSS)
Time Frame
Baseline and over 72 weeks
Title
Mean change from Baseline in Patient global assessment (PGA)
Time Frame
Baseline and over 72 weeks
Title
Proportion of responders (ACR CRISS > 0.6)
Time Frame
Over 72 weeks
Title
Mean change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time Frame
Baseline and over 72 weeks
Title
Mean change from Baseline in Forced Vital Capacity (FVC)% predicted
Time Frame
Baseline and over 72 weeks
Title
Mean change from Baseline in diffusing capacity of lung for carbon monoxide (DLCO)% predicted
Time Frame
Baseline and over 72 weeks
Title
Mean change from Baseline in Physician Global Assessment (MDGA)
Time Frame
Baseline and over 72 weeks
Title
Number of subjects with adverse events (AEs) including any AEs, treatment-emergent AEs (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs)
Time Frame
Over 72 weeks
Title
Percentage of subjects with AEs, TEAEs, SAEs, AESIs
Time Frame
Over 72 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years (male or female) at time of providing written informed consent Documented diagnosis of SSc according to ACR / EULAR criteria 2013 mRSS ≥ 15 and ≤ 45 Disease duration ≤ 5 years defined as the time from the first non-Raynaud's phenomenon manifestation Subjects within first 18 months of disease duration from first non-Raynaud's phenomenon manifestation. Exclusion Criteria: Primary rheumatic autoimmune disease other than dcSSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, mixed connective tissue disorder, polymyositis, and dermatomyositis, as determined by the investigator Note: Subjects with fibromyalgia, secondary Sjogren's syndrome, and scleroderma-associated myopathy or myositis at Screening are not excluded Positive anti-centromere autoantibodies at Screening Evidence of severe chronic kidney disease with estimated glomerular filtration rate < 45 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation) or receiving dialysis. Additionally, subjects with current confirmed diagnosis of diabetes mellitus and requiring medication, with eGFR < 90 mL/min/1.73m2 will be excluded from the study. History of documented thrombotic episode eg, PE, DVT, myocardial infarction, thromboembolic stroke at any time Note: past superficial thrombophlebitis more than two years from Screening is not exclusionary Documented thrombophilic abnormalities including blood hyperviscosity, protein S or protein C deficiency, anti-thrombin-3 deficiency, plasminogen deficiency, antiphospholipid syndrome, Factor V Leiden mutation, dysfibrinogenemia, or prothrombin G20210A mutation Greater than 3 specified current risk factors for TEEs (documented and currents conditions): atrial fibrillation, coronary disease, diabetes mellitus, dyslipidemia, hypertension, obesity (Body Mass Index ≥ 30 kg/m2), recent significant trauma, and immobility (wheelchair-bound or bedridden) Ongoing active serious infection at Screening (including, but not limited to, pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) Malignancy in the past 2 years, except for non-melanoma skin cancer, cervical carcinoma in situ, or other in situ cancer if it has been excised and treated within in the past year Known hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total urine protein concentration > 0.2 g/L) Known IgA deficiency or serum IgA level < 5% lower limit of normal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
CSL Behring
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Arizona - Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Pacific Arthritis Care Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
University of California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Lombardi Cancer Center-Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Alliance for Multispecialty Research
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Louisiana State University Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
John Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Boston University Amyloidosis Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48108
Country
United States
Facility Name
Rutgers Clinical Research Center
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Northwell Health
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Hospital For Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Cleveland Clinic - Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Altoona Center For Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
University of Pennsylvania - Perelman Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
The University Of Texas Medical School At Houston (Utms)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
APRILLUS Asistencia e Investigacion Clinica
City
Buenos Aires
ZIP/Postal Code
C1194AAO
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
S2000SDV
Country
Argentina
Facility Name
Hospital Militar Central
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1426AAL
Country
Argentina
Facility Name
Sanatorio Parque S.A y Consultorios Externos Asociados
City
Rosario
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
John Hunter Hospital / Autoimmune Resource and Research Centre
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
PARC Clinical Research
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5005
Country
Australia
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Mount Sinai Hospital, The Rebecca Macdonald Centre For Arthritis
City
Toronto
ZIP/Postal Code
M5T 3L9
Country
Canada
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
CHRU de Lille Hopital Huriez
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Internal Medicine, Nantes University Hospital
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Assistance Publique - Hopitaux de Paris (AP-HP)
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
CHU de Rennes-Hopital Sud
City
Rennes
ZIP/Postal Code
35203
Country
France
Facility Name
Centre Hospitalier Universitaire de Rouen-Hopital
City
Rouen cedex
ZIP/Postal Code
76000
Country
France
Facility Name
CHU Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Kerckhoff Klinik GmbH, Abteilung für Rheumatologie und Klinische Immunologie Rheumatologie
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Charite - Universitaetsmedizin Berlin - Campus Charite Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitaetsklinikum Freiburg- Klinik fuer Rheumatologie und Klinische Immunologie
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
University Hospital of Cologne
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitaetsmedizin der Johannes Gutenberg
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
University Hospital Of Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Hospital St. Josef
City
Wuppertal
ZIP/Postal Code
42105
Country
Germany
Facility Name
Universita degli Study di Ancona
City
Ancona
ZIP/Postal Code
60121
Country
Italy
Facility Name
Universita Degli Studi Di Bari Aldo Moro
City
Bari
ZIP/Postal Code
70121
Country
Italy
Facility Name
Universita degli Studi Di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Universita degli Studi Firenze
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
UOC Immunoreumatologia
City
L'Aquila
ZIP/Postal Code
67100
Country
Italy
Facility Name
Azienda Ospedaliera Gaetano Pini
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Modena University
City
Modena
ZIP/Postal Code
41121
Country
Italy
Facility Name
Universita degli Studi di Napoli Federico II
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Centro de Investigacion y Tratamiento Reumatologico S.C.
City
Ciudad de México
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Centro Integral en Reumatologia, SA de CV
City
Guadalajara
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Centro De Estudios De Investigation Basica Y Clinica S.C
City
Jalisco
ZIP/Postal Code
44690
Country
Mexico
Facility Name
Cliditer, S.A. DE C.V.
City
Mexico City
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Instituto Nacional De Ciencias Medicas Y Nutricion
City
Mexico
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Centro de Alta Especialidad en Reumatologia
City
San Luis Potosi
ZIP/Postal Code
78213
Country
Mexico
Facility Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
City
Bialystok
ZIP/Postal Code
15-369
Country
Poland
Facility Name
University Clinical Centre, Medical University of Gdansk
City
Gdańsk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
Facility Name
Klinika Dermatologii Szpital im. Dzieciątka Jezus
City
Warszawa
ZIP/Postal Code
00-001
Country
Poland
Facility Name
Klinika i Poliklinika Układowych Chorób Tkanki Łącznej Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
City
Warszawa
ZIP/Postal Code
02-637
Country
Poland
Facility Name
Complejo Hospitalario Universitario A Coruna
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitari Materno Infantil Vall Dhebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Univ 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Infanta Luisa Quirónsalud
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Facility Name
Hospital Universitari Dr.Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Cantonal Hospital St. Gallen - Klinik fuer Rheumatologie
City
Saint Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Countess of Chester Hospital
City
Chester
ZIP/Postal Code
CH2 1UL
Country
United Kingdom
Facility Name
Chapel Allerton Hospital
City
Leeds
ZIP/Postal Code
LS7 4SA
Country
United Kingdom
Facility Name
Royal Free Hospital-Royal Free London NHS Foundation Trust
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
CSL will consider requests to share Individual Patient Data (IPD) from systemic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
IPD Sharing Time Frame
IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.
IPD Sharing Access Criteria
Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee. An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee. The requesting party must execute an appropriate data sharing agreement before IPD will be made available.

Learn more about this trial

Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)

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