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Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis

Primary Purpose

Scleroderma, Systemic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Riociguat (Adempas, BAY63-2521)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scleroderma, Systemic

Eligibility Criteria

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

Inclusion Criteria:

  • Men or women aged 18 years and older
  • Systemic sclerosis, as defined by ACR/EULAR (American College of Rheumatology/European League Against Rheumatism) 2013 criteria
  • dcSSc (diffuse cutaneous systemic sclerosis) according to the LeRoy criteria, ie, skin fibrosis proximal to the elbows and knees in addition to acral fibrosis
  • Disease duration of ≤ 18 months (defined as time from the first non-Raynaud's phenomenon manifestation)
  • ≥ 10 and ≤ 22 mRSS (modified Rodnan skin score) units at the screening visit
  • FVC (forced vital capacity) ≥ 45% of predicted at screening
  • DLCO (diffusion capacity of the lung for carbon monoxide) ≥ 40% of predicted (hemoglobin-corrected) at screening
  • Negative serum pregnancy test in a woman of childbearing potential at the screening visit
  • Women of childbearing potential must agree to use adequate contraception when sexually active. "Adequate contraception" is defined as any combination of at least 2 effective methods of birth control, of which at least 1 is a physical barrier (e.g. condom with hormonal contraception like implants or combined oral contraceptives, condom with intrauterine devices). This applies since signing of the informed consent form until 30 (+5) days after the last study drug administration.

Exclusion Criteria:

  • Limited cutaneous SSc (systemic sclerosis) at screening
  • Major surgery (including joint surgery) within 8 weeks prior to screening
  • Hepatic insufficiency classified as Child-Pugh C
  • Patients with isolated AST or ALT >3xULN or bilirubin >2xULN can be included in the trial under the condition of additional monitoring during the trial
  • Estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73 m^2 (Modification of Diet in Renal Disease formula) or on dialysis at the screening visit. Patients entering the trial with eGFR 15-29 mL/min/1.73 m^2 will be undergo additional monitoring of renal function
  • Any prior history of renal crisis
  • Sitting SBP (systolic blood pressure) < 95 mmHg at the screening visit
  • Sitting heart rate < 50 beats per minute (BPM) at the screening visit
  • Left ventricular ejection fraction < 40% prior to screening
  • Any form of pulmonary hypertension as determined by right heart catheterization
  • Pulmonary disease with FVC < 45% of predicted or DLCO (hemoglobin-corrected) < 40% of predicted at screening
  • Active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization
  • Not permitted prior and concomitant medication
  • Pregnant or breast feeding women
  • Women of childbearing potential not willing to use adequate contraception and not willing to agree to 4-weekly pregnancy testing from Visit 1 (first administration of study drug) onwards until 30 (+5) days after last study drug intake.

Sites / Locations

  • Mayo Clinic - Scottsdale
  • UCLA David Geffen School of Medicine
  • Stanford University School of Medicine
  • University of Connecticut Health Center
  • Georgetown University Medical Center
  • University of Michigan Health System
  • Rutgers Robert Wood Johnson Medical School
  • Medical University of South Carolina Medical Center
  • Memorial Hermann-Texas Medical Center
  • University of Utah Health Care
  • Liverpool Hospital
  • Royal Adelaide Hospital
  • Monash Medical Centre
  • St Vincent's Hospital
  • Royal Perth Hospital
  • CU Saint-Luc/UZ St-Luc
  • UZ Gent
  • UZ Leuven Gasthuisberg
  • St. Joseph's Healthcare - Hamilton
  • Arthritis Program Research Group, Inc.
  • Mount Sinai Hospital
  • Sir Mortimer B. Davis Jewish General Hospital
  • Revmatologicky ustav
  • Hôpital Pellegrin - Bordeaux
  • Centre Hospitalier Universitaire - Grenoble
  • Hopital Claude-Huriez CHRU
  • Cochin - Paris
  • CHU STRASBOURG - Hôpital de Hautepierre
  • Universitätsklinikum Ulm
  • Universitätsklinikum Erlangen
  • Kerckhoff-Klinik GmbH
  • Universitätsklinikum Köln
  • Debreceni Egyetem Klinikai Kozpont
  • Pecsi Tudomanyegyetem Klinikai Kozpont
  • A.O.U. Policlinico Umberto I
  • A.O.U. di Cagliari
  • A.O.U. Careggi
  • A.O.U. Pisana
  • A.O. di Padova
  • Gunma University Hospital
  • Hokkaido University Hospital
  • Tohoku University Hospital
  • Nippon Medical School Hospital
  • Institute of Rheumatology Tokyo Women's Medical University
  • Universitair Medisch Centrum St. Radboud
  • University Medical Center Utrecht
  • Wellington Hospital
  • Kantonsspital St. Gallen
  • Universitätsspital Basel
  • UniversitätsSpital Zürich
  • Cukurova Univ. Tip. Fak. Balcali Hastanesi
  • Hacettepe Universitesi Tip Fakultesi
  • Istanbul Universitesi Istanbul Tip Fakultesi
  • Dokuz Eylul Universitesi Tip Fakultesi
  • Hope Hospital
  • Freeman Hospital
  • Ninewells Hospital
  • Aintree University Hospital
  • Royal Free Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Riociguat

Placebo

Arm Description

Main treatment phase of 52 weeks: participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a-titration period of up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received sham-titration in a dose-titration period of up to 10 weeks followed by a maintenance period.

Main treatment phase of 52 weeks: participants received matching placebo tablets to riociguat as sham titration in a dose-titration period up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a dose-titration period of up to 10 weeks followed by a maintenance period.

Outcomes

Primary Outcome Measures

Change From Baseline in Modified Rodnan Skin Score (mRSS) to Week 52
The mRSS is a validated physical examination method for estimating skin thickness. It correlates with biopsy measures of collagen in the dermis and reflects prognosis and visceral involvement, especially in early disease. It is scored on 0 (normal) to 3+ (severe induration) ordinal scales over 17 body areas, with a maximum score of 51 (higher score means worse situation) and is used to categorize severity of SSc. A decrease in the mean change of mRSS shows mRSS improved.

Secondary Outcome Measures

CRISS (American College of Rheumatology Composite Response Index for Clinical Trials) at Week 52 Reported as Number of Participants With a CRISS Probability >=0.60 or <0.60 From Baseline to Week 52
CRISS forms a composite response index consisting of SSc-related organ involvement and the following five variables: mRSS, FVC percent predicted, physician's and patient's global assessments, and HAQ-DI score (from SHAQ patient-reported outcome). The resulting index is a 2-step process that captures clinically meaningful worsening of internal organ involvement and the core variables that show change. Patients for whom the predicted CRISS probability was ≥ 0.60 were considered improved, while patients for whom the predicted probability was < 0.60 were considered not improved.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score to Week 52
The HAQ-DI is a composite measure from which a 'Standard Disability Index' score can be computed to assess a patient's disability level. Generally, a score of 0-1 represents mild to moderate difficulty, 1-2 moderate to severe disability and 2-3 severe to very severe disability. The HAQ-DI comprises 20 items that assess patient abilities across 8 functional activities: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item is rated on a 4-point scale: 0=Without ANY difficulty, 1=With SOME difficulty, 2=With MUCH difficulty, 3=UNABLE to do. The 8 scores of the 8 sections are summed and divided by 8. In the event that one section is not completed by a subject then the summed score would be divided by 7. The final overall HAQ-DI score ranges from 0 to 3 and positive change indicates worse health-related quality of life (HRQoL).
Change From Baseline in Patient's Global Assessment Score to Week 52
The patient's global assessments (a self-report) quantified the overall disease activity or severity of SSc, with scores ranging from 0 (good) to 10 (worse). Positive change in the patient's global assessments score indicates worsening.
Change From Baseline in Physician's Global Assessment Score to Week 52
The physician's global assessments (reported by the physician) quantified the overall disease activity or severity of SSc, with scores ranging from 0 (good) to 10 (worse). Positive change in the physician's global assessments score indicates worsening.
Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted to Week 52
Negative change in FVC percent predicted indicates worsening.

Full Information

First Posted
November 3, 2014
Last Updated
January 17, 2020
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT02283762
Brief Title
Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis
Official Title
A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2015 (Actual)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
March 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To investigate if Riociguat is effective in the treatment of systemic sclerosis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma, Systemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Riociguat
Arm Type
Experimental
Arm Description
Main treatment phase of 52 weeks: participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a-titration period of up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received sham-titration in a dose-titration period of up to 10 weeks followed by a maintenance period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Main treatment phase of 52 weeks: participants received matching placebo tablets to riociguat as sham titration in a dose-titration period up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a dose-titration period of up to 10 weeks followed by a maintenance period.
Intervention Type
Drug
Intervention Name(s)
Riociguat (Adempas, BAY63-2521)
Intervention Description
Starting dose 0.5 mg TID, increase by 0.5 mg every 2 weeks until highest possible dose of 2.5 mg TID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sham-titration
Primary Outcome Measure Information:
Title
Change From Baseline in Modified Rodnan Skin Score (mRSS) to Week 52
Description
The mRSS is a validated physical examination method for estimating skin thickness. It correlates with biopsy measures of collagen in the dermis and reflects prognosis and visceral involvement, especially in early disease. It is scored on 0 (normal) to 3+ (severe induration) ordinal scales over 17 body areas, with a maximum score of 51 (higher score means worse situation) and is used to categorize severity of SSc. A decrease in the mean change of mRSS shows mRSS improved.
Time Frame
Baseline to week 52
Secondary Outcome Measure Information:
Title
CRISS (American College of Rheumatology Composite Response Index for Clinical Trials) at Week 52 Reported as Number of Participants With a CRISS Probability >=0.60 or <0.60 From Baseline to Week 52
Description
CRISS forms a composite response index consisting of SSc-related organ involvement and the following five variables: mRSS, FVC percent predicted, physician's and patient's global assessments, and HAQ-DI score (from SHAQ patient-reported outcome). The resulting index is a 2-step process that captures clinically meaningful worsening of internal organ involvement and the core variables that show change. Patients for whom the predicted CRISS probability was ≥ 0.60 were considered improved, while patients for whom the predicted probability was < 0.60 were considered not improved.
Time Frame
Week 52
Title
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score to Week 52
Description
The HAQ-DI is a composite measure from which a 'Standard Disability Index' score can be computed to assess a patient's disability level. Generally, a score of 0-1 represents mild to moderate difficulty, 1-2 moderate to severe disability and 2-3 severe to very severe disability. The HAQ-DI comprises 20 items that assess patient abilities across 8 functional activities: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item is rated on a 4-point scale: 0=Without ANY difficulty, 1=With SOME difficulty, 2=With MUCH difficulty, 3=UNABLE to do. The 8 scores of the 8 sections are summed and divided by 8. In the event that one section is not completed by a subject then the summed score would be divided by 7. The final overall HAQ-DI score ranges from 0 to 3 and positive change indicates worse health-related quality of life (HRQoL).
Time Frame
Baseline to week 52
Title
Change From Baseline in Patient's Global Assessment Score to Week 52
Description
The patient's global assessments (a self-report) quantified the overall disease activity or severity of SSc, with scores ranging from 0 (good) to 10 (worse). Positive change in the patient's global assessments score indicates worsening.
Time Frame
Baseline to week 52
Title
Change From Baseline in Physician's Global Assessment Score to Week 52
Description
The physician's global assessments (reported by the physician) quantified the overall disease activity or severity of SSc, with scores ranging from 0 (good) to 10 (worse). Positive change in the physician's global assessments score indicates worsening.
Time Frame
Baseline to week 52
Title
Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted to Week 52
Description
Negative change in FVC percent predicted indicates worsening.
Time Frame
Baseline to week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women aged 18 years and older Systemic sclerosis, as defined by ACR/EULAR (American College of Rheumatology/European League Against Rheumatism) 2013 criteria dcSSc (diffuse cutaneous systemic sclerosis) according to the LeRoy criteria, ie, skin fibrosis proximal to the elbows and knees in addition to acral fibrosis Disease duration of ≤ 18 months (defined as time from the first non-Raynaud's phenomenon manifestation) ≥ 10 and ≤ 22 mRSS (modified Rodnan skin score) units at the screening visit FVC (forced vital capacity) ≥ 45% of predicted at screening DLCO (diffusion capacity of the lung for carbon monoxide) ≥ 40% of predicted (hemoglobin-corrected) at screening Negative serum pregnancy test in a woman of childbearing potential at the screening visit Women of childbearing potential must agree to use adequate contraception when sexually active. "Adequate contraception" is defined as any combination of at least 2 effective methods of birth control, of which at least 1 is a physical barrier (e.g. condom with hormonal contraception like implants or combined oral contraceptives, condom with intrauterine devices). This applies since signing of the informed consent form until 30 (+5) days after the last study drug administration. Exclusion Criteria: Limited cutaneous SSc (systemic sclerosis) at screening Major surgery (including joint surgery) within 8 weeks prior to screening Hepatic insufficiency classified as Child-Pugh C Patients with isolated AST or ALT >3xULN or bilirubin >2xULN can be included in the trial under the condition of additional monitoring during the trial Estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73 m^2 (Modification of Diet in Renal Disease formula) or on dialysis at the screening visit. Patients entering the trial with eGFR 15-29 mL/min/1.73 m^2 will be undergo additional monitoring of renal function Any prior history of renal crisis Sitting SBP (systolic blood pressure) < 95 mmHg at the screening visit Sitting heart rate < 50 beats per minute (BPM) at the screening visit Left ventricular ejection fraction < 40% prior to screening Any form of pulmonary hypertension as determined by right heart catheterization Pulmonary disease with FVC < 45% of predicted or DLCO (hemoglobin-corrected) < 40% of predicted at screening Active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization Not permitted prior and concomitant medication Pregnant or breast feeding women Women of childbearing potential not willing to use adequate contraception and not willing to agree to 4-weekly pregnancy testing from Visit 1 (first administration of study drug) onwards until 30 (+5) days after last study drug intake.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic - Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5404
Country
United States
Facility Name
UCLA David Geffen School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1670
Country
United States
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Rutgers Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Medical University of South Carolina Medical Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Memorial Hermann-Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah Health Care
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
St Vincent's Hospital
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
CU Saint-Luc/UZ St-Luc
City
Bruxelles - Brussel
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
St. Joseph's Healthcare - Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Facility Name
Arthritis Program Research Group, Inc.
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 3R7
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3L9
Country
Canada
Facility Name
Sir Mortimer B. Davis Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T1E2
Country
Canada
Facility Name
Revmatologicky ustav
City
Praha 2
ZIP/Postal Code
128 50
Country
Czechia
Facility Name
Hôpital Pellegrin - Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Centre Hospitalier Universitaire - Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Hopital Claude-Huriez CHRU
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Cochin - Paris
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
CHU STRASBOURG - Hôpital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Universitätsklinikum Ulm
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
Kerckhoff-Klinik GmbH
City
Bad Nauheim
State/Province
Hessen
ZIP/Postal Code
61231
Country
Germany
Facility Name
Universitätsklinikum Köln
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont
City
Pecs
ZIP/Postal Code
7632
Country
Hungary
Facility Name
A.O.U. Policlinico Umberto I
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Facility Name
A.O.U. di Cagliari
City
Cagliari
State/Province
Sardegna
ZIP/Postal Code
09042
Country
Italy
Facility Name
A.O.U. Careggi
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50139
Country
Italy
Facility Name
A.O.U. Pisana
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Facility Name
A.O. di Padova
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Gunma University Hospital
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Institute of Rheumatology Tokyo Women's Medical University
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-0054
Country
Japan
Facility Name
Universitair Medisch Centrum St. Radboud
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Wellington Hospital
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
State/Province
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Universitätsspital Basel
City
Basel
Country
Switzerland
Facility Name
UniversitätsSpital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Cukurova Univ. Tip. Fak. Balcali Hastanesi
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Hacettepe Universitesi Tip Fakultesi
City
Ankara
Country
Turkey
Facility Name
Istanbul Universitesi Istanbul Tip Fakultesi
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Dokuz Eylul Universitesi Tip Fakultesi
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Hope Hospital
City
Salford
State/Province
Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle Upon Tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Aintree University Hospital
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27746061
Citation
Distler O, Pope J, Denton C, Allanore Y, Matucci-Cerinic M, de Oliveira Pena J, Khanna D. RISE-SSc: Riociguat in diffuse cutaneous systemic sclerosis. Respir Med. 2017 Jan;122 Suppl 1:S14-S17. doi: 10.1016/j.rmed.2016.09.011. Epub 2016 Sep 28.
Results Reference
background
Links:
URL
https://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer products
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Learn more about this trial

Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis

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