Trial Condition(s):
Scleroderma, Systemic
Efficacy and safety of Riociguat in patients with systemic sclerosis
Bayer Identifier:
16277
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
To investigate if Riociguat is effective in the treatment of systemic sclerosis
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
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Locations Revmatologicky ustav Praha 2, Czech Republic, 128 50 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Gent GENT, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CU Saint-Luc/UZ St-Luc BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Careggi Firenze, Italy, 50139 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Policlinico Umberto I Roma, Italy, 00161 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. di Cagliari Cagliari, Italy, 09042 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. di Padova Padova, Italy, 35128 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Pisana Pisa, Italy, 56126 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St Vincent's Hospital Fitzroy, Australia, 3065 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Monash Medical Centre Clayton, Australia, 3168 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Adelaide Hospital Adelaide, Australia, 5000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istanbul Universitesi Istanbul Tip Fakultesi Istanbul, Turkey, 34093 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hacettepe Universitesi Tip Fakultesi Ankara, Turkey | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Köln Köln, Germany, 50937 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Erlangen Erlangen, Germany, 91054 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kerckhoff-Klinik GmbH Bad Nauheim, Germany, 61231 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Perth Hospital 6000, Australia, PERTH | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitair Medisch Centrum St. Radboud Nijmegen, Netherlands, 6525 GA | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Medical Center Utrecht Utrecht, Netherlands, 3584 CX | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UniversitätsSpital Zürich Zürich, Switzerland, 8091 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Free Hospital London, United Kingdom, NW3 2QG | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Freeman Hospital Newcastle Upon Tyne, United Kingdom, NE7 7DN | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hope Hospital Salford, United Kingdom, M6 8HD | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aintree University Hospital Liverpool, United Kingdom, L9 7AL | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital Claude-Huriez CHRU LILLE, France, 59037 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Universitaire - Grenoble GRENOBLE, France, 38043 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Stanford Hospital Palo Alto, United States, 94304 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Utah Health Care Salt Lake City, United States, 84132 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UCLA David Geffen School of Medicine Los Angeles, United States, 90095-1670 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mayo Clinic - Scottsdale Scottsdale, United States, 85259-5404 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rutgers Robert Wood Johnson Medical School New Brunswick, United States, 08901 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Michigan Health System Ann Arbor, United States, 48109 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MedStar Georgetown University Hospital Washington, United States, 20007 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Memorial Hermann-Texas Medical Center Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Arthritis Program Research Group, Inc. Newmarket, Canada, L3Y 3R7 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsspital Basel Basel, Switzerland | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hokkaido University Hospital Sapporo, Japan, 060-8648 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tohoku University Hospital Sendai, Japan, 980-8574 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institute of Rheumatology Tokyo Women's Medical University Shinjuku-ku, Japan, 162-0054 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nippon Medical School Hospital Bunkyo-ku, Japan, 113-8603 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Connecticut Health Center Farmington, United States, 06030 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical University of South Carolina Medical Center Charleston, United States, 29425 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sir Mortimer B. Davis Jewish General Hospital Montreal, Canada, H3T1E2 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mount Sinai Hospital Toronto, Canada, M5T 3L9 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Debreceni Egyetem Klinikai Kozpont Debrecen, Hungary, 4032 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pecsi Tudomanyegyetem Klinikai Kozpont Pecs, Hungary, 7632 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cochin - Paris PARIS, France, 75674 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHU STRASBOURG - Hôpital de Hautepierre STRASBOURG, France, 67098 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Pellegrin - Bordeaux BORDEAUX, France, 33000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Joseph's Healthcare - Hamilton Hamilton, Canada, L8N 1Y2 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gunma University Hospital Maebashi, Japan, 371-8511 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ninewells Hospital Dundee, United Kingdom, DD1 9SY | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Liverpool Hospital Liverpool, Australia, 2170 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wellington Hospital Wellington, New Zealand, 6021 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Ulm Ulm, Germany, 89081 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cukurova Univ. Tip. Fak. Balcali Hastanesi Adana, Turkey, 01330 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Dokuz Eylul Universitesi Tip Fakultesi Izmir, Turkey, 35340 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kantonsspital St. Gallen St. Gallen, Switzerland, 1009 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
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)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Change from baseline in modified Rodnan skin score (mRSS) to Week 52The 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.Timeframe: Baseline to week 52
Secondary Outcome
- 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 52CRISS 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.Timeframe: Week 52
- Change from baseline in Health Assessment Questionnaire disability index (HAQ-DI) score to Week 52The 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).Timeframe: Baseline to week 52
- Change from baseline in patient’s global assessment score to Week 52The 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.Timeframe: Baseline to week 52
- Change from baseline in physician’s global assessment score to Week 52The 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.Timeframe: Baseline to week 52
- Change from baseline in forced vital capacity (FVC) percent predicted to Week 52Negative change in FVC percent predicted indicates worsening.Timeframe: Baseline to week 52
Additional Information
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