Status:
COMPLETED
Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis
Lead Sponsor:
Bayer
Conditions:
Scleroderma, Systemic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To investigate if Riociguat is effective in the treatment of systemic sclerosis
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 15 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2019
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT02283762
Start Date
January 15 2015
End Date
March 28 2019
Last Update
February 5 2020
Active Locations (59)
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1
Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States, 85259-5404
2
UCLA David Geffen School of Medicine
Los Angeles, California, United States, 90095-1670
3
Stanford University School of Medicine
Palo Alto, California, United States, 94304
4
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030