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Trial record 2 of 2 for:    riociguat scleroderma

Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT02283762
First received: November 3, 2014
Last updated: July 31, 2017
Last verified: July 2017
  Purpose
To investigate if Riociguat is effective in the treatment of systemic sclerosis

Condition Intervention Phase
Scleroderma, Systemic Drug: Riociguat (Adempas, BAY63-2521) Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Change in mRSS (modified Rodnan skin score) [ Time Frame: Baseline to week 52 ]

Secondary Outcome Measures:
  • American College of Rheumatology Combined Response Index for Systemic Sclerosis (CRISS) at Week 52 [ Time Frame: 52 weeks ]
  • Health Assessment Questionnaire disability index (HAQ-DI) domain (separately from the Scleroderma Health Assessment Questionnaire [SHAQ] as part of the calculation of the CRISS algorithm) [ Time Frame: 52 weeks ]
  • Patient's global assessment [ Time Frame: Baseline to 52 weeks ]
  • Physician's global health assessment on a scaled rating [ Time Frame: Baseline to 52 weeks ]
  • Change in FVC (forced vital capacity) % predicted [ Time Frame: Baseline to 52 weeks ]

Enrollment: 121
Actual Study Start Date: January 15, 2015
Estimated Study Completion Date: June 30, 2022
Estimated Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Riociguat
Increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5mg TID and maintenance period of 42 weeks
Drug: Riociguat (Adempas, BAY63-2521)
Starting dose 0.5 mg TID, increase by 0.5mg very 2 weeks until highest possible dose of 2.5 mg TID
Placebo Comparator: Placebo
Sham-titration
Drug: Placebo
Sham-titration

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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/1.73m2 (Modification of Diet in Renal Disease formula) or on dialysis at the screening visit. Patients entering the trial with eGFR 15-29 mL/min/1.73m2 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02283762

  Show 72 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02283762     History of Changes
Other Study ID Numbers: 16277
2014-001353-16 ( EudraCT Number )
Study First Received: November 3, 2014
Last Updated: July 31, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 18, 2017