Clinical Trial: Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
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 (dc
Brief Summary: To investigate if Riociguat is effective in the treatment of systemic sclerosis
Detailed Summary:
Sponsor: Bayer
Current Primary Outcome: Change in mRSS (modified Rodnan skin score) [ Time Frame: Baseline to week 52 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome:
- mRSS progression rate [ Time Frame: 52 weeks ]
- mRSS regression rate [ Time Frame: 52 weeks ]
- Patient's global health assessment on a scaled rating [ Time Frame: Baseline to 52 weeks ]
- Physician's global health assessment on a scaled rating [ Time Frame: Baseline to 52 weeks ]
- HRQoL (health related quality of life) assessment via patient questionnaires [ Time Frame: Baseline to 52 weeks ]
- Digital ulcer net burden (defined as total number of ulcers at time point minus number of ulcers at baseline) [ Time Frame: Baseline to 52 weeks ]
- Proportion of patients who do not develop new ulcers [ Time Frame: 52 weeks ]
- Change in FVC (forced vital capacity) [ Time Frame: Baseline to 52 weeks ]
- Change in DLCO (diffusion capacity of the lung for carbon monoxide) [ Time Frame: Baseline to 52 weeks ]
- Combined Response Index for Systemic Sclerosis (CRISS) [ Time Frame: 52 weeks ]
- Number of participants with need for escape therapy [ Time Frame: 52 weeks ]
Information By: Bayer
Dates:
Date Received: November 3, 2014
Date Started: January 15, 2015
Date Completion: June 30, 2022
Last Updated: May 4, 2017
Last Verified: May 2017