Trial · NCT02283762
Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis
NCT02283762, Phase 2, Completed, Bayer; results first posted 2019-01-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis. Trials, record NCT02283762. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02283762
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis
- NCT number
- NCT02283762
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 121 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Scleroderma, Systemic
- Interventions
- Riociguat (Adempas, BAY63-2521), Placebo
- First posted
- 2014-11-05
- Last updated
- 2020-02-05
- Other registries' IDs
- eudract:2014-001353-16
- Results first posted
- 2019-01-25
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Modified Rodnan Skin Score (mRSS) to Week 52 | Baseline 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 | 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 | 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. |
| Secondary | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score to Week 52 | Baseline 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). |
| Secondary | Change From Baseline in Patient's Global Assessment Score to Week 52 | Baseline 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. |
| Secondary | Change From Baseline in Physician's Global Assessment Score to Week 52 | Baseline 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. |
| Secondary | Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted to Week 52 | Baseline to week 52 | Negative change in FVC percent predicted indicates worsening. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Modified Rodnan Skin Score (mRSS) to Week 52 | Baseline to week 52 | Full analysis set (FAS: all participants randomized and treated with study medication) with evaluable data for this outcome measure. | score on a scale | MEAN |
| SECONDARY | 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 | Week 52 | Full analysis set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score to Week 52 | Baseline to week 52 | FAS with evaluable data for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Patient's Global Assessment Score to Week 52 | Baseline to week 52 | FAS with evaluable data for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Physician's Global Assessment Score to Week 52 | Baseline to week 52 | FAS with evaluable data for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted to Week 52 | Baseline to week 52 | FAS with evaluable data for this outcome measure. | FVC percent predicted | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Modified Rodnan Skin Score (mRSS) to Week 52 | Riociguat (Adempas, BAY63-2521) | -2.088 | Standard Deviation 5.658 | score on a scale | |
| Change From Baseline in Modified Rodnan Skin Score (mRSS) to Week 52 | Placebo | -0.769 | Standard Deviation 8.243 | score on a scale | |
| 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 | Riociguat (Adempas, BAY63-2521) | CRISS probability ≥ 0.60 | 11 | Participants | |
| 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 | Placebo | CRISS probability ≥ 0.60 | 11 | Participants | |
| 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 | Riociguat (Adempas, BAY63-2521) | CRISS probability < 0.60 | 49 | Participants | |
| 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 | Placebo | CRISS probability < 0.60 | 50 | Participants | |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score to Week 52 | Riociguat (Adempas, BAY63-2521) | Baseline | 0.888 | Standard Deviation 0.665 | score on a scale |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score to Week 52 | Placebo | Baseline | 0.693 | Standard Deviation 0.688 | score on a scale |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score to Week 52 | Riociguat (Adempas, BAY63-2521) | Change from baseline | 0.054 | Standard Deviation 0.381 | score on a scale |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score to Week 52 | Placebo | Change from baseline | 0.127 | Standard Deviation 0.418 | score on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Treatment Phase (MT) | STARTED | Riociguat (Adempas, BAY63-2521) | 60 | |
| Main Treatment Phase (MT) | STARTED | Placebo | 61 | |
| Main Treatment Phase (MT) | COMPLETED | Riociguat (Adempas, BAY63-2521) | 42 | |
| Main Treatment Phase (MT) | COMPLETED | Placebo | 46 | |
| Main Treatment Phase (MT) | NOT COMPLETED | Riociguat (Adempas, BAY63-2521) | 18 | |
| Main Treatment Phase (MT) | NOT COMPLETED | Placebo | 15 | |
| Long-term Extension Phase (LTE) | STARTED | Riociguat (Adempas, BAY63-2521) | 42 | |
| Long-term Extension Phase (LTE) | STARTED | Placebo | 45 | |
| Long-term Extension Phase (LTE) | COMPLETED | Riociguat (Adempas, BAY63-2521) | 32 | |
| Long-term Extension Phase (LTE) | COMPLETED | Placebo | 31 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events476
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | Riociguat-Riociguat (LTE Phase) | 3 | 42 | 3 |
| other | Palpitations | Cardiac disorders | Placebo-Riociguat (LTE Phase) | 1 | 45 | 1 |
| other | Palpitations | Cardiac disorders | Riociguat (Main Treatment Phase) | 8 | 60 | 8 |
| other | Palpitations | Cardiac disorders | Placebo (Main Treatment Phase) | 3 | 61 | 3 |
| other | Abdominal distension | Gastrointestinal disorders | Riociguat-Riociguat (LTE Phase) | 0 | 42 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Placebo-Riociguat (LTE Phase) | 4 | 45 | 6 |
| other | Abdominal distension | Gastrointestinal disorders | Riociguat (Main Treatment Phase) | 4 | 60 | 5 |
| other | Abdominal distension | Gastrointestinal disorders | Placebo (Main Treatment Phase) | 1 | 61 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Riociguat-Riociguat (LTE Phase) | 3 | 42 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo-Riociguat (LTE Phase) | 1 | 45 | 3 |
1 to 10 of 476Source ClinicalTrials.gov
See all 476 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Riociguat-Riociguat (LTE Phase) | 0 | 42 |
| Total, all-cause mortality | Placebo-Riociguat (LTE Phase) | 0 | 45 |
| Total, all-cause mortality | Riociguat (Main Treatment Phase) | 1 | 60 |
| Total, all-cause mortality | Placebo (Main Treatment Phase) | 1 | 61 |
| Total, other adverse events | Riociguat-Riociguat (LTE Phase) | 38 | 42 |
| Total, other adverse events | Placebo-Riociguat (LTE Phase) | 39 | 45 |
| Total, other adverse events | Riociguat (Main Treatment Phase) | 55 | 60 |
| Total, other adverse events | Placebo (Main Treatment Phase) | 49 | 61 |
| Total, serious adverse events | Riociguat-Riociguat (LTE Phase) | 10 | 42 |
| Total, serious adverse events | Placebo-Riociguat (LTE Phase) | 11 | 45 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02283762
GET https://conductscience.org/api/trials/v1/NCT02283762/events?page=2