Trial · NCT02663895
Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis
NCT02663895, Phase 2, Completed, Stanford University; results first posted 2021-06-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis. Trials, record NCT02663895. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02663895
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis
- NCT number
- NCT02663895
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Systemic Sclerosis, Calcinosis
- Interventions
- Oral treprostinil
- First posted
- 2016-01-26
- Last updated
- 2021-06-10
- Results first posted
- 2021-06-10
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-related Adverse Events Following Treatment With Oral Treprostinil | 12 months | Number of participants with treatment-related adverse events following treatment with oral treprostinil at 12 months. We defined adverse event as any untoward medical experience occurring to a subject during a clinical trial whether or not it is related to the study drug. |
| Primary | Median Rate of Change of Calcinosis in Radiograph Following Treatment With Oral Treprostinil as Assessed by a Novel Radiographic Scoring System | Baseline, month 12 | Median rate of change of calcinosis in radiograph following treatment with oral treprostinil as assessed by the Scleroderma Clinical Trial Consortium (SCTC) radiographic scoring system. Historical average SCTC scores in this patient population have ranged from 4.08 to 472.88, with higher scores indicating more severe symptoms. The SCTC radiographic score for calcinosis is a validated radiographic scoring system to assess the severity of calcinosis affecting the hands of patients with SSc that accounts for area coverage, density, and anatomic location, higher scores mean worse calcinosis. Physician rates density and percentage of area for 22 regions of each hand, each deferentially weighted in the overall score; individual region values are multiplied my their weight then summed to create an overall score. |
| Secondary | Change in Scleroderma Health Assessment Questionnaire (SHAQ) | Baseline, 12 months | The Scleroderma Health Assessment Questionnaire (SHAQ) has two parts. The first part is a disability index (DI) that consists of the mean of 8 scores from 8 sections (dressing, arising, eating, walking, hygiene, reach, grip, and activities) ranging from 0 (without any difficulty) to 3 (unable to do), with scores summed and divided by 8. The result is the Health Assessment Questionnaire (HAQ)-DI score, which ranges between 0 and 3. The second part consists of 6 visual analogue scales (VAS) each ranging from 0 (better outcome) to 10 (worse outcome). * Pain (SHAQ-VAS-Pain) * Intestinal (SHAQ-VAS-GI) * Breathing (SHAQ-VAS-Breathing) * Raynaud (SHAQ-VAS-Raynaud) * Digital ulcers (SHAQ-VAS-DU) * Disease Severity (SHAQ-VAS-Disease Severity) |
| Secondary | Change in Cochin Hand Functional Scale | Baseline, 12 months | Cochin Hand Functional Scale is a 18-question scale, each question ranges from 0 to 5, with a total score range of 0-90. Higher scores indicates higher disability. |
| Secondary | Change in Short Form (SF)-36 | Baseline, 12 months | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The higher the score the less disability. |
| Secondary | Change in Mawdsley Calcinosis Questionnaire | Baseline, 12 months | Mawdsley Calcinosis Questionnaire is an 18-question survey with an overall score of 0-10; each individual question ranges from 0-10, scores are totaled and averaged to and divided by 18 to create the overall score. Higher scores indicate higher disability from calcinosis. |
| Secondary | Change in Raynaud Condition Score | Baseline, 12 months | The Raynaud Condition Score is a single question questionnaire, ranges from 0-10, where 10 indicates more active Raynaud phenomenon. Raynaud is an exaggerated vascular response to cold exposure or emotion with at least a 2-phase color change in finger(s) and often toe(s) consisting of pallor, cyanosis, and/or reactive hyperemia: usually one phase is pallor. |
| Secondary | Change in Patient Global Assessment of Calcinosis Severity | Baseline, 12 months | Patient global assessment of calcinosis severity at 1 year versus baseline. Score range: 0 to 10 (higher scores indicate more severe calcinosis). |
| Secondary | Change in Physician Global Assessment of Calcinosis Severity | Baseline, 12 months | Physician global assessment of calcinosis severity at 1 year versus baseline. Score range: 0 to 10 (higher scores indicate more severe calcinosis). |
| Secondary | Baseline Cortical Area Measured by HR-pQCT in SSc Patients With Calcinosis. | Baseline visit (average approximately 3 hours for the scan) | Bone cortical area is a bone microarchitecture measurement assessed by High Resolution peripheral Quantitative Computed Tomography (HRpQCT) at the distal tibia. Lower levels of cortical area are associated with more bone fragility. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-related Adverse Events Following Treatment With Oral Treprostinil | 12 months | Of the 12 patients enrolled in this study, all received at least one dose of study treatment and were evaluated for safety. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Median Rate of Change of Calcinosis in Radiograph Following Treatment With Oral Treprostinil as Assessed by a Novel Radiographic Scoring System | Baseline, month 12 | Participants who completed the protocol are included in the analysis. | percent change | MEDIAN |
| SECONDARY | Change in Scleroderma Health Assessment Questionnaire (SHAQ) | Baseline, 12 months | Participants with survey data are included in the analysis. | score on a scale | MEDIAN |
| SECONDARY | Change in Cochin Hand Functional Scale | Baseline, 12 months | Participants with survey data are included in the analysis. | score on a scale | MEDIAN |
| SECONDARY | Change in Short Form (SF)-36 | Baseline, 12 months | Participants with survey data are included in the analysis. | score on a scale | MEDIAN |
| SECONDARY | Change in Mawdsley Calcinosis Questionnaire | Baseline, 12 months | Participants with survey data are included in the analysis. | score on a scale | MEDIAN |
| SECONDARY | Change in Raynaud Condition Score | Baseline, 12 months | Participants with survey data are included in the analysis. | score on a scale | MEDIAN |
| SECONDARY | Change in Patient Global Assessment of Calcinosis Severity | Baseline, 12 months | Participants with survey data are included in the analysis. | score on a scale | MEDIAN |
| SECONDARY | Change in Physician Global Assessment of Calcinosis Severity | Baseline, 12 months | Participants with survey data are included in the analysis. | score on a scale | MEDIAN |
| SECONDARY | Baseline Cortical Area Measured by HR-pQCT in SSc Patients With Calcinosis. | Baseline visit (average approximately 3 hours for the scan) | Participants with High Resolution peripheral Quantitative Computed Tomography device (HRpQCT) data were included in the analysis. | mm^2 | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-related Adverse Events Following Treatment With Oral Treprostinil | Oral Treprostinil | 11 | Participants | ||
| Median Rate of Change of Calcinosis in Radiograph Following Treatment With Oral Treprostinil as Assessed by a Novel Radiographic Scoring System | Oral Treprostinil | 22.2 | Full Range 5.3 to 85.5 | percent change | |
| Change in Scleroderma Health Assessment Questionnaire (SHAQ) | Oral Treprostinil | HAQ-DI | 0 | Full Range -0.08 to 0.1 | score on a scale |
| Change in Scleroderma Health Assessment Questionnaire (SHAQ) | Oral Treprostinil | SHAQ-VAS-Pain | -0.03 | Full Range -0.1 to 0.13 | score on a scale |
| Change in Scleroderma Health Assessment Questionnaire (SHAQ) | Oral Treprostinil | SHAQ-VAS-GI | 0.03 | Full Range 0 to 0.25 | score on a scale |
| Change in Scleroderma Health Assessment Questionnaire (SHAQ) | Oral Treprostinil | SHAQ-VAS-Breathing | 0 | Full Range -0.15 to 0.3 | score on a scale |
| Change in Scleroderma Health Assessment Questionnaire (SHAQ) | Oral Treprostinil | SHAQ-VAS-Raynaud | 0 | Full Range -0.1 to 0.2 | score on a scale |
| Change in Scleroderma Health Assessment Questionnaire (SHAQ) | Oral Treprostinil | SHAQ-VAS-DU | 0 | Full Range -0.15 to 0.1 | score on a scale |
| Change in Scleroderma Health Assessment Questionnaire (SHAQ) | Oral Treprostinil | SHAQ-VAS-Disease Severity | 0 | Full Range -0.05 to 0.1 | score on a scale |
| Change in Cochin Hand Functional Scale | Oral Treprostinil | -0.17 | Full Range -1 to 4.33 | score on a scale |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oral Treprostinil | 12 | |
| Overall Study | COMPLETED | Oral Treprostinil | 5 | |
| Overall Study | NOT COMPLETED | Oral Treprostinil | 7 |
Source ClinicalTrials.gov
Adverse events10
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 | Headache | Nervous system disorders | Oral Treprostinil | 8 | 12 | |
| other | Abdominal Pain | Gastrointestinal disorders | Oral Treprostinil | 6 | 12 | |
| other | Diarrhea | Gastrointestinal disorders | Oral Treprostinil | 5 | 12 | |
| other | Nausea | Gastrointestinal disorders | Oral Treprostinil | 3 | 12 | |
| other | Flushing | General disorders | Oral Treprostinil | 2 | 12 | |
| other | Jaw Pain | Musculoskeletal and connective tissue disorders | Oral Treprostinil | 2 | 12 | |
| other | dizziness | General disorders | Oral Treprostinil | 2 | 12 | |
| other | hypotension | Cardiac disorders | Oral Treprostinil | 1 | 12 | |
| other | epistaxis | Ear and labyrinth disorders | Oral Treprostinil | 1 | 12 | |
| other | weight loss | General disorders | Oral Treprostinil | 1 | 12 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oral Treprostinil | 0 | 12 |
| Total, other adverse events | Oral Treprostinil | 11 | 12 |
| Total, serious adverse events | Oral Treprostinil | 0 | 12 |
Source ClinicalTrials.gov
Papers28
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/NCT02663895
GET https://conductscience.org/api/trials/v1/NCT02663895/results?page=2