Trial · NCT01166139
Nilotinib in the Treatment of Systemic Sclerosis
NCT01166139, Phase 2, Completed, Hospital for Special Surgery, New York; results first posted 2017-10-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nilotinib in the Treatment of Systemic Sclerosis. Trials, record NCT01166139. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01166139
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nilotinib in the Treatment of Systemic Sclerosis
- NCT number
- NCT01166139
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Hospital for Special Surgery, New York
- Conditions
- Systemic Sclerosis
- Interventions
- Nilotinib (Tasigna)
- First posted
- 2010-07-20
- Last updated
- 2017-10-04
- Results first posted
- 2017-10-04
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 6 Months and 12 months treatment | |
| Secondary | Improvement of Modified Rodnan Skin Score Reported as a Mean (Units Equals Number of Points) | 6 Months of treatment | Efficacy of Nilotinib in patients with systemic sclerosis, as defined by an improvement in the Modified Rodnan Skin Score (MRSS) The Modified Rodnan Skin Score (MRSS) measures dermal skin thickness through the examination of 17 body areas: fingers, hands, forearms, arms, feet, legs, and thighs (in pairs), and face, chest, and abdomen. The skin score is evaluated by manual palpation in each of these areas. The skin score is 0 for uninvolved skin, 1 for mild thickening, 2 for moderate thickening, and 3 for severe thickening (hidebound skin). The total skin score is the sum of the skin scores of the individual areas where the minimum score is 0 and the maximum score is 51. A higher score indicates greater severity of disease. |
| Secondary | Efficacy of Nilotinib in Patients With Systemic Sclerosis, as Defined by an Improvement in the Modified Rodnan Skin Score | 12 months treatment | Improvement in Modified Rodnan skin score reported as a mean (units equals number of points). The Modified Rodnan Skin Score (MRSS) measures dermal skin thickness through the examination of 17 body areas: fingers, hands, forearms, arms, feet, legs, and thighs (in pairs), and face, chest, and abdomen. In each of these areas, the skin score is evaluated by manual palpation. The skin score is 0 for uninvolved skin, 1 for mild thickening, 2 for moderate thickening, and 3 for severe thickening (hidebound skin). The total skin score is the sum of the skin scores of the individual areas. The minimum score is 0 and the maximum score is 51. A higher score indicates greater severity of disease. |
Source ClinicalTrials.gov
Outcomes3
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 Adverse Events as a Measure of Safety and Tolerability | 6 Months and 12 months treatment | Adverse Events | NUMBER | |
| SECONDARY | Improvement of Modified Rodnan Skin Score Reported as a Mean (Units Equals Number of Points) | 6 Months of treatment | units on a scale | NUMBER | |
| SECONDARY | Efficacy of Nilotinib in Patients With Systemic Sclerosis, as Defined by an Improvement in the Modified Rodnan Skin Score | 12 months treatment | units on a scale | NUMBER |
Source ClinicalTrials.gov
Results by group3
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 Adverse Events as a Measure of Safety and Tolerability | Nilotinib 400 mg Twice Daily | 71 | Adverse Events | ||
| Improvement of Modified Rodnan Skin Score Reported as a Mean (Units Equals Number of Points) | Nilotinib 400 mg Twice Daily | 4.2 | units on a scale | ||
| Efficacy of Nilotinib in Patients With Systemic Sclerosis, as Defined by an Improvement in the Modified Rodnan Skin Score | Nilotinib 400 mg Twice Daily | 6.3 | units on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nilotinib 400 mg Twice Daily | 10 | |
| Overall Study | COMPLETED | Nilotinib 400 mg Twice Daily | 7 | |
| Overall Study | NOT COMPLETED | Nilotinib 400 mg Twice Daily | 3 |
Source ClinicalTrials.gov
Adverse events40
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 | Prolonged QTC | Cardiac disorders | Nilotinib 400 mg Twice Daily | 6 | 7 | 9 |
| other | Increased AST | Investigations | Nilotinib 400 mg Twice Daily | 5 | 7 | 6 |
| other | Elevated Total Bilirubin | Investigations | Nilotinib 400 mg Twice Daily | 5 | 7 | 6 |
| other | Increased ALT | Investigations | Nilotinib 400 mg Twice Daily | 4 | 7 | 5 |
| other | Anemia | Blood and lymphatic system disorders | Nilotinib 400 mg Twice Daily | 3 | 7 | 3 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Nilotinib 400 mg Twice Daily | 3 | 7 | 3 |
| other | Headache | Nervous system disorders | Nilotinib 400 mg Twice Daily | 3 | 7 | 3 |
| other | Nausea | Ear and labyrinth disorders | Nilotinib 400 mg Twice Daily | 2 | 7 | 2 |
| other | Reflux | Gastrointestinal disorders | Nilotinib 400 mg Twice Daily | 2 | 7 | 2 |
| other | Elevated ESR | Blood and lymphatic system disorders | Nilotinib 400 mg Twice Daily | 2 | 7 | 2 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nilotinib 400 mg Twice Daily | 0 | 7 |
| Total, other adverse events | Nilotinib 400 mg Twice Daily | 7 | 7 |
| Total, serious adverse events | Nilotinib 400 mg Twice Daily | 2 | 7 |
Source ClinicalTrials.gov
Papers2
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/NCT01166139
GET https://conductscience.org/api/trials/v1/NCT01166139/events?page=2