Trial · NCT00677092
Pilot Study of Imatinib Mesylate to Treat Nephrogenic Systemic Fibrosis
NCT00677092, Phase 2, Completed, Massachusetts General Hospital; results first posted 2017-05-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pilot Study of Imatinib Mesylate to Treat Nephrogenic Systemic Fibrosis. Trials, record NCT00677092. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00677092
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Study of Imatinib Mesylate to Treat Nephrogenic Systemic Fibrosis
- NCT number
- NCT00677092
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Nephrogenic Systemic Fibrosis
- Interventions
- Imatinib mesylate
- First posted
- 2008-05-13
- Last updated
- 2017-05-19
- Results first posted
- 2017-05-19
- Limitations and caveats
- PI left institution in 2009; Data collected cannot be associated with specific participants and analyzed for secondary outcome measure or adverse event data entry.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Assess Skin Tethering | Baseline and Month 4 | The modified Rodnan Skin Score is the accepted clinical measure of scleroderma skin activity. The investigator assessed the thickening of the skin using the modified Rodnan Skin Score through simple palpation on 17 different skin sites in the fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Skin thickness was assessed on a scale of 0 to 3; 0 representing normal skin and 3 being severe thickening. The sum of the individual scores can range from 0 (normal) to 51 (severe thickening in all 17 areas). Percentage change is calculated as the Month 4 Score - Baseline Score/Baseline Score \* 100. A negative percentage change indicates improvement. |
| Secondary | Change From Baseline in Maximal Extension of Elbows and Knees | Baseline and Month 4 | |
| Secondary | Change From Baseline in Histologic Appearance of Skin Biopsy | Baseline and Month 4 | |
| Secondary | Change From Baseline in Visual Analog Scale (VAS) for Pain | Baseline and Month 4 | |
| Secondary | Change From Baseline in Health Assessment Questionnaire (HAQ) Score | Baseline and Month 4 | |
| Secondary | Change From Baseline in Short Form 36 (SF-36) Score | Baseline and Month 4 |
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 | Percentage Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Assess Skin Tethering | Baseline and Month 4 | All enrolled participants with Baseline and Month 4 data available for analysis. | percentage change in mRSS score | MEAN |
| SECONDARY | Change From Baseline in Maximal Extension of Elbows and Knees | Baseline and Month 4 | PI left institution in 2009; Data collected cannot be associated with specific participants and analyzed for secondary outcome measure. | ||
| SECONDARY | Change From Baseline in Histologic Appearance of Skin Biopsy | Baseline and Month 4 | PI left institution in 2009; Data collected cannot be associated with specific participants and analyzed for secondary outcome measure. | ||
| SECONDARY | Change From Baseline in Visual Analog Scale (VAS) for Pain | Baseline and Month 4 | PI left institution in 2009; Data collected cannot be associated with specific participants and analyzed for secondary outcome measure. | ||
| SECONDARY | Change From Baseline in Health Assessment Questionnaire (HAQ) Score | Baseline and Month 4 | PI left institution in 2009; Data collected cannot be associated with specific participants and analyzed for secondary outcome measure. | ||
| SECONDARY | Change From Baseline in Short Form 36 (SF-36) Score | Baseline and Month 4 | PI left institution in 2009; Data collected cannot be associated with specific participants and analyzed for secondary outcome measure. |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Assess Skin Tethering | Imatinib Mesylate Treatment | -24 | Standard Deviation 14 | percentage change in mRSS score |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Imatinib Mesylate Treatment | 12 | |
| Overall Study | Received Study Treatment | Imatinib Mesylate Treatment | 11 | |
| Overall Study | COMPLETED | Imatinib Mesylate Treatment | 6 | |
| Overall Study | NOT COMPLETED | Imatinib Mesylate Treatment | 6 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Imatinib Mesylate Treatment | ||
| Total, other adverse events | Imatinib Mesylate Treatment | 0 | 0 |
| Total, serious adverse events | Imatinib Mesylate Treatment | 0 | 0 |
Source ClinicalTrials.gov
Papers5
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/NCT00677092
GET https://conductscience.org/api/trials/v1/NCT00677092/registered