Trial · NCT00555581
Imatinib Mesylate (Gleevec) in the Treatment of Systemic Sclerosis
NCT00555581, Phase 2, Completed, Hospital for Special Surgery, New York; results first posted 2018-02-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Imatinib Mesylate (Gleevec) in the Treatment of Systemic Sclerosis. Trials, record NCT00555581. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00555581
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Imatinib Mesylate (Gleevec) in the Treatment of Systemic Sclerosis
- NCT number
- NCT00555581
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Hospital for Special Surgery, New York
- Conditions
- Systemic Sclerosis
- Interventions
- Imatinib Mesylate
- First posted
- 2007-11-08
- Last updated
- 2018-02-06
- Results first posted
- 2018-02-06
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Improvement in the Modified Rodnan Skin Score | 12 months | Improvement in the Modified Rodnan Skin Score (MRSS) is measured by Mean change (and 95% Confidence Interval) from Baseline mean to Month 12 mean.Measure Description: 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 0 for uninvolved skin through 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. The mean change in MRSS represents the average change in total skin score from baseline to month 12. |
| Secondary | Improvement in Indices of Pulmonary Function Measured by Change in FVC % Predicted | 12 months | This outcome measure includes patients with and without the presence of Interstitial Lung Disease (ILD). Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from the lungs after taking a deep breath. It is used to determine the severity of lung disease. Improvement in FVC % predicted is measured by Mean change (and 95% Confidence Interval) from Baseline mean to Month 12 mean. Results are compared to the predicted values that are calculated from a patients age, size, weight, and sex. Results are considered normal if FVC is 80 percent or more of the predicted value. Mean change in FVC % predicted is measured by the average change in FVC% percent predicted from baseline to month 12. |
| Secondary | Improvement in Indices of Pulmonary Function Measured by Change DLCO hb Adj % Predicted | 12 months | This outcome measure includes patients with and without the presence of Interstitial Lung Disease (ILD). Diffusion capacity of the lungs for carbon monoxide (DLCO) measures how much oxygen travels from the alveoli of the lungs to the blood stream. DLCO is adjusted for hemoglobin as small changes in hemoglobin concentration can affect the carbon monoxide transfer. DLCO results are compared to normal values for a patient's height, age, sex, and ethnicity. A DLCO result that is at least 80% of the predicted value is considered normal. Improvement in DLCO hb adj % predicted is measured by Mean change (and 95% Confidence Interval) from Baseline mean to Month 12 mean (the average change in DLCO hb adj% from baseline to month 12). |
| Secondary | Change From Baseline at Month 12 in Short Form-36 (SF-36) Questionnaire:Mental Component Summary | 12 months | The Short Form 36 (SF-36) is a validated 36 item questionnaire which measures quality of life across eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health. The mental component score is composed of a subset of the 8 health domains. Each component is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability.The SF-36 mental component can be obtained by looking at the mean average of all the emotionally relevant items. Change in Short Form 36 mental (SF-36 MC) is measured by Mean change (and 95 % Confidence Interval) from Baseline mean to Month 12 mean (the average change in SF-36 mental component from baseline to month 12). |
| Secondary | Scleroderma Health Assessment Questionnaire Disability Index | 12 months | The Scleroderma Health Assessment Questionnaire (SHAQ) consist of the Health Assessment Questionnaire (HAQ) and 8 other domains which include scales looking at pain, patient global assessment, vascular, digital ulcers, lung involvement, and gastrointestinal involvement. It addresses scleroderma related manifestations that contribute to disability. It is a quality of life measure. Each question is scored from 0 (without difficulty) to 3 (unable to do). Some domains in the SHAQ are visual analog scales that are measured first and then changed to a 0-3 scale. The maximum from each category is added together and divided by the number of categories completed. Change in Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI) is measured as Mean Change (and 95% Confidence Interval) from Baseline mean to Month 12 mean (the average change in SHAQ-DI from baseline to month 12). |
| Secondary | Change From Baseline at Month 12 in Short Form-36 (SF-36) Questionnaire: Physical Component Summary | 12 months | The Short Form 36 (SF-36) is a 36 item questionnaire which measures quality of life across eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health. The physical component score is composed of a subset of the 8 health domains.The SF-36 physical component can be obtained by looking at the mean average of all the physically relevant items. Each component is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability. Change in Short Form 36 physical component (SF-36 PC) is measured by Mean change (and 95 % Confidence Interval) from Baseline mean to Month 12 mean (the average change in SF-36 physical component from baseline to month 12). |
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 | Improvement in the Modified Rodnan Skin Score | 12 months | units on a scale | MEAN | |
| SECONDARY | Improvement in Indices of Pulmonary Function Measured by Change in FVC % Predicted | 12 months | FVC% | MEAN | |
| SECONDARY | Improvement in Indices of Pulmonary Function Measured by Change DLCO hb Adj % Predicted | 12 months | DLCO% | MEAN | |
| SECONDARY | Change From Baseline at Month 12 in Short Form-36 (SF-36) Questionnaire:Mental Component Summary | 12 months | units on a scale | MEAN | |
| SECONDARY | Scleroderma Health Assessment Questionnaire Disability Index | 12 months | units on a scale | MEAN | |
| SECONDARY | Change From Baseline at Month 12 in Short Form-36 (SF-36) Questionnaire: Physical Component Summary | 12 months | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Improvement in the Modified Rodnan Skin Score | 400 mg Daily of Imatinib Mesylate | -6.6 | 95% Confidence Interval -8.7 to -4.5 | units on a scale | |
| Improvement in Indices of Pulmonary Function Measured by Change in FVC % Predicted | 400 mg Daily of Imatinib Mesylate | 6.4 | 95% Confidence Interval 1.9 to 10.9 | FVC% | |
| Improvement in Indices of Pulmonary Function Measured by Change DLCO hb Adj % Predicted | 400 mg Daily of Imatinib Mesylate | 5.5 | 95% Confidence Interval -1.5 to 12.4 | DLCO% | |
| Change From Baseline at Month 12 in Short Form-36 (SF-36) Questionnaire:Mental Component Summary | 400 mg Daily of Imatinib Mesylate | -6.6 | 95% Confidence Interval -12.5 to -0.7 | units on a scale | |
| Scleroderma Health Assessment Questionnaire Disability Index | 400 mg Daily of Imatinib Mesylate | 0.02 | 95% Confidence Interval -0.15 to 0.18 | units on a scale | |
| Change From Baseline at Month 12 in Short Form-36 (SF-36) Questionnaire: Physical Component Summary | 400 mg Daily of Imatinib Mesylate | 6.8 | 95% Confidence Interval 1.7 to 15.3 | 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 | 400 mg Daily of Imatinib Mesylate | 30 | |
| Overall Study | COMPLETED | 400 mg Daily of Imatinib Mesylate | 24 | |
| Overall Study | NOT COMPLETED | 400 mg Daily of Imatinib Mesylate | 6 |
Source ClinicalTrials.gov
Adverse events30
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 | Edema | General disorders | 400 mg Daily of Imatinib Mesylate | 25 | 30 | 33 |
| other | Nausea | Metabolism and nutrition disorders | 400 mg Daily of Imatinib Mesylate | 22 | 30 | 22 |
| other | Myalgias | Musculoskeletal and connective tissue disorders | 400 mg Daily of Imatinib Mesylate | 21 | 30 | 21 |
| other | CK elevation | Blood and lymphatic system disorders | 400 mg Daily of Imatinib Mesylate | 13 | 30 | 13 |
| other | Fatigue | General disorders | 400 mg Daily of Imatinib Mesylate | 18 | 30 | 18 |
| other | Pyrosis | Gastrointestinal disorders | 400 mg Daily of Imatinib Mesylate | 7 | 30 | 7 |
| other | Vomiting | Metabolism and nutrition disorders | 400 mg Daily of Imatinib Mesylate | 7 | 30 | 7 |
| other | Weight Loss | Metabolism and nutrition disorders | 400 mg Daily of Imatinib Mesylate | 5 | 30 | 5 |
| other | Headaches | Nervous system disorders | 400 mg Daily of Imatinib Mesylate | 7 | 30 | 7 |
| other | Effusions | Respiratory, thoracic and mediastinal disorders | 400 mg Daily of Imatinib Mesylate | 3 | 30 | 3 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 400 mg Daily of Imatinib Mesylate | 1 | 30 |
| Total, other adverse events | 400 mg Daily of Imatinib Mesylate | 25 | 30 |
| Total, serious adverse events | 400 mg Daily of Imatinib Mesylate | 12 | 30 |
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/NCT00555581
GET https://conductscience.org/api/trials/v1/NCT00555581/events?page=2