Trial · NCT01545427
Proof of Concept Trial of Gleevec (Imatinib) in Active Diffuse Scleroderma
NCT01545427, Phase 2, Terminated, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Proof of Concept Trial of Gleevec (Imatinib) in Active Diffuse Scleroderma. Trials, record NCT01545427. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01545427
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Proof of Concept Trial of Gleevec (Imatinib) in Active Diffuse Scleroderma
- NCT number
- NCT01545427
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Conditions
- Scleroderma
- Interventions
- Imatinib mesylate, Placebo
- First posted
- 2012-03-06
- Last updated
- 2012-03-07
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in the levels of fibrotic and inflammatory biomarkers in plasma samples. | Plasma samples were taken at baseline (0), 3 and 6 months (study end). | Twenty-six fibrotic and inflammatory biomarkers were measured: PDGF-AA, PDGF-AB/BB, IL-13, IL-17, VEGF, TGF-beta1, sVCAM-1, sICAM-1, sE-selectin, MMP-9, tPAI-1, IL-1alpha, IL-1 beta, IL-4, IL-6, IL-10, IL-12p70, IL-13, TNF- alpha, sCD40L, IFN- gamma, MCP-1, MCP-3, MIP-1 alpha, MIP-1 beta, and chemokine ligand 5 (CCL5 - also known as RANTES). Biomarkers were measured using multiplexed immunoassays (Millipore Corp., MA) and ELISA for TGF- beta 1 (BD Biosciences, NJ). |
| Primary | Changes in the levels of fibrotic and inflammatory biomarkers in skin biopsies. | Baseline and 6 months (study end). | Twenty-six fibrotic and inflammatory biomarkers were measured: PDGF-AA, PDGF-AB/BB, IL-13, IL-17, VEGF, TGF-beta1, sVCAM-1, sICAM-1, sE-selectin, MMP-9, tPAI-1, IL-1alpha, IL-1 beta, IL-4, IL-6, IL-10, IL-12p70, IL-13, TNF- alpha, sCD40L, IFN- gamma, MCP-1, MCP-3, MIP-1 alpha, MIP-1 beta, and chemokine ligand 5 (CCL5 - also known as RANTES). Biomarkers were measured using multiplexed immunoassays (Millipore Corp., MA) and ELISA for TGF- beta 1 (BD Biosciences, NJ). |
| Secondary | Modified Rodnan Skin Score (MRSS) | Baseline, 3 months and 6 months (study end). | The Modified Rodnan Skin Score (MRSS) is a validated outcome measurement and is the usual primary outcome measurement for all trials of disease modification in scleroderma. It is positively correlated with internal organ involvement and has been shown to improve or worsen in many patients. |
| Secondary | Adverse events and serious adverse events | From treatment start until 4 weeks after after the patient has stopped study participation | This study will use the CTCAE (NCI Common Terminology Criteria for Adverse Events) versions 3.0 for toxicity and adverse event reporting. If multiple dose-reducing toxicities are present, the greatest dose reduction schedule should be used. Information about all adverse events will be collected and recorded on the Adverse Event Case Report Form and followed as appropriate. Serious adverse events occurring more than 4 weeks after study discontinuation need only be reported if a relationship to the study drug (or therapy) is suspected. |
| Secondary | Health Assessment Questionnaire | Baseline, 3 months and 6 months (study end). | |
| Secondary | Patient Global Assessment | Baseline, 3 months and 6 months (study end). | Patient assessment of global disease activity on a 100 mm visual analog scale. |
| Secondary | Physician Global Assessment | Baseline, 3 months and 6 months (study end). | Physician global assessment of disease activity on a 100 mm visual analog scale. |
| Secondary | The Short Form (36) Health Survey | Baseline and 6 months. | |
| Secondary | Health Transitiion Score | Baseline and 6 months. | "Compared to 6 months ago, how do you rate your health overall?: Much worse, worse, same, better, much better". |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
Papers10
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/NCT01545427
GET https://conductscience.org/api/trials/v1/NCT01545427/registered