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Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Patients With Systemic Sclerosis

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ClinicalTrials.gov Identifier: NCT00613171
Recruitment Status : Completed
First Posted : February 12, 2008
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study will investigate the efficacy and safety of STI571 for the treatment of fibrosis in patients with systemic sclerosis. Other purposes of the study are to investigate whether STI571 is effective in improving lung functions and other test results called biomarkers. Whether STI571 is well-absorbed in systemic sclerosis patients' gut will also be investigated by testing the drug level in the blood (pharmacokinetics).

Condition or disease Intervention/treatment Phase
Systemic Sclerosis, Scleroderma Drug: STI571 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-centre, Open-label, Proof of Concept (PoC) Study to Evaluate the Efficacy and Tolerability of STI571 for the Treatment of Fibrosis in Patients With Systemic Sclerosis
Study Start Date : January 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Arm Intervention/treatment
Experimental: 1 Drug: STI571
STI571 tablets taken orally once a day
Other Name: Gleevec, Glivec




Primary Outcome Measures :
  1. Percentage change from baseline in modified Rodnan Skin Score (MRSS) at each time point of analysis [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Assessment of non-response, partial response, complete response, remission or relapse assessed by MRSS values. [ Time Frame: 48 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients who are equal to or older than 18 years of age and who have early diffuse systemic sclerosis (Disease duration < 18 months from the first non-Raynaud's symptom)
  • Patients with a modified Rodnans Skin Score (MRSS) of at least 20 in the absence of trunk involvement or a MRSS of at least 16 in patients with trunk involvement
  • Practicing two acceptable forms of contraception

Exclusion Criteria:

  • Concurrent connective tissue diseases other than systemic sclerosis
  • Significant pre-existing heart, liver, lungs, digestive system, blood and other diseases, cancer
  • Conditions that might mimic the potential side effects of STI571 (blood conditions, liver damage, chronic diarrhea, edema)
  • Concurrent medical therapies (or during last 6 weeks before first dosing) that may potentially influence outcome of the study
  • allergic to the study medication
  • Pregnancy
  • Breast feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00613171


Locations
United States, Illinois
Novartis Investigator Site
Chicago, Illinois, United States, 60611
United States, Maryland
Novartis Investigator Site
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Novartis Investigator Site
Boston, Massachusetts, United States, 02118
Germany
Novartis Investigator Site
Erlangen, Germany
Italy
Novartis Investigator Site
Florence, Italy
Switzerland
Novartis Investigator Site
Zurich, Switzerland
United Kingdom
Novartis Investigator Site
London, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Principal Investigator: NOVARTIS Novartis investigator site

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00613171     History of Changes
Other Study ID Numbers: CSTI571E2205
First Posted: February 12, 2008    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Systemic sclerosis, scleroderma, fibrosis, STI571, imatinib

Additional relevant MeSH terms:
Sclerosis
Fibrosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action