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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00613171
First received: January 25, 2008
Last updated: May 2, 2012
Last verified: May 2012
History of Changes

January 25, 2008
May 2, 2012
January 2008
January 2010   (final data collection date for primary outcome measure)
Percentage change from baseline in modified Rodnan Skin Score (MRSS) at each time point of analysis [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Percentage change from baseline in modified Rodnan Skin Score (MRSS) at each time point of analysis [ Time Frame: throughout the study ]
Complete list of historical versions of study NCT00613171 on ClinicalTrials.gov Archive Site
Assessment of non-response, partial response, complete response, remission or relapse assessed by MRSS values. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Assessment of non-response, partial response, complete response, remission or relapse assessed by MRSS values. [ Time Frame: throughout the study ]
Not Provided
Not Provided
 
Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Patients With Systemic Sclerosis
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

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).
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Systemic Sclerosis, Scleroderma
Drug: STI571
STI571 tablets taken orally once a day
Other Name: Gleevec, Glivec
Experimental: 1
Intervention: Drug: STI571
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
Not Provided
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Italy,   Switzerland,   United Kingdom
 
NCT00613171
CSTI571E2205
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Principal Investigator: NOVARTIS Novartis investigator site
Novartis
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP