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: July 8, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Systemic Sclerosis, Scleroderma
Drug: STI571
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Assessment of non-response, partial response, complete response, remission or relapse assessed by MRSS values. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: January 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: STI571
STI571 tablets taken orally once a day
Other Name: Gleevec, Glivec

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00613171     History of Changes
Other Study ID Numbers: CSTI571E2205
Study First Received: January 25, 2008
Last Updated: July 8, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Switzerland: Swissmedic
Italy: National Institute of Health

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

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

ClinicalTrials.gov processed this record on September 22, 2014