Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00613171
Recruitment Status : Completed
First Posted : February 12, 2008
Results First Posted : May 21, 2021
Last Update Posted : July 7, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
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
Actual Study Start Date : January 2, 2008
Actual Primary Completion Date : January 13, 2010
Actual Study Completion Date : January 13, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Arm Intervention/treatment
Experimental: ST1571
Participants received ST1571 100 mg tablets, orally, once daily. Initiated at an oral dose of 200 mg/day for 4 weeks then titrated up to 400 mg/day for 2 weeks followed by 600 mg/day until Week 24, if well tolerated.
Drug: STI571
STI571 tablets taken orally once a day
Other Name: Gleevec, Glivec




Primary Outcome Measures :
  1. Change From Baseline in Modified Rodnan Skin Score (MRSS) at Each Time Point of Analysis [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and Week 48/End of Study (EOS) ]
    The efficacy of oral STI571 in participants with systemic sclerosis is defined by an improvement in MRSS. Skin thickness was assessed clinically in each of 17 body areas and scored using a 0-3 scale, where 0= normal, 1= mild thickness, 2= moderate thickness, and 3= severe thickness (maximum score 51). A higher score indicates greater severity of the disease.

  2. Number of Participants With Adverse Events (AE's) and Serious Adverse Events (SAE's) [ Time Frame: Baseline to Week 48/EOS ]
    An AE is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to the study drug. An SAE is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization, is medically significant, i.e., defined as an event that jeopardizes the patient or may require medical or surgical intervention to prevent one of the outcomes listed above.


Secondary Outcome Measures :
  1. Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values [ Time Frame: Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and Week 48/End of Study (EOS) ]
    The following MRSS categories were calculated for up to Week 48: Non-response: a reduction in MRSS <25%, Partial response: a reduction in MRSS between 25-<50%, Complete response: a reduction in MRSS between 50-<80%, Remission: a reduction in MRSS ≥80%.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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 participants who are equal to or older than 18 years of age and who have early diffuse cutaneous systemic sclerosis (Disease duration < 18 months from the first non-Raynaud's symptom)
  • Participants 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
  • Female patients of childbearing potential practicing two acceptable forms of contraception

Exclusion Criteria:

  • SSc patients with a MRSS greater than 35
  • 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
Layout table for location information
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
Layout table for investigator information
Principal Investigator: NOVARTIS Novartis investigator site
Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00613171    
Other Study ID Numbers: CSTI571E2205
First Posted: February 12, 2008    Key Record Dates
Results First Posted: May 21, 2021
Last Update Posted: July 7, 2021
Last Verified: July 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Systemic sclerosis, scleroderma, fibrosis, STI571, imatinib
Additional relevant MeSH terms:
Layout table for MeSH terms
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Fibrosis
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action