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Imatinib Mesylate (Gleevec) in the Treatment of Systemic Sclerosis

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ClinicalTrials.gov Identifier: NCT00555581
Recruitment Status : Completed
First Posted : November 8, 2007
Results First Posted : February 6, 2018
Last Update Posted : February 6, 2018
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Systemic Sclerosis
Intervention: Drug: Imatinib Mesylate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
400 mg Daily of Imatinib Mesylate

All patients were treated with imatinib mesylate at a target dose of 400 mg daily by mouth for 12 months. Dose modifications and interruptions were made for AE and were recorded. After 12 months of treatment, imatinib was stopped for 3 months. Patients were reassessed and offered entrance to an extension phase of the trial.

Imatinib Mesylate: In initial phase, patients will be treated with Gleevec 400 mg daily for 12 months. In the extension phase, patients will be treated with Gleevec 400 mg daily for 27 months.


Participant Flow:   Overall Study
    400 mg Daily of Imatinib Mesylate
STARTED   30 
COMPLETED   24 
NOT COMPLETED   6 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
400 mg Daily of Imatinib Mesylate

All patients were treated with imatinib mesylate at a target dose of 400 mg daily by mouth for 12 months. Dose modifications and interruptions were made for AE and were recorded. After 12 months of treatment, imatinib was stopped for 3 months. Patients were reassessed and offered entrance to an extension phase of the trial.

Imatinib Mesylate: In initial phase, patients will be treated with Gleevec 400 mg daily for 12 months. In the extension phase, patients will be treated with Gleevec 400 mg daily for 27 months.


Baseline Measures
   400 mg Daily of Imatinib Mesylate 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Participants]
Count of Participants
 
<=18 years   0 
Between 18 and 65 years   29 
>=65 years   1 
Age 
[Units: Years]
Mean (Full Range)
 48 
 (18 to 71) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      24  80.0% 
Male      6  20.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      4  13.3% 
Not Hispanic or Latino      26  86.7% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      4  13.3% 
White      26  86.7% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   30 
Disease Duration 
[Units: Years]
Mean (Standard Deviation)
 
Early   2.1  (1.2) 
Late   6.1  (1.6) 
Anti-Scl70 positive 
[Units: Participants]
Count of Participants
 9 
MRSS at baseline [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 30.3  (8.7) 
[1] The Modified Rodnan Skin Score (MRSS) measures dermal skin thickness through the examination of 17 body areas: fingers, hands, forearms, arms, feet, legs, and thighs (in pairs), and face, chest, and abdomen. In each of these areas, the skin score is evaluated by manual palpation. The skin score is 0 for uninvolved skin, 1 for mild thickening, 2 for moderate thickening, and 3 for severe thickening (hidebound skin). The total skin score is the sum of the skin scores of the individual areas. The minimum score is 0 and the maximum score is 51. A higher score indicates greater severity of disease.


  Outcome Measures

1.  Primary:   Improvement in the Modified Rodnan Skin Score   [ Time Frame: 12 months ]

2.  Secondary:   Improvement in Indices of Pulmonary Function Measured by Change in FVC % Predicted   [ Time Frame: 12 months ]

3.  Secondary:   Improvement in Indices of Pulmonary Function Measured by Change DLCO hb Adj % Predicted   [ Time Frame: 12 months ]

4.  Secondary:   Change From Baseline at Month 12 in Short Form-36 (SF-36) Questionnaire:Mental Component Summary   [ Time Frame: 12 months ]

5.  Secondary:   Scleroderma Health Assessment Questionnaire Disability Index   [ Time Frame: 12 months ]

6.  Secondary:   Change From Baseline at Month 12 in Short Form-36 (SF-36) Questionnaire: Physical Component Summary   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Robert F. Spiera
Organization: Hospital for Special Surgery
phone: 212-774-2048
e-mail: spierar@hss.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT00555581     History of Changes
Other Study ID Numbers: 27049
First Submitted: November 7, 2007
First Posted: November 8, 2007
Results First Submitted: June 12, 2017
Results First Posted: February 6, 2018
Last Update Posted: February 6, 2018