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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00512902
Date of registration: 06/08/2007
Prospective Registration: No
Primary sponsor: University of California, Los Angeles
Public title: A Study Using The Experimental Drug Called Imatinib (Gleevec) in Subjects With Systemic Sclerosis
Scientific title: Pilot Study to Examine The Use of Imatinib (Gleevec) For The Treatment of Active Alveolitis in Systemic Sclerosis
Date of first enrolment: August 2007
Target sample size: 20
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00512902
Study type:  Interventional
Study design:   
Phase:  Phase 1/Phase 2
Countries of recruitment
United States
Contacts
Name:     Daniel E. Furst, MD
Address: 
Telephone:
Email:
Affiliation:  University of California, Los Angeles
Key inclusion & exclusion criteria

Inclusion Criteria:

1. All patients must fulfill the criteria for SSc by ACR criteria

2. Age of entry into the study = 18 yrs

3. FVC <85% of predicted.

4. Able to complete the 6MWT with a walking distance = 150 m

5. Patients must have dyspnea on exertion (grade = 2 on the Magnitude of Task component
of the Mahler Modified Dyspnea Index).

6. SSc for = 10 years, with onset defined as the date of the first non-Raynaud
manifestation typical of systemic sclerosis.

7. Patients may have limited (cutaneous thickening distal but not proximal to elbows and
knees, with or without facial involvement) or diffuse (cutaneous thickening proximal
to elbows and knees, often involving the chest or abdomen) cutaneous SSc (Medsger
1995).

8. Patients must show some evidence of alveolitis as defined by an HRCT of the lung which
shows ground glass opacification as a radiographic marker of "alveolitis" or finely
reticulated fibrosis or they must have alveolitis by BAL ( = 3% PMN's or = 2%
eosinophils).

9. Female patients of childbearing potential must have negative pregnancy test within 7
days before initiation of study drug dosing.

10. Patients must be able to provide written voluntary informed consent.

Exclusion Criteria:

1. FVC = 50% of predicted or DLCO (corrected for Hgb but not for alveolar volume) = 35%
of predicted (suggesting severe probably irreparable disease and/or significant
pulmonary vascular involvement by SSc).

2. FEV1/FVC ratio <65% (to exclude significant airflow obstruction)

3. Clinically significant abnormalities on HRCT not attributable to SSc (e.g., lung mass,
extensive scarring due to previous infection, etc.)

4. Clinically significant pulmonary hypertension documented on right heart
catheterization (i.e., right ventricular systolic pressure of >50 mm Hg and/or mean
PAP =30 mm Hg) pulmonary pressure or echocardiographic evidence of PAH (if echo
cardiographic systolic pressure = 55 mmHg) or FVC/DLCO ratio >1.6 on pulmonary
function testing

5. Persistent unexplained hematuria (>10 RBCs/hpf).

6. History of persistent leukopenia (white blood cell count <3500), neutropenia (absolute
neutrophil count < 1500) or thrombocytopenia (platelet count <100,000).

7. Clinically significant anemia (<9.0 gm/dl)

8. Serum creatinine >ULN.

9. Pregnancy (documented by urine pregnancy test), breast feeding

10. If of child-bearing potential, failure regularly to employ a reliable means of
contraception

11. Active infection of the lung or elsewhere, whose management would be compromised by
Imatinib

12. Unreliability, drug abuse (including active alcoholism)

13. Any chronic, debilitating illness (other than SSc)

14. Smoking of cigars, pipes or cigarettes during the past 6 months

15. Baseline liver function tests (ALT or AST or bilirubin >1.5 x upper limit of normal

16. Previous use of prednisone > 10 mg per day. If on prednisone =10 mg/d, dose must have
been stable for > 1 month.

17. All other medication with putative disease-modifying properties (e.g.,
D-penicillamine, cyclophosphamide, azathioprine, methotrexate, colchicine, Potaba)
must be discontinued 1 month prior to beginning study medication.

18. Patient is < 5 years since she/he had a primary malignancy except: if the other
primary malignancy is not currently clinically significant nor requiring active
intervention, or if other primary malignancy is a basal cell skin cancer or a cervical
carcinoma in situ. Existence of any other malignant disease is not allowed except
after consultation with the PI.

19. Patient with Grade III/IV cardiac problems as defined by the New York Heart
Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6
months of study)

20. Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes,
chronic renal disease, or active uncontrolled infection).

21. Patient has known chronic liver disease (i.e., chronic active hepatitis and
cirrhosis).

22. Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.

23. Use of contraindicated medications at baseline.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Systemic Sclerosis
Alveolitis
Intervention(s)
Drug: Imatinib
Primary Outcome(s)
Treatment-related Adverse Events [Time Frame: Baseline vs. Endpoint (1 year)]
Secondary Outcome(s)
Change in DLco [Time Frame: Baseline vs. Endpoint (1 year)]
Change in Modified Rodnan Skin Score (MRSS) [Time Frame: Baseline vs. Endpoint]
Change in FVC (Forced Vital Capacity) [Time Frame: Baseline vs. Endpoint (1 year)]
Change in TLC (Total Lung Capacity) [Time Frame: Baseline vs. Endpoint (1 year)]
Secondary ID(s)
CST1571EUS210
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Novartis Pharmaceuticals
Ethics review
Results
Results available: Yes
Date Posted: 27/10/2014
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00512902
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