Low-Dose Oral Imatinib for Scleroderma Pulmonary Involvement

• Status: Unknown status
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to verify effect and tolerability of imatinib on pulmonary and skin fibrosis in patients affected by systemic sclerosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera Universitaria Policlinico
• Collaborator: Università Politecnica delle Marche
• Treatments: Imatinib Mesylate

Criteria

Inclusion Criteria:

• SSc with active pulmonary involvement refractory to conventional immunosuppressive regimen

• Presence of active interstitial alveolitis (presence of grade 2 exertional dyspnea according to Mahler Dyspnea Index AND worsening of lung function tests PLUS interstitial alveolitis assessed by HRCTscan, ground-glass pattern involving at least two lung segments OR dyspnea (as defined above)PLUS Interstitial alveolitis assessed by HRCTscan (AS DEFINED ABOVE) AND neutrophilic or eosinophilic alveolitis detected through broncoalveolar lavage

• Resistance to conventional immunosuppressive treatment (worsening or lack of improvement of lung function tests after cyclophosphamide therapy, conducted for at least three months, with a cumulative dosage > or = 6 g

• Age 18-80 years

• Ability ti give an informed consent

• Use of an acceptable method of birth control; pregnancy will be ruled out before study beginning

Exclusion Criteria:

• Connective tissue diseases other than SSc

• Smoking Habit

• Pregnancy or lactation

• HBV or HCV infection

• Severe anaemia (Hb< or = 8g/dl)

• Hepatic disease (ALT or ALP>1.5 fold above normal levels)

• Moderate or severe renal failure (creatinine clearance<59ml/min)

• Severe heart failure, with ejection fraction < or = 35% measured by echocardiography

• thyroid disease with clinical evidence of hyperthyroidism treated with substitutive therapy