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Low-Dose Oral Imatinib for Scleroderma Pulmonary Involvement

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Azienda Ospedaliera Universitaria Policlinico.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Università Politecnica delle Marche
Information provided by:
Azienda Ospedaliera Universitaria Policlinico
ClinicalTrials.gov Identifier:
NCT00573326
First received: December 13, 2007
Last updated: September 2, 2009
Last verified: September 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Systemic Sclerosis
 Drug: Imatinib
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Low-Dose Oral Imatinib in the Treatment of Scleroderma Pulmonary Involvement: A Phase II Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Scleroderma
U.S. FDA Resources

Further study details as provided by Azienda Ospedaliera Universitaria Policlinico:

Primary Outcome Measures:
  • Improvement of the pulmonary interstitial disease, evaluated by spirometry and DLCO, lung HRCTscan, emogasanalysis. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cutaneous Involvement, evaluated by the modified Rodnan skin score; quality of life and patient physical and emotional well being, evaluated by SF-36 score and HAQ [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Imatinib 200 mg p.o. once a day for 6 months
 Drug: Imatinib
200 mg p.o. once a day for 6 months

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573326

Contacts
Contact: Paolo Fraticelli, Dr +390715964256 p.fraticelli@ospedaliriuniti.marche.it
Contact: Armando Gabrielli, Professor +390712206104 a.gabrielli@univpm.it

Locations
Italy
Università Politecnica delle Marche Recruiting
Ancona, Italy, 60020
Contact: Paolo Fraticelli, Dr     +390715964256     p.fraticelli@ospedaliriuniti.marche.it    
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Policlinico
Università Politecnica delle Marche
Investigators
Study Chair: Armando Gabrielli, MD Università Politecnica delle Marche
  More Information

No publications provided

Responsible Party: Paolo Fraticelli/MD, Università Politecnica delle Marche
ClinicalTrials.gov Identifier: NCT00573326     History of Changes
Other Study ID Numbers: FARM 69J AJ9, EudraCT code:2007-005322-68
Study First Received: December 13, 2007
Last Updated: September 2, 2009
Health Authority: Italy: The Italian Medicines Agency

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

ClinicalTrials.gov processed this record on May 22, 2013