NCT00573326

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2007

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

September 3, 2009

Status Verified

September 1, 2009

Enrollment Period

1.3 years

First QC Date

December 13, 2007

Last Update Submit

September 2, 2009

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Improvement of the pulmonary interstitial disease, evaluated by spirometry and DLCO, lung HRCTscan, emogasanalysis.

    1 year

Secondary Outcomes (1)

  • 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

    1 year

Study Arms (1)

1

EXPERIMENTAL

Imatinib 200 mg p.o. once a day for 6 months

Drug: Imatinib

Interventions

ImatinibDRUG

200 mg p.o. once a day for 6 months

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università Politecnica delle Marche

Ancona, Ancona, 60020, Italy

RECRUITING

Related Publications (1)

  • Fraticelli P, Gabrielli B, Pomponio G, Valentini G, Bosello S, Riboldi P, Gerosa M, Faggioli P, Giacomelli R, Del Papa N, Gerli R, Lunardi C, Bombardieri S, Malorni W, Corvetta A, Moroncini G, Gabrielli A; Imatinib in Scleroderma Italian Study Group. Low-dose oral imatinib in the treatment of systemic sclerosis interstitial lung disease unresponsive to cyclophosphamide: a phase II pilot study. Arthritis Res Ther. 2014 Jul 8;16(4):R144. doi: 10.1186/ar4606.

    PMID: 25007944DERIVED

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Armando Gabrielli, MD

    Università Politecnica delle Marche

    STUDY CHAIR

Central Study Contacts

Paolo Fraticelli, Dr

CONTACT

+390715964256p.fraticelli@ospedaliriuniti.marche.it

Armando Gabrielli, Professor

CONTACT

+390712206104a.gabrielli@univpm.it

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 13, 2007

First Posted

December 14, 2007

Study Start

February 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

September 3, 2009

Record last verified: 2009-09

Locations

IT(1)