Completed

Pilot Study to Examine The Use of Imatinib (Gleevec) For The Treatment of Active Alveolitis in Systemic Sclerosis

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What is being tested

Imatinib

Drug
Who is being recruted

Connective Tissue Diseases+1

+ Scleroderma, Systemic

+ Skin Diseases

Over 18 Years
+33 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: August 2007
See protocol details

Summary

Principal SponsorUniversity of California, Los Angeles
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2007

Actual date on which the first participant was enrolled.

Systemic sclerosis is a rare, progressive disease that leads to hardening and tightening of the skin and connective tissues. It usually begins with a few dry patches of skin on the hands or face that begin getting thicker and harder. These patches then spread to other areas of the skin. In some cases, systemic sclerosis also affects the blood vessels an internal organs. Systemic sclerosis is one of a group of arthritic conditions called connective tissue disorders, a person's antibodies are directed against their own tissues.

Official TitlePilot Study to Examine The Use of Imatinib (Gleevec) For The Treatment of Active Alveolitis in Systemic Sclerosis
NCT00512902
Principal SponsorUniversity of California, Los Angeles
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Connective Tissue DiseasesScleroderma, SystemicSkin DiseasesSkin and Connective Tissue Diseases

Criteria

10 inclusion criteria required to participate
All patients must fulfill the criteria for SSc by ACR criteria
Age of entry into the study ≥ 18 yrs
FVC <85% of predicted.
Able to complete the 6MWT with a walking distance ≥ 150 m
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23 exclusion criteria prevent from participating
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).
FEV1/FVC ratio <65% (to exclude significant airflow obstruction)
Clinically significant abnormalities on HRCT not attributable to SSc (e.g., lung mass, extensive scarring due to previous infection, etc.)
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
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
SSc patients receiving Imatinib (Gleevec, up to 600 mg) QD PO for up to 1 year.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

UCLA David Geffen School of Medicine, Division of Rheumatology

Los Angeles, United StatesOpen UCLA David Geffen School of Medicine, Division of Rheumatology in Google Maps
CompletedOne Study Center