Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Participants With Systemic Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 21 July 2021
• Main ID: NCT00613171
• Date of registration: 25/01/2008
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Participants With Systemic Sclerosis
• Scientific title: A Multi-centre, Open-label, Proof of Concept (PoC) Study to Evaluate the Efficacy and Tolerability of STI571 for the Treatment of Fibrosis in Patients With Systemic Sclerosis
• Date of first enrolment: January 2, 2008
• Target sample size: 27
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00613171
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Germany, Italy, Switzerland, United Kingdom, United States

Contacts

• Name: NOVARTIS
• Affiliation: Novartis investigator site

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male and female participants who are equal to or older than 18 years of age and who
have early diffuse cutaneous systemic sclerosis (Disease duration < 18 months from the
first non-Raynaud's symptom)

- Participants with a modified Rodnans Skin Score (MRSS) of at least 20 in the absence
of trunk involvement or a MRSS of at least 16 in patients with trunk involvement

- Female patients of childbearing potential practicing two acceptable forms of
contraception

Exclusion Criteria:

- SSc patients with a MRSS greater than 35

- Concurrent connective tissue diseases other than systemic sclerosis

- Significant pre-existing heart, liver, lungs, digestive system, blood and other
diseases, cancer

- Conditions that might mimic the potential side effects of STI571 (blood conditions,
liver damage, chronic diarrhea, edema)

- Concurrent medical therapies (or during last 6 weeks before first dosing) that may
potentially influence outcome of the study

- Allergic to the study medication

- Pregnancy

- Breast feeding



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Sclerosis, Scleroderma

Intervention(s)

Drug: STI571

Primary Outcome(s)

Number of Participants With Adverse Events (AE's) and Serious Adverse Events (SAE's) [Time Frame: Baseline to Week 48/EOS]

Change From Baseline in Modified Rodnan Skin Score (MRSS) at Each Time Point of Analysis [Time Frame: Baseline, Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and Week 48/End of Study (EOS)]

Secondary Outcome(s)

Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values [Time Frame: Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and Week 48/End of Study (EOS)]

Secondary ID(s)

CSTI571E2205

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/05/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00613171