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Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease

Study acronym: NINTOC-TU
StatusRecruiting
PhasePhase 3
Started2025-07-01
View on ClinicalTrials.gov ↗

Amendment history

2026-04-07
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-01-01→confirmed 2025-07-01
Study sitesdetails revised at 1 of 1 site
2024-11-18
Study Status v2
Start date2024-04-01→2025-01-01
2024-03-19
Study Status, Outcome Measures, Eligibility v1
Eligibility criteria+15 characters
[...] od Clinical Practice (ICH-GCP) and local regulations signed prior tobefore any study procedure. Documented diagnosis of systemic scler [...] etil, methotrexate; should be on stable doses for ≥ 8 weeks prior tobefore and including the screening visit (W0). Patients may be tre [...] but no new therapy or withdrawal of therapy within 8 weeks prior tobefore the first screening visit (W0). Patients taking oral glucoc [...] f ≤ 10 mg/day prednisone or equivalent for at least 8 weeks prior tobefore the baseline visit. Patients of childbearing potential shou [...] egnant or breastfeeding women. Major surgery within 8 weeks prio [...] [...]
Secondary endpoints10 to 11 entries
A change in the patient's andglobal assessment of disease activity A change in the physician's global assessment of disease activity Assessment of absolute changes in compared to baseline values on the modified Rodnan skin Score (mRSS)
2024-02-29
Original filing
The study includes adult patients with systemic sclerosis (SSc) with interstitial lung disease (ILD) to evaluate the efficacy and safety of nintedanib plus tocilizumab combination therapy compared to standard therapy (methotrexate, mycophenolate mofetil) for 56 weeks.
Trial Details
NCT Number NCT06297096
Lead Sponsor National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Collaborators: Medical Research Agency, Poland
Conditions Systemic Sclerosis, Interstitial Lung Disease
Enrollment 86 participants
Start Date 2025-07-01
Primary Completion 2027-12-30 (estimated)
Study Completion 2028-03-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-08