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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

January 1, 2025

Primary Completion Date

December 30, 2027

Study Completion Date

March 30, 2028

Conditions
Systemic SclerosisInterstitial Lung Disease
Interventions
DRUG

Tocilizumab

Tocilizumab 162 mg s.c./week

DRUG

Nintedanib

Nintedanib - established doses of nintedanib for adults in the treatment of ILD, also SSc-ILD: 2 x 150 mg daily, in the event of e.g. increased liver enzyme levels, poorer treatment tolerance (e.g. diarrhea), the dose can be reduced to 2 x 100 mg

DRUG

Standard therapy

mycophenolate mofetil stable dose from 1000 - 3000 mg daily tablet 500 mg or 250 mg regardless of the preparation (Mycofit, CellCept, Mycophenolate mofetil, Myfenax) or methotrexate 10-25 mg/week orally or subcutaneously as above, regardless of the preparation

Trial Locations (1)

02-637

Centrum Wsparcia Badań Klinicznych, Warsaw

Sponsors
All Listed Sponsors
collaborator

Medical Research Agency, Poland

OTHER_GOV

lead

National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

NETWORK

NCT06297096 - Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease | Biotech Hunter | Biotech Hunter