Actively Recruiting
Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease
Led by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland · Updated on 2026-04-08
86
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
Sponsors
N
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Lead Sponsor
M
Medical Research Agency, Poland
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18-74 years at the date of signing informed consent
- Signed written informed consent before any study procedure
- Diagnosed with systemic sclerosis according to American College of Rheumatology and EULAR criteria, with active disease and disease duration of 72 months or less
- Interstitial lung disease confirmed by HRCT with at least 10% lung involvement
- Modified Rodnan skin score between 10 and 45 inclusive
- On stable doses of mycophenolate mofetil or methotrexate for at least 8 weeks before screening
- No new therapy or withdrawal of therapy within 8 weeks before screening
- Taking oral glucocorticosteroids at stable doses of 10 mg/day prednisone or less for at least 8 weeks before baseline
- Women of childbearing potential must agree to use effective contraception or abstain from sexual activity during the study and for 3 months after last dose
You will not qualify if you...
- Unable to give informed consent
- Pregnant or breastfeeding women
- Major surgery within 8 weeks before screening
- Rheumatic diseases other than systemic sclerosis, except secondary Sjögren's syndrome
- Active diverticulitis or severe enteritis
- Untreated lipid disorders
- Live or attenuated vaccine within 4 weeks before treatment
- Known allergies to monoclonal antibodies or peanut/soya
- Liver enzyme levels (AST, ALT) greater than 1.5 times upper limit of normal
- Bilirubin greater than 1.5 times upper limit of normal
- Creatinine clearance below 30 ml/min
- Significant pulmonary hypertension
- Airway obstruction (FEV1/FVC less than 0.7) or other significant lung abnormalities
- Heart failure NYHA class III or IV
- More than 4 digital ulcers or history of severe digital necrosis
- Bleeding risk or recent thrombotic events
- Stroke or heart attack within 6 months before screening
- Prior use of pirfenidone or nintedanib within 6 months before enrollment
- Recent plasmapheresis, plasma exchange, immunoglobulin, or certain biologic treatments
- Use of prednisone over 10 mg/day or certain immunosuppressants within 8 weeks before screening
- Unstable background therapy with methotrexate or mycophenolate mofetil in last 8 weeks
- Chronic liver disease
- Active or recent serious infections including tuberculosis and viral infections
- Positive SARS-CoV-2 PCR test at screening
- Active or history of cancer except certain skin and cervical cancers
- Drug or alcohol abuse
- Inability to understand or comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Centrum Wsparcia Badań Klinicznych
Warsaw, Masovian Voivodeship, Poland, 02-637
Actively Recruiting
Research Team
M
Maria Maślińska, PhD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here