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

ConditionsSystemic SclerosisInterstitial Lung Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-74
SponsorNational Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men or women aged 18-74 at the date of signing the informed consent.

Written informed consent in accordance with the International Harmonization Guidelines Harmonized Tripartite: Guidelines for Good Clinical Practice (ICH-GCP) and local regulations signed before any study procedure.

Documented diagnosis of systemic sclerosis according to the criteria of the American College of Rheumatology (ACR) and The European Alliance of Associations for Rheumatology (former name - European League Against Rheumatism) - EULAR, meeting the criteria of active disease [patients with limited and diffused SSc)] and with an overall disease duration of less than or equal to (≤ 72 months).

Patients with interstitial lung disease (ILD) confirmed by HRCT (min. 10% lung involvement).

Disqualifiers

Patients not fully capable of giving informed consent.

Pregnant or breastfeeding women.

Major surgery within 8 weeks before screening (W0A).

Rheumatic disease other than systemic sclerosis (systemic lupus erythematosus, rheumatoid arthritis, mixed connective tissue disease). Diagnosis of secondary Sjögren's syndrome is acceptable.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tocilizumab

    Drug

    Tocilizumab 162 mg s.c./week

  • Nintedanib

    Drug

    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

  • Standard therapy

    Drug

    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

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: combined therapy Nintedanib + Tocilizumab with or without standard treatment + extended diagnosticsExperimental treatment 3 interventions
Group B: standard treatment (reference group) + extended diagnosticsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The decrease in forced vital capacity (FVC) of the lungs

The decrease in forced vital capacity (FVC) of the lungs expressed in ml calculated after 56 weeks of treatment

Time frame
56 weeks

Secondary outcomes

1

Change in percent lung involvement

Change in percent lung involvement assessed by computed tomography (HRCT%) from baseline to assessment in 56 weeks of study

Time frame
56 weeks
2

Assessment of absolute changes in DLCO

Assessment of absolute changes in DLCO at week 56 compared to baseline (baseline)

Time frame
56 weeks
3

Assessment of the absolute changes in predicted FVC%

Assessment of the the absolute changes in predicted FVC% at week 56 from baseline

Time frame
56 weeks
4

Change in the Six-minute walk test (6MWT) result

Change in the Six-minute walk test (6MWT) result at week 56 compared to the baseline value

Time frame
56 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

Lead sponsor

Medical Research Agency, Poland

Collaborator

Source ClinicalTrials.gov
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