protocolSection identificationModule nctId: NCT06297096, orgStudyIdInfo id: NIGRIR_004NINTOC-TU, briefTitle: Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease, acronym: NINTOC-TU, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-12-30, completionDateStruct date: 2028-03-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland, class: NETWORK, collaborators name: Medical Research Agency, Poland, descriptionModule briefSummary: 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., conditionsModule conditions: Systemic Sclerosis, conditions: Interstitial Lung Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 86, type: ESTIMATED, armsInterventionsModule interventions name: Tocilizumab, interventions name: Nintedanib, interventions name: Standard therapy, outcomesModule primaryOutcomes measure: The decrease in forced vital capacity (FVC) of the lungs, secondaryOutcomes measure: Change in percent lung involvement, secondaryOutcomes measure: Assessment of absolute changes in DLCO, secondaryOutcomes measure: Assessment of the absolute changes in predicted FVC%, secondaryOutcomes measure: Change in the Six-minute walk test (6MWT) result, secondaryOutcomes measure: Change in the Health Assessment Questionnaire-Disability Index (HAQ-DI) score, secondaryOutcomes measure: A change in the patient's global assessment of disease activity, secondaryOutcomes measure: A change in the physician's global assessment of disease activity, secondaryOutcomes measure: Assessment of the absolute changes from baseline in total scores in St. George's Respiratory Questionnaire (SGRQ), secondaryOutcomes measure: Assessment of absolute changes compared to baseline values on the modified Rodnan skin Score (mRSS), secondaryOutcomes measure: Percentage of participants with threshold improvement from baseline in modified Rodnan skin Score (mRSS), secondaryOutcomes measure: Percentage of participants with modified Rodnan skin Score (mRSS) improvement greater than or equal to (>/=) 20%, 40%, or 60%, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 74 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centrum Wsparcia Badań Klinicznych, city: Warsaw, state: Mazowieckie, zip: 02-637, country: Poland, contacts name: Justyna Kwiatkowska-Golańska, role: CONTACT, phone: 22 6880632, phoneExt: +48, email: justyna.kwiatkowska-golanska@spartanska.pl, contacts name: Maria Maślińska, PhD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.22977, lon: 21.01178, hasResults: False