[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07710105":3,"trial-entities:NCT07710105":144,"trial-summary:NCT07710105":147},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":46,"secondary_outcomes":51,"sex":58,"minimum_age":59,"maximum_age":26,"healthy_volunteers":15,"eligibility_criteria":60,"std_ages":91,"locations":94,"central_contacts":117,"overall_officials":120,"references":121,"see_also_links":143},"NCT07710105","STU00226008","Ocrevus Zunovo for MS: Mixed Methods","Ocrevus Zunovo for Patients With Multiple Sclerosis: Mixed Methods on Barriers and Facilitators to Use and Retention","RECRUITING","2028-12","2026-07","2026-07-20","2026-06-12","Northwestern University","OTHER",false,"Ocrevus Zunovo implementation, feasibility, acceptability, patient satisfaction, treatment persistence, and impact on MS disease outcomes will be analyzed in this mixed methods study. This study will incorporate clinical data and questionnaire results from MS patients who take Ocrevus Zunovo as well as qualitative interviews with MS patients, family members, and other individuals involved in Ocrevus Zunovo treatment. The purpose of this study is to synthesize implementation strategies that improve patient access to high-efficacy MS therapies in real-world settings.","Patients with MS who are clinically seen at the Northwestern Memorial Hospital system and are eligible for Ocrevus Zunovo (OZ) initiation may enroll in this study. OZ will be administered by the clinical infusion center.\n\nThe study will enroll 50 OZ-treated MS patients over the course of 15-18 months, at approximately 4 patients per month. Participants will each be surveyed and followed at three main timepoints: (1) enrollment, as close as possible to the time of first OZ dosing, (2) 6 months of follow up, and (3) 12 months of follow up.\n\nThe study will also conduct 100 semi-structured interviews, where facilitators and barriers will be recorded by patients, relevant stakeholders in their care and insurance billing, administrators, and clinical staff members.",[19],"Multiple Sclerosis",[21,22,19,23,24],"Ocrevus Zunovo","Ocrelizumab","Disease-modifying therapy","Subcutaneous injection","OBSERVATIONAL",null,[],{"count":29,"type":30},150,"ESTIMATED",[32,37,42],{"type":14,"name":33,"description":34,"armGroupLabels":35},"Clinical Questionnaires","Clinical course will be followed, including retention in treatment, patient-reported outcomes, and clinical events (new or incident demyelinating lesions on MRI or disease attacks).",[36],"Clinical Arm",{"type":14,"name":38,"description":39,"armGroupLabels":40},"Semi-Structured Interviews","Semi-structured interviews will be conducted using an interview guide. Interviews will be audio-recorded, transcribed, and documented via field notes.",[41],"Interview Arm",{"type":43,"name":21,"description":44,"armGroupLabels":45},"DRUG","Ocrevus Zunovo (OZ) is a U.S. Food and Drug Administration-approved twice yearly subcutaneous injection, indicated for patients with relapsing and primary progressive multiple sclerosis (RMS and PPMS), given by a health care professional.",[36,41],[47],{"measure":48,"description":49,"timeFrame":50},"Patient Satisfaction and Treatment Persistence","For MS patients treated with OZ, to measure MS patient satisfaction and treatment persistence on Ocrevus at 6 and 12 months.","From enrollment to 12-month follow-up visit",[52,55],{"measure":53,"description":54,"timeFrame":50},"Barriers and Facilitators to Ocrevus Zunovo","To characterize barriers and facilitators of OZ prescribing by MS physicians using a rigorous qualitative approach across patients and other stakeholders in their care (family members, clinicians, pharmacy\u002Finfusion staff, care coordinators, administrators, and payer-facing staff).",{"measure":56,"description":57,"timeFrame":50},"Quality of Life and Patient-Reported Outcomes","To determine the quality of life and patient-reported outcomes of people with MS treated with OZ at enrollment, 6 and 12 months.","ALL","18 Years",{"inclusion":61,"exclusion":69,"raw_text":90},[62,63,64,65,66,67,68],"Age of 18 years or older","Resident of the USA","Seen at Northwestern Medicine","Meets diagnostic criteria (2024) for MS, either RMS or PPMS","Diagnosis of MS (G35) on file by a neurologist","Wants to start or restart a DMT for MS","Willing to be in a 12-month follow up study",[70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89],"Unclear diagnosis of MS","Incarcerated","Unable to provide informed consent","Current participant in an MS or any experimental therapy clinical trial","Moribund","Unable to speak a language for which consent processes are available at Northwestern Hospitals","Currently taking a DMT that has not been washed out (e.g. recent treatment with Cladribine, Natalizumab, sphingosine 1-phosphate inhibitor, implying the last DMT is still actively immunosuppressing the patient)","Current chemotherapy","History of stem cell transplant, CAR-T or other chemo-ablative procedures","Unwilling to complete surveys over the course of the following 12 months","No access to computer or telephone","Prior allergic reaction or intolerance to Ocrelizumab IV or SubQ or any monoclonal antibody therapy","Hypogammaglobulinemia IgG level \\\u003C500","Leukopenia \\\u003C2.0","Active hepatitis or latent hepatitis B","Elevated liver enzymes 3 times the upper limit of normal","Tuberculosis","Current serious infection, e.g. COVID-19, shingles, active pneumonia, progressive multifocal leukoencephalopathy, etc.","Currently pregnant, breastfeeding, or a person of childbearing capacity who is sexually active without a documented plan of current contraceptive methods.","Any other diagnosis or reason deemed to make the participant unfit for participation by the study PI","Inclusion Criteria:\n\n* Age of 18 years or older\n* Resident of the USA\n* Seen at Northwestern Medicine\n* Meets diagnostic criteria (2024) for MS, either RMS or PPMS\n* Diagnosis of MS (G35) on file by a neurologist\n* Wants to start or restart a DMT for MS\n* Willing to be in a 12-month follow up study\n\nExclusion Criteria:\n\n* Unclear diagnosis of MS\n* Incarcerated\n* Unable to provide informed consent\n* Current participant in an MS or any experimental therapy clinical trial\n* Moribund\n* Unable to speak a language for which consent processes are available at Northwestern Hospitals\n* Currently taking a DMT that has not been washed out (e.g. recent treatment with Cladribine, Natalizumab, sphingosine 1-phosphate inhibitor, implying the last DMT is still actively immunosuppressing the patient)\n* Current chemotherapy\n* History of stem cell transplant, CAR-T or other chemo-ablative procedures\n* Unwilling to complete surveys over the course of the following 12 months\n* No access to computer or telephone\n* Prior allergic reaction or intolerance to Ocrelizumab IV or SubQ or any monoclonal antibody therapy\n* Hypogammaglobulinemia IgG level \\\u003C500\n* Leukopenia \\\u003C2.0\n* Active hepatitis or latent hepatitis B\n* Elevated liver enzymes 3 times the upper limit of normal\n* Tuberculosis\n* Current serious infection, e.g. COVID-19, shingles, active pneumonia, progressive multifocal leukoencephalopathy, etc.\n* Currently pregnant, breastfeeding, or a person of childbearing capacity who is sexually active without a documented plan of current contraceptive methods.\n* Any other diagnosis or reason deemed to make the participant unfit for participation by the study PI",[92,93],"ADULT","OLDER_ADULT",[95],{"facility":96,"status":8,"city":97,"state":98,"zip":99,"country":100,"contacts":101,"geoPoint":114},"Northwestern Memorial Hospital","Chicago","Illinois","60611","United States",[102,107,111],{"name":103,"role":104,"phone":105,"email":106},"Dylan Rice, B.A.","CONTACT","312-503-5298","dylan.rice@northwestern.edu",{"name":108,"role":104,"phone":109,"email":110},"Audrey Chang, B.A.","312-503-8639","audrey.chang@northwestern.edu",{"name":112,"role":113},"Farrah J Mateen, MD, PhD","PRINCIPAL_INVESTIGATOR",{"lat":115,"lon":116},41.85003,-87.65005,[118,119],{"name":103,"role":104,"phone":105,"email":106},{"name":108,"role":104,"phone":109,"email":110},[],[122,125,128,131,134,137,140],{"type":123,"citation":124},"BACKGROUND","Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77-101. doi:10.1191\u002F1478088706qp063oa.",{"pmid":126,"type":123,"citation":127},"17872937","Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007 Dec;19(6):349-57. doi: 10.1093\u002Fintqhc\u002Fmzm042. Epub 2007 Sep 14.",{"pmid":129,"type":123,"citation":130},"19664226","Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186\u002F1748-5908-4-50.",{"pmid":132,"type":123,"citation":133},"40975101","Montalban X, Lebrun-Frenay C, Oh J, Arrambide G, Moccia M, Amato MP, Amezcua L, Banwell B, Bar-Or A, Barkhof F, Butzkueven H, Ciccarelli O, Chataway J, Cohen JA, Comi G, Correale J, Deisenhammer F, Filippi M, Fiol J, Freedman MS, Fujihara K, Granziera C, Green AJ, Hartung HP, Hellwig K, Kappos L, Kimbrough D, Killestein J, Lublin F, Marignier R, Marrie RA, Miller A, Otero-Romero S, Ontaneda D, Ramanathan S, Reich D, Rocca MA, Rovira A, Saidha S, Salter A, Sastre-Garriga J, Saylor D, Solomon AJ, Sormani MP, Stankoff B, Tintore M, Tremlett H, Van der Walt A, Viswanathan S, Wiendl H, Wildemann B, Yamout B, Zaratin P, Calabresi PA, Coetzee T, Thompson AJ. Diagnosis of multiple sclerosis: 2024 revisions of the McDonald criteria. Lancet Neurol. 2025 Oct;24(10):850-865. doi: 10.1016\u002FS1474-4422(25)00270-4.",{"pmid":135,"type":123,"citation":136},"40245351","Newsome SD, Krzystanek E, Selmaj KW, Dufek M, Goldstick L, Pozzilli C, Figueiredo C, Townsend B, Kletzl H, Bortolami O, Zecevic D, Giacobino C, Clinch S, Shen YA, Bhullar GD, Schneble HM, Centonze D. Subcutaneous Ocrelizumab in Patients With Multiple Sclerosis: Results of the Phase 3 OCARINA II Study. Neurology. 2025 May 13;104(9):e213574. doi: 10.1212\u002FWNL.0000000000213574. Epub 2025 Apr 17.",{"pmid":138,"type":123,"citation":139},"28002688","Montalban X, Hauser SL, Kappos L, Arnold DL, Bar-Or A, Comi G, de Seze J, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Rammohan KW, Selmaj K, Traboulsee A, Sauter A, Masterman D, Fontoura P, Belachew S, Garren H, Mairon N, Chin P, Wolinsky JS; ORATORIO Clinical Investigators. Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):209-220. doi: 10.1056\u002FNEJMoa1606468. Epub 2016 Dec 21.",{"pmid":141,"type":123,"citation":142},"28002679","Hauser SL, Bar-Or A, Comi G, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Montalban X, Rammohan KW, Selmaj K, Traboulsee A, Wolinsky JS, Arnold DL, Klingelschmitt G, Masterman D, Fontoura P, Belachew S, Chin P, Mairon N, Garren H, Kappos L; OPERA I and OPERA II Clinical Investigators. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):221-234. doi: 10.1056\u002FNEJMoa1601277. Epub 2016 Dec 21.",[],{"nct_id":4,"conditions":145,"biomarkers":146},[19],[],{"nct_id":4,"found":148,"summary":149,"prompt_version":159},true,{"design":150,"status":151,"heading":152,"summary":153,"follow_up":154,"word_count":155,"commitments":156,"compensation":157,"drugs_mentioned":158},"This is an observational study involving 150 participants. It will gather information from patients and conduct interviews.","completed","Ocrevus Zunovo for MS: Mixed Methods Study","This observational study is looking at how Ocrevus Zunovo (OZ), an FDA-approved injection for Multiple Sclerosis (MS), is used in real-world settings. It's designed for people with relapsing MS (RMS) or primary progressive MS (PPMS). The study wants to understand how well OZ works, if patients are satisfied with it, and if they continue using it. Researchers will collect clinical information and survey results from 50 MS patients taking OZ. They will also conduct 100 interviews with patients, family members, and others involved in MS care to learn about their experiences. You can join if you are 18 or older, live in the USA, are seen at Northwestern Medicine, have a confirmed MS diagnosis, and want to start or restart an MS treatment. The study aims to improve how high-efficacy MS treatments are accessed.","Participants will be followed for 12 months after enrollment.",134,"You would be surveyed and followed at three time points: at enrollment, at 6 months, and at 12 months. Ocrevus Zunovo will be given by a healthcare professional.","Not stated in the trial record.",[21],"v2"]