Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT06159712
Status:
UNKNOWN
Last Update Posted:
2023-12-07
First Post:
2023-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Study of High-Efficacy Disease Modifying Treatment of Relapsing Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Researchers compare immunologic, virologic and epigenetic factors in patients with multiple sclerosis in standard 2.line treatment with ocrelizumab, rituximab, ofatumumab and natalizumab by taking extra blood samples and compare it to a healthy control group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2023-11-28', 'studyFirstSubmitQcDate': '2023-11-28', 'lastUpdatePostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Relapses', 'timeFrame': '1 year', 'description': 'Number of patients with relapse or relapses from start of treatment from baseline to 12 months'}, {'measure': 'Annualized Relapse Rate', 'timeFrame': '1 year', 'description': 'Annualized Relapse Rate based on the total amount of relapses per year from baseline to 12 months'}, {'measure': 'T-cells, B-cell subsets and monocyte-subsets', 'timeFrame': '1 year', 'description': 'Changes in frequency of T-cells, B-cell-subsets and monocyte-subsets from baseline, 6 months and to 12 months'}, {'measure': 'EBV', 'timeFrame': '1 year', 'description': 'Changes in Epstein Barr-Virus DNA load from baseline, 6 months and to 12 months'}, {'measure': 'HERVs', 'timeFrame': '1 year', 'description': 'Changes in Human Endogenous Retrovirus expression from baseline, 6 months and to 12 months'}, {'measure': 'Complement', 'timeFrame': '1 year', 'description': 'Changes in complement system activity from baseline, 6 months and to 12 months'}, {'measure': 'MRI lesions', 'timeFrame': '1 year', 'description': 'Changes in number of lesions on MRI scans of the brain from baseline, 6 months and to 12 months'}], 'primaryOutcomes': [{'measure': 'Changes in B cell populations', 'timeFrame': '1 year', 'description': 'Changes in B cell populations in the four treatment groups'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsing Remitting Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The goal of this prospective, multi-center, non-blinded, non-randomized, non-intervention clinical trial is to compare immunologic, virologic and epigenetic factors in patients with active multiple sclerosis in standard 2.line treatment with ocrelizumab, rituximab, ofatumumab or natalizumab in Region Midt, Denmark. It aims to answer how the immunologic, virologic and epigenetic response in these patients are compared to healthy controls, and analyze their treatment effect in relation to this response. Participants will get an extra blood sample, when they have their routine blood samples taken.', 'detailedDescription': 'The CoSHED RMS study will include patients with active multiple sclerosis aged 18-65 years fulfilling the criteria for 2. line treatment and starting treatment with one of the four high-efficacy disease modifying treatments ocrelizumab, rituximab, ofatumumab or natalizumab. Researchers will compare immunologic, virologic and epigenetic parameters in the four treatment groups to a age and gender matched healthy control group. The study duration is 12 months, and patients can continue in an extension phase for additional 12 month. The primary endpoint is changes in B cell populations between the four treatments within 12 months. The study will evaluate a number of efficacy and safety endpoints using clinical, MRI, routine blood samples and research biomarkers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Multiple sclerosis diagnosis and definition of disease course according to the 2017 McDonald criteria\n* Expanded disability status scale (EDSS) ≤6.5\n* Signed written informed consent\n* Fulfilling criteria for active MS: Treatment naïve relapsing remitting multiple sclerosis (RRMS) patients (never treated, or no DMT the previous 2 years):\n\n * 2 relapse previous 12 months OR\n\n 1 relapse previous 12 months with severe residual symptoms and EDSS ≥ 3.0 OR\n\n 1 relapse previous 12 months AND ≥9 T2 lesions on brain and/or spinal cord MRI AND\n 1. contrast-enhancing lesion or ≥1 new or enlarging T2 lesion on brain and/or spinal cord MRI previous 12 month\n\n Previously treated RRMS patients:\n * 1 relapse previous 12 months OR\n * 1 contrast-enhancing lesion or ≥2 new/enlarging T2 lesions on brain and/or spinal cord MRI previous 12 months\n\nExclusion Criteria:\n\n* Pregnancy or breast feeding\n* Lack of effective contraception for women of child-bearing potential (effective contraception include oral contraception, intrauterine devices and other forms of contraception with failure rate \\<1%)\n* Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization\n* Known active malignant disease\n* Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease\n* Positive test for HIV, hepatitis B or C, or tuberculosis\n* Negative test for varicella zoster\n* Lymphopenia grade 2 (0.5 to 0.8 × 10\\^9/L) or higher grades of lymphopenia (in case of switching from fingolimod lymphopenia grade 2 can be accepted if lymphocytes are rising markedly compared to on treatment levels)\n* Neutropenia grade 2 (1.0 to 1.5 × 10\\^9/L) or higher grades\n* Thrombocytopenia grade 2 (50 to 75 × 10\\^9/L) or higher grades\n* Previous treatment with alemtuzumab or hematopoietic stem-cell transplantation\n* Previous treatment with cladribine, CD20-depleting antibodies, daclizumab or other immune suppressive treatment which is judged to still exert immune suppressive effect by treating physician\n* Methylprednisolone treatment within 1 month of baseline visit\n* Findings on the screening MRI judged to preclude participation by the treating physician\n* Other diseases judged to be relevant by the treating physician\n* Contraindication to MRI\n* Known allergy or hypersensitivity to rituximab or ocrelizumab, rituximab, ofatumumab or natalizumab'}, 'identificationModule': {'nctId': 'NCT06159712', 'acronym': 'CoSHEDRMS', 'briefTitle': 'Comparative Study of High-Efficacy Disease Modifying Treatment of Relapsing Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Comparative Study of High-Efficacy Disease Modifying Treatment of Relapsing Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'CoSHED'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Ocrelizumab', 'description': 'Patients with active multiple sclerosis starting standard treatment with ocrelizumab', 'interventionNames': ['Other: Blood samples']}, {'type': 'OTHER', 'label': 'Rituximab', 'description': 'Patients with active multiple sclerosis starting standard treatment with rituximab', 'interventionNames': ['Other: Blood samples']}, {'type': 'OTHER', 'label': 'Ofatumumab', 'description': 'Patients with active multiple sclerosis starting standard treatment with ofatumumab', 'interventionNames': ['Other: Blood samples']}, {'type': 'OTHER', 'label': 'Natalizumab', 'description': 'Patients with active multiple sclerosis starting standard treatment with natalizumab', 'interventionNames': ['Other: Blood samples']}, {'type': 'OTHER', 'label': 'Healthy controls', 'description': 'An age and gender matched healthy control group', 'interventionNames': ['Other: Blood samples']}], 'interventions': [{'name': 'Blood samples', 'type': 'OTHER', 'description': 'Extra blood samples', 'armGroupLabels': ['Healthy controls', 'Natalizumab', 'Ocrelizumab', 'Ofatumumab', 'Rituximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Helene Nørrelund', 'role': 'CONTACT', 'email': 'hwn@au.dk', 'phone': '+4593508486'}, {'name': 'Camilla Mærsk-Møller, MD', 'role': 'CONTACT', 'email': 'cammae@rm.dk', 'phone': '+4521392792'}], 'facility': 'Aarhus University', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'centralContacts': [{'name': 'Camilla Mærsk-Møller, MD', 'role': 'CONTACT', 'email': 'cammae@rm.dk', 'phone': '+4521392792'}, {'name': 'Morten Stilund, MD', 'role': 'CONTACT', 'email': 'mortstil@rm.dk', 'phone': '+4578430926'}], 'overallOfficials': [{'name': 'Morten Stilund, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Aarhus'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'After finishing the study, available for 1 year', 'ipdSharing': 'YES', 'description': 'All IPD that underlie results in a publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Gødstrup Hospital', 'class': 'OTHER'}, {'name': 'Regionshospitalet Viborg, Skive', 'class': 'OTHER'}, {'name': 'Sorbonne University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}