Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT01160666
Status:
COMPLETED
Last Update Posted:
2012-07-03
First Post:
2010-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Belimumab in Subjects With Primary Sjögren's Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012859', 'term': "Sjogren's Syndrome"}], 'ancestors': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C511911', 'term': 'belimumab'}, {'id': 'D000906', 'term': 'Antibodies'}], 'ancestors': [{'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-01', 'studyFirstSubmitDate': '2010-07-09', 'studyFirstSubmitQcDate': '2010-07-09', 'lastUpdatePostDateStruct': {'date': '2012-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'response rate', 'timeFrame': 'week 28', 'description': "A response is defined as the fulfilment of any 2 of the 5 following response criteria(values are compared to that of baseline \\[Day0\\]):\n\n* ≥ 30% reduction of the patient's dryness VAS\n* ≥ 30% reduction of the patient's fatigue VAS\n* ≥ 30% reduction of the patient's musculoskeletal pain VAS\n* ≥ 30% reduction of the physician's systemic activity VAS\n* ≥ 25% reduction of serum levels of any of the following B cell activation biomarkers (free light chains of immunoglobulin, beta2-microglobulin, monoclonal component, cryoglobulinemia, IgG) or ≥ 25% C4 increase"}], 'secondaryOutcomes': [{'measure': 'safety and tolerability of belimumab', 'timeFrame': '52 weeks', 'description': 'Evaluate the safety and tolerability of belimumab in subjects with SS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Belimumab', "Sjögren's syndrome", 'Sjögren disease'], 'conditions': ["Sjögren's Syndrome"]}, 'referencesModule': {'references': [{'pmid': '26639390', 'type': 'DERIVED', 'citation': "Bowman SJ, Fisher BA. Stratifying primary Sjogren's syndrome: killers in the balance? Arthritis Res Ther. 2015 Dec 7;17:351. doi: 10.1186/s13075-015-0878-9."}, {'pmid': '26336930', 'type': 'DERIVED', 'citation': "Seror R, Nocturne G, Lazure T, Hendel-Chavez H, Desmoulins F, Belkhir R, Ravaud P, Benbijja M, Poirier-Colame V, Taoufik Y, Mariette X. Low numbers of blood and salivary natural killer cells are associated with a better response to belimumab in primary Sjogren's syndrome: results of the BELISS study. Arthritis Res Ther. 2015 Sep 4;17(1):241. doi: 10.1186/s13075-015-0750-y."}]}, 'descriptionModule': {'briefSummary': "Sjögren's syndrome (SS) is a systemic autoimmune disease characterized by an increase in BAFF (BLyS) levels and a resulting B cell hyperactivity. B cells are involved in the pathogenesis of SS in both systemic and glandular features, and B cell downregulation may lead to a decrease of disease activity. Moreover, pathogenesis of SS is closed to that of Systemic lupus erythematosus, where Belimumab has been proven to be effective.", 'detailedDescription': "Sjögren's syndrome (SS) is a systemic autoimmune disease characterized by an increase in BAFF (BLyS) levels and a resulting B cell hyperactivity. B cells are involved in the pathogenesis of SS in both systemic and glandular features, and B cell downregulation may lead to a decrease of disease activity. Moreover, pathogenesis of SS is closed to that of Systemic lupus erythematosus, where Belimumab has been proven to be effective.\n\nThis phase II open-label study has 2 mains objectives:\n\n* To evaluate the proof of concept of efficacy of belimumab in subjects with SS\n* To evaluate the safety and tolerability of belimumab in subjects with SS Belimumab will be administered (10mg/kg on D0 D14 D28 and every 28 days for 24 weeks, with extension to 48 weeks if responders) to all patients"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a diagnosis of primary SS according to the updated American European Consensus Group Criteria. In addition, patients must be always positive for anti-SSA or anti-SSB antibodies\n* Have the presence, at screening, of Systemic involvement (polysynovitis, skin, renal, lung, CNS involvement, peripheral neuropathy, vasculitis, autoimmune cytopenia, defined in Annex 1) or persistent (up to 2 months) parotid, submandibular or lachrymal gland swelling of more than 2 cm OR\n\nObjective sicca (positive oral and/or ocular tests reported in the American European Consensus Group Criteria) with at least one among the following biological features of serum B lymphocyte activation :\n\nincreased IgG levels increased free light chain levels of immunoglobulins (according to central laboratory ranges) increased serum beta2-microglobulin levels decreased C4 levels (C4 levels inferior to central laboratory ranges) monoclonal gammapathy cryoglobulinemia OR\n\n* SS of more recent onset, i.e., less than 5 years of duration of symptoms, associated with:\n\n * oral or ocular dryness\n * fatigue\n * musculoskeletal pain (i.e, 3 criteria for response as reported at page (ix-x), characterized by VAS score more than 50/100 in all the 3 fields.\n\nExclusion Criteria:\n\n1. Any BLyS-targeted (BLyS-receptor fusion protein \\[BR3\\], TACI Fc, or belimumab) at any time.\n2. Any of the following within 364 days of Day 0:\n\n * B-cell targeted therapy (eg, rituximab, other anti-CD20 agents, anti-CD22 \\[epratuzumab\\], anti-CD52 \\[alemtuzumab\\]\n * A biologic investigational agent other than B cell targeted therapy (eg, abetimus sodium, anti CD40L antibody \\[BG9588/ IDEC 131\\]).\n\n4- Intravenous or oral cyclophosphamide within 180 days of Day 0.\n\n5- Any of the following within 90 days of Day 0:\n\n* Anti-TNF therapy\n* Interleukin-1 receptor antagonist\n* Abatacept\n* Interleukin-6 receptor antagonist\n* Intravenous immunoglobulin\n* Prednisone \\> 100 mg/day\n* Plasmapheresis.\n\n 9- Very severe SS disease.\n\n 10- Major organ or hematopoietic stem cell/marrow transplant.\n\n 11- Unstable or uncontrolled acute or chronic diseases not due to SS\n\n 13- History of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix.\n\n 14- Required management of acute or chronic infections, as follows:\n* Currently on any suppressive therapy for a chronic infection\n* Hospitalization for treatment of infection within 60 days of Day 0.\n* Use of parenteral (IV or IM) antibiotics\n\n 16- Historically or at screening positive test for HIV antibody, hepatitis C virus antibodies, or, hepatitis B surface antigen (HbsAg) (with or without positive serum HBV DNA), or antiHBcAg positivity (without anti-HbsAg positivity).\n\n 17- Grade 3 or greater laboratory abnormality based on the protocol toxicity scale except for the following that are allowed:\n* Stable Grade 3 prothrombin time (PT) secondary to warfarin treatment.\n* Stable Grade 3/4 proteinuria (≤ 6 g/24 hour equivalent by spot urine protein to creatinine ratio allowed). (mentioned earlier in Exclusion #8)\n* Stable Grade 3 neutropenia or stable Grade 3 white blood cell count.'}, 'identificationModule': {'nctId': 'NCT01160666', 'acronym': 'BELISS', 'briefTitle': "Efficacy and Safety of Belimumab in Subjects With Primary Sjögren's Syndrome", 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': "A Phase 2, Proof of Concept, 52-Week Open Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS (BAFF) Antibody, in Subjects With Primary Sjögren's Syndrome", 'orgStudyIdInfo': {'id': 'P090208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1: Belilumab', 'interventionNames': ['Drug: Belimumab']}], 'interventions': [{'name': 'Belimumab', 'type': 'DRUG', 'otherNames': ['HGS1006, LymphoStat-B™,', 'Human Monoclonal Anti-BLyS (BAFF) Antibody', 'Benlysta'], 'description': 'Belimumab will be administered at 10 mg/kg at Days 0, 14, 28 and then every 28 days until week 24 for all patients and week 48 for those considered responders at week 28.', 'armGroupLabels': ['1: Belilumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'Assistance Publique - Hôpitaux de Paris : BICETRE Hospital', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}], 'overallOfficials': [{'name': 'Xavier Mariette, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rheumatology Department of BICETRE Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Human Genome Sciences Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}