{"_id":"jbvHDTaW4DNenS5GQ","bibbaseid":"nationalinstituteofallergy-niaid-elotuzumabinimmunoglobuling4relateddiseaseigg4rd-2021","author_short":["National Institute of Allergy","(NIAID), I. D."],"bibdata":{"bibtype":"techreport","type":"Clinical trial registration","title":"Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD)","url":"https://clinicaltrials.gov/ct2/show/NCT04918147","abstract":"This is a two-part multi-center clinical trial in participants with active IgG4-RD. Part 1 (Cohort 1a and Cohort 1B) is an open-label, dose escalation phase to determine the safety of elotuzumab for investigation in IgG4-RD. Part 2 (Cohort 2) is a randomized, placebo-controlled, double-blinded (masked) trial phase to compare the effects of elotuzumab and prednisone to elotuzumab placebo and prednisone in participants with IgG4 RD. Approximately 75 participants with active IgG4-RD will be enrolled in the overall program, 12 in Part 1 and 63 in Part 2. Randomization in Part 2: 2 to 1, with approximately forty-two participants randomized to elotuzumab plus prednisone taper, and twenty-one participants randomized to placebo for elotuzumab plus prednisone taper. The total duration of participant follow-up in this trial will be 48 weeks (11 months).","number":"NCT04918147","urldate":"2021-06-22","institution":"clinicaltrials.gov","author":[{"firstnames":[],"propositions":[],"lastnames":["National Institute of Allergy"],"suffixes":[]},{"firstnames":["Infectious","Diseases"],"propositions":[],"lastnames":["(NIAID)"],"suffixes":[]}],"collaborator":"Autoimmunity Centers of Excellence and Bristol-Myers Squibb and Rho Federal Systems Division, Inc.","month":"June","year":"2021","note":"ZSCC: NoCitationData[s0] ubmitted: June 4, 2021","bibtex":"@techreport{national_institute_of_allergy_and_infectious_diseases_niaid_elotuzumab_2021,\n\ttype = {Clinical trial registration},\n\ttitle = {Elotuzumab in {Immunoglobulin} {G4}-{Related} {Disease} ({IgG4}-{RD})},\n\turl = {https://clinicaltrials.gov/ct2/show/NCT04918147},\n\tabstract = {This is a two-part multi-center clinical trial in participants with active IgG4-RD.\n\nPart 1 (Cohort 1a and Cohort 1B) is an open-label, dose escalation phase to determine the safety of elotuzumab for investigation in IgG4-RD.\n\nPart 2 (Cohort 2) is a randomized, placebo-controlled, double-blinded (masked) trial phase to compare the effects of elotuzumab and prednisone to elotuzumab placebo and prednisone in participants with IgG4 RD.\n\nApproximately 75 participants with active IgG4-RD will be enrolled in the overall program, 12 in Part 1 and 63 in Part 2. Randomization in Part 2: 2 to 1, with approximately forty-two participants randomized to elotuzumab plus prednisone taper, and twenty-one participants randomized to placebo for elotuzumab plus prednisone taper.\n\nThe total duration of participant follow-up in this trial will be 48 weeks (11 months).},\n\tnumber = {NCT04918147},\n\turldate = {2021-06-22},\n\tinstitution = {clinicaltrials.gov},\n\tauthor = {{National Institute of Allergy and Infectious Diseases (NIAID)}},\n\tcollaborator = {{Autoimmunity Centers of Excellence} and {Bristol-Myers Squibb} and {Rho Federal Systems Division, Inc.}},\n\tmonth = jun,\n\tyear = {2021},\n\tnote = {ZSCC: NoCitationData[s0] \nubmitted: June 4, 2021},\n}\n\n\n\n","author_short":["National Institute of Allergy","(NIAID), I. D."],"key":"national_institute_of_allergy_and_infectious_diseases_niaid_elotuzumab_2021","id":"national_institute_of_allergy_and_infectious_diseases_niaid_elotuzumab_2021","bibbaseid":"nationalinstituteofallergy-niaid-elotuzumabinimmunoglobuling4relateddiseaseigg4rd-2021","role":"author","urls":{"Paper":"https://clinicaltrials.gov/ct2/show/NCT04918147"},"metadata":{"authorlinks":{}}},"bibtype":"techreport","biburl":"https://bibbase.org/zotero/saracatanese","dataSources":["eTsH756eicg6vxuG3","TZeKmKj6mKcyHY3tK"],"keywords":[],"search_terms":["elotuzumab","immunoglobulin","related","disease","igg4","national institute of allergy","(niaid)"],"title":"Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD)","year":2021}