@techreport{national_institute_of_allergy_and_infectious_diseases_niaid_elotuzumab_2021,
	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 = {{National Institute of Allergy and Infectious Diseases (NIAID)}},
	collaborator = {{Autoimmunity Centers of Excellence} and {Bristol-Myers Squibb} and {Rho Federal Systems Division, Inc.}},
	month = jun,
	year = {2021},
	note = {ZSCC: NoCitationData[s0] 
ubmitted: June 4, 2021},
}

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