Safety and tolerability of an anti-CD19 monoclonal antibody, MEDI-551, in subjects with systemic sclerosis: A phase I, randomized, placebo-controlled, escalating single-dose study

Arthritis Research and Therapy

Volumn 18, Issue 1, 2016, Pages

  Schiopu, Elena ^a   Chatterjee, Soumya ^b   Hsu, Vivien ^c   Flor, Armando ^d   Cimbora, Daniel ^d   Patra, Kaushik ^d   Yao, Wenliang ^d   Li, Jing ^d   Streicher, Katie ^d   McKeever, Kathleen ^d,e   White, Barbara ^d,f   Katz, Eliezer ^d   Drappa, Jorn ^d   Sweeny, Sarah ^d   Herbst, Ronald ^d  

^a UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^b LERNER RESEARCH INSTITUTE   (United States)

^c ROBERT WOOD JOHNSON MEDICAL SCHOOL   (United States)

^d MEDIMMUNE   (United States)

^e ULTRAGENYX PHARMACEUTICAL INC   (United States)

^f Corbus Pharmaceuticals ^*  (United States)

Author keywords

B cells; CD19; Pharmacodynamics; Pharmacokinetics; Scleroderma; Systemic sclerosis

Indexed keywords

INEBILIZUMAB; PLACEBO; CD19 ANTIGEN; CD19 MOLECULE, HUMAN; MEDI-551; MONOCLONAL ANTIBODY;

ADULT; ARTHRALGIA; ARTICLE; B LYMPHOCYTE; CLINICAL ARTICLE; CONTROLLED STUDY; COUGHING; CYTOPENIA; DIARRHEA; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG SAFETY; DRUG TOLERABILITY; ECG ABNORMALITY; FATIGUE; FEMALE; HEADACHE; HOT FLUSH; HUMAN; HYPERGLYCEMIA; HYPERSENSITIVITY; IMMUNOGENICITY; INFECTION; INFUSION RELATED REACTION; KIDNEY DISEASE; LIMB PAIN; LIP DISEASE; LYMPHOCYTE DEPLETION; MALE; MULTICENTER STUDY; NAUSEA; NIGHT SWEAT; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL; PLASMA CELL; RANDOMIZED CONTROLLED TRIAL; RASH; SINGLE DRUG DOSE; SUPRAVENTRICULAR PREMATURE BEAT; SUPRAVENTRICULAR TACHYCARDIA; SYSTEMIC SCLEROSIS; TONGUE ULCER; UPPER EXTREMITY DEEP VEIN THROMBOSIS; UPPER RESPIRATORY TRACT INFECTION; AGED; AREA UNDER THE CURVE; CLINICAL TRIAL; ENZYME LINKED IMMUNOSORBENT ASSAY; FLOW CYTOMETRY; MIDDLE AGED; RECEIVER OPERATING CHARACTERISTIC;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIGENS, CD19; AREA UNDER CURVE; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; FLOW CYTOMETRY; HUMANS; MALE; MIDDLE AGED; ROC CURVE; SCLERODERMA, SYSTEMIC;

EID: 85008626287     PISSN: 14786354     EISSN: 14786362     Source Type: Journal    
DOI: 10.1186/S13075-016-1021-2     Document Type: Article

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