Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.

Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.
Tocilizumab: Therapeutic/Pharmacologic Class of Drug:
Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.
Type of Dosage Form:
Concentrate for solution for infusion.
Route of Administration:
Intravenous (i.v.) infusion.

Tocilizumab

Sex: Female, Male

The Brief Assessment of Cognition in Schizophrenia (BACS) is the metric used to characterize cognition in this study. The BACS consists of 6 subscales: Verbal Memory (range 0-75), Working Memory (range 0-28), Motor Speed (range 0-100), Verbal Fluency (measure is total number of words generated in two 60 second trials), Attention and Processing speed (range 0-110), and Executive Function (range 0-22). For each subscale, higher scores reflect better cognition. For each subscale, a Standard Deviation Score was calculated based on normative data (Keefe et al. Norms and standardization of the Brief Assessment of Cognition in Schizophrenia (BACS). Schizophrenia Research 102 (2008) 108-115). The BACS composite score is calculated as the average Standard Deviation Score of the 6 subscale scores. The change in BACS composite score was calculated as the BACS composite score at 8 weeks minus the BACS composite score at baseline.

Change in Cognition

The Positive and Negative Symptoms Scale (PANSS) is the metric used to characterize psychotic symptoms in this study. The PANSS consists of 30 items, each scored 1-7. The range for the PANSS total score is 30-210. There are 3 subscales - PANSS positive score (range 7-49), PANSS negative score (range 7-49), and PANSS general score (range 16-112). PANSS total score is the summation of these 3 subscales. Higher values for the total and subscale scores reflect more severe psychopathology. A positive change in PANSS total score reflects an increase in psychopathology. A negative change in PANSS total score reflects a decrease in psychopathology.

Change in Total Psychotic Symptoms

Following a screening evaluation, participants will receive two infusions of Tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of Tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.
Tocilizumab: Therapeutic/Pharmacological Class of Drug:
Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.
Type of Dosage Form:
Concentrate for solution for infusion.
Route of Administration:
Intravenous (i.v.) infusion.

Overall Study

Dr. Brian Miller

Schizophrenia

Therapeutic/Pharmacologic Class of Drug:
Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.
Type of Dosage Form:
Concentrate for solution for infusion.
Route of Administration:
Intravenous (i.v.) infusion.

Georgia Health Sciences University

An Open-Label Trial of Tocilizumab in Schizophrenia

Brian Miller

Assistant Professor

Methotrexate (MTX) 10 mg/week for 2 weeks, 15 mg/week for 2 weeks, 20 mg/week for 8 weeks

Arthritis, Rheumatoid

CH-1504

10mg/week for 2 weeks escalated to 15mg/week for 2 weeks escalated to 20mg/week for 8 weeks

Methotrexate (MTX)

The Rebecca MacDonald Centre for Arthritis and Autoimmune Disease

A Study to Assess CH1504 in Patients With Active Rheumatoid Arthritis

A Phase II, Multi-center, Randomized, Double-blind, Methotrexate Controlled Study to Assess the Clinical Efficacy, Safety, and Tolerability of CH-1504 in Subjects With Active Rheumatoid Arthritis

antirheumatics/diarrhea

An Open-Label Trial of Tocilizumab in Schizophrenia

A Study to Assess CH1504 in Patients With Active Rheumatoid Arthritis

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