Phase 1 Trial of Type II Collagen (CII) APL A12 in Rheumatoid Arthritis Patients
Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
Participant gender:
Summary
This is a Phase I clinical trial to determine whether orally administered APL A12 at one or
more doses is superior to placebo in effecting a 25% reduction in interferon (IFN)
stimulation index in 1(II)-stimulated culture of peripheral blood mononuclear (PBMC) obtained
from patients with Rheumatoid Arthritis (RA), which will be the primary outcome variable. In
an effort to learn more about the mechanism of action of APL A12, the investigators will
assess Th1/Th2/Th3 cytokine production in supernatants from 48h and 144h cultures of PBMC
stimulated by 1(II) and by APL A12 above. The investigators will assess function of CD4+
CD25+ T regs to determine whether APL A12 improves their suppressive function. Flow cytometry
combined with intracellular cytokine staining will be used in an effort to determine which T
cell subset(s) is/are experiencing shifts in cytokine expression.