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Phase 1 Trial of Type II Collagen (CII) APL A12 in Rheumatoid Arthritis Patients

NCT01123655 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-03-19

Study results available
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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.

Conditions

Interventions

DRUG

APLA12

Intervention: Drug treatment will be stopped or interrupted if indicated. Medical care will be provided at no cost to the patient.

DRUG

Placebo

Drug treatment will be stopped or interrupted if indicated. Medical care will be provided at no cost to the patient.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Arnold E Postlethwaite, MD · Memphis VA Medical Center, Memphis, TN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01123655 on ClinicalTrials.gov