Arthritis, Rheumatoid Clinical Trial
Official title:
Phase I/II Open Label Evaluation of Safety and Feasibility of 6 Months IV PRTX-100 Administrations in Previous Rheumatoid Arthritis Study Participants and Development of Immunological Samples for Assay Development From Normal Volunteers
Part A Primary Objective To determine the safety of six months of PRTX-100 administration.
Part B Primary Objective To obtain antisera from normal volunteers that have developed
anti-PRTX-100 antibodies.
Secondary Objective(s) To assess rheumatoid arthritis activity during the period of PRTX-100
treatment To evaluate the development of anti-PRTX-100 antibodies To explore feasibility of
joint evaluations with ultrasound To explore feasibility of biomarkers as disease markers
Although the majority of RA patients achieve an amelioration of their RA with older disease
modifying agents such as methotrexate and leflunomide, all of these agents provoke adverse
events. The newer more active biological agents have a distinct safety profile that includes
an increased risk of serious infections. They have an annual treatment expense in the tens of
thousands of dollars a year. PRTX-100 may be able to modify the disease course of rheumatoid
arthritis with an improved safety profile compared to available agents and a dosing regimen
comparable to the therapies currently available. This study is done to describe the adverse
event profile of 6 μg/kg of PRTX-100 administered IV for longer periods of treatment that
might be required for RA therapy. Secondary objectives include: evaluation of the clinical
response of subjects with previous administration of PRTX-100; evaluation of anti-PRTX
antibody presence and effect on activity; evaluation of "Power Doppler" ultrasound in the
assessment of joint inflammation; and evaluation of biomarkers.
Assay development is an intrinsic part of drug and biological development. The current assay
for anti-PRTX-100 antibodies depends on a very limited supply of serum available from
individuals in early trials. It will be necessary to obtain adequate antisera to provide
immunological reagents for this assay. It is not known whether the character of anti-PRTX-100
antibodies from volunteers is similar to those produced by patients with immunological
disorders on cytotoxic therapy. Antisera will be developed in normal volunteers. The
anti-PRTX-100 antibody assay will need to be standardized with a new anti-PRTX-100 antibody
source compared to the present human reagent.
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