Acute Rheumatoid Arthritis Clinical Trial
Official title:
An OPEN LABEL Phase II Safety Study of Bovine Intestinal Alkaline Phosphatase (bIAP), an Inflammation Modulating Moiety, in RA Patients
This is a proof of concept study asking if alkaline phosphatase injections can reduce acute inflammation in rheumatoid arthritis patients.
This is a proof of concept study to establish the safety of subcutaneous (sc) treatment and the efficacy of alkaline phosphatase (AP) in reducing specific pro-inflammatory cytokines during and after 3 days of twice daily s.c. treatment. A total dose of 12000 Units AP will be administered by 2000 IU s.c. injection twice daily for 3 days. Subjects will be closely followed for 8 days and regular clinical observations will be made during 3 months. Close out will be 3 months after initiation of treatment. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment