NCT01416493

Bovine Intestinal Alkaline Phosphatase (bIAP) Modulating Rheumatoid Arthritis

An OPEN LABEL Phase II Safety Study of Bovine Intestinal Alkaline Phosphatase (bIAP), an Inflammation Modulating Moiety, in RA Patients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Alloksys Life Sciences B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a proof of concept study asking if alkaline phosphatase injections can reduce acute inflammation in rheumatoid arthritis patients.

Detailed description

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.

Conditions

• Acute Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	s.c. injections of bovine intestinal Alkaline Phosphatase	daily subcutaneous treatment with two injections of 2000IU bIAP for three days

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2011-08-15
• Last updated: 2015-03-10

Locations

1 site across 1 country: United Kingdom