REUMAP. An Open Label Phase I/IIb Safety-biased Study of bIAP in RA

• Research type

  Research Study

• Full title

  An Open Label Phase I/IIb Safety-Biased Study of Bovine Intestinal Alkaline Phosphatase (bIAP), An Inflammation Modulating Moiety in Rheumatoid Arthritis

• IRAS ID

  14653

• Contact name

  Anthony Hammond

• Sponsor organisation

  Alloksys Life Sciences B.V.

• Eudract number

  2008-007346-63

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Alkaline Phosphatase (AP) is a biological enzyme found in all mammals, typically in the blood circulation, gut, liver and womb. It functions to protect from infection and tissue damage by neutralising certain bacterial toxins (LPS) and cell nucleus debris (nucleotides). Prior studies have shown that supplementing natural blood levels of AP by high dose (24000 - 48000 IU) intravenous infusion can protect patients against death and kidney failure in cases of septic shock (blood poisoning) and can abolish the inflammatory shock-like response which occurs in heart-lung by-pass operations. These effects are associated with reduction of levels of key inflammatory signalling molecules such TNF-alpha and IL-6. Rheumatoid arthritis is a common chronic, destructive joint disease caused by abnormal activation of the immune system disease and is characterised by high levels of TNF-alpha and IL-6 (amongst other factors) in blood and joints. Blockade of these molecules by modern therapies has revolutionised the treatment of arthritis in the last 10 years. LPS and cell nuclear debris are capable of activating the immune system to produce these inflammatory messengers, so the REUMAP study is aimed to find proof of concept that AP given by subcutaneous (under the skin) injection (SC) can reduce the levels of these inflammatory mediators and whether there is any reduction in the patient's measureable disease activity for up to 3 months after treatment. While AP has had no adverse effects given directly into the circulation, the safety of the SC route of administration will be critically studied in this phase 1b designed protocol.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  11/H0703/12

• Date of REC Opinion

  5 Apr 2011

• REC opinion

  Further Information Favourable Opinion