RAPID-I
- Conditions
- Acute pancreatitisDigestive System
- Registration Number
- ISRCTN16935761
- Lead Sponsor
- niversity of Liverpool
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 290
Current participant inclusion criteria as of 14/08/2018:
1. Adult patients attending A&E at or admitted to recruiting hospitals via a general practitioner with a new diagnosis of AP established by two of:
1.1. Typical continuous upper abdominal pain;
1.2. Amylase and/or lipase three or more times the upper limit of normal;
1.3. Characteristic findings on abdominal imaging (if undertaken urgently by CT or magnetic resonance imaging, MRI);
2. Patients in whom trial treatment can be started within 12 hours of recorded admission and allowing 120 min for pharmacy to prepare trial medication
3. Patients from whom appropriate consent is obtained (consent to be given by the patient or their legal representative).
Previous participant inclusion criteria:
1. Adult patients attending A&E at recruiting centres from whom appropriate consent is obtained (consent to be given by the patient or their legal representative)
2. Patients in whom trial treatment can be started within 12 hours of admission (allowing 120 min for Pharmacy to prepare trial medication)
3. A new diagnosis of AP (all severity levels) as established by two of:
3.1. Typical continuous upper abdominal pain
3.2. Amylase and/or lipase three or more times the upper limit of normal
3.3. Characteristic findings on abdominal imaging (if undertaken urgently)
NB Please note all severity levels of AP are to be included in the trial
1. Age < 18 or > 85
2. Body weight > 200 kg
3. Onset of abdominal pain more than 24 hours before admission to hospital
4. Known previous acute pancreatitis or chronic pancreatitis
5. Known multiple sclerosis, systemic vasculitis, Guillain-Barré syndrome or other demyelinating disorder
6. Known epilepsy
7. Moderate to severe heart failure and/or coronary heart disease (New York Heart Association (NYHA) Functional Class III/IV)
8. On home oxygen or home mechanical ventilation
9. Known advanced liver disease, on waiting list for liver transplantation or considered unsuitable for transplantation
10. Known cancer for which chemotherapy and/or radiotherapy is ongoing or was completed within less than 6 months from admission
11. Known haematological malignancy
12. Known cancer that is end-stage with ongoing palliative care or for which palliative care is appropriate
13. Known established infection prior to the onset of acute pancreatitis
14. Known history of (including that identified on chest x-ray) or household contact with individuals who have tuberculosis or opportunistic infection
15. Known history of infective hepatitis
16. Known immunosuppressive or biologic therapy within one month of admission
17. Known live vaccines or therapeutic infectious agents within one month of admission
18. Known hypersensitivity to infliximab or to inactive components of REMICADE® or to any murine proteins
19. Known pregnancy or lactation at the time of admission
20. Women of childbearing potential who do not agree to use adequate contraception up to Day 90
21. Known to be currently participating in a trial testing any investigational medicinal product or participation in a clinical study involving a medicinal product in the last three months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy outcome measure will be the difference in mean serum C-reactive protein measured on Days 2, 4, 7, 14 and 28 (summated as area under the curve) in either active arm (5 mg/kg or 10 mg/kg) versus the placebo arm; Timepoint(s): End of the study
- Secondary Outcome Measures
Name Time Method