Comparison of infliximab and ciclosporin in steroid resistant ulcerative colitis

Not Applicable

Completed

• Conditions: Acute severe steroid resistant ulcerative colitis; Digestive System; Ulcerative colitis

• Registration Number: ISRCTN22663589
• Lead Sponsor: Swansea University (UK)

Brief Summary

2014 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/24785401 protocol 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27329657 results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27595142 results 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28399515 results of nested qualitative study in healthcare professionals 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31615445 results of nested qualitative study in patients results 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/36890533/ Model-based cost-utility analysis (added 10/03/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-16
• Study Completion: 2014-08-31
• Last Update Posted: 20 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

Current inclusion criteria as of 22/10/2012:
1.1. Patients admitted acutely (ie an emergency admission) with severe colitis (as evidenced by eg a Mayo score of at least 2 on endoscopic finding) who fail to respond to approximately 2-5 days of intravenous hydrocortisone therapy, who also have either:
1.2. A histological diagnosis of ulcerative colitis in this episode
OR
1.3. A histological diagnosis of indeterminate colitis in this episode, where clinical judgement (based on macroscopic appearance, disease distribution or previous history) suggests a diagnosis of ulcerative colitis rather than Crohn?s disease
OR
1.4. Typical symptoms of ulcerative colitis but histology awaited
OR
1.5. A history of ulcerative colitis (previously confirmed histologically)

Previous inclusion criteria until 22/10/2012:
1. Patients with ulcerative colitis (UC) diagnosed on histological evidence
2. Inpatients with documented evidence of acute severe UC (based on sigmoidoscopic appearances and Truelove and Witts' criteria)
3. Continuing acute severe UC (according to Truelove and Witts criteria) after three days intravenous hydrocortisone

Exclusion Criteria

Current exclusion criteria as of 22/10/2012:
1. Patient aged under 18 years of age on admission
2. Patient with histological diagnosis inconsistent with ulcerative colitis (indeterminate colitis is not necessarily ?inconsistent with ulcerative?-see inclusion criteria b)
3. Patient with enteric infection confirmed on stool microscopy or culture or histology (includes salmonella, shigella, clostridium difficile, campylobacter and CMV)
4. Patient from a vulnerable group
5. Patient unable to consent for themselves
6. Patient who are pregnant (as evidenced by +ve pregnancy test) or currently lactating
7. Women of child-bearing potential who are not prepared to use adequate contraception during treatment with infliximab and for 6 months afterwards in line with the Summary of Product Characteristics
8. Patient with current malignancy, excluding basal cell carcinoma
9. Patient with serious co-morbidities, including:
9.1. Immunodeficiency
9.2. Myocardial infarction (within last month)
9.3. Moderate or severe heart failure (NYHA class III or IV)
9.4. Acute stroke (within last month)
9.5. Respiratory failure
9.6. Renal failure
9.7. Hepatic failure
9.8. Active, or suspected active tuberculosis
9.9. Other severe infections (as determined by the investigator) such as sepsis, abscesses and opportunistic infections
10.1. Patient with a history of hypersensitivity to
10.2. Infliximab (Remicade)
10.3. Ciclosporin (Sandimmun and Neoral)
10.4. Polyethoxylated oils (Sandimmun Concentrate for IV Infusion)
11. Concomitant use of tacrolimus or rosuvastatin
12. Patients who do not speak English well enough to take part in the study, and for whom local translation services cannot be provided
13. Where clinical need determines the patient should undergo emergency colectomy without further medical treatment
14. Patients currently taking part in other clinical trials
15. Patients who have received treatment with either infliximab or ciclosporin in the three months before admission
16. Patient with contraindication(s) to treatment with Infliximab or Ciclosporin

Previous exclusion criteria until 22/10/2012:
1. Age under 18 years on the day of admission
2. Treatment with either infliximab or ciclosporin in the three months before admission
3. Positive stool microscopy or culture for enteric infection, including salmonella, shigella and Clostridium difficile
4. Pregnancy and lactation
5. Malignancy, excluding basal cell carcinoma
6. Other serious co-morbidities, including immunodeficiency, myocardial infarction, acute stroke, respiratory, renal or hepatic failure
7. Severe cognitive impairment
8. Patients unable to consent for themselves
9. Patients who do not speak English well enough to take part in the study
10. Where clinical need determines the patient should undergo emergency colectomy without further medical treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measures as of 22/10/2012:<br> The primary outcome measure is quality-adjusted survival, weighted by scores on the disease-specific CCQ.<br><br> Previous primary outcome measures until 22/10/2012:<br> Quality of life, measured at 3, 6, 12 and 24 months with the following:<br> 1. Disease specific questionnaire: UK-Inflammatory Bowel Disease Questionnaire (IBDQ)<br> 2. Generic questionnaires: The 12-item short form health survey (SF-12) and EQ-5D<br>