Comparison of infliximab and ciclosporin in steroid resistant ulcerative colitis: a Trial - CONSTRUCT

Phase 1

Conditions: Acute severe steroid resistant ulcerative colitis
MedDRA version: 14.1 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders

Registration Number: EUCTR2008-001968-36-GB

Lead Sponsor: Swansea University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 250

Inclusion Criteria

Patients able to consent for themselves
Patients with a history of UC diagnosed on endoscopic appearnace and confirmed histologically. If a patient is not known to have UC on admission, they may be recruited on clinical grounds and withdrawn from the allocated treatment (but retained within the trial unless not yet randomised) if the diagnosis not confirmed subsequently on histology. If withdrawn from allocated treatment, treatment continues at discretion of consultant.
A negative stool culture is required prior to recruitment in patients not previously known to have UC
Patients with known UC should have a verified stool culture prior to RCT entry but MAY enter if it is not available AND the presentation is not atypical AND delay would disqualify them, PROVIDED stool culture is read within a maximum of 48 hours. If this is positive, the patient will be withdrawn from the allocated treatment protocol (and treated purely at clinical dsicretion), but retained within the trial unless not yet randomised).
Inpatients with documented evidence of acute severe ulcerative colitis (based on sigmoidoscopic appearances, see Protocol Appendix 4))
Continuing acute severe ulcerative colitis after two to five days of intravenous hydrocortisone, defined as stool frequency >8 stools/day or a stool frequency of between 3-8 stools/day with a CRP >45mgs/l. A clinical judgement of failure to respond in patients not meeting these criteria will be accepted provided the reason is documented.
Women of child-bearing potential must be prepared to use adequate contraception during treatment with Remicade (infliximab) and for 6 months afterwards in line with the Summary of Product Characteristics.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Age under 18 years on day of admission
Treatment with infliximab or ciclosporin in the three months before admission
Positive stool microscopy or culture for enteric infection, including salmonella, shigella, campylobacter and Clostridium difficile
Histological evidence of CMV infection
Pregnancy and lactation
Current malignancy, excluding basal cell carcinoma
Other serious co-morbidities, including immunodeficiency, myocardial infarction, acute stroke, respiratory, renal or hepatic failure
Patients with suspected active tuberculosis
Patients with other severe infections (as determined by the investigator) such as sepsis, absesses and opportunistic infections
Patients with moderate or severe heart failure (NYHA class III/IV)
Patients with a history of hypersensitivity to infliximab or ciclosporin
Concomitant use of tacrolimus or rosuvastation
Patients with known hypersensitivity to polyethoxylated oils (Sandimmun Concentrate for IV Infusion)
Where clinical need determines the patient should undergo emergency colectomy without further medical treatment
Severe cognitive impairment
Patients who do not speak English well enough to take part in the study
Patients currently taking part in other clinical trials
Patients from vulnerable groups (see Protocol Appendix 5) with the exception of severe illness as this will be the reason for their acute admission and treatment

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the clinical and cost effectiveness of infliximab and ciclosporin for patients with acute severe steroid resistant ulcerative colitis;<br> Secondary Objective: Compare quality of life (QoL) across the two treatment groups (infliximab and ciclosporing)<br> Compare mortality, disease activity and morbidity across the two treatment groups<br> Compare emergency colectomy rates across the two treatment groups<br> Investigate the views of patients regarding treatments<br> Compare the cost effectiveness of the two treatments in terms of cost per quality-adjusted life year, using primary data from the two years of trial and to extend this comparison by modelling lifetime costs and effects.<br> ;Primary end point(s): To establish the efficacy of the two therapies specifically with relation to the need for surgery, disease activity, quality of life and cost effectiveness over a protracted period.

Secondary Outcome Measures

Name	Time	Method

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