Recruiting studies for ulcerative colitis

The IBD trial unit currently has five investigator initiated studies available for patients with ulcerative colitis.
The following studies are open for recruitment:

TOFA Histology
Investigator:
Prof. dr. G.R.A.M. D’Haens

Protocol: Tofa Histology
IP: tofacitinib (CP-690,55) (oral JAK inhibitor)

Contact: ibdstudies@amc.uva.nl

Status: RECRUITING

This is an open label exploratory study to investigate the effects of 10 mg BID tofacitinib in the colonic mucosa of patients with moderate to severe, active ulcerative colitis.
Study medication will be administered orally (as tablets), twice daily, for 8 weeks (56 days). Each subject will have 6 out-patient visits.

Patients who improve on treatment, per investigators discretion, will be offered continued treatment at the same dose after this study until marketing of Xeljanz for UC.

ACCURE
Investigator:
Prof. dr. G. D’Haens (PI)
Dr. C. Buskens (PI)
Prof. dr. W. Bemelman (PI)
Drs. M. Stellingwerf

Contact: m.e.stellingwerf@amc.uva.nl

Status: RECRUITING

The objective of this study is to evaluate the short-term and medium-term effectiveness of appendectomy to maintain remission in patients with an established diagnosis of ulcerative colitis treated for a relapse, but never treated with immunomodulators or biologicals.

The primary endpoint is the one year UC relapse rate in both groups defined both clinically and endoscopically based on the Mayo-score.

Main inclusion criteria
– Aged 18 years and older
– Established diagnosis of ulcerative colitis.
– Disease relapse less than 1 year prior to randomisation medically treated until remission
– Clinical (Mayo score <3) and endoscopic (Mayo score 0 or 1) remission
– Negative stool culture (including Gonorrhea and Chlamydia)
– Obtained written informed consent

Main exclusion criteria
– Prior appendectomy or other abdominal surgery
– Any suspicion of Crohn’s disease
– Disease treated with immunomodulators or biologicals
– Toxic megacolon or severe ongoing colitis at time of randomimsation
– Patients with active extra-intestinal infections, liver or kidney failure, mayor lung and heart co-morbidity.
– Insufficient command of Dutch or cognitively unable to complete Dutch questionnaires

LOVE-UC
Investigator:
Prof. dr. G.R.A.M. D’Haens

Protocol: 2014-100756
IP: vedolizumab

Contact: ibdstudies@amc.uva.nl

Status: RECRUITING

An open label observational phase IV study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study)

Main inclusion criteria
Early Ulcerative colitis
Diagnosis of UC < 4 years prior to enrollment
– Demonstrated failure to respond to aminosalicylates or intolerance to aminoslicylates and: failure to respond to topical or systemic corticosteroids or intolerance to corticosteroids or: need for 1 course of steroids since diagnosis

Late ulcerative colitis
– Demonstrated failure to respond to aminosalicylates or intolerance to aminosalicylates and: failure to respond to at least 3 months of thiopurines or intolerance to TP and: failure to respond to at least 1 anti-TNF or intolerance to anti-TNF or loss of response to at least 1 anti-TNF.

Main exclusion criteria
Prior treatment with vedolizumab; extensive colonic resection.

Treatment: Open label vedolizumab 300 mg on week 0, 2, 6, 14 – 46

OPTIC Trial
Investigator:
Dr. M. Löwenberg (PI)
Drs. S. van Gennep (PhD-student)

Protocol: 2015-005260-41
IP: mercaptopurine

Contact: s.vangennep@amc.uva.nl
Pager: 63500

Status: RECRUITING

A double blinded randomized placebo-controlled trial to determine the efficacy of optimized mercaptopurine therapy in patients with ulcerative colitis.

Main inclusion criteria
– Active ulcerative colitis despite ≥ 2 grams oral mesalamine treatment
– Need for treatment with oral corticosteroids

Main exclusion criteria
– Prior treatment with thiopurines (azathioprine, mercaptopurine or thioguanine) or biologicals (infliximab, adalimumab, golimumab and vedolizumab)
– History of colon dysplasia or cancer
– Extensive colonic resection

Treatment
Intervention arm: remission-induction treatment with prednisone for 8 weeks (fixed tapering scheme), 1 year mercaptopurine treatment (optimal dosing by therapeutic drug monitoring) and continuation with oral mesalamine treatment ( ≥ 2 g/day).

Placebo arm: remission-induction treatment with prednisone for 8 weeks (fixed tapering scheme), 1 year placebo treatment and continuation with oral mesalamine treatment ( ≥ 2 g/day).