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:

Investigator:
Prof. dr. W.A. Bemelman (PI)
Dr. C.J. Buskens (PI)
Prof. dr. G.R.A.M. D’Haens (PI)
M.A. Reijntjes (Study coordinator)

Contact: m.a.reijntjes@amsterdamumc.nl

Status: RECRUITING

Study Acronym: COSTA-study
Design: Multicenter prospective observational cohort study
Aim: to evaluate the effect of appendectomy surgery for therapy-refractory ulcerative colitis patients including therapy with biologicals.

The primary endpoint is remission defined as : Steroid-free remission rate (Total Mayo score ≤2 with a maximum endoscopic mayo score of 1) at 12 months after appendectomy without switch of therapy.

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: CLOSED FOR RECRUITMENT

Study Acronym: TOFA Histology
Design: open label exploratory study
Aim: to investigate the effects of 10 mg BID tofacitinib in the colonic mucosa of patients with moderate to severe, active ulcerative colitis.

Treatment: tofacitinib will be administered orally (as tablets), twice daily, for 8 weeks (56 days). Each subject will have 6 out-patient visits.

Investigator:
Prof. dr. W.A. Bemelman (PI)
Dr. C.J. Buskens (PI)
Prof. dr. G.R.A.M. D’Haens (PI)
Drs. L. Heuthorst (study coordinator)

Contact: l.heuthorst@amsterdamumc.nl

Status: RECRUITING

Study Acronym: ACCURE-trial
Design: multicenter randomized controlled trial
Aim: to evaluate the effect of appendectomy to maintain remission in patients with ulcerative colitis treated for a relapse within 12 months prior to randomization.

Patients will be randomized to laparoscopic appendectomy or to no appendectomy in day care setting. The primary endpoint is the one year UC relapse rate in both groups, based on the clinical and endoscopical Mayo-score.

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

Protocol: 2015-005260-41
IP: mercaptopurine

Contact: s.vangennep@amc.uva.nl

Status: RECRUITING

Study Acronym: OPTIC Trial
Design: a double blinded randomized placebo-controlled trial
Aim: to determine the efficacy of optimized mercaptopurine therapy in patients with ulcerative colitis.

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).

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

Protocol: 2014-100756
IP: vedolizumab (iv)

Contact: ibdstudies@amc.uva.nl

Status: CLOSED FOR RECRUITMENT

Study Acronym: LOVE-UC
Phase: 4
Design: an open label observational study
Aim: 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)

Treatment: 1 year open label vedolizumab 300 mg on week 0, 2, 6, 14 – 46

Recruitment closed.