Recruiting studies for ulcerative colitis

The IBD trial unit currently has several investigator initiated studies available for patients with ulcerative colitis.

The following studies are open for recruitment:

PROPHETIC
Investigator:
Prof. dr. G.R.A.M. D’Haens (PI)

Protocol: RP1907
IP: tofacitinib

Contact: ibdstudies@amsterdamumc.nl

Status: RECRUITING

COSTA
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

This is a multi-center, prospective observational cohort study 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.

TURN2
Investigator:
Prof. dr. C. Ponsioen

Protocol:
IP:

Contact: ibdstudies@amsterdamumc.nl

Status: RECRUITING

ACCURE
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

This is a multi-center, randomized controlled trial 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.

OPTIC
Investigator:
Dr. M. Löwenberg (PI)

Protocol: 2015-005260-41
IP: mercaptopurine

Contact:

Status: RECRUITING

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

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).