NCT02910245 (OPTIC) is a Phase 3 clinical trial of Mercaptopurine (Purinethol) in Colitis, Ulcerative, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).

Who is sponsoring NCT02910245?

NCT02910245 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).

What drugs are being tested in NCT02910245?

Interventions in NCT02910245: Mercaptopurine (Purinethol), Placebo, Mesalamine, Prednisone.

What condition does NCT02910245 study?

NCT02910245 studies Colitis, Ulcerative.

Is NCT02910245 still recruiting?

NCT02910245 is currently status unknown. Last updated 6 January 2020.

Last reviewed 2020-01-06 · How we verify

NCT02910245: OPTIC

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy of Optimized Thiopurine Therapy in Ulcerative Colitis (OPTIC)

Status unknown Phase 3 Last updated 6 January 2020

What this trial tests

Phase 3 trial testing Mercaptopurine (Purinethol) in Colitis, Ulcerative in 136 participants. Status unknown.

Timeline

1 November 2016

Primary endpoint
30 April 2022

30 April 2022

Quick facts

Lead sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	136
Start date	1 November 2016
Primary completion	30 April 2022
Estimated completion	30 April 2022
Sites	12 locations across Netherlands

Drugs / interventions tested

Mercaptopurine (Purinethol) — full drug profile →
Placebo
Mesalamine — full drug profile →
Prednisone (prednisone) — full drug profile →

Conditions studied

Colitis, Ulcerative — all drugs for Colitis, Ulcerative →

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) — full company profile →

Who can join

Adults 18 to 80, any sex, with Colitis, Ulcerative. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Clinical and endoscopic remission
Time frame: After 52 weeks of treatment
Defined as a SCCAI-score ≤ 4, a UCEIS-score ≤ 3 and a total Mayo score ≤ 2, with no individual subscore \>1.

Sponsor's own description

This project is a double-blind, randomized, placebo-controlled, multicenter trial in the Netherlands. The aim of this study is to investigate the therapeutic efficacy of optimized 6-mercaptopurine (6-MP) in ulcerative colitis patients. Therapeutic drug monitoring (TDM) will be performed in order to optimize treatment outcomes and objective endoscopic endpoints will be used.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Colitis, Ulcerative

Currently open trials in the same condition.

NCT07302360 — A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis · recruiting
NCT07242248 — A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disea · recruiting
NCT07196748 — A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Col · Phase 3 · recruiting
NCT07102368 — A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany · recruiting
NCT06651281 — Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Coli · Phase 3 · recruiting

Other Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) trials

Trials by the same sponsor.

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NCT07359482 — sElective Serotonin reuPtake inhibitoRs In posT-covid After COVID-19 · Phase 3 · not yet recruiting
NCT07457957 — Effectiveness of an mHealth Innovation on the Impact of Menstrual Complaints in Adolescents · NA · not yet recruiting
NCT06909045 — Adaptive vs. Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease · NA · recruiting
NCT07316127 — Immunoadsorption in Autoimmune Long COVID · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02910245 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Last refreshed: 6 January 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02910245.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing