Colitis, UlcerativePhase 3OPTICNCT02910245
Mercaptopurine Therapy in Ulcerative Colitis
A Phase 3 study testing Mercaptopurine (Purinethol), Mesalamine and Prednisone in people with Colitis, Ulcerative, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 12 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- Mercaptopurine (Purinethol), Mesalamine and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 12 sitesNetherlands
- Study dates
- Nov 2016to 30 Apr 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of UC by endoscopy and histopathology
- Patients between 18 and 80 years of age
- Active disease, despite oral treatment with at least 2g/day 5-ASA
- Treatment with oral corticosteroids is required
Who cannot join
- Prior treatment with thiopurines
- Prior treatment with biologics (e.g. anti-TNF agents and vedolizumab)
- Current pregnancy (a pregnancy test will be performed if necessary according to the treating physician)
- Chronic Obstructive Pulmonary Disease (COPD)
- Acute coronary heart disease
- (Bacterial) gastroenteritis has to be treated first
Show all 21Show fewer
- Coagulation disorders
- Active malignancy
- History of colonic dysplasia/cancer
- Extensive colonic resection, i.e. subtotal colectomy with <15 cm colon in situ
- Concomitant therapy with drugs interfering with MP metabolism, like allopurinol, ribavirin or anti-epileptics.
- Known systemic fungal infections or parasitic infections have to be treated first
- Known duodenal or ventricular ulcus
- Substance abuse, such as alcohol (> 80 gram/day - one standard glass contains 10 gram of alcohol), I.V. drugs and inhaled drugs. If the subject has a history of substance abuse, to be considered for inclusion into the protocol, the subject must have abstained from using the abused substance for at least 2 years. Subjects receiving methadone within the past 2 years are also excluded
- Positive tuberculosis screen (when a screening is performed at the discretion of the treating physician)
- Active hepatitis B virus or hepatitis C virus infection defined as a positive anti-HCV, HBsAg and/or anti-HBcore screening.
- Leucopenia (Neutrophil count < 1,8x10^9/L)
- Thrombopenia (Platelets < 90x10^9/L)
- Elevated liver enzymes (>2x ULN)
- Abnormal renal function (eGFR< 30 mL/min)
- Other conditions which in the opinion of the investigator may interfere with the subject's ability to comply with the study procedure
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Netherlands12 sites, 12 recruiting
- Recruiting
Noordwest Ziekenhuisgroep
Alkmaar
Dirk van Asseldonk, MD PhD, dp.van.asseldonk@nwz.nl
- Recruiting
Flevoziekenhuis
Almere Stad
Marco Mundt, mmundt@flevoziekenhuis.nl
- Recruiting
Meander MC
Amersfoort, 3813 TZ
Bindia Jharap, MD, PhD, b.jharap@meandermc.nl
- Recruiting
Amsterdam UMC, location VUMC
Amsterdam, 1081 HZ
Nanne de Boer, MD, PhD, khn.deboer@vumc.nl
Sara van Gennep, MD, +31205667805, s.vangennep@amc.uva.nl
- Recruiting
OLVG Oost
Amsterdam, 1090 HM
JM Jansen, MD, j.m.jansen@olvg.nl
- Recruiting
Amsterdam UMC, location AMC
Amsterdam, 1105AZ
Mark Löwenberg, MD, PhD, +31205667621, m.lowenberg@amc.uva.nl
Sara van Gennep, MD, +31205667805, s.vangennep@amc.uva.nl
- Recruiting
Amstelland Hospital
Amsterdam
M. Gielen, MD, margi@zha.nl
- Recruiting
Tergooi Hospital
Hilversum, 1213 XZ
Itta M Minderhoud, iminderhoud@tergooi.nl
Jan van den Brande, jvandenbrande@tergooi.nl
- Recruiting
Westfriesgasthuis
Hoorn
X.G. Vos, MD, PhD, X.G.Vos@westfriesgasthuis.nl
- Recruiting
St. Antonius Hospital
Nieuwegein, 3435 CM
Petra van Boeckel, MD, p.van.boeckel@antoniusziekenhuis.nl
- Recruiting
Sint Franciscus Gasthuis
Rotterdam
R. West, R.West@Franciscus.nl
- Recruiting
MC Haaglanden
The Hague, 2512 VA
Nidhi Srivastava, MD, n.srivastava@mchaaglanden.nl
About this study
Official title: Efficacy of Optimized Thiopurine Therapy in Ulcerative Colitis (OPTIC)
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.
Read the detailed description
Subjects will receive treatment with oral prednisone 40 mg/day for 2 weeks, followed by fixed tapering over 6 weeks. Half of the subjects will be randomized to concomitant 6-MP 1-1.5 mg/kg/day and half will receive concomitant placebo treatment. During the entire course of the trial all subjects will receive maintenance treatment with 5-ASA in an oral dose of at least 2 gram per day. Subjects will be subjected to one colonoscopy at baseline and one sigmoidoscopy in week 52 in order to assess endoscopic disease activity.
Data will be collected using electronic case report forms (eCRF) with Castor EDC. Quality and data validation procedures will be applied to ensure the validity and accuracy of the clinical database. Monitoring of the study will be done according to the GCP guidelines and following a monitoring plan. The financier of the study, ZonMw Goed Gebruik Geneesmiddelen, has the right to perform an audit if seen necessary.
- Conditions
- Colitis, Ulcerative
- Being tested
- Mercaptopurine (Purinethol), Placebo, Mesalamine, Prednisone
- Keywords
- Therapeutic Drug Monitoring, Mercaptopurine (6-MP), Thiopurine, Efficacy
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mercaptopurine (Purinethol)Drug
Also called Purinethol
PlaceboDrug
MesalamineDrug
Also called Asacol, Mezavant, Pentasa, Salofalk
PrednisoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Mercaptopurine (Purinethol) | Active comparator | Mercaptopurine (Purinethol),1-1.5 mg/kg/day oral, 52 weeks \& Prednisone, 40 mg/day oral, 2 weeks, followed by fixed tapering over 6 weeks OR budesonide (cortiment) 9 mg/day during 8 weeks \& Mesalamine, 2 g/day oral, 52 weeks. Receives: Drug: Mercaptopurine (Purinethol); Drug: Mesalamine; Drug: Prednisone |
| Placebo | Placebo comparator | Placebo, 1-1.5 mg/kg/day, 52 weeks \& Prednisone, 40 mg/day oral, 2 weeks, followed by fixed tapering over 6 weeks OR budesonide (cortiment) 9 mg/day during 8 weeks \& Mesalamine, 2 g/day oral, 52 weeks. Receives: Drug: Placebo; Drug: Mesalamine; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and endoscopic remission
Defined as a SCCAI-score ≤ 4, a UCEIS-score ≤ 3 and a total Mayo score ≤ 2, with no individual subscore >1.
Measured: After 52 weeks of treatment
Secondary outcomes (9)
(Serious) Adverse Events
Occurrence of (serious) adverse events ((S)AE)
Measured: Continue during 52 weeks of treatment
Leukocyte counts
Measured: Every 6 weeks during 52 weeks of treatment
Liver function tests
Measured: Every 6-12 weeks during 52 weeks of treatment
Occurrence of subjective thiopurine intolerance
Measured: Every 6-12 weeks during 52 weeks of treatment
6-TGN levels
Measured: Every 6-12 weeks during 52 weeks of treatment
6-MMP levels
Measured: Every 6-12 weeks during 52 weeks of treatment
Occurrence of treatment failure
Measured: Continue during 52 weeks of treatment
Occurrence of upscaling treatment
Occurrence of upscaling treatment to biologicals (anti-TNF agents or vedolizumab)
Measured: Continue during 52 weeks of treatment
Treatment costs
Budget-impact analysis and cost-utility analysis
Measured: Every 3 months during 52 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startNov 2016
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, M. Lowenberg, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Mark Löwenberg, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910245
- Sponsor's protocol ID
- SA652012
- Acronym
- OPTIC
- Status last verified
- Jan 2020
- First submitted
- 9 Sep 2016
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hasskamp J, Meinhardt C, Patton PH, Timmer A. Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2025 Feb 27;2(2):CD000478. doi: 10.1002/14651858.CD000478.pub5.
PubMed 40013523
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Optimized Thiopurine Therapy in Ulcerative Colitis (OPTIC)
- ClinicalTrials.gov ID
- NCT02910245
- Acronym / sponsor ID
- OPTIC / SA652012
- Conditions
- Colitis, Ulcerative
- Keywords
- Therapeutic Drug Monitoring, Mercaptopurine (6-MP), Thiopurine, Efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Nov 2016 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects will receive treatment with oral prednisone 40 mg/day for 2 weeks, followed by fixed tapering over 6 weeks. Half of the subjects will be randomized to concomitant 6-MP 1-1.5 mg/kg/day and half will receive concomitant placebo treatment. During the entire course of the trial all subjects will receive maintenance treatment with 5-ASA in an oral dose of at least 2 gram per day. Subjects will be subjected to one colonoscopy at baseline and one sigmoidoscopy in week 52 in order to assess endoscopic disease activity.
Data will be collected using electronic case report forms (eCRF) with Castor EDC. Quality and data validation procedures will be applied to ensure the validity and accuracy of the clinical database. Monitoring of the study will be done according to the GCP guidelines and following a monitoring plan. The financier of the study, ZonMw Goed Gebruik Geneesmiddelen, has the right to perform an audit if seen necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mercaptopurine (Purinethol) | Active comparator | Drug: Mercaptopurine (Purinethol), Drug: Mesalamine, Drug: PrednisoneMercaptopurine (Purinethol),1-1.5 mg/kg/day oral, 52 weeks \& Prednisone, 40 mg/day oral, 2 weeks, followed by fixed tapering over 6 weeks OR budesonide (cortiment) 9 mg/day during 8 weeks \& Mesalamine, 2 g/day oral, 52 weeks. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Mesalamine, Drug: PrednisonePlacebo, 1-1.5 mg/kg/day, 52 weeks \& Prednisone, 40 mg/day oral, 2 weeks, followed by fixed tapering over 6 weeks OR budesonide (cortiment) 9 mg/day during 8 weeks \& Mesalamine, 2 g/day oral, 52 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of UC by endoscopy and histopathology
- Patients between 18 and 80 years of age
- Active disease, despite oral treatment with at least 2g/day 5-ASA
- Treatment with oral corticosteroids is required
Key exclusion criteria (21 listed)
- Prior treatment with thiopurines
- Prior treatment with biologics (e.g. anti-TNF agents and vedolizumab)
- Current pregnancy (a pregnancy test will be performed if necessary according to the treating physician)
- Chronic Obstructive Pulmonary Disease (COPD)
- Acute coronary heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mercaptopurine (Purinethol)Also: Purinethol | Drug | Mercaptopurine (Purinethol) |
| Placebo | Drug | Placebo |
| MesalamineAlso: Asacol, Mezavant, Pentasa, Salofalk | Drug | Mercaptopurine (Purinethol), Placebo |
| Prednisone | Drug | Mercaptopurine (Purinethol), Placebo |
Primary outcome
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.
9 secondary outcomes
(Serious) Adverse Events
Time frame: Continue during 52 weeks of treatment
Leukocyte counts
Time frame: Every 6 weeks during 52 weeks of treatment
Liver function tests
Time frame: Every 6-12 weeks during 52 weeks of treatment
Occurrence of subjective thiopurine intolerance
Time frame: Every 6-12 weeks during 52 weeks of treatment
6-TGN levels
Time frame: Every 6-12 weeks during 52 weeks of treatment
6-MMP levels
Time frame: Every 6-12 weeks during 52 weeks of treatment
Occurrence of treatment failure
Time frame: Continue during 52 weeks of treatment
Occurrence of upscaling treatment
Time frame: Continue during 52 weeks of treatment
Treatment costs
Time frame: Every 3 months during 52 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Derived from this study: PubMed 40013523Hasskamp J, Meinhardt C, Patton PH, Timmer A. Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2025 Feb 27;2(2):CD000478. doi: 10.1002/14651858.CD000478.pub5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Löwenberg, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mercaptopurine (Purinethol), Mesalamine and Prednisone in people with Colitis, Ulcerative, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 12 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Löwenberg, MD, PhD (+31205667621, m.lowenberg@amc.uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and endoscopic remission (time frame: After 52 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02910245, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.