NCT03151525

Brief Summary

Ulcerative colitis patients treated with Infliximab (IFX) in deep remission after at least 12 months of treatment will be randomized to continue IFX or to stop IFX and start Azathioprine (AZA). Each patient will be followed for 12 months.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

May 8, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2020

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

2.4 years

First QC Date

May 8, 2017

Last Update Submit

May 10, 2017

Conditions

Colitis, Ulcerative

Outcome Measures

Primary Outcomes (1)

  • Relapse rate

    relapse rate in the two study groups.

    12 months

Secondary Outcomes (4)

  • Relapse time

    12 months

  • Number of adverse events [Safety and Tolerability]

    12 months

  • Number of serious adverse events [Safety and Tolerability]

    12 months

  • Identification of potential risk factors for relapse. Age, sex, smoking habits, histological healing of mucosa and each Mayo subscore at baseline will be examined

    12 months

Other Outcomes (1)

  • Direct costs [Pharmacokinetics]

    12 months

Study Arms (2)

Azathioprine

EXPERIMENTAL

Azathioprine 2-2.5 mg/kg/day, according to approved indication

Drug: Azathioprine

Infliximab

ACTIVE COMPARATOR

Infliximab 5 mg/kg every 8 weeks

Drug: Infliximab

Interventions

AzathioprineDRUG

AZA treatment after IFX withdrawal for maintenance of remission

Azathioprine
InfliximabDRUG

IFX treatment for maintenance of remission

Infliximab

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 -65 years
  • Written informed consent and willing to adhere to study procedures.
  • Therapy with infliximab since at least 12 months, with one infusion every 8 weeks (a maximum interval between two infusions of ± 3 weeks is allowed)
  • Global Mayo score at baseline ≤ 2
  • All Mayo subscores ≤ 1
  • Absence of rectal bleeding
  • Effective methods to avoid pregnancy during the study period

You may not qualify if:

  • Disabling and persisting extraintestinal manifestation at baseline
  • Patients unable to comply with study procedures
  • Known intolerance or previous allergic reaction to thiopurines
  • Concomitant therapy with allopurinol
  • Any disease not compatible with the use of infliximab or azathioprine, as per clinician's judgement.
  • Need for dose escalation of infliximab in the last 12 months prior to baseline.
  • White blood cell count \< 3000/mmc or absolute clinically relevant lymphopenia at baseline
  • Active pregnancy or breastfeeding; willing for pregnancy during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IBD Center

Rozzano, MI, 20089, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40013523DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

AzathioprineInfliximab

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

ThionucleosidesSulfur CompoundsOrganic ChemicalsMercaptopurinePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Silvio Danese, MD, PhD

CONTACT

+390282245555IBDclinicaltrials@humanitas.it

Gionata Fiorino, MD, PhD

CONTACT

+390282245555daniela.gilardi@humanitas.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized parallel two-arm prospective open-label study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2017

First Posted

May 12, 2017

Study Start

May 8, 2017

Primary Completion

October 3, 2019

Study Completion

April 3, 2020

Last Updated

May 12, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)