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Two Therapeutic Strategies for the Maintenance of Remission in Patients With Ulcerative Colitis (SCILLA)

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ClinicalTrials.gov Identifier: NCT03151525
Recruitment Status : Unknown
Verified May 2017 by Istituto Clinico Humanitas.
Recruitment status was:  Recruiting
First Posted : May 12, 2017
Last Update Posted : May 12, 2017
Sponsor:
Collaborator:
Agenzia Italiana del Farmaco
Information provided by (Responsible Party):
Istituto Clinico Humanitas

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.


Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Drug: Azathioprine Drug: Infliximab Phase 4

Detailed Description:

All eligible subjects will be able to participate in the study at any infusion occurred after 12 months since the beginning. They will be screened by medical history, physical examination, blood and faecal tests (included C-reactive protein and faecal calprotectin), as required by clinical practice. No children, pregnant or breastfeeding women, or elder subjects will be included. A colonoscopy + biopsies in the area of greater inflammation will be performed within ± 3 weeks since the baseline visit. The subjects can then be randomized and receive their first dose of study medication.

Subjects will be then evaluated every 8 weeks for the following 12 months from the randomization. Clinical and blood tests will be performed, and the partial Mayo Score will be calculated at each visit, until the final visit, when a new colonoscopy with biopsies will be repeated and the global Mayo Score will be evaluated. At final visit a new faecal sample for calprotectin will be collected.

Safety of the study treatments will be evaluated at each study visit. In case of study agent discontinuation, the patient will be managed according to usual practice and followed for the entire study period. Patients randomized in AZA arm, could restart IFX.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized parallel two-arm prospective open-label study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Two Therapeutic Strategies for the Maintenance of Clinical and Endoscopic Remission in Patients With Ulcerative Colitis Treated by Infliximab
Actual Study Start Date : May 8, 2017
Estimated Primary Completion Date : October 3, 2019
Estimated Study Completion Date : April 3, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Azathioprine
Azathioprine 2-2.5 mg/kg/day, according to approved indication
Drug: Azathioprine
AZA treatment after IFX withdrawal for maintenance of remission

Active Comparator: Infliximab
Infliximab 5 mg/kg every 8 weeks
Drug: Infliximab
IFX treatment for maintenance of remission




Primary Outcome Measures :
  1. Relapse rate [ Time Frame: 12 months ]
    relapse rate in the two study groups.


Secondary Outcome Measures :
  1. Relapse time [ Time Frame: 12 months ]
    Mean time to relapse in the two groups

  2. Number of adverse events [Safety and Tolerability] [ Time Frame: 12 months ]
    Number of adverse events of the two study strategies

  3. Number of serious adverse events [Safety and Tolerability] [ Time Frame: 12 months ]
    Number of serious adverse events of the two study strategies

  4. Identification of potential risk factors for relapse. Age, sex, smoking habits, histological healing of mucosa and each Mayo subscore at baseline will be examined [ Time Frame: 12 months ]
    Potential risk factor for relapse will be evaluated by univariable analysis, and a multivariable analysis will be performed for all factors with p<0.30. Risk factors will be also analysed by logistic regression. Analysis of predetermined baseline characteristics (age, sex, smoking habits, histological healing of mucosa at baseline, and each Mayo subscore (stool number, presence of blood, colonic ulcerations) excluding the physician global assessment) to identify predictive factors for relapse.


Other Outcome Measures:
  1. Direct costs [Pharmacokinetics] [ Time Frame: 12 months ]
    Direct costs of the two treatment strategies



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
  • Sustained steroid-free remission in the last 6 months prior to inclusion, except for use of steroids as a preventive measure for infliximab infusion reaction, if required by local guidelines.
  • Global Mayo score at baseline ≤ 2
  • All Mayo subscores ≤ 1
  • Absence of rectal bleeding
  • Effective methods to avoid pregnancy during the study period

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151525


Contacts
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Contact: Silvio Danese, MD, PhD +390282245555 IBDclinicaltrials@humanitas.it
Contact: Gionata Fiorino, MD, PhD +390282245555 daniela.gilardi@humanitas.it

Locations
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Italy
IBD Center Recruiting
Rozzano, MI, Italy, 20089
Contact: Silvio Danese, MD, PhD    0039028224 ext 5555    IBDclinicaltrials@humanitas.it   
Contact: Gionata Fiorino, MD, PhD    0039028224 ext 5555    gionata.fiorino@humanitas.it   
Sponsors and Collaborators
Istituto Clinico Humanitas
Agenzia Italiana del Farmaco
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Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT03151525    
Other Study ID Numbers: 1685
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Azathioprine
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs