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Golimumab in Steroid-dependent Ulcerative Colitis: Induction and Maintenance of Clinical and Endoscopic Remission (UC-GOL)

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ClinicalTrials.gov Identifier: NCT02412085
Recruitment Status : Unknown
Verified April 2015 by Istituto Clinico Humanitas.
Recruitment status was:  Recruiting
First Posted : April 8, 2015
Last Update Posted : April 8, 2015
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas

Brief Summary:

This is an open-label, phase IV trial. Adult patients, with moderately to severe, steroid dependent, acute ulcerative colitis not previously exposed to anti-TNF, will receive subcutaneous golimumab treatment, according to EU marketing authorization from baseline through week 14.

At week 16, patients achieving clinical and endoscopic remission will continue with Golimumab, 50 mg or 100 mg (depending on body weight) every 4 weeks, through week 52.

Patients not achieving clinical and endoscopic remission will be treated with infliximab, according to marketing authorization, and followed through week 52. This is not considered as an interventional arm but, since infliximab in Italy is considered as the first-line treatment for UC patients, as the usual clinical practice.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study to Evaluate the Efficacy of Golimumab for Induction and Maintenance of Clinical and Endoscopic Remission in Patients With Steroid-dependent Ulcerative Colitis
Study Start Date : March 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Golimumab

Arm Intervention/treatment
Experimental: Golimumab
Subcutaneous golimumab
Drug: Golimumab

Subcutaneous golimumab. Induction regimen: 200 mg (week 0), 100 mg (week 2)

Maintenance regimen:

  • body weight < 80kg: 50 mg every 4 weeks
  • body weight ≥ 80 kg: 100 mg every 4 weeks
Other Name: Simponi




Primary Outcome Measures :
  1. clinical and endoscopic steroid-free remission [ Time Frame: week 16 ]
    Total Mayo score ≤2, with no sub-score >1. No concomitant corticosteroid therapy.


Secondary Outcome Measures :
  1. clinical response [ Time Frame: week 16 ]
    Decrease in total Mayo score of at least 2 point and 30 %

  2. percentage of patients in clinical and endoscopic remission [ Time Frame: week 52 ]
    Total Mayo score ≤2, with no sub-score >1

  3. percentage of patients in clinical remission [ Time Frame: week 52 ]
    partial Mayo score ≤2, with no sub-score >1

  4. percentage of patients with mucosal healing [ Time Frame: week 16 and 52 ]
    complete mucosal healing: endoscopic sub-score 0

  5. percentage of patients with histological healing [ Time Frame: week 16 and 52 ]
    histological healing: Geboes score <3 and no Mayo sub-score >1

  6. quality of life [ Time Frame: week 16 and 52 ]
    IBDQ questionnaire

  7. percentage of infliximab responders [ Time Frame: week 52 ]
  8. identification of patients that would benefit from golimumab therapy [ Time Frame: through week 52 ]
    evaluation of baseline characteristics of patients to identify potential response-predictive factors.



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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:

  • patients aged 18-65 years
  • ability to understand the study procedures and sign the informed consent
  • ulcerative colitis diagnosed at least 6 months before
  • no previous exposure to anti-TNFs
  • Global Mayo score ≥ 6 (with endoscopic sub-score ≥2) at baseline
  • steroid-dependent disease
  • women of childbearing potential must accept effective contraception during study participation and for at leas 6 months after the end of study participation

Exclusion Criteria:

  • Crohn's disease or undetermined colitis
  • active infections or previous infections not completely resolved at baseline
  • malignancies in the previous 5 years
  • suspected latent tuberculosis infection
  • every other potentially harmful clinical condition, in the opinion of the investigator
  • patients with moderately to severe heart failure (NYHA class III/IV)
  • hepatic or renal failure
  • pregnant or lactating women or women planning a pregnancy between baseline and the 3 months after study completion
  • not permitted concomitant medications

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): NCT02412085


Contacts
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Contact: Silvio Danese, MD, PhD 0039028224 ext 5555 sdanese@hotmail.com
Contact: Gionata Fiorino, MD, PhD 0038028224 ext 5555 gionata.fiorino@humanitas.it

Locations
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Italy
IBD Center Recruiting
Rozzano, MI, Italy, 20089
Contact: Silvio Danese, MD, PhD    0039028224 ext 5555    sdanese@hotmail.com   
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
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Study Chair: Silvio Danese, MD, PhD IBD Center, Humanitas Research Hospital, Rozzano (MI) ITALY

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Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT02412085     History of Changes
Other Study ID Numbers: 1371
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015

Keywords provided by Istituto Clinico Humanitas:
golimumab
ulcerative colitis
steroid-dependent

Additional relevant MeSH terms:
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Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs