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"Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial" (SIMILAR)

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ClinicalTrials.gov Identifier: NCT02452151
Recruitment Status : Unknown
Verified May 2015 by J.M. Jansen, MD, Onze Lieve Vrouwe Gasthuis.
Recruitment status was:  Not yet recruiting
First Posted : May 22, 2015
Last Update Posted : May 22, 2015
Sponsor:
Collaborator:
Santeon
Information provided by (Responsible Party):
J.M. Jansen, MD, Onze Lieve Vrouwe Gasthuis

Brief Summary:
The objective of this study is to compare the efficacy of Infliximab-Biosimilar to Infliximab-Innovator and to demonstrate its noninferiority, in patients with ulcerative colitis or Crohn's disease in remission under treatment with infliximab up to 3 months.

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Crohn's Disease Drug: Infliximab-Biosimilar Drug: Infliximab-Innovator Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Santeon InflixMab biosimILAr Research A Randomized, Controlled, Double Blind, Phase 4 Noninferiority Trial to Assess Efficacy of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission.
Study Start Date : August 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Arm Intervention/treatment
Experimental: Infliximab-biosimilar
Infliximab-Biosimilar (Inflectra) (5mg/kg or 10mg/kg) by intravenous (IV) infusion administered as a 2-hour infusion per dose as treatment. In total 4 to 6 doses of the study drug will be administered while continuing patient's dosing intervals, ranging between 6 to 10 weeks.
Drug: Infliximab-Biosimilar
Active Comparator: Infliximab-Innovator
Infliximab-Innovator (Remicade) (5mg/kg or 10mg/kg) by intravenous (IV) infusion administered as a 2-hour infusion per dose as treatment. In total 4 to 6 doses of the study drug will be administered while continuing patient's dosing intervals, ranging between 6 to 10 weeks.
Drug: Infliximab-Innovator



Primary Outcome Measures :
  1. Relapse rate [ Time Frame: 3 months ]
    Efficacy of Infliximab-Biosimilar and Infliximab will be assessed by evaluation of the relapse rate for each diagnosis seperately.

  2. Duration of clinical remission [ Time Frame: 3 months ]
    Efficacy of Infliximab-Biosimilar and Infliximab will be assessed by evaluation of the the duration of clinical remission for each diagnosis seperately.



Information from the National Library of Medicine

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

Inclusion Criteria:

Patients, male or female, aged above 18 years at time of enrolment will be selected from hospital databases based on appointments for Infliximab infusion as treatment for IBD. Patients are eligible for inclusion if they have an established diagnosis of ulcerative colitis or Crohn's disease, are in clinical remission and are medically treated with Infliximab for at least 12 weeks prior to inclusion.

Exclusion Criteria:

  1. Patient has an allergy or hypersensitivity to one of the components of infliximab and/or immunoglobulin products, except hypersensitivity reactions which have a positive response to hydrocortisone and thereby are under control.
  2. Patient has a current diagnosis with hepatitis B, hepatitis C or an infection with human immunodeficiency virus (HIV)-1 or 2. Patients with a past history of chronic hepatitis B or hepatitis C will not be excluded.
  3. Patient has a history of tuberculosis (TB) or a current diagnosis of TB or other severe or chronic infection such as abscess, opportunistic infection or invasive fungal infection. Patients with a past history of a severe or chronic infection will not be excluded.
  4. Patient has had recent exposure to persons with active TB. In that case screening for latent TB (defined as a positive result for interferon-γ release assay (IGRA) with a negative examination of chest X-ray) will be performed. If there is sufficient documentation of prophylaxis or complete resolution following TB-treatment based on hospital-specific guidelines the patient can be enrolled. If the result of the IGRA is indeterminate at screening, 1 retest will be done. If the repeated IGRA result is indeterminate again, the patient will be excluded. Patients with a positive IGRA result and a negative examination of chest X-ray who has received at least the first 30 days of TB-therapy can be enrolled.
  5. Patient who is taking any of the following concomitant medications or treatment:

    • Corticosteroids (prednisone, prednisolone or budosenide).
    • Live or live-attenuated vaccine within 8 weeks of randomization.
    • Any other biological treatments than infliximab.
    • Subtotal and total colectomy prior to randomization.
    • Any planned abdominal surgery for IBD at the time of randomization and/or during the study period.
  6. Patient has one or more of the following medical conditions:

    • Active entero-vesical, entero-retroperitoneal, entero-cutaneous and entero-vaginal fistula for within 6 months prior to screening. Entero-enteral fistulae without clinical significant symptoms upon investigator's opinion and anal fistulae without draining problems are allowed.
    • Current short bowel syndrome.
    • History of any malignancy within the 5 years prior to randomization except cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma or completely excised and cured squamous carcinoma of the uterine cervix.
    • History of lymphoma or lymphproliferative disease or bone marrow hyperplasia.
    • New York Heart Association (NYHA) class III or IV heart failure.
    • History of organ transplantation, including corneal graft/transplantation.
  7. Patient has had treatment with any other investigational device or medical product within 4 weeks of randomization or 5 half-lives, whichever is longer.
  8. Female patient who is currently pregnant, breastfeeding or planning to become pregnant or breastfeed within 6 months of the last dose of study drug.

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): NCT02452151


Contacts
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Contact: Jeroen Jansen, MD J.M.Jansen@olvg.nl

Sponsors and Collaborators
Onze Lieve Vrouwe Gasthuis
Santeon

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Responsible Party: J.M. Jansen, MD, Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier: NCT02452151     History of Changes
Other Study ID Numbers: SIMILAR
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: May 2015
Keywords provided by J.M. Jansen, MD, Onze Lieve Vrouwe Gasthuis:
Inflectra
Infliximab
Biosimilar
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents