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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Crohn's Disease; Colitis, Ulcerative
• Intervention / Treatment: Drug: Infliximab-Biosimilar; Drug: Infliximab-Innovator

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse rate	Efficacy of Infliximab-Biosimilar and Infliximab will be assessed by evaluation of the relapse rate for each diagnosis seperately.	3 months
Duration of clinical remission	Efficacy of Infliximab-Biosimilar and Infliximab will be assessed by evaluation of the the duration of clinical remission for each diagnosis seperately.	3 months

Collaborators and Investigators

• Sponsor: Onze Lieve Vrouwe Gasthuis
• Collaborators: Santeon

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: May 20, 2015
• First Submitted That Met QC Criteria: May 21, 2015
• First Posted (Estimate): May 22, 2015

Study Record Updates

• Last Update Posted (Estimate): May 22, 2015
• Last Update Submitted That Met QC Criteria: May 21, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Infliximab; Biosimilar; Inflectra
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Colitis; Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Antirheumatic Agents; Gastrointestinal Agents; Dermatologic Agents; Infliximab
• Other Study ID Numbers: SIMILAR