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

NCT02452151 | Unknown Phase 4

• 1 other identifier: SIMILAR
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colitis, Ulcerative; Crohn's Disease

Keywords

Inflectra; Infliximab; Biosimilar

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Infliximab-biosimilar

EXPERIMENTAL

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

Infliximab-Innovator

ACTIVE COMPARATOR

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

Interventions

Infliximab-Biosimilar DRUG

Infliximab-biosimilar

Infliximab-Innovator DRUG

Infliximab-Innovator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Onze Lieve Vrouwe Gasthuis: lead
• Santeon: collaborator

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Jeroen Jansen, MD

CONTACT

J.M.Jansen@olvg.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: J.M. Jansen, MD

Study Record Dates

• First Submitted: May 20, 2015
• First Posted: May 22, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 22, 2015

Record last verified: 2015-05