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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 June 2015
• Main ID: NCT02452151
• Date of registration: 20/05/2015
• Prospective Registration: Yes
• Primary sponsor: Onze Lieve Vrouwe Gasthuis
• Public title: "Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial" SIMILAR
• Scientific 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.
• Date of first enrolment: August 2015
• Target sample size: 300
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT02452151
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
• Phase: Phase 4

Contacts

• Name: Jeroen Jansen, MD

Key inclusion & exclusion 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-? 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Crohn's Disease

Intervention(s)

Drug: Infliximab-Biosimilar

Drug: Infliximab-Innovator

Primary Outcome(s)

Duration of clinical remission [Time Frame: 3 months]

Relapse rate [Time Frame: 3 months]

Secondary ID(s)

SIMILAR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Santeon