Colitis, UlcerativePhase 4SIMILARNCT02452151
"Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial"
A Phase 4 study testing Infliximab-Biosimilar and Infliximab-Innovator in people with Colitis, Ulcerative and Crohn's Disease, run by Onze Lieve Vrouwe Gasthuis.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colitis, Ulcerative, Crohn's Disease
- What is being tested?
- Infliximab-Biosimilar and Infliximab-Innovator
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Sep 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
- New York Heart Association (NYHA) class III or IV heart failure.
- History of organ transplantation, including corneal graft/transplantation.
- Patient has had treatment with any other investigational device or medical product within 4 weeks of randomization or 5 half-lives, whichever is longer.
- Female patient who is currently pregnant, breastfeeding or planning to become pregnant or breastfeed within 6 months of the last dose of study drug.
Trial locations and contacts
No sites are listed yet.
Jeroen Jansen, MD contact
About this study
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.
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
- Being tested
- Infliximab-Biosimilar, Infliximab-Innovator
- Keywords
- Inflectra, Infliximab, Biosimilar
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infliximab-BiosimilarDrug
Infliximab-InnovatorDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Infliximab-Innovator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse rate
Efficacy of Infliximab-Biosimilar and Infliximab will be assessed by evaluation of the relapse rate for each diagnosis seperately.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Onze Lieve Vrouwe Gasthuis
- Sponsor type
- University, hospital or other
- Collaborators
- Santeon
- Responsible party
- Principal investigator, J.M. Jansen, MD, Onze Lieve Vrouwe Gasthuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452151
- Sponsor's protocol ID
- SIMILAR
- Acronym
- SIMILAR
- Status last verified
- May 2015
- First submitted
- 20 May 2015
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02452151
- Acronym / sponsor ID
- SIMILAR / SIMILAR
- Conditions
- Colitis, Ulcerative, Crohn's Disease
- Keywords
- Inflectra, Infliximab, Biosimilar
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Onze Lieve Vrouwe GasthuisUniversity, hospital or other
- Collaborators
- Santeon
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 22 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infliximab-biosimilar | Experimental | Drug: Infliximab-BiosimilarInfliximab-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. |
| Infliximab-Innovator | Active comparator | Drug: Infliximab-InnovatorInfliximab-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (19 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infliximab-Biosimilar | Drug | Infliximab-biosimilar |
| Infliximab-Innovator | Drug | Infliximab-Innovator |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeroen Jansen, MD contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infliximab-Biosimilar and Infliximab-Innovator in people with Colitis, Ulcerative and Crohn's Disease, run by Onze Lieve Vrouwe Gasthuis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeroen Jansen, MD (J.M.Jansen@olvg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse rate (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2015; AzTrials last refreshed its copy on 8 Nov 2026.