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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 20 August 2018
Main ID:  EUCTR2014-004904-31-BE
Date of registration: 29/07/2016
Prospective Registration: Yes
Primary sponsor: Mundipharma Pharmaceuticals B.V.
Public title: A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.
Scientific title: An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.
Date of first enrolment: 21/09/2016
Target sample size: 156
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004904-31
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: Baseline measurements of Remicade therapy are used as reference.
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries of recruitment
Belgium Netherlands
Contacts
Name: Dr. Y.J.B. van Megen   
Address:  Leusderend24 3832 RC Leusden Netherlands
Telephone: +31334508270
Email: yvonne.vanmegen@mundipharma.nl
Affiliation:  Mundipharma Pharmaceuticals B.V.
Name: Dr. Y.J.B. van Megen   
Address:  Leusderend24 3832 RC Leusden Netherlands
Telephone: +31334508270
Email: yvonne.vanmegen@mundipharma.nl
Affiliation:  Mundipharma Pharmaceuticals B.V.
Key inclusion & exclusion criteria
Inclusion criteria:
1. Male or female, age =18 years.
2. Subject will have a confirmed diagnosis of RA, UC or CD.
3. Stable remission defined as HBI=4, SCCAI<3, DAS 28<3.2 at screening.
4. Stable and continuous treatment with Remicade during the last 30 weeks, and no foreseen dose adjustment for the coming 2 months for infliximab.
5. Stable concomitant treatment; if concomitant drugs than stable for 4 months and no foreseen changes in drugs.
For RA: stable and continuous treatment with MTX.
6. Non-pregnant, non-nursing female.
7. Subject capable of understanding and signing an informed consent form.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion criteria:
1. Subjects with evidence of the following major co-morbidities such as: severe diabetic mellitus, tuberculosis (TB), severe infections, uncontrollable hypertension, severe cardiovascular disease (New York Heart Association [NYHA] class 3 or 4) and/or severe respiratory diseases.
2. Any other condition/disease, which in the opinion of the investigator makes the subject ineligible for the study.
3. Any clinically relevant hypersensitivity to (anaphylaxis or infusion related reactions) infliximab or to other murine proteins
4. Change of major co-medication during the last 4 months prior to screening and foreseen dose adjustment during the next 2 months:
RA: Initiation of systemic corticosteroids or synthetic DMARDs or other medication, which according to the investigator would interfere with the stability of the disease.
UC and CD: Initiation of systemic corticosteroids or an immunosuppressant or other medication, which according to the investigator would interfere with the stability of the disease.
5. Change in treatment with Remicade during the last 30 weeks due to disease related factors, not including dose/frequency adjustments due to serum infliximab concentration measurements.
6. Simultaneous treatment with another biological or a not registered NCE.
7. Psychiatric or mental disorders, alcohol abuse or other substance abuse (and/or history of opioid abuse), language barriers or other factors which makes adherence to the study protocol impossible.
8. Inadequate birth control, pregnancy, and/or breastfeeding.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

Trade Name: Remsima (infliximab)
Pharmaceutical Form: Powder for concentrate for solution for injection/infusion

Primary Outcome(s)
Main Objective: To demonstrate that the infliximab serum concentration of Remsima™ is non-inferior to the infliximab serum concentration of Remicade , 16 weeks after switch from Remicade to Remsima™ in subjects with CD, UC or RA in stable remission for > 30 weeks measured by a bridging enzyme-linked immunosorbent assay (ELISA).
Primary end point(s): Infliximab serum concentration of Remsima™ 16 weeks after switch from Remicade by ELISA compared to baseline.
Secondary Objective: Not applicable.
Timepoint(s) of evaluation of this end point: Week 16.
Secondary Outcome(s)
Secondary end point(s): • Infliximab serum concentration of Remsima™ 8 weeks after switch from Remicade by ELISA compared to baseline.
• Antibody to infliximab (ATI) levels at 8 and 16 weeks after switch from Remicade by radio-immune assay (RIA) compared to baseline.
• Disease activity:
For CD: Harvey-Bradshaw Index (HBI), and serum C-reactive protein (CRP) at week 8 and 16 compared to baseline. Faecal calprotectin at week 16 compared to baseline.
For UC: Simple Clinical Colitis Activity Index (SCCAI), and serum CRP at week 8 and 16 compared to baseline. Faecal calprotectin at week 16 compared to baseline.
For RA: DAS-28 score and serum CRP at week 8 and 16 compared to baseline.
• European Quality of Life-5 Dimensions (EQ-5D) score, overall and per disease group at week 16 compared to baseline.
• Adverse events (AEs), serious adverse events (SAEs) and infusion reactions at week 8 and 16 compared to incidence and type of adverse drug reactions (ADR) of Remicade at baseline.
Timepoint(s) of evaluation of this end point: At 8 and 16 weeks.
Secondary ID(s)
2014-004904-31-NL
IFX4501
Source(s) of Monetary Support
Mundipharma Pharmaceuticals B.V.
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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