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.

• 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
• Affiliation: Mundipharma Pharmaceuticals B.V.

• Name: Dr. Y.J.B. van Megen
• 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)

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.

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).

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)

IFX4501

2014-004904-31-NL

Source(s) of Monetary Support

Mundipharma Pharmaceuticals B.V.