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.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 156

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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