Reumatoid Arthritis/Rheumatism
Conditions
Interventions
The IMP in this study is the by EMA approved infliximab biosimilar, Remsima.
Eligible subjects will have been treated for more than 30 weeks with Remicade
before they are enrolled in this study. Eli
Phase IV
Serum inliximab concentration
Sponsors
Mundipharma
Eligibility
Age
18 Years to 64 Years
Inclusion 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
Exclusion criteria
Exclusion criteria: 1. Subjects with evidence of the following major comorbidities such as: severe diabetic mellitus, tuberculosis, 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 adjustments 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 drug concentration measurements. 6. Simultaneous treatment with another biological or a not registered New Chemical Entity. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Infliximab serum concentration of Remsima* 16 weeks after switch from Remicade by ELISA compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Infliximab serum concentration of Remsima* 8 weeks after switch from Remicade by bridging ELISA. • Anti-drug infliximab (ADI) levels at 8 and 16 weeks after switch from Remicade by radio-immune assay (RIA). • Disease activity: For CD: Harvey-Bradshaw Index (HBI), and serum C-reactive protein (CRP) at week 8 and 16 and faecal calprotectin at week 16. For UC: Simple Clinical Colitis Activity Index (SCCAI), and serum CRP at week 8 and 16 and faecal calprotectin at week 16. For RA: Disease Activity Score (DAS)-28 score and serum CRP at week 8 and 16. • Serial measurements in EQ-5D score, overall and per disease group at week 16. • Incidence and type of AEs, SAEs and infusion reactions at week 8 and 16 (Remsima*). | — |
Countries
Belgium, Netherlands
Outcome results
None listed