Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).
Conditions
Interventions
Trade Name: Remsima (infliximab)
Pharmaceutical Form: Powder for concentrate for solution for injection/infusion
Sponsors
Mundipharma Pharmaceuticals B.V.
Eligibility
Sex/Gender
All
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=4, SCCAI=65 years) yes F.1.3.1 Number of subjects for this age range 59
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Objective: Not applicable.;Primary end point(s): Infliximab serum concentration of Remsima™ 16 weeks after switch from Remicade by ELISA compared to baseline. ;Timepoint(s) of evaluation of this end point: Week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Contacts
Public ContactDr. Y.J.B. van Megen
Mundipharma Pharmaceuticals B.V.
Outcome results
None listed