Visit number | 1 Screening | 2 Inclusion* | 3 | 4 | 5 | 6 | 7 | 8 | 9 |
Week (from inclusion) | – | 0 | 4 | 8 | 16 | 24 | 32 | 40 | 48 |
Informed consent† | □ | ||||||||
Endoscopy and/or MRI | □‡ | □‡ | |||||||
Registration of demographics and medical history | □ | ||||||||
Registration of adverse events and changes in concomitant medication | □ | □ | □ | □ | □ | □ | □ | □ | □ |
Focused physical examination | □ | □ | □ | □ | □ | □ | □ | □ | |
Pregnancy test | □ | ||||||||
Biochemical parameters§ ▸ Blood sample ▸ Faecal sample | □ | □ | □ | □ | □ | □ | □ | □ | □ |
Study medication | □ | □ | □ | □ | □ | □ | |||
Blood sample before infusion¶ | □** | □ | □ | □ | □ | □ | □ | □ | □ |
Blood sample after infusion (other arm) and 1 h after the end of infusion¶ | □** | □ | □ | □ | □ | □ | □ |
*Defined as time of next scheduled treatment.
†Acquire a signed written informed consent prior to conducting any study-related procedures.
‡Endoscopy and/or MRI between visits 1 and 2, and at 4–0 weeks before visit 9.
§C reactive protein, haemoglobin, white cell counts, platelets, albumin, creatinine, alanine aminotransferase, bilirubuin and faecal calprotectin.
¶Blood sample for determination of infliximab (IFX) and anti-IFX antibody.
**Note, normally scheduled IFX therapy, not study medication.