Efficacy and safety of granulocyte, monocyte/macrophage adsorptive in pediatric ulcerative colitis

Table 1 ADAPT trial key inclusion criteria

Children and adolescents < 18 yr and with a body weight ≥ 30 kg

Ulcerative colitis documented by clinical symptoms, endoscopic findings and histology since at least 3 mo prior to inclusion

Moderate active ulcerative colitis at baseline, defined as a PUCAI score between 35 and 64

Pancolitis or left-sided colitis

Receiving or having received one or more of the following medicinal products before screening:

Sulfasalazine, mesalamine and other 5-aminosalicylic acid agents for 4 wk or more with a stable dose for the last 2 wk

0.5 mg/kg per body weight with a maximum of 20 mg per day of prednisone with a stable dose for the last 2 wk, or

6-mercaptopurine or azathioprine for 12 wk or more with a stable dose for the last 4 wk

PUCAI: Pediatric ulcerative colitis activity index.