Clinical Trials Study
Copyright ©The Author(s) 2016.
World J Gastroenterol. May 7, 2016; 22(17): 4389-4396
Published online May 7, 2016. doi: 10.3748/wjg.v22.i17.4389
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
Table 2 ADAPT schedule of assessments
Visit01020304050607080910
Day-070007142128
Week-10123467812
Apheresis(▲)(▲)(▲)
Physical examination
Endoscopy/EAI4(●)5
PUCAI
Clin. Chemistry222
ESR222
Urinalysis222
Fecal sample
Coagulation222
Vital signs111
Concomitant medication
Adverse events3
Table 3 Categories of pediatric ulcerative colitis activity index changes at week 12
Significant improvement≥ 35
Moderate improvement≥ 20
Small improvement≥ 10
No change< 10
Table 4 Patient demography
Characteristicmean ± SD [range]
Age (yr)13.5 ± 2.6 [8.1-17.8]
Weight (kg)47.7 ± 11.3 [31.0-72.2]
Height (cm)157.3 ± 12.3 [132.0-175.0]
Duration of disease3.1 ± 3.2 [0.2-14]
Smoking statusNo patient ever smoked
Malen = 1352.0%
Femalen = 1248.0%
Caucasiann = 2288.0%
Oriental (near East)n = 28.0%
Othern = 14.0%
Pancolitisn = 1872%
Left sidedn = 728%
Entry PUCAI scoremean = 42.6median = 40
Entry EAI score (median)mean = 7.0median = 7.5
Table 5 Improvement in PUCAI at week 12, patients with post-baseline scores
Analysis setnmeanSD95%CI
ITT2022.319.912.9-31.6
PP836.35.831.4-41.1
Table 6 Pediatric ulcerative colitis activity index category improvement, week 12 - intention-to-treat set
Categoryn%
Significant improvement945.0
Moderate improvement525.0
Small improvement15.0
No change525.0
Table 7 Changes in endoscopy activity index
Analysis setmeanSD95%CIn
ITT-3.02.5-4.8-(-1.2)10
PP-2.82.5-5.4-(-0.2)6
Table 8 Adverse events, n
RelationSeverityAEs;
patients
(safety set)
NoneMild35; 12 (48%)
Moderate7; 4 (16%)
Severe0; 0 (0%)
Total42; 13 (52%)
Possibly or definitely relatedMild15; 6 (24%)
Moderate6; 5 (20%)
Severe0; 0 (0%)
Total21; 8 (32%)