NCT03488030: RISE AR

A Study to Evaluate Disease Control, Treatment Patterns, Burden of Disease and Quality of Life in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD)

Completed Results posted Last updated 8 February 2022

What this trial tests

trial in Crohn Disease in 246 participants. Completed in 31 May 2019.

Timeline

12 December 2018

Primary endpoint
31 May 2019

31 May 2019

Quick facts

Lead sponsor	Takeda
Status	Completed
Study type	OBSERVATIONAL
Enrollment	246
Start date	12 December 2018
Primary completion	31 May 2019
Estimated completion	31 May 2019
Sites	7 locations across Argentina

Conditions studied

• Crohn Disease — all drugs for Crohn Disease →
• Colitis, Ulcerative — all drugs for Colitis, Ulcerative →
• Inflammatory Bowel Disease — all drugs for Inflammatory Bowel Disease →

Sponsor

Takeda — full company profile →

Who can join

18 and older, any sex, with Crohn Disease or Colitis, Ulcerative. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Crohn's Disease: Percentage of Participants With Active CD at Day 1 Primary · Day 1

Percentage of participants with active CD were observed, where active CD was defined as Harvey Bradshaw index (HBI) greater than or equal to (\>=) 8 or Crohn's disease active index (CDAI) \>= 220 points. CDAI assessed CD based on clinical signs and symptoms such as number of liquid stools, intensity of abdominal pain, general wellbeing, presence of comorbid conditions, use of antidiarrheal, physical examination and laboratory findings. Total score ranged from 0 to 600 points. Higher score indicated more severe disease. HBI consisted of 5 clinical parameters: general well-being, abdominal pain,

Group	Value	95% CI
Crohn's Disease	9.3	4.3 – 16.9

Ulcerative Colitis: Percentage of Participants With Active UC at Day 1 Primary · Day 1

Percentage of participants with active disease UC disease were observed, where UC was defined as 9-point Partial Mayo Score (pMayo score) \>=5. The Mayo score was composed of four categories (bleeding, stool frequency, physician assessment, and endoscopic appearance) rated from 0 to 3 that are summed to give a total score that ranges from 0 to 12. The pMayo score was previously compared with the full Mayo score and categorized participants as being in remission (score of 0 to 2), having mild disease (pMayo of 3 or 4) or moderate to severe disease (pMayo of \>=5).

Group	Value	95% CI
Ulcerative Colitis	7.7	3.9 – 13.3

Number of Participants With Moderate to Severe CD or UC Stratified by Steroid Behavior Secondary · Day 1

Group	Value	95% CI
Crohn's Disease	28
Ulcerative Colitis	71
Crohn's Disease	16
Ulcerative Colitis	12
Crohn's Disease	5
Ulcerative Colitis	7
Crohn's Disease	52
Ulcerative Colitis	54

Number of Participants With Moderate to Severe CD or UC Stratified by Anthropometric Information Secondary · Day 1

Anthropometric information included height, weight and body mass index (BMI). BMI ranges: underweight (BMI less than \[\<\] 18.50 kilogram per square meter (kg/m\^2), normal range (BMI between 18.50 and 24.99 kg/m\^2), overweight (BMI between 25.00 and 29.99 kg/m\^2), obese (BMI \>=30.00 kg/m\^2).

Height (cm)

Group	Value	95% CI
Crohn's Disease	NA
Ulcerative Colitis	NA

Weight (kg)

Group	Value	95% CI
Crohn's Disease	NA
Ulcerative Colitis	NA

BMI, underweight

Group	Value	95% CI
Crohn's Disease	3
Ulcerative Colitis	8

BMI, normal range

Group	Value	95% CI
Crohn's Disease	54
Ulcerative Colitis	55

BMI, overweight

Group	Value	95% CI
Crohn's Disease	33
Ulcerative Colitis	55

BMI, obese

Group	Value	95% CI
Crohn's Disease	11
Ulcerative Colitis	27

Number of Participants With Moderate to Severe CD or UC Based on Medical History, Comorbidities or Extra Intestinal Manifestation (EIM) Secondary · Day 1

Medical history was defined as an EIM or non-EIM according to the investigator's judgement.

With medical history, comorbidity or EIM

Group	Value	95% CI
Crohn's Disease	49
Ulcerative Colitis	74

Without medical history, comorbidity or EIM

Group	Value	95% CI
Crohn's Disease	52
Ulcerative Colitis	71

Crohn's Disease: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization Secondary · Day 1

The Montreal classification index for CD was used to classify the extent of the disease activity. It consisted of two parameters: location and behavior of the disease activity. There were four different disease locations presented: Location 1 (L1) is ileum, Location 2 (L2) is colonic disease, Location 3 (L3) is ileocolon and Location 4 (L4) is isolated upper gastrointestinal (GI) tract disease. The first three categories (L1-L3) was combined with L4 where disease sites coexisted. There were 4 different categories for the behavior of the disease activity: Behavior 1 (B1) was non stenosing or no

Location, L1

Group	Value	95% CI
Crohn's Disease	9

Location, L1+L4

Group	Value	95% CI
Crohn's Disease	2

Location, L2

Group	Value	95% CI
Crohn's Disease	52

Location, L2+L4

Group	Value	95% CI
Crohn's Disease	0

Location, L3

Group	Value	95% CI
Crohn's Disease	33

Location, L3+L4

Group	Value	95% CI
Crohn's Disease	4

Location, L4

Group	Value	95% CI
Crohn's Disease	1

Behavior, B1

Group	Value	95% CI
Crohn's Disease	35

Ulcerative Colitis: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization Secondary · Day 1

Montreal classification index for UC was used to classify the extent and severity of the disease activity. There were three subgroups of UC defined by extent of inflammation: Extent 1 (E1) =Ulcerative distal UC proctitis and proctosigmoiditis, Extent 2 (E2) =Left-sided mucosa inflammation extending up to splenic flexure and Extent 3 (E3) =Pancolitis mucosa inflammation up to proximal transverse colon and beyond. Severity of UC as S0=Clinical remission (asymptomatic),S1 =Mild UC (passage of four or fewer stools/day \[with or without blood\],absence of any systemic illness, and normal inflammato

Extent Inflammation, E1-Distal: Proctitis

Group	Value	95% CI
Ulcerative Colitis	13

Extent Inflammation, E1-Distal: Proctosigmoiditis

Group	Value	95% CI
Ulcerative Colitis	4

Extent of Inflammation, E2

Group	Value	95% CI
Ulcerative Colitis	60

Extent of Inflammation, E3

Group	Value	95% CI
Ulcerative Colitis	66

Severity, S0

Group	Value	95% CI
Ulcerative Colitis	66

Severity, S1

Group	Value	95% CI
Ulcerative Colitis	33

Severity, S2

Group	Value	95% CI
Ulcerative Colitis	30

Severity, S3

Group	Value	95% CI
Ulcerative Colitis	14

Number of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years Secondary · Within previous 3 years including Day 1

Various types of therapies for IBD included salicylic derivatives, corticosteroids, immunosuppressors, biologic therapy, antibiotics, nutrition support and others. One participant could use more than one therapy.

Salicylic derivatives

Group	Value	95% CI
Crohn's Disease	63
Ulcerative Colitis	142

Corticosteroids

Group	Value	95% CI
Crohn's Disease	56
Ulcerative Colitis	101

Immunosuppressors

Group	Value	95% CI
Crohn's Disease	66
Ulcerative Colitis	85

Biologic therapy

Group	Value	95% CI
Crohn's Disease	80
Ulcerative Colitis	49

Antibiotics

Group	Value	95% CI
Crohn's Disease	14
Ulcerative Colitis	13

Nutrition support

Group	Value	95% CI
Crohn's Disease	0
Ulcerative Colitis	0

Other

Group	Value	95% CI
Crohn's Disease	9
Ulcerative Colitis	25

Duration of IBD Treatment During Previous 3 Years Secondary · Within previous 3 years including Day 1

Time between the beginning of IBD treatment until the end of treatment. For participants with ongoing IBD treatment at Day 1, stop date was considered as Day 1 date visit. Various types of therapies for IBD included salicylic derivates, corticosteroids, immunosuppressors, biologic therapy, antibiotics, nutrition support and others. One participant could use more than one therapy.

Salicylic derivates treatment

Group	Value	95% CI
Crohn's Disease	35.90	0.52 – 35.97
Ulcerative Colitis	33.11	0.03 – 35.97

Corticosteroids treatment

Group	Value	95% CI
Crohn's Disease	3.74	0.03 – 35.97
Ulcerative Colitis	3.96	0.03 – 35.97

Immunosuppressors treatment

Group	Value	95% CI
Crohn's Disease	21.13	0.03 – 35.97
Ulcerative Colitis	19.54	0.03 – 35.97

Biologic therapy treatment

Group	Value	95% CI
Crohn's Disease	29.26	0.03 – 35.97
Ulcerative Colitis	17.97	0.03 – 35.97

Antibiotics treatment

Group	Value	95% CI
Crohn's Disease	1.33	0.26 – 35.97
Ulcerative Colitis	0.59	0.07 – 1.28

Number of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy During Previous 3 Years Secondary · Within previous 3 years including Day 1

Biologic therapies included infliximab, adalimumab, vedolizumab, certolizumab, golimumab, and ustekimumab. For participants with ongoing biologic therapy at Day 1, stop date was considered as Day 1 date visit.

Group	Value	95% CI
Crohn's Disease	17
Ulcerative Colitis	23
Crohn's Disease	51
Ulcerative Colitis	18
Crohn's Disease	2
Ulcerative Colitis	1
Crohn's Disease	1
Ulcerative Colitis	0

Number of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies With Reasons Secondary · Within previous 3 years including Day 1

Adverse reaction

Group	Value	95% CI
Crohn's Disease	4
Ulcerative Colitis	0

Pregnancy

Group	Value	95% CI
Crohn's Disease	1
Ulcerative Colitis	2

Surgery

Group	Value	95% CI
Crohn's Disease	4
Ulcerative Colitis	0

Poor effectiveness

Group	Value	95% CI
Crohn's Disease	16
Ulcerative Colitis	8

Remission

Group	Value	95% CI
Crohn's Disease	2
Ulcerative Colitis	0

Patient decision

Group	Value	95% CI
Crohn's Disease	0
Ulcerative Colitis	3

Patient poor adherence

Group	Value	95% CI
Crohn's Disease	1
Ulcerative Colitis	0

Patient access to treatment

Group	Value	95% CI
Crohn's Disease	1
Ulcerative Colitis	1

Number of Participants With Moderate to Severe CD or UC Who Had IBD Treatment Initiation on Day 1 Secondary · Day 1

Group	Value	95% CI
Crohn's Disease	11
Ulcerative Colitis	20

Sponsor's own description

The purpose of this study is to evaluate the percentage of moderate to severe IBD participants with active disease at Day 1.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Real-world clinical characteristics and therapeutic strategies in patients with moderate-to-severe inflammatory bowel disease in Argentina: Data from the RISE-AR study.
   Olivera PA, Balderramo D, Lasa JS, Zubiaurre I, et al · · 2025 · cited 1× · PMID 39549817 · DOI 10.1016/j.gastrohep.2024.502287