A Prospective Non-interventional Multicenter Study to Evaluate the Effectiveness of Adalimumab in Korean Patients With Ulcerative Colitis (UC) and Identify Potential Predictors of Clinical Response in Routine Clinical Practice

NCT02499263 | Completed Results

• 1 other identifier: P15-346
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 19

Brief Summary

This is a prospective, single country, multi-center study in participants with ulcerative colitis (UC) treated with adalimumab. Up to 147 participants are enrolled at approximately 20 sites. The baseline assessment is performed prior to the first dose of adalimumab (Visit 1). Study visits are conducted at weeks 8, 16, 24, 32, 40, 48 and 56 after baseline in accordance with clinical practice. All participants will have one Follow-up for safety approximately 70 days after the last dose of adalimumab.

Conditions

Ulcerative Colitis

Keywords

Adalimumab trough level; Fecal Calprotectin; Fecal microbiota

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants Who Were Week 8 Responders With Durable Clinical Response at Week 56

  Durable clinical response was defined as reduction in complete Full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at both Week 8 and 56. Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment \[PGA\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.

  Week 56

• Percentage of Participants With Clinical Response at Week 8

  Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.

  Week 8

• Percentage of Participants With Clinical Response at Week 24

  Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 24. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.

  Week 24

• Percentage of Participants With Clinical Response at Week 56

  Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 56. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.

  Week 56

Secondary Outcomes (26)

• Percentage of Participants With Clinical Remission at Week 8

  Week 8

• Percentage of Participants With Clinical Remission at Week 56

  Week 56

• Percentage of Participants Who Were Week 8 Responders With Clinical Remission at Week 8

  Week 8

• Percentage of Participants Who Were Week 8 Responders With Clinical Remission at Week 56

  Week 56

• Percentage of Participants With Steroid-free Remission at Week 8

  Week 8

Study Arms (1)

Participants with Ulcerative Colitis (UC)

Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label in participants with active moderate-to-severe UC.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with moderate to severe ulcerative colitis (UC) receiving adalimumab per the Korean label.

You may qualify if:

• Participant must be an adult ≥19 years
• Participant with active moderate to severe ulcerative colitis with Mayo score of ≥ 6 points and endoscopic sub-score of ≥ 2 points despite treatment with corticosteroids and/or immunosuppressants.
• Participant must have tuberculosis (TB) Screening Assessment in accordance Korean reimbursement guidelines.
• Participants who had started on adalimumab treatment in normal clinical practice setting by their physician.
• Participant must provide written authorization form to use personal and/or health data prior to the entry into the study.

You may not qualify if:

• Female participants who are pregnant or breast feeding
• Participant with any contraindication to adalimumab
• Participant that is participating in other clinical trials

Sponsors & Collaborators

• AbbVie: lead

Study Sites (19)

Kyungpook National Univ Hosp /ID# 153133

Daegu, Daegu Gwang Yeogsi, 41944, South Korea

Location

St. Vincent's Hospital /ID# 138455

Suwon, Gyeonggido, 16247, South Korea

Location

Ajou University Hospital /ID# 138457

Suwon, Gyeonggido, 16499, South Korea

Location

Inje University Busan Paik Hospital /ID# 138451

Pusan, Gyeongsangbuk-do, 47392, South Korea

Location

Inha University Hospital /ID# 150176

Junggu, Incheon Gwang Yeogsi, 22332, South Korea

Location

Chonnam National University Hospital /ID# 138450

Gwangju, Jeonranamdo, 61469, South Korea

Location

Kyung Hee University Medical Center /ID# 138453

Dongdaemun-gu, Seoul Teugbyeolsi, 02447, South Korea

Location

Kangbuk Samsung Hospital /ID# 150175

Jongno-Gu, Seoul Teugbyeolsi, 03181, South Korea

Location

Severance Hospital /ID# 138456

Seoul, Seoul Teugbyeolsi, 03722, South Korea

Location

Samsung Medical Center /ID# 138449

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

SMG-SNU Boramae Medical Center /ID# 138448

Seoul, Seoul Teugbyeolsi, 07061, South Korea

Location

Keimyung Univ Dongsan medical /ID# 138447

Daegu, 700-712, South Korea

Location

Daejeon St. Mary's Hospital /ID# 138445

Daejeon, 301-723, South Korea

Location

Chosun University Hospital /ID# 138454

Gwangju, 61453, South Korea

Location

Korea University Anam Hospital /ID# 138446

Seoul, 02841, South Korea

Location

Seoul National University Hospital /ID# 138443

Seoul, 03080, South Korea

Location

Ewha Womans University Mokdong /ID# 138444

Seoul, 07985, South Korea

Location

Inje University Seoul Paik Hos /ID# 138452

Seoul, 100-032, South Korea

Location

Chung-Ang University Med. Ctr. /ID# 138441

Seoul, 156-755, South Korea

Location

Related Links

• Regarding Medicine Information

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fecal samples : Fecal calprotectin and the composition of Fecal microbiota. Blood samples : Trough level of adalimumab \& Antibodies against adalimumab.

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Limitations and Caveats

This was an observational study in routine clinical practice. Inherent limitations leading to potential bias were lack of randomization and small number of intent to treat participants who completed the study without any major protocol deviations.

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 16, 2015
• Study Start: June 11, 2015
• Primary Completion: September 17, 2018
• Study Completion: September 17, 2018
• Last Updated: November 1, 2019
• Results First Posted: November 1, 2019

Record last verified: 2019-10

Locations

KR (19)