Clinical trial NCT02499263: 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
Official title: A Prospective Multicenter Study to Observe the Effectiveness on Ulcerative Colitis and Predictive Factors of Clinical Response in Korean Patients Treated With Adalimumab (EUREKA Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Keywords: Adalimumab trough level
Fecal Calprotectin
Fecal microbiota
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-07-16
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with moderate to severe ulcerative colitis (UC) receiving adalimumab per the Korean label.

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.

Detailed description: This is a prospective, single-country, multi-center study in UC patients treated with adalimumab. The prescription of adalimumab is at the discretion of the physician in accordance with clinical practice and label, is made independently from this study, and preceded the decision to offer the patient the opportunity to participate in this study.

Up to 147 subjects are planned to be enrolled at approximately 20 sites. The baseline assessment is performed prior to the first dose of adalimumab (Visit 1). Participants are administered adalimumab 160 mg at Week 0, 80 mg at Week 2, and then 40 mg every other week per the Korean label. Study visits are conducted at Weeks 8, 16, 24, 32, 40, 48 and 56 after baseline in accordance with clinical practice. All participants had one Follow-up for safety approximately 70 days after the last dose of adalimumab.

Clinical response is assessed at Week 8, and participants with clinical response at Week 8 can continue on adalimumab treatment as per Korean reimbursement guidelines. Clinical response is defined as a decrease from baseline in the total Mayo score by at least 3 points and at least 30% with an accompanying decrease in rectal bleeding subscore of at least 1 point or absolute rectal bleeding sub-score of 0 or 1.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Percentage of Participants Who Were Week 8 Responders With Durable Clinical Response at Week 56
timeFrame: Week 56
measure: Percentage of Participants With Clinical Response at Week 8
timeFrame: Week 8
measure: Percentage of Participants With Clinical Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Clinical Response at Week 56
timeFrame: Week 56
Secondary outcomes:
measure: Percentage of Participants With Clinical Remission at Week 8
timeFrame: Week 8
measure: Percentage of Participants With Clinical Remission at Week 56
timeFrame: Week 56
measure: Percentage of Participants Who Were Week 8 Responders With Clinical Remission at Week 8
timeFrame: Week 8
measure: Percentage of Participants Who Were Week 8 Responders With Clinical Remission at Week 56
timeFrame: Week 56
measure: Percentage of Participants With Steroid-free Remission at Week 8
timeFrame: Week 8
measure: Percentage of Participants With Steroid-free Remission at Week 56
timeFrame: Week 56
measure: Percentage of Participants Who Were Week 8 Responders With Steroid-free Remission at Week 8
timeFrame: Week 8
measure: Percentage of Participants Who Were Week 8 Responders With Steroid-free Remission at Week 56
timeFrame: Week 56
measure: Percentage of Participants With Steroid-free Response at Week 8
timeFrame: Week 8
measure: Percentage of Participants With Steroid-free Response at Week 56
timeFrame: Week 56
measure: Percentage of Participants Who Were Week 8 Responders With Steroid-free Response at Week 8
timeFrame: Week 8
measure: Percentage of Participants Who Were Week 8 Responders With Steroid-free Response at Week 56
timeFrame: Week 56
measure: Percentage of Participants With Mucosal Healing at Week 8
timeFrame: Week 8
measure: Percentage of Participants With Mucosal Healing at Week 56
timeFrame: Week 56
measure: Percentage of Participants Who Were Week 8 Responders With Mucosal Healing at Week 8
timeFrame: Week 8
measure: Percentage of Participants Who Were Week 8 Responders With Mucosal Healing at Week 56
timeFrame: Week 56
measure: Change in Partial Mayo Score From Baseline to Week 8 in Participants Who Were Clinical Responders at Week 56
timeFrame: Baseline, Week 8
measure: Change in Full Mayo Score From Baseline to Week 8 in Participants Who Were Clinical Responders at Week 56
timeFrame: Baseline, Week 8
measure: Change in Full Mayo Score From Baseline to Week 56 in Participants Who Were Clinical Responders at Week 56
timeFrame: Baseline, Week 56
measure: Fecal Calprotectin Level at Week 8
timeFrame: Week 8
measure: Fecal Calprotectin Level at Week 56
timeFrame: Week 56
measure: Fecal Calprotectin Level at Week 8 in Participants Who Were Clinical Responders at Week 8
timeFrame: Week 8
measure: Fecal Calprotectin Level at Week 56 in Participants Who Were Clinical Responders at Week 8
timeFrame: Week 56
measure: Fecal Calprotectin Level at Week 8 in Participants Who Were Clinical Responders at Week 56
timeFrame: Week 8
measure: Fecal Calprotectin Level at Week 56 in Participants Who Were Clinical Responders at Week 56
timeFrame: Week 56
measure: Change in the Composition of Fecal Microbiota From Baseline to Week 8 and Week 56
timeFrame: Week 0, Week 8, Week 56
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National Univ Hosp /ID# 153133
state: Daegu Gwang Yeogsi
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital /ID# 138457
state: Gyeonggido
city: Suwon
country: Korea, Republic of
facility: St. Vincent's Hospital /ID# 138455
state: Gyeonggido
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital /ID# 138451
state: Gyeongsangbugdo
city: Jung-gu
country: Korea, Republic of
facility: Inha University Hospital /ID# 150176
state: Incheon Gwang Yeogsi
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital /ID# 138450
state: Jeonranamdo
city: Dongdaemun-gu
country: Korea, Republic of
facility: Kyung Hee University Medical Center /ID# 138453
state: Seoul Teugbyeolsi
city: Jongno-Gu
country: Korea, Republic of
facility: Kangbuk Samsung Hospital /ID# 150175
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Severance Hospital /ID# 138456
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 138449
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center /ID# 138448
state: Seoul Teugbyeolsi
city: Daegu
country: Korea, Republic of
facility: Keimyung Univ Dongsan medical /ID# 138447
city: Daejeon
country: Korea, Republic of
facility: Daejeon St. Mary's Hospital /ID# 138445
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital /ID# 138454
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital /ID# 138446
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 138443
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong /ID# 138444
city: Seoul
country: Korea, Republic of
facility: Inje University Seoul Paik Hos /ID# 138452
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Med. Ctr. /ID# 138441
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: