N/A
Completed N=146
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
Source: ClinicalTrials.gov NCT02499263 ↗Enrolled (actual)
146
Serious AEs
6.2%
Results posted
Nov 2019
Primary outcomePrimary: Percentage of Participants Who Were Week 8 Responders With Durable Clinical Response at Week 56 — 53.95 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Were Week 8 Responders With Durable Clinical Response at Week 56 |
53.95 | — |
| PRIMARY Percentage of Participants With Clinical Response at Week 8 |
52.05 | — |
| PRIMARY Percentage of Participants With Clinical Response at Week 24 |
54.11 | — |
| PRIMARY Percentage of Participants With Clinical Response at Week 56 |
37.67 | — |
| SECONDARY Percentage of Participants With Clinical Remission at Week 8 |
23.97 | — |
| SECONDARY Percentage of Participants With Clinical Remission at Week 56 |
21.92 | — |
| SECONDARY Percentage of Participants Who Were Week 8 Responders With Clinical Remission at Week 8 |
23.97 | — |
| SECONDARY Percentage of Participants Who Were Week 8 Responders With Clinical Remission at Week 56 |
35.53 | — |
| SECONDARY Percentage of Participants With Steroid-free Remission at Week 8 |
12.33 | — |
| SECONDARY Percentage of Participants With Steroid-free Remission at Week 56 |
21.23 | — |
| SECONDARY Percentage of Participants Who Were Week 8 Responders With Steroid-free Remission at Week 8 |
12.33 | — |
| SECONDARY Percentage of Participants Who Were Week 8 Responders With Steroid-free Remission at Week 56 |
34.21 | — |
| SECONDARY Percentage of Participants With Steroid-free Response at Week 8 |
30.82 | — |
| SECONDARY Percentage of Participants With Steroid-free Response at Week 56 |
36.30 | — |
| SECONDARY Percentage of Participants Who Were Week 8 Responders With Steroid-free Response at Week 8 |
30.82 | — |
| SECONDARY Percentage of Participants Who Were Week 8 Responders With Steroid-free Response at Week 56 |
51.32 | — |
| SECONDARY Percentage of Participants With Mucosal Healing at Week 8 |
39.04 | — |
| SECONDARY Percentage of Participants With Mucosal Healing at Week 56 |
30.14 | — |
| SECONDARY Percentage of Participants Who Were Week 8 Responders With Mucosal Healing at Week 8 |
39.04 | — |
| SECONDARY Percentage of Participants Who Were Week 8 Responders With Mucosal Healing at Week 56 |
46.05 | — |
| SECONDARY Change in Partial Mayo Score From Baseline to Week 8 in Participants Who Were Clinical Responders at Week 56 |
1.89 | — |
| SECONDARY Change in Full Mayo Score From Baseline to Week 8 in Participants Who Were Clinical Responders at Week 56 |
3.17 | — |
| SECONDARY Change in Full Mayo Score From Baseline to Week 56 in Participants Who Were Clinical Responders at Week 56 |
2.38 | — |
| SECONDARY Fecal Calprotectin Level at Week 8 |
456.89 | — |
| SECONDARY Fecal Calprotectin Level at Week 56 |
380.17 | — |
| SECONDARY Fecal Calprotectin Level at Week 8 in Participants Who Were Clinical Responders at Week 8 |
336.33 | — |
| SECONDARY Fecal Calprotectin Level at Week 56 in Participants Who Were Clinical Responders at Week 8 |
281.87 | — |
| SECONDARY Fecal Calprotectin Level at Week 8 in Participants Who Were Clinical Responders at Week 56 |
464.58 | — |
| SECONDARY Fecal Calprotectin Level at Week 56 in Participants Who Were Clinical Responders at Week 56 |
415.40 | — |
| SECONDARY Change in the Composition of Fecal Microbiota From Baseline to Week 8 and Week 56 |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT02499263). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.