An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— OPAL  

Official title:

Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02808780
• Other study ID #: CR105891
• Secondary ID: CNTO148UCO4001
• Status: Active, not recruiting
• Start date: December 16, 2016
• Est. completion date: December 10, 2026

Study information

• Verified date: June 2024
• Source: Janssen Biotech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to describe the long-term safety risks in adult participants with moderate-to-severe ulcerative colitis who are treated with Simponi.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 537
• Est. completion date: December 10, 2026
• Est. primary completion date: December 10, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have moderate-to-severe ulcerative colitis of at least 3 months' duration prior to enrollment, confirmed by endoscopy at any time in the past

• For enrollment into the Simponi-exposed cohort meets one of the following:

1. The participant is currently receiving Simponi ,or

2. The participant is continuing to receive Simponi after participation in an ulcerative colitis study, or

3. The participant is scheduled to receive Simponi within 30 days after enrollment

• For Thiopurine cohort:

1. The participant is currently receiving thiopurines, having received at least 12 consecutive weeks of therapy prior to registry entry

2. Participant must not be receiving other approved biologic agents, including Simponi, or any investigational agents at enrollment

3. Participant may have received biologics other than Simponi or investigational agents prior to enrollment

Exclusion Criteria:

• Participants who cannot be treated with Simponi or thiopurines

• Participants with a previous diagnosis of lymphoma or hematologic malignancy at any time prior to enrollment

• Participants currently receiving an investigational or biologic agent other than Simponi

• Participants with any condition for which, in the opinion of the investigator, participation in the registry would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Biotech, Inc.

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Czechia,  France,  Germany,  Greece,  Korea, Republic of,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term Safety: Participants with Adverse Events of Interest (AEIs) and Serious Adverse Events (AEs) Including Malignancies, Pregnancies, and Non-serious Malignancies	Descriptive analysis of serious adverse events, adverse events of interest (including lymphoma & other malignancies), pregnancies, and non-serious malignancies in participants less than (<) 30 years of age will be reported.	6 years
Secondary	Clinical Disease Status as Assessed by Partial Mayo Score	The partial Mayo score, a validated tool used to assess disease status in participants with ulcerative colitis, will be utilized to assess clinical status in this registry. Information will be obtained using 3 of the individual components of the full Mayo score, including stool frequency, rectal bleeding, and PGA (Physician's Global Assessment). Each component score ranges from 0 (normal) to 3 (severe disease) and the score is the sum of those three categories. The total Partial Mayo Score will be calculated as the sum of the scores of all 3 components for each participant that ranges from 0-9.	6 years
Secondary	Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score	The SIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The total score ranges from 10 (worst health) to 70 (best health).	6 years
Secondary	EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Score	The EQ-5D-5L is a standardized non-disease specific instrument for describing and assessing health-related quality of life.This instrument evaluates 5 areas including mobility, ability for self-care, ability in usual activities, pain/discomfort and anxiety/depression.There also is a self-evaluated 100-point health assessment.	6 years
Secondary	Work Productivity and Activity Impairment Questionnaire - Ulcerative Colitis (WPAI-UC)	The WPAI-UC is a validated instrument that measures the effect of ulcerative colitis (UC) symptoms on a patient's life (eg, diarrhea, loss of appetite, weight loss, abdominal pain, fever, joint pain, skin sores, rectal bleeding) and on his or her ability to work and perform regular activities.	6 years
Secondary	Treatment Satisfaction Questionnaire for Medication (TSQM) Score	The TSQM is a 14-question instrument that gauges a patient's experience with his or her medication.The questionnaire was designed to evaluate the effectiveness, side effects, and convenience of the medication over a period of 2- to 3-weeks or since the last time it was taken.	6 years
Secondary	Health Care Utilization: Evaluate the Number of Each Hospitalizations in Participants in Each Cohort	Number of hospitalizations in participants in each cohort will be reported.	6 years
Secondary	Health Care Utilization: Evaluate the Reasons for Hospitalization in Participants in Each Cohort	Reasons for hospitalization in participants in each cohort will be reported.	6 years