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NCT Number: NCT02808780

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Inflammatory Bowel Diseases Intestinal Diseases Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Salzburg, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • The participant is currently receiving Simponi ,or
  • The participant is continuing to receive Simponi after participation in an ulcerative colitis study, or
  • The participant is scheduled to receive Simponi within 30 days after enrollment
  • For Thiopurine cohort:
  • The participant is currently receiving thiopurines, having received at least 12 consecutive weeks of therapy prior to registry entry
  • Participant must not be receiving other approved biologic agents, including Simponi, or any investigational agents at enrollment
  • 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

Treatment and study plan

Primary outcomes

  1. Long-term Safety: Participants with Adverse Events of Interest (AEIs) and Serious Adverse Events (AEs) Including Malignancies, Pregnancies, and Non-serious Malignancies

    Time frame: 6 years

    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.

Secondary outcomes

  1. Clinical Disease Status as Assessed by Partial Mayo Score

    Time frame: 6 years

    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.

  2. Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score

    Time frame: 6 years

    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).

  3. EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Score

    Time frame: 6 years

    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.

  4. Work Productivity and Activity Impairment Questionnaire - Ulcerative Colitis (WPAI-UC)

    Time frame: 6 years

    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.

  5. Treatment Satisfaction Questionnaire for Medication (TSQM) Score

    Time frame: 6 years

    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. Health Care Utilization: Evaluate the Number of Each Hospitalizations in Participants in Each Cohort

    Time frame: 6 years

    Number of hospitalizations in participants in each cohort will be reported.

  7. Health Care Utilization: Evaluate the Reasons for Hospitalization in Participants in Each Cohort

    Time frame: 6 years

    Reasons for hospitalization in participants in each cohort will be reported.

Sponsors and collaborators

Lead sponsor

Janssen Biotech, Inc.

Industry

Registry information

Official study title

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

Acronym: OPAL

Important dates

Study start
2016
Primary completion
2026
Study completion
2027
First posted
Jun 22, 2016
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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