Clinical trial NCT02808780: An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
Official title: Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
Simponi (Golimumab)
Thiopurines
Lymphoma
Malignancies
Lead sponsor: Janssen Biotech, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-22
Enrollment: 537
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with moderate-to-severe ulcerative colitis for at least 3 months prior to enrollment will be observed

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Long-term Safety: Participants with Adverse Events of Interest (AEIs) and Serious Adverse Events (AEs) Including Malignancies, Pregnancies, and Non-serious Malignancies
timeFrame: 6 years
Secondary outcomes:
measure: Clinical Disease Status as Assessed by Partial Mayo Score
timeFrame: 6 years
measure: Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score
timeFrame: 6 years
measure: EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Score
timeFrame: 6 years
measure: Work Productivity and Activity Impairment Questionnaire - Ulcerative Colitis (WPAI-UC)
timeFrame: 6 years
measure: Treatment Satisfaction Questionnaire for Medication (TSQM) Score
timeFrame: 6 years
measure: Health Care Utilization: Evaluate the Number of Each Hospitalizations in Participants in Each Cohort
timeFrame: 6 years
measure: Health Care Utilization: Evaluate the Reasons for Hospitalization in Participants in Each Cohort
timeFrame: 6 years
Other outcomes:
Locations:
city: Murrieta
country: United States
state: California
city: Rialto
country: United States
state: California
city: Ventura
country: United States
state: California
city: Coral Gables
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Lake Worth
country: United States
state: Florida
city: Lauderdale Lakes
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Suwanee
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Sylvania
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Lansdowne Town Center
country: United States
state: Virginia
city: Salzburg
country: Austria
city: Sankt Poelten Noe
country: Austria
city: Vienna
country: Austria
city: New Westminster
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Oshawa
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Plzen
country: Czechia
city: Clermont-Ferrand
country: France
city: Clichy
country: France
city: Creteil
country: France
city: Grenoble
country: France
city: Montpellier
country: France
city: Nice
country: France
city: Pierre Bénite
country: France
city: Saint Priest en jarez
country: France
city: Strasbourg Cedex
country: France
city: Berlin
country: Germany
city: Dessau Roblau
country: Germany
city: Halle
country: Germany
city: Hamburg
country: Germany
city: Heidelberg
country: Germany
city: Kiel
country: Germany
city: Leipzig
country: Germany
city: Ludwigshafen
country: Germany
city: Lyneburg
country: Germany
city: Muenchen
country: Germany
city: Saarbrucken
country: Germany
city: Athens
country: Greece
city: Heraklion
country: Greece
city: Ioannina
country: Greece
city: Thessaloniki
country: Greece
city: Busan
country: Korea, Republic of
city: Gyeonggi-Do
country: Korea, Republic of
city: Seongnam-Si
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: A Coruna
country: Spain
city: Barcelona
country: Spain
city: Córdoba
country: Spain
city: Fuenlabrada
country: Spain
city: Huelva
country: Spain
city: Madrid
country: Spain
city: Majadahonda
country: Spain
city: San Sebastian De Los Reyes
country: Spain
city: Valencia
country: Spain
city: Vigo
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Janssen Biotech, Inc.
name: Janssen Biotech, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: