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



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:December 16, 2016
End Date:July 30, 2031
Contact:Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:
Email:JNJ.CT@sylogent.com

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

The purpose of this study is to compare the incidence of lymphoma in adult participants with
moderate-to-severe ulcerative colitis who are treated with Simponi versus those treated with
thiopurines.

This is an observational prospective long-term exposure registry of adult participants with
moderate-to-severe ulcerative colitis. Two cohorts, a Simponi-exposed cohort and a comparator
cohort treated with thiopurines, will be enrolled in study. Approximately 6,000 participants
are planned for enrollment, with 3,000 participants in the Simponi-exposed cohort and 3,000
participants in the comparator cohort. Participants will receive treatments in a routine
clinical setting as prescribed by their physician. After enrollment, during the 10-year
follow-up period, a participant may stop his or her ulcerative colitis treatment regimen and
switch to a new treatment regimen. Lymphoma incidence will be primarily assessed by a
questionnaire that will be sent to the investigator to obtain complete medical information
about each case. An expert panel of medical specialists with extensive experience in lymphoma
will be convened to validate cases of lymphoma. Besides assessing the incidence of lymphoma,
long-term safety will be evaluated by capturing other adverse events of interest and serious
adverse events.

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 Comparator 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
We found this trial at
25
sites
6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Chicago, Illinois 60611
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Chicago, Illinois 60637
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Coral Gables, Florida
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2510 Lakeland Drive
Flowood, Mississippi 39232
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Fort Myers, Florida 33901
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4671 South Congress Avenue
Lake Worth, Florida 33461
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Lansdowne, Virginia 20176
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4700 North State Road 7
Lauderdale Lakes, Florida 33319
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Los Angeles, California 90095
(310) 825-4321
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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1150 Northwest 72nd Avenue
Miami, Florida 33126
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Miami, Florida 33145
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Miami, Florida 33172
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Miami, Florida 33155
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28078 Baxter Road
Murrieta, California 92563
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8141 West Center Road
Omaha, Nebraska 68124
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Rialto, California 92377
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1 Kajetanerplatz
Salzburg, 5020
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San Antonio, Texas 78229
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8550 Datapoint Drive
San Antonio, Texas 78229
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Tampa, Florida 33614
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1835 Knoll Drive
Ventura, California 93003
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