Ulcerative ColitisOPALNCT02808780
An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
An observational study of Ulcerative Colitis, run by Janssen Biotech, Inc. at 63 sites in 9 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- How many people
- 535 participants
- Where
- 63 sitesin 9 countries
- Study dates
- 16 Dec 2016to 11 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with moderate-to-severe ulcerative colitis for at least 3 months prior to enrollment will be observed
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
63 sites in 9 countries.
63 sites in 9 countries
United States16 sites
Study site
Chicago, Illinois
Study site
Coral Gables, Florida
Study site
Fort Myers, Florida
Study site
Houston, Texas
Study site
Lake Worth, Florida
Study site
Lansdowne Town Center, Virginia
Study site
Lauderdale Lakes, Florida
Study site
Miami, Florida
Study site
Murrieta, California
Study site
Pittsburgh, Pennsylvania
Study site
Rialto, California
Study site
San Antonio, Texas
Study site
Suwanee, Georgia
Study site
Sylvania, Ohio
Study site
Tampa, Florida
Study site
Ventura, California
Germany11 sites
Study site
Berlin
Study site
Dessau Roblau
Study site
Halle
Study site
Hamburg
Study site
Heidelberg
Study site
Kiel
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Leipzig
Study site
Ludwigshafen
Study site
Lyneburg
Study site
München
Study site
Saarbrücken
Spain11 sites
Study site
A Coruña
Study site
Barcelona
Study site
Córdoba
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Fuenlabrada
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Huelva
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Madrid
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Majadahonda
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San Sebastián de los Reyes
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Valencia
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Vigo
Study site
Zaragoza
France9 sites
Study site
Clermont-Ferrand
Study site
Clichy
Study site
Créteil
Study site
Grenoble
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Montpellier
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Nice
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Pierre-Bénite
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Saint-Priest-en-Jarez
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Strasbourg
Canada4 sites
Study site
New Westminster, British Columbia
Study site
Oshawa, Ontario
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Ottawa, Ontario
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Vancouver, British Columbia
Greece4 sites
Study site
Athens
Study site
Heraklion
Study site
Ioannina
Study site
Thessaloniki
South Korea4 sites
Study site
Busan
Study site
Gyeonggi-do
Study site
Seongnam-si
Study site
Seoul
Austria3 sites
Study site
Salzburg
Study site
Sankt Poelten Noe
Study site
Vienna
About this study
Official title: 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.
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis, Simponi (Golimumab), Thiopurines, Lymphoma, Malignancies
- Medical subject headings
- Colitis, Ulcerative, Lymphoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Simponi-exposed cohort | Participants receiving Simponi at enrollment and are still receiving Simponi after participation in a therapeutic trial or participants scheduled to receive Simponi within 30 days after enrollment. Participants in this cohort may be receiving Simponi alone or in combination with thiopurines but must not be receiving other approved biologics or investigational agents at enrollment. Participants may have received other approved biologics or investigational agents prior to enrollment. | |
| Thiopurine cohort | Participants currently receiving thiopurines, having received at least 12 consecutive weeks of therapy prior to registry entry. Participants must not be receiving approved biologic agents, including Simponi, or investigational agents at enrollment. These patients may have received biologics other than Simponi or investigational agents prior to enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 years
Secondary outcomes (7)
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.
Measured: 6 years
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).
Measured: 6 years
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.
Measured: 6 years
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.
Measured: 6 years
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.
Measured: 6 years
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.
Measured: 6 years
Health Care Utilization: Evaluate the Reasons for Hospitalization in Participants in Each Cohort
Reasons for hospitalization in participants in each cohort will be reported.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study start16 Dec 2016
- Primary completion10 Dec 2026 (estimated)
- Study completion11 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 535 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Biotech, Inc. Clinical Trial, Study director, Janssen Biotech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808780
- Sponsor's protocol ID
- CR105891
- Other IDs
- CNTO148UCO4001
- Acronym
- OPAL
- Status last verified
- Nov 2026
- First submitted
- 30 May 2016
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02808780
- Acronym / sponsor ID
- OPAL / CR105891
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis, Simponi (Golimumab), Thiopurines, Lymphoma, Malignancies
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 535 participants (actual)
- Lead sponsor
- Janssen Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2016 (actual)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 11 Mar 2027 (estimated)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simponi-exposed cohort | – | –Participants receiving Simponi at enrollment and are still receiving Simponi after participation in a therapeutic trial or participants scheduled to receive Simponi within 30 days after enrollment. Participants in this cohort may be receiving Simponi alone or in combination with thiopurines but must not be receiving other approved biologics or investigational agents at enrollment. Participants may have received other approved biologics or investigational agents prior to enrollment. |
| Thiopurine cohort | – | –Participants currently receiving thiopurines, having received at least 12 consecutive weeks of therapy prior to registry entry. Participants must not be receiving approved biologic agents, including Simponi, or investigational agents at enrollment. These patients may have received biologics other than Simponi or investigational agents prior to enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with moderate-to-severe ulcerative colitis for at least 3 months prior to enrollment will be observed
Key inclusion criteria (9 listed)
- 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:
- For Thiopurine cohort:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
Clinical Disease Status as Assessed by Partial Mayo Score
Time frame: 6 years
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score
Time frame: 6 years
EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Score
Time frame: 6 years
Work Productivity and Activity Impairment Questionnaire - Ulcerative Colitis (WPAI-UC)
Time frame: 6 years
Treatment Satisfaction Questionnaire for Medication (TSQM) Score
Time frame: 6 years
Health Care Utilization: Evaluate the Number of Each Hospitalizations in Participants in Each Cohort
Time frame: 6 years
Health Care Utilization: Evaluate the Reasons for Hospitalization in Participants in Each Cohort
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Biotech, Inc. Clinical Trial study director
Janssen Biotech, Inc.
63 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Janssen Biotech, Inc. at 63 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States, Germany, Spain, France, Canada and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.