A Study to Assess Real-world Outcomes for Long-Term Use of Guselkumab (LUNAR)

Long-Term Use of Guselkumab: Non-interventional Assessment of Real-world Outcomes

The purpose of this study is to evaluate how long guselkumab remains in participants with moderate to severe crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are Inflammatory bowel disease, a group of inflammatory conditions of the colon and small intestine.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Disease

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• Switzerland
  • Bern, Switzerland, 3001
    • Recruiting
    • Gastroenterologische Praxis und Crohn-Collitis Zentrum Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will include participants with confirmed diagnosis of moderate-to-severe crohn's disease (CD) or ulcerative colitis (UC) disease.

Description

Inclusion Criteria:

• Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of drug. Decision to prescribe must solely be made by the treating physician. Enrolment must take place before or on the day of the first administration (but after treatment decision by physician)
• Must have confirmed diagnosis of moderate-to-severe UC or CD disease record in their medical records
• Must sign a participation agreement/Informed consent form (ICF) allowing source data verification in accordance with local requirements

Exclusion criteria:

• Contraindicated to guselkumab per the label
• Is currently enrolled in an interventional clinical study
• Has been previously exposed to Interleukin (IL)-23 inhibitors, including tremfya (guselkumab), skyrizi (risankizumab) and omvoh (mirikizumab). As an exception, participants with history of ustekinumab exposure may be included
• History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and/or small molecules)
• Is unable to provide informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD); Participants with confirmed diagnosis of moderate-to-severe UC or CD treated with guselkumab as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available from standard clinical practice and medical records will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Guselkumab Persistence	Persistence with guselkumab will be measured through time to discontinuation (defined as time at which the next infusion should have taken place for a participant after their last scheduled infusion).	Up to Week 96

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characteristics of Participants Receiving Guselkumab Treatment: Age	Characteristics of participants (age) receiving guselkumab treatment will be reported.	At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Sex	Characteristics of participants (sex) receiving guselkumab treatment will be reported.	At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Height	Characteristics of participants (height) receiving guselkumab treatment will be reported.	At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Disease Severity	Characteristics of participants (disease severity at index) receiving guselkumab treatment will be reported.	At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Age at Diagnosis	Characteristics of participants (age at diagnosis) receiving guselkumab treatment will be reported.	At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Disease Duration	Characteristics of participants (disease duration) receiving guselkumab treatment will be reported.	At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Comorbid Diagnoses	Characteristics of participants (comorbid diagnoses) receiving guselkumab treatment will be reported.	At Baseline
Number of Participants with Early Responses to Guselkumab Measured Using Participant Reported Outcome (PRO-2) Components	Number of participants with early responses to guselkumab will be assessed using PRO-2 components and reported via participant diaries. Measurements captured include stool frequency, rectal bleeding, and abdominal pain.	Baseline (at Week 0), Weeks 1, 2, 4, 8 and 12
Number of Participants with Early Responses to Guselkumab Measured Using Bowel Urgency	Number of participants with early responses to guselkumab will be assessed using bowel urgency and reported via participant diaries. Bowel urgency from participants will be asked as yes or no.	Baseline (at Week 0), Weeks 1, 2, 4, 8 and 12
Number of Participants Achieving Clinical Response for CD as Measured by Harvey-Bradshaw Index (HBI)	HBI score is used to assess disease severity and treatment effectiveness. The HBI consists of a 5-part questionnaire, assessing general wellbeing, abdominal pain, number of liquid stools per day, abdominal mass and complications. Clinical response for CD is defined as the HBI score less than or equal to (<=) 4 or a decrease in HBI by greater than or equal to (>=) 3 from baseline.	Weeks 12, 48 and 96
Number of Participants Achieving Clinical Response for UC as Measured by Partial Mayo Score (PMS)	Mayo scoring system is used to assess disease severity and treatment effectiveness. The PMS comprises 3 categories: rectal bleeding, SF, and physician assessment. These are rated from 0-3 and are totaled to give a total score that ranges from 0-12. Clinical response for UC is defined as the PMS score less than (<) 4 or >= 30 percent (%) reduction from baseline.	Weeks 12, 48 and 96
Number of Participants Achieving Clinical Remission for CD as Measured by HBI	HBI score is used to assess disease severity and treatment effectiveness. The HBI consists of a 5-part questionnaire, assessing general wellbeing, abdominal pain, number of liquid stools per day, abdominal mass and complications. Clinical remission for CD is defined as the HBI score <= 4.	Weeks 12, 48 and 96
Number of Participants Achieving Clinical Remission for UC as Measured by PMS	Mayo scoring system is used to assess disease severity and treatment effectiveness. The PMS comprises 3 categories: rectal bleeding, SF, and physician assessment. These are rated from 0-3 and are totaled to give a total score that ranges from 0-12. Clinical remission for UC is defined as the PMS < 2 and a rectal bleeding subscore of 0.	Weeks 12, 48 and 96
Number of Participants Achieving Corticosteroid-free Clinical Response for CD as Measured by HBI	Corticosteroid-free clinical response for CD is defined as a reduction in HBI by >=3 points from baseline or achieving HBI <=4 with no use of corticosteroids for at least 30 days.	Weeks 12, 48 and 96
Number of Participants Achieving Corticosteroid-free Clinical Response for UC as Measured by PMS	Corticosteroid-free clinical response for UC is defined as PMS <4 or >=30% reduction from baseline and no use of steroids for at least 30 days.	Weeks 12, 48 and 96
Number of Participants Achieving Corticosteroid-free Clinical Remission for CD as Measured by HBI	Corticosteroid-free remission for CD is defined as no use of steroids for at least 30 days and a HBI score <=4.	Weeks 12, 48 and 96
Number of Participants Achieving Corticosteroid-free Clinical Remission for UC as Measured by PMS	Corticosteroid-free clinical remission for UC is defined as a PMS score of <2, no use of corticosteroids for at least 30 days and a rectal bleeding subscore of 0.	Weeks 12, 48 and 96
Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for CD	Corticosteroid-free PRO-2 remission in CD participants is defined as an abdominal pain (AP) score <=1 and a mean stool frequency (SF) score <=3 and no worsening of AP or SF compared with baseline and no use of steroids for at least 30 days.	Baseline (Week 0), Weeks 12, 48 and 96
Number of Participants Achieving Corticosteroid-Free PRO-2 Remission for UC	Corticosteroid-free PRO-2 remission in UC participants is defined as a SF score of 0 or 1, where it has not increased from baseline, and a rectal bleeding sub score of 0 with no use of steroids for at least 30 days.	Baseline (Week 0), Weeks 12, 48 and 96
Characteristics of Participants Receiving Guselkumab Treatment: Smoking Status and History	Characteristics of participants (smoking status and history) receiving guselkumab treatment will be reported.	At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Weight	Characteristics of participants (weight) receiving guselkumab treatment will be reported.	Baseline (Week 0), Weeks 4, 8, 12, 48 and 96
Characteristics of Participants Receiving Guselkumab Treatment: History of UC/CD	Characteristics of participants (history of UC/CD) receiving guselkumab treatment will be reported.	At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Previous Inflammatory Bowel Disease (IBD) Medication Use	Characteristics of participants (previous IBD medication use) receiving guselkumab treatment will be reported.	At Baseline
Characteristics of Participants Receiving Guselkumab Treatment: Previous IBD-Related Surgeries	Characteristics of participants (Previous IBD-related surgeries) receiving guselkumab treatment will be reported.	At Baseline
Number of Participants with Adverse Events (AEs)	An adverse event is any untoward medical occurrence in a participant administered a medicinal product based on appropriate medical judgment. An AE does not necessarily have a causal relationship with the treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal finding or lack of expected pharmacological action), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.	Up to Week 96
Number of Participants with Drug-Related Adverse Events	An adverse event is any untoward medical occurrence in a participant administered a medicinal product based on appropriate medical judgment. An AE does not necessarily have a causal relationship with the treatment. An adverse event is considered drug-related if there is at least a reasonable possibility that the study drug contributed to the event.	Up to Week 96
Number of Participants with Serious Adverse Events (SAE)	An adverse event is any untoward medical occurrence in a participant administered a medicinal product based on appropriate medical judgment. An AE does not necessarily have a causal relationship with the treatment. An SAE is any event that results in death, is life-threatening, requires or prolongs hospitalization, causes significant disability, or is otherwise medically significant.	Up to Week 96
Number of Participants with Drug-Related Serious Adverse Events	An adverse event is any untoward medical occurrence in a participant administered a medicinal product based on appropriate medical judgment. SAE is any event that results in death, is life-threatening, requires or prolongs hospitalization, causes significant disability, or is otherwise medically significant based on appropriate medical judgment. An SAE is considered drug-related if there is at least a reasonable possibility that the study drug contributed to the event.	Up to Week 96
Number of Participants with C-reactive protein (CRP) Normalization	CRP normalization is defined as as <= 5 milligrams/litre (mg/L) since baseline (among participants with elevated CRP at Baseline).	Baseline (at Week 0), Weeks 4, 12, 48 and 96
Change in CRP Levels	Change in CRP levels since guselkumab initiation will be reported.	Weeks 4, 12, 48 and 96
Number of Participants with Fecal Calprotectin Normalization	Number of participants with fecal calprotectin normalization will be reported. Normalization is defined as percentage of fecal calprotectin (fCAL) <=250 micrograms/gram (mcg/g) since baseline (among participants with Calprotectin elevation at Baseline).	Baseline (at Week 0), Weeks 4, 12, 48 and 96
Change in Fecal Calprotectin Levels	Change in Fecal calprotectin levels since guselkumab initiation will be reported.	Weeks 4, 12, 48 and 96
Change in Leukocytes Count	Change in Leukocytes count will be reported.	Baseline (at Week 0), Weeks 4, 12, 48 and 96
Change in Hemoglobin Levels	Change in hemoglobin levels to assess anaemia will be reported.	Baseline (at Week 0), Weeks 4, 12, 48 and 96
Change in Transferrin Saturation Levels	Change in transferrin saturation Levels to assess anaemia will be reported.	Baseline (at Week 0), Weeks 4, 12, 48 and 96
Change in Ferritin Levels	Change in Ferritin Levels to assess anaemia will be reported.	Baseline (at Week 0), Weeks 4, 12, 48 and 96
Number of Participants Receiving Concomitant IBD Medications During Guselkumab Treatment	Number of participants receiving concomitant IBD medications during guselkumab treatment will be reported.	Baseline up to Week 96
Change from Baseline in Health-related Quality of Life (HRQoL) as Measured by PRO-2 Components for CD	Change from baseline in HRQoL for CD will be measured by PRO-2 components. The CD PRO-2 consists of 2 items: abdominal pain (AP) and stool frequency (SF). AP is a numeric variable with a score between 0-3 and is self-reported by the participant for the 3 days preceding assessment as 0 (no pain), 1 (mild), 2 (moderate) or 3 (severe pain). SF is also a numeric variable calculated the number of liquid stools a participant has experienced over the past 3 days.	Baseline (at Week 0), Weeks 24, 48, 72, and 96
Change from Baseline in HRQoL as Measured by PRO-2 Components for UC	Change from baseline in HRQoL for UC will be measured by PRO-2 components. The UC PRO-2 is composed of rectal bleeding and stool frequency. Rectal bleeding is a numeric variable with a score between 0-3 and is self-reported by the participants for the 3 days preceding assessment as 0 (None), 1 (Streaks of blood with stool in less than half of the cases), 2 (Obvious blood with stools in most cases) or 3 (Blood alone passes). SF is also a numeric variable calculated the number of liquid stools a participant has experienced over the past 3 days.	Baseline (at Week 0), Weeks 24, 48, 72, and 96
Change from Baseline in HRQoL as Measured by Bowel Urgency	Change from baseline in HRQoL as measured by bowel urgency will be reported. Bowel urgency from participants will be asked as yes or no.	Baseline (at Week 0), Weeks 1, 2, 4, 8, 12, 24, 48, 72, and 96
Changes from Baseline in HRQoL as Measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ)	SIBDQ is a HRQoL tool measuring physical, social, and emotional status in IBD participants. The SIBDQ offers a broader evaluation of IBD-specific QoL across ten dimensions, including digestive, physical, emotional, and social aspects. The SIBDQ consists of 10- item survey measuring HRQoL over the last 2 weeks (frequency of bowel movement, abdominal cramps, fatigue, lack of energy, worry of surgery, fear of no toilet, ability to relax, irritability, impact on leisure, impact on intimacy). The total score ranges from 10 to 70, where high score indicates better QoL.	Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96
Changes from Baseline in HRQoL as Measured by Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Questionnnaire	FACIT-F consists of 13 items to characterize fatigue symptoms and their impact on daily activities and function. It includes items such as tiredness, weakness, listlessness, lack of energy, and the impact of these feelings on daily functioning (for example, sleeping and social activities) over the last 7 days. The total FACIT-F score ranges from 0 to 52, with a higher score indicating less fatigue.	Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96
Change from Baseline in HRQoL as Measured by Treatment Satisfaction Questionnaire for Medication (TSQM-9)	TSQM-9 is an abbreviated version of the 14-item TSQM, and is a reliable and valid measure to assess treatment satisfaction. It consists of 9 items distributed in the domains: side effects, effectiveness, convenience, and global satisfaction, with scores at each domain ranging from 0 to 100. with higher score indicating higher treatment satisfaction.	Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96
Change from Baseline in HRQol as Measured by Work Productivity and Activity Questionnaire (WPAI)	WPAI assesses impairment of work and regular activities due to overall health and symptoms. WPAI measures past-7-day work and activity that impact in Scores range from 0% (no impairment) to 100% (complete impairment); higher = worse. Absenteeism, presenteeism, and overall work impairment are for employed participant and activity impairment is for all participants.	Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96
Change from Baseline in HRQoL as Measured by PROMIS Sleep Disturbance Short Form 8b (PROMIS 8b)	The PROMIS 8b is a questionnaire based on the PROMIS sleep disturbance and sleep-related Impairment item banks. It contains the 8 best-performing items of these banks belonging to categories relating to qualitative, quantitative, behavioral, and symptom based dimensions of sleep and was found to provide greater measurement precision compared with other assessment instruments.	Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96
Change from Baseline in HRQoL as Measured by Short-CONFIDE Survey for IBD (s-CS-IBD)	s-CS-IBD is shortened version of the CONFIDE questionnaire (Short-CONFIDE Survey for IBD consisting of 5 selected questions to better understand how IBD impacts sexual activity and if guselkumab treatment can improve this situation.	Baseline (at Week 0), Weeks 12, 24, 48, 72 and 96
Number of Participants Achieving Endoscopic Response in Participants with CD as Measured by Simple Endoscopy Score-CD (SES-CD)	Endoscopic response is defined as 50% improvement from baseline in SES-CD total score, or SES-CD total score <= 4.	Baseline (at Week 0), Weeks 48 and 96
Number of Participants Achieving Endoscopic Remission in Participants with CD as Measured by SES-CD	Endoscopic remission is defined as SES-CD total score <= 4 with at least 2 points reduction from baseline and no sub-score >1 in any individual component.	Baseline (at Week 0), Weeks 48 and 96
Number of Participants Achieving Endoscopic Improvement in Participants with UC as Measured by Mayo Score	Endoscopic Improvement is defined as a Mayo score <=1.	Baseline (at Week 0), Weeks 12, 48 and 96
Number of Participants Achieving Endoscopic Normalization in Participants with UC as Measured by Mayo Score	Endoscopic normalization is defined as a Mayo score =0.	Baseline (at Week 0), Weeks 12, 48 and 96
Number of Participants Achieving Histologic Improvement	Histologic improvement is defined as neutrophil infiltration in < 5% of crypts, no crypt destruction, no erosions and ulcerations or granulation tissue according to the Geboes grading system, that is, Geboes score <=3.1.	At Weeks 0, 48 and 96
Number of Participants Achieving Histologic Remission	Histologic remission is defined as the absence of neutrophils from the mucosa (both lamina propria and epithelium), no crypt destruction, no erosions, and ulcerations or granulation tissue according to the Geboes grading system, that is, Geboes score <=2B.0.	At Weeks 0, 48 and 96
Number of Participants with CD Achieving Intestinal Ultrasound (IUS) Response	IUS Response is defined as reduction of bowel wall thickness (BWT) of >= 25% or normalization (<= 3 millimeter [mm]) of the most affected segment in participants with increased BWT (>3 mm) at baseline.	Baseline (at Week 0), Weeks 24, 48, 72, and 96
Number of Participants with CD Achieving IUS Remission	IUS Remission is defined as Normalization of BWT (<=3 mm) and vascularity (no signal or short signal in color Doppler of the most affected segment) in participants with increased BWT (>3mm) at baseline.	Baseline (at Week 0), Weeks 24, 48, 72, and 96
Change from Baseline in Number of UC/CD Emergency Room Visits	Change from baseline in the number of emergency room visits for treatment of UC/CD will be reported.	Baseline (at Week 0), Weeks 12, 48 and 96
Change from Baseline in Number of UC/CD-Hospitalizations	Change from baseline in the number of hospitalizations for treatment of UC/CD will be reported.	Baseline (at Week 0), Weeks 12, 48 and 96
Change from Baseline in Number of UC/CD Surgeries	Change from baseline in the number of surgeries for treatment of UC/CD will be reported.	Baseline (at Week 0), Weeks 12, 48 and 96

Collaborators and Investigators

• Sponsor: Janssen-Cilag A.G., Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2026
• Primary Completion (Estimated): April 10, 2029
• Study Completion (Estimated): April 10, 2029

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases
• Other Study ID Numbers: CNTO1959IBD4008 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu