A study of guselkumab in participants with fistulizing, perianal Crohn’s disease
| ISRCTN | ISRCTN15970897 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15970897 |
| EudraCT/CTIS number | 2021-000491-10 |
| IRAS number | 1005481 |
| ClinicalTrials.gov number | NCT05347095 |
| Secondary identifying numbers | CNTO1959CRD3005, IRAS 1005481, CPMS 52671 |
- Submission date
- 12/05/2022
- Registration date
- 07/11/2022
- Last edited
- 08/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Background and study aims
Crohn’s disease is a chronic inflammatory disease that can affect any part of the digestive tract. It causes inflammation in lining of digestive tract and development of ulcers. A major complication of Crohn’s disease are perianal fistulas (infected tunnels develop between skin and digestive tract at end of the latter).
Guselkumab is a medicine that targets interleukin (IL)-23*and blocks it from binding to its receptor (protein that binds to specific molecule). By blocking the effects of IL-23, inflammation is reduced thus preventing disease from worsening.
*Specific protein involved in inflammation.
This study is designed to see if guselkumab is effective and safe for treatment of fistulizing, perianal Crohn’s disease.
Who can participate?
Study will include male and female participants 18 years and older with fistulizing, perianal Crohn’s disease.
What does the study involve?
The study will be conducted in 3 phases:
1. Screening (Up to 6 weeks)
2. Treatment (Up to 48 weeks): Participants will be randomly (like flip of coin) divided into 3 groups to receive the treatment.
• Group 1: Guselkumab Dose 1 as an injection in vein at the beginning followed by Dose 1 as an injection under skin afterwards.
• Group 2: Guselkumab Dose 1 as an injection in vein at the beginning followed by guselkumab Dose 2 injection under skin afterwards.
• Group 3: Placebo as an injection in vein at the beginning followed by an injection under skin afterwards. Participants who respond to placebo will continue this and the ones who don’t respond will start receiving guselkumab Dose 3 followed by Dose 1 as injection under skin afterwards.
Participants who complete assessment at Week 48 may have option to participate in long-term extension phase and will receive guselkumab until Week 96.
3. Safety follow-up (Up to Week 64)
During study visits a variety of tests will be carried out including but not limited to, blood tests, MRI, questionnaires, vital signs, and suicidality assessments. All side effects will be recorded until study ends (Up to 118 weeks).
What are the possible benefits and risks of participating?
There is no established benefit to participants of this study. Based on scientific theory, taking guselkumab may improve fistulizing, perianal Crohn's disease. However, this cannot be guaranteed because guselkumab is still under investigation as a treatment and it is not known whether guselkumab will work.
If participants are put into the placebo treatment group, they will not receive guselkumab until they are not responding to placebo. (Participants who don’t respond to placebo, will start receiving guselkumab.)
Participants may experience some benefit from participation in the study that is not due to receiving study drug itself, but due to regular visits and assessments monitoring overall health. Participation may help other people with fistulizing, perianal Crohn's disease in the future.
Participants may have side effects from the drugs or procedures used in this study that may be mild to severe and even life-threatening, and they can vary from person to person. The most common, known risks are getting symptoms such as serious infections and reactivation of latent infections, hypersensitivity reactions, including serious hypersensitivity reactions, liver injury, and malignancy after getting the study drug. There are other, less frequent risks. The participant information sheet and informed consent form, which will be signed by every participant agreeing to participate in the study, includes a detailed section outlining the known risks to participating in the study.
Not all possible side effects and risks related to guselkumab are known at this moment. During the study, the sponsor may learn new information about guselkumab. The study doctor will tell participants as soon as possible about any new information that might make them change their mind about being in the study, such as new risks.
To minimize the risk associated with taking part in the study, participants are frequently reviewed for any side effects and other medical events. Participants are educated to report any such events to the study doctor who will provide appropriate medical care. Any serious side effects that are reported to the sponsor are thoroughly reviewed by a specialist drug safety team.
There are no costs to participants to be in the study. The sponsor will pay for the study drug and tests that are part of the study. The participant will receive reasonable reimbursement for study-related costs (e.g., travel/parking costs).
Where is the study run from?
Parexel International (Ireland)
When is the study starting and how long is it expected to run for?
May 2022 to May 2027
Who is funding the study?
Janssen-Cilag Limited (UK)
Who is the main contact?
Dr Kamal Patel, kamal.patel@stgeorges.nhs.uk
Contact information
Dr Clinical Trials Information
Scientific
Scientific
Janssen-Cilag International NV
Turnhoutseweg 30
Beerse
2340
Belgium
| RA-RNDUS-ClnclTrlsEU@its.jnj.com |
Dr Kamal Patel
Principal Investigator
Principal Investigator
St Georges University Hospitals
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
| Phone | +44 7508471362 |
|---|---|
| kamal.patel@stgeorges.nhs.uk |
Study information
| Study design | Interventional double blind randomized parallel group placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | A phase 3, randomized, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of guselkumab in participants with fistulizing, perianal Crohn’s disease |
| Study acronym | FUZION CD |
| Study hypothesis | Main objective: To evaluate how effective guselkumab is for the treatment of fistulizing, perianal Crohn’s disease. Secondary objectives: 1. To further evaluate how effective guselkumab is for treatment of fistulizing, perianal Crohn’s disease. 2. To assess the overall safety of guselkumab. |
| Ethics approval(s) | Approved 19/07/2022, North West - Liverpool Central Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 2071048016; liverpoolcentral.rec@hra.nhs.uk), ref: 22/NW/0169 |
| Condition | Fistulizing Crohn's disease, perianal Crohn's disease |
| Intervention | Group 1: Guselkumab - Participants will receive guselkumab Dose 1 intravenous (IV) infusion followed by Dose 2 subcutaneously (SC). Participants will receive matching placebo to maintain the blind. Participants who are eligible and willing to continue guselkumab may enter the Long-Term Extension (LTE) period and continue to receive guselkumab. Group 2: Guselkumab - Participants will receive guselkumab Dose 1 IV infusion followed by Dose 3 SC. Participants will receive matching placebo to maintain the blind. Participants who are eligible and willing to continue guselkumab may enter the LTE period and continue to receive guselkumab. Group 3: Placebo - Participants will receive placebo IV infusion followed by placebo SC. At Week 24, placebo non-responders will continue to receive guselkumab Dose 4 followed by guselkumab Dose 2 SC. Participants will receive matching placebo to maintain the blind. Participants who are eligible and willing to continue guselkumab may enter the LTE period and continue to receive guselkumab. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Guselkumab, placebo |
| Primary outcome measure | Percentage of participants who achieve combined fistula remission at week 24. Time frame Week 24 Percentage of participants who achieve combined fistula remission at Week 24 will be reported. |
| Secondary outcome measures | 1. Percentage of participants who achieve combined fistula remission at week 48. Time frame Week 48 Percentage of participants who achieve combined fistula remission at Week 48 will be reported. 2. Percentage of participants who achieve clinically assessed fistula remission at week 24. Time frame Week 24 Percentage of participants who achieve clinically assessed fistula remission will be reported. 3. Percentage of participants who achieve radiological fistula remission based on radiological findings assessed by MRI at week 24. Time frame Week 24 Percentage of participants who achieve radiological fistula remission based on radiological findings assessed by MRI will be reported. 4. Percentage of participants who achieve clinically assessed fistula response at week 24. Time frame Week 24 Percentage of participants who achieve clinically assessed fistula response at Week 24 will be reported. Clinically assessed fistula response is defined as closure of at least 50 percent (%) of all external openings that were draining at baseline. 5. Percentage of Participants who Achieve Clinically Assessed Fistula Response at Week 12. Time frame Week 12 Percentage of participants who achieve clinically assessed fistula response at Week 12 will be reported. Clinically assessed fistula response is defined as closure of at least 50% of all external openings that were draining at baseline. 6. Change from Baseline in Crohn's Disease Activity Index (CDAI) by Visit Over Time Through Week 48. Time frame Baseline up to Week 48 Change from baseline in CDAI by visit over time will be reported. CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid or very soft stools, abdominal pain (AP)/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being with scores ranging from 0 to approximately 600. The last 4 variables are scored over 7 days by the participant on a diary card that participants are to complete on a daily basis. 7. Percentage of Participants who Achieve Clinical Remission (CDAI less than [<] 150) by Visit Over Time Through Week 48 Among Participants with CDAI Greater than (>) 150 at Baseline. Time frame Through Week 48 Percentage of participants who achieve clinical remission (CDAI <150) by visit over time through Week 48 among participants with CDAI >150 at baseline will be reported. CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid or very soft stools, abdominal pain [AP]/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being with scores ranging from 0 to approximately 600. The last 4 variables are scored over 7 days by the participant on a diary card that participants are to complete on a daily basis. 8. Percentage of Participants who Achieve a Clinical Response by Visit Over Time Through Week 48 Among Participants with CDAI >150 at Baseline. Time frame Through Week 48 Percentage of participants who achieve a clinical response by visit over time through Week 48 among participants with CDAI >150 at baseline will be reported. Clinical response is defined greater than or equal to (>=) 100-point reduction from baseline in CDAI, or CDAI <150. 9. Percentage of Participants who Achieve Steroid-free Clinical Remission by Visit Over Time Through Week 48 Among Participants with CDAI >150 at Baseline. Time frame Through Week 48 Percentage of participants who achieve steroid-free clinical remission by visit over time through Week 48 among participants with CDAI >150 at baseline will be reported. Steroid-free clinical remission is defined as CDAI <150 and not receiving corticosteroids by visit over time through Week 48 among participants with CDAI >150 at baseline. 10. Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Response Among Participants With CDAI >220 at Baseline at Week 24 and 48. Time frame Week 24 and Week 48 Percentage of participants who achieve combined clinical response and clinically assessed fistula response among participants with CDAI >220 at baseline at baseline will be reported. Clinical response is defined >=100-point reduction from baseline in CDAI, or CDAI <150. Clinically assessed fistula response is defined as closure of at least 50% of all external openings that were draining at baseline. 11. Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Remission Among Participants With CDAI >220 at Baseline at Week 24 and 48. Time frame Week 24 and Week 48 Percentage of participants who achieve combined clinical remission and clinically assessed fistula remission among participants with CDAI >220 at baseline at will be reported. Clinical remission is defined as CDAI <150. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression. 12. Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Remission Among Participants with CDAI >220 at Baseline at Week 24 and 48. Time frame Week 24 and Week 48 Percentage of participants who achieve combined clinical response and clinically assessed fistula remission among participants with CDAI >220 at baseline will be reported. Clinical response is defined >=100-point reduction from baseline inCDAI, or CDAI <150. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression. 13. Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Response Among Participants with CDAI >220 at Baseline at Week 24 and 48. Time frame 24 and Week 48 Percentage of participants who achieve combined clinical remission and clinically assessed fistula response among participants with CDAI >220 at baseline will be reported. Clinically assessed fistula response is defined as closure of at least 50% of all external openings that were draining at baseline. 14. Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Response at Week 24 and Week 48. Time frame 24 and Week 48 Percentage of participants who achieve combined clinical response and clinically assessed fistula response at Week 24 and Week 48 will be reported. Clinical response is defined >=100-point reduction from baseline in CDAI, or CDAI <150. Clinically assessed fistula response is defined as closure of at least 50% of all external openings that were draining at baseline. 15. Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Remission at Week 24 and Week 48. Time frame 24 and Week 48 Percentage of participants who achieve combined clinical response and clinically assessed fistula remission at Week 24 and Week 48 will be reported. Clinical response is defined >=100-point reduction from baseline in CDAI, or CDAI <150. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression. 16. Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Response at Week 24 and Week 48. Time frame 24 and Week 48 Percentage of participants who achieve combined clinical remission and clinically assessed fistula response at Week 24 and Week 48 will be reported. Clinically assessed fistula response is defined as closure of at least 50% of all external openings that were draining at baseline. 17. Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Remission at Week 24 and Week 48. Time frame 24 and Week 48 Percentage of participants who achieve combined clinical remission and clinically assessed fistula remission will be reported. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression. 18. Change from Baseline in Perianal Disease Activity Index (PDAI) Overall Score, Discharge Score, and Pain Score by Visit Over Time Through Week 48. Time frame Baseline up to Week 48 Change from baseline in PDAI overall score, discharge score, and pain score by visit over time through Week 48 will be reported. The PDAI is a scoring system to evaluate the severity of perianal lesion associated with Crohn's disease. It includes the following 5 items: (a) Discharge; (0=no discharge to 4= Gross fecal soiling) (b) Pain; (0=no activity to 4= severe pain, severe limitation) (c) Restriction of sexual activity;(0=no perianal disease/skin tags to 4= unable to engage in sexual activity) (d) Type of perianal disease; (0=no perianal disease/skin tags to 4=Anal sphincter ulceration or fistulae with significant undermining ok skin) and (e) Degree of induration; (0=no induration to 4=gross fluctuance/abscess. Higher scores indicate more severe or active disease. 19. Percentage of Participants who Achieve Clinically Assessed Fistula Response by Visit Over Time Through Week 48. Time frame Through Week 48 Percentage of participants with clinically assessed fistula response by visit over time through Week 48 will be reported. Clinically assessed fistula response is defined as closure of at least 50% of all external openings that were draining at baseline. 20. Percentage of Participants who Achieve Clinically Assessed Fistula Remission by Visit over Time Through Week 48. Time frame Through Week 48 Percentage of participants with clinically assessed fistula remission by visit over through Week 48 time will be reported. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression. 21. Percentage of Participants who Achieve Clinically Assessed Fistula Remission at Week 48 Among the Participants who Achieve Clinical Fistula Remission at Week 24. Time frame Week 48 Percentage of participants who achieve clinically assessed fistula remission at Week 48 among the participants who achieve clinical fistula remission at Week 24 will be reported. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression. 22. Percentage of Participants who Achieve Clinically Assessed Fistula Remission at Week 48 Among Those who Achieve Fistula Remission or Response at Week 24. Time frame Week 48 Percentage of participants achieving clinically assessed fistula remission at Week 48 among those who achieve fistula remission or response (defined either by clinical or radiological assessment) at Week 24 will be reported. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression. 23. Time to Clinical Fistula Remission. Time frame Up to Week 96 Time to clinical fistula remission will be reported. Clinical fistula remission is defined as 100% closure of all treated external openings without development of new fistulas or abscesses and without any drainage by the external openings (occurring spontaneously or after gentle finger compression). 24. Percentage of Participants who Achieve Radiological Fistula Predominantly Fibrotic Status for all Existent Fistulas Assessed by MRI at Week 24 and Week 48. Time frame Week 24 and Week 48 Percentage of participants who achieve radiological fistula predominantly fibrotic status for all existent fistulas assessed by MRI at Week 24 and Week 48 will be reported. 25. Percentage of participants who Achieve Radiological Remission Based on Radiological Findings Assessed by MRI at Week 48. Time frame Week 48 Percentage of participants with radiological remission based on radiological findings assessed by MRI at Week 48 will be reported. Radiological remission is defined as absence of collections >2 cm of the perianal fistulas, confirmed by a blinded central review of the MRI results. 26. Percentage of Participants who Achieve Radiological Remission Assessed by MRI at Week 48 Among the Participants who Achieve Radiological Remission at Week 24. Time frame Week 48 Percentage of participants who achieve radiological remission assessed by MRI at Week 48 among the participants who achieve radiological remission at Week 24 will be reported. Radiological remission is defined as absence of collections >2 cm of the perianal fistulas, confirmed by a blinded central review of the MRI results. 27. Percentage of Participants who Achieve Combined Clinically Assessed and Radiological Fistula Remission at Week 48 Among the Participants who Achieve Combined Clinical and Radiological Fistula Remission at Week 24. Time frame Week 48 Percentage of participants who achieve combined clinically assessed and radiological (assessed by MRI) fistula remission at Week 48 among the participants who achieve combined clinical and radiological fistula remission at Week 24. 28. Percentage of Participants who Achieve Combined Clinically Assessed and Radiological Fistula Remission as Week 48 Among the Participants with Clinical Fistula Response at Week 24. Time frame Week 48 Percentage of participants who achieve combined clinically assessed and radiological (assessed by MRI) fistula remission at Week 48 among the participants who achieve clinical fistula response at Week 24 will be reported. 29. Percentage of Participants with Proctitis at Week 48 Among Participants with MRI confirmed Proctitis at Baseline. Time frame Week 48 Percentage of participants with proctitis at Week 48 among participants with MRI-confirmed proctitis at baseline will be reported. Proctitis is defined as the inflammation of the lining of the rectum. 30. Change from Baseline in Magnetic Resonance Novel Index for Fistula imaging in Crohn’s disease (MAGNIFI-CD) by Visit Over Time Through Week 48. Time frame Baseline up to Week 48 Change from baseline in MAGNIFI-CD by visit over time through Week 48 will be reported. The MAGNIFI-CD is based on MRI assessment of 6 items including number of fistula tracts, fistula length, hyperintensity of primary tract on post[1]contrast T1-weighted images, dominant feature, extension, and inflammatory mass. The total MAGNIFI-CD score ranges from 0 (no disease activity) to 25 (severe disease activity). It assesses the MRI data and determines perianal fistulizing CD activity with improved operating characteristics compared to the Van Assche Index (VAI) and the modified VAI (mVAI). 31. Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) by Visit Over Time Through Week 48. Time frame Baseline up to Week 48 Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) by visit over time through Week 48 will be reported. The IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD to evaluate patient reported outcomes (PROs) across 4 dimensions: bowel symptoms (loose stools, AP), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes. 32. Change From Baseline in Functional Assessment of Chronic Illness Therapyfatigue (FACIT-F) Score by Visit Over Time Through Week 48. Time frame Baseline up to Week 48 Change From baseline in FACIT-F Score at Week 48 will be reported. The FACIT-F is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists of 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score is calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue. 33. Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Crohn’s Disease (WPAI:CD) by Visit Over Time Through Week 48. Time frame Baseline up to Week 48 Change from baseline in WPAI:CD by visit over time through Week 48 will be reported. The WPAI:CD assesses the impact of CD on work and activity during the past 7 days. The specificity of WPAI:CD is achieved by replacing "health problems" in the general health version of the WPAI with "CD." It consists of 6 questions, which elicit the following information: employment status; hours missed due to CD; hours missed due to other reasons; hours actually worked; the degree to which CD affected productivity while working from 0 (no effect) to 10 (maximum impairment); and the degree to which CD affected regular activities (from 0- 10). The sum of worktime missed and impairment at work yields the overall work impairment (productivity loss) score; scores are expressed as percent of impairment/productivity loss, with higher scores indicating greater impairment. 34. Change from Baseline in Quality-of-life as Assessed by European Quality-of-Life Five Dimension Five Level Scale (EQ5D-5L) Score by Visit Over Time Through Week 48. Time frame Baseline up to Week 48 Change from baseline in quality-of-life (EQ5D-5L) score by visit over time through Week 48 will be reported. The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). 35. Change from Baseline in the Jorge-Wexner Score by Visit Over Time Through Week 48. Time frame Baseline through to Week 48 Change from baseline in the Jorge-Wexner score by visit over time through Week 48 will be reported. The Jorge-Wexner scoring system cross-tabulates frequencies and different anal incontinence presentations. 36. Change from Baseline in the Inflammatory Bowel Disease-Disability Index (IBD-DI) by Visit Over Time Through Week 48. Time frame Baseline through to Week 48 Change from baseline in the Inflammatory Bowel Disease-Disability Index (IBD-DI) by visit over time through Week 48 will be reported. The IBD-DI consists of 28 items that evaluate the 5 domains of overall health, body function, body structures, activity participation and environmental factors. Each item response is graded from 0 to 4 for each area evaluated (0 = very good; 1 = Good; 2 = medium; 3 = Bad; 4 = Very bad). The final composite score representative of the overall degree of disability ranging from -80 (maximum degree of disability) to 22 (no disability). |
| Overall study start date | 29/04/2022 |
| Overall study end date | 17/05/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 280 |
| Participant inclusion criteria | 1. Must have a diagnosis of Crohn’s disease with a minimum duration of at least 3 months 2. Has at least one active draining perianal fistula as a complication of Crohn’s disease, confirmed by screening magnetic resonance imaging (MRI) results 3. Is naïve to biologics, or demonstrated inadequate response or intolerance to conventional therapies or approved biologic therapies for Crohn's Disease (CD) |
| Participant exclusion criteria | 1. Has a very severe luminal disease activity 2. History of or concurrent rectovaginal fistulas, rectal and/or anal stenosis or other active complications of perianal disease 3. Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery or preclude fistula evaluation 4. Any medical contraindications preventing study participation 5. Has a history of ongoing, chronic or recurrent enteral or systemic infectious disease |
| Recruitment start date | 29/04/2022 |
| Recruitment end date | 12/02/2025 |
Locations
Countries of recruitment
- Australia
- Belgium
- Canada
- Egypt
- England
- France
- Germany
- Greece
- Hungary
- Israel
- Italy
- Japan
- Jordan
- Lebanon
- Netherlands
- Northern Ireland
- Poland
- Portugal
- Russian Federation
- Saudi Arabia
- Spain
- Sweden
- Taiwan
- Türkiye
- Ukraine
- United Kingdom
Study participating centres
St Georges Hospital
Blackshaw Road
London
SW17 0QT
United Kingdom
London
SW17 0QT
United Kingdom
Fairfield General Hospital
Fairfield General Hospital
Rochdale Old Road
Bury
BL9 7TD
United Kingdom
Rochdale Old Road
Bury
BL9 7TD
United Kingdom
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
Newcastle upon Tyne
NE1 4LP
United Kingdom
Guy's & St Thomas Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
London
SE1 7EH
United Kingdom
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom
Hull
HU3 2JZ
United Kingdom
Ulster Hospital
Upper Newtownards Rd
Dundonald
Belfast
BT16 1RH
United Kingdom
Dundonald
Belfast
BT16 1RH
United Kingdom
Queen Elizabeth Hospital
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Edgbaston
Birmingham
B15 2GW
United Kingdom
St Marks Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom
Harrow
HA1 3UJ
United Kingdom
Sponsor information
Janssen-Cilag International NV
Industry
Industry
Turnhoutseweg 30
Beerse
2340
Belgium
| RA-RNDUS-ClnclTrlsEU@its.jnj.com |
Funders
Funder type
Industry
Janssen-Cilag Limited
No information available
Results and Publications
| Intention to publish date | 01/09/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Publication on website Coded study data will be shared via secure Sponsor systems. Data sharing will be in accordance with current data privacy legislation and restricted to authorised parties with the necessary confidentiality agreements in place. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
08/04/2024: ClinicalTrials.gov number added.
13/02/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 15/02/2024 to 12/02/2025.
2. The overall study end date was changed from 08/05/2025 to 17/05/2027.
3. The intention to publish date was changed from 01/09/2026 to 01/09/2027.
22/05/2023: Internal review.
02/12/2022: Internal review.
12/05/2022: Trial's existence confirmed by NHS HRA.
