A Study of Surgical Interventions in Fistulizing Conditions

• ClinicalTrials.gov Identifier: NCT04940611
• Recruitment Status: Active, not recruiting
• First Posted: June 25, 2021
• Last Update Posted: April 30, 2024
• Sponsor: Takeda
• Information provided by (Responsible Party): Takeda

Tracking Information

• First Submitted Date: June 18, 2021
• First Posted Date: June 25, 2021
• Last Update Posted Date: April 30, 2024
• Actual Study Start Date: August 5, 2021
• Estimated Primary Completion Date: May 2, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 18, 2021)

Percentage of Participants who Achieve Clinical Remission of Fistula [ Time Frame: Baseline up to 24 months ]

Clinical remission for Complex perianal fistula in Crohn's Disease (CPF-CD) and Complex Cryptoglandular Fistula (CCF) is defined as closure of all index treated external fistula openings that were draining at baseline as assessed clinically despite gentle finger compression. Clinical remission for Rectovaginal fistula with Crohn's Disease (CD-RVF) is defined as epithelization of the index external fistula opening (vaginal opening) compared to baseline.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 18, 2021)

• Percentage of Participants With Post-surgical Complications [ Time Frame: Baseline, 3, 6, 12 and 24 months post-index surgery ]
  Post-surgical complications for CPF-CD and CCF is defined as post-index surgery perianal pain, bleeding, infection, urinary retention, delayed or poor wound healing, anal stenosis, and fecal incontinence related to index surgery. Post-surgical complications for CD-RVF is defined as post-index surgery vaginal bleeding, infection, urinary retention, urinary tract infections (UTIs), discharge, delayed or poor wound healing, anal stenosis, fecal incontinence, and pain with intercourse or others related to index surgery.
• Percentage of Participants who Achieve Combined Remission [ Time Frame: Baseline, 3, 6, 12 and 24 months post-index surgery ]
  Combined remission for CPF-CD and CCF is defined as closure of all index external fistula openings treated with surgery that were draining at baseline as assessed clinically despite gentle finger compression, and absence of fluid collections greater than (>) 2 centimeter (cm) in at least 2 dimensions, as confirmed by pelvic magnetic resonance imaging (MRI) or other imaging procedure. Combined remission for CD-RVF is defined as 100 percent (%) cessation of drainage on both clinical exam with deep palpation (deeper bimanual exam/palpation with speculum and/or anoscope) and epithelization of the index external fistula opening (vaginal opening) compared to baseline; and absence of fluid collection as assessed by MRI or other imaging procedure.
• Percentage of Participants who Achieve Cessation of Drainage in Treated Fistula [ Time Frame: Baseline, 3, 6, 12 and 24 months post-index surgery ]
  Cessation of drainage for CPF-CD and CCF is defined as 100% cessation of drainage from index treated fistula, as assessed clinically. Cessation of drainage for CD-RVF is defined as 100% cessation of drainage on clinical exam with deep palpation (deeper bimanual exam/palpation with speculum and/or anoscope) from the index treated fistula.
• Percentage of Participants With Relapse of Fistula in Clinical Remission [ Time Frame: Baseline, 3, 6, 12 and 24 months post-index surgery ]
  Relapse for CPF-CD and CCF is defined as reopening of any surgically treated index fistulae as clinically assessed; or the development of a perianal fluid collection >2 cm in at least 2 dimensions of the perianal fistula(s) treated, confirmed by MRI assessment or other imaging procedure; or drainage. Relapse for CD-RVF is defined as reopening of any surgically treated index fistulae as clinically assessed; or appearance of fluid collection as assessed by MRI or other imaging procedure; or drainage.
• Percentage of Participants With New Perianal Abscess [ Time Frame: Baseline, 3, 6, 12 and 24 months post-index surgery ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Surgical Interventions in Fistulizing Conditions
• Official Title: SPOTLITE: Prospective Observational Study on the Clinical Outcomes of Surgical Interventions in Complex Fistulizing Conditions (CPF-CD, CD-RVF, CCF)

Brief Summary

In this study, participants with complex fistulizing conditions will be treated with surgical interventions according to their clinic's standard practice.

The aim of the study is to generate real-world evidence on standard of care for surgical interventions and related outcomes when treating complex fistulizing conditions.

The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.

Detailed Description

This is a non-interventional, prospective study of participants with complex fistulizing conditions (CPF-CD, CD develops CD-RVF and CCF) who are currently undergoing surgical intervention in the real world clinical setting.

The study will enroll approximately 750 participants. The data will be collected prospectively at the study sites and will be recorded into electronic data capture forms (EDCs). Participants will be enrolled to the following observational cohorts:

• Participants With CPF-CD
• Participants With CD-RVF
• Participants With CCF

This multi-center study will be conducted in the United States, Canada, Europe, and Israel. Participants undergoing surgical interventions to treat fistulas will be enrolled from surgical and gastrointestinal (GI) specialty sites. The overall duration of the study will be 24 months. Data will be collected at baseline with follow-up information collected approximately every 3 to 6 months.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Participants undergoing surgical interventions to treat fistulas (CPF-CD, CD-RVF and CCF) from surgical and GI specialty sites.

Condition

• Crohns Disease
• Fistula
• Rectovaginal Fistula
• Complex Perianal Fistula
• Complex Cryptoglandular Fistula

• Intervention: Not Provided

Study Groups/Cohorts

• Participants With CPF-CD
  Participants diagnosed with CPF-CD will undergo surgical intervention according to their clinic's standard practice to treat the index fistula, and will be observed prospectively for 24 months post-index surgery.
• Participants With CD-RVF
  Participants diagnosed with CD-RVF will undergo surgical intervention according to their clinic's standard practice to treat the index fistula, and will be observed prospectively for 24 months post-index surgery.
• Participants With CCF
  Participants diagnosed with CCF will undergo surgical intervention according to their clinic's standard practice to treat the index fistula, and will be observed prospectively for 24 months post-index surgery.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: June 18, 2021): 750
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2, 2026
• Estimated Primary Completion Date: May 2, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

Participants with CPF-CD

1. CPF-CD that meets one or more of the following criteria:

   • High inter-sphincteric, high trans-sphincteric, extra-sphincteric or supra-sphincteric fistula, or
   • Presence of greater than or equal to (>=) 2 external openings, or
   • Associated perianal abscess(es)

2. Physician has made the decision to treat with a specific surgical intervention. Procedures may include:

   • Fistulotomy, fistula plug, fibrin glue, advancement flap (AF), ligation of inter-sphincteric fistula tract (LIFT), flap repair, fistulectomy, proctectomy, stem cell therapy, other; and seton for palliative purposes.

Participants with CD-RVF: Rectovaginal fistula per physician diagnosis

1. Physician has made the decision to treat with a specific surgical intervention. Procedures may include:

• Fistulotomy, fistula plug, fibrin glue, AF, LIFT, flap repair, fistulectomy, proctectomy, stem cell therapy, gracilis muscle interposition/tissue grafts, martius procedure, abdominal procedures, other; and seton use for palliative purposes.

Participants with CCF:

1. Complex cryptoglandular fistula that meets one or more of the following criteria:

   • Mid or high trans-sphincteric, or
   • Anterior in women, or
   • Horseshoe fistula

2. Physician has made the decision to treat with a specific surgical intervention. Procedures may include:

   • Fistulotomy, fistula plug, fibrin glue, AF, LIFT, flap repair, fistulectomy, proctectomy, stem cell therapy, other; and seton use for palliative purposes

Exclusion Criteria:

Participants who meet any below mentioned criterion among CPF-CD, CD-RVF, and CCF diagnosis will be excluded from the study.

1. Current participation in interventional clinical trials.
2. Has CPF-CD: fistula connection to bladder or another organ
3. Has CCF: diagnosis of Inflammatory Bowel Disease (IBD), including Ulcerative Colitis, and Crohn's Disease (CD).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Belgium, Canada, Czechia, France, Israel, Italy, Netherlands, United Kingdom, United States

Administrative Information

• NCT Number: NCT04940611
• Other Study ID Numbers: Alofisel-5007
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• URL: https://vivli.org/ourmember/takeda/

• Current Responsible Party: Takeda
• Original Responsible Party: Same as current
• Current Study Sponsor: Takeda
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Study Director; Takeda

• PRS Account: Takeda
• Verification Date: April 2024