Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
44
Countries
1
Sites
2
Anal fistula
To investigate the efficacy of adjuvant anti-TNFα treatment to standard surgical treatment of complex cryptoglandular anal fistulas.
Key facts
- Sponsor
- Aarhus University Hospital
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 1 Sep 2023 → ongoing
- Decision date (initial)
- 2023-02-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Novo Nordisk Foundation · Independent Research Fund Denmark
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To investigate the efficacy of adjuvant anti-TNFα treatment to standard surgical treatment of complex cryptoglandular anal fistulas.
Conditions and MedDRA coding
Anal fistula
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 1. Complex (i.e. intershincteric or low transsphincteric fistulas with extension, high transsphincteric- ,supra- or ekstrasphincteric fistulas cryptoglandular fistulas that persist in spite of 6 months seton drainage and repeated curettage every 8- 12 weeks and where the presence of extensions and/or inflammatory activity contradicts surgical closure of the fistula
- 2. Not diagnosed with Crohn´s disease implying a. Normal ileocolonoscopy < 6 months b. Normal capsule endoscopy of the small bowel < 6 months c. No granulomas in tissue samples from external fistula opening
- 3. Age 18-65 years
- 4. Speaks and understands Danish
- 5. Received surgical standard treatment (repeated curettage and seton) for at least 6 months
Exclusion criteria 6
- 1. Pregnancy
- 2. Colostomy
- 3. Smoker or non-smoker for < 8 weeks
- 4. Anti-TNFα treatment contradicted (chronic infections or malignancy)
- 5. MRI-scan contradicted
- 6. Females of child-bearing age not using contraception
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Improvement in fistula disease after 15 months of treatment to a degree where it enables surgical closure of fistula
Secondary endpoints 7
- Drop in Perianal Disease Activity index > 2 after 6, 12 and 15 months of treatment
- Improvement evaluated by MRI after 15 and 30 months of treatment or prior
- Improvement of Quality of Life (CAF-QOL-score) after 6, 12, 15 and 30 months
- Patients who fulfill primary endpoint and achieve fistula healing 3, 6 and 12 months after fistula closure
- Time from treatment start to achieved primary endpoint
- Changes in fistula classification and activity
- Complications to the medical treatment
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
SUB05647MIG · Substance
- Active substance
- Azathioprine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 45625 mg milligram(s)
- Max treatment duration
- 30 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02681MIG · Substance
- Active substance
- Infliximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 25500 mg milligram(s)
- Max treatment duration
- 30 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20722 · Substance
- Active substance
- Saline
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFUSION
- Max daily dose
- 250 ml millilitre(s)
- Max total dose
- 10000 ml millilitre(s)
- Max treatment duration
- 30 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 2
SUB20722 · Substance
- Active substance
- Saline
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFUSION
- Max daily dose
- 250 ml millilitre(s)
- Max total dose
- 10000 ml millilitre(s)
- Max treatment duration
- 15 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
8 mm kalktablet indkapsuleret i gelatine
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aarhus University Hospital
- Sponsor organisation
- Aarhus University Hospital
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Aarhus University Hospital
- Contact name
- Anders Dige
Public contact point
- Organisation
- Aarhus University Hospital
- Contact name
- Anders Dige
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus University ORG-100028380
|
Aarhus N, Denmark | On site monitoring, Code 9 |
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 44 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Aarhus University Hospital
Department of Hepatology and Gastroenterology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Bispebjerg Hospital
Abdominalcenter K, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400, Copenhagen Nv
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2023-09-01 | 2023-09-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | CAF-Qol | 1 |
| Protocol (for publication) | PDAI_Symptomer inkontinense | 1 |
| Protocol (for publication) | Protocol | 3 |
| Protocol (for publication) | Protocol_changes approved | 4 |
| Protocol (for publication) | Protocol_changes marked | 4.1 |
| Protocol (for publication) | Protocol_changes unmarked | 4.1 |
| Recruitment arrangements (for publication) | rekruttering | 1 |
| Subject information and informed consent form (for publication) | Deltagerinformation | 3 |
| Subject information and informed consent form (for publication) | samtykkeerklring | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | Azathioprine Tablets 50mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Produktspecifikation_indkapslet azathioprin-placebo_ version 21122022 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | zessly-epar-product-information_en | 1 |
| Synopsis of the protocol (for publication) | Synopsis | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-11-03 | Denmark | Acceptable 2023-02-08
|
2023-02-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-23 | Denmark | Acceptable | 2025-02-25 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-29 | Denmark | Acceptable 2025-12-15
|
2025-12-15 |