Crohn's DiseasePhase 3NCT01986127
Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients
A Phase 3 study testing Adalimumab in people with Crohn's Disease, run by Sara Varea at 13 sites in Spain.
Trial summary
We study if the administration of intralesional Adalimumab (directly injected in the stricture) associated to endoscopic dilatation has a higher success rate at week 8 compared with placebo in patients with Crohn's disease who had confirmed intestinal stenosis (3 stenosis as maximum) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Adalimumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 13 sitesSpain
- Study dates
- 14 Feb 2014to 30 Jun 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
Who may be able to join
- Patients of both sexes older than 18 years
- Patient diagnosed of CROHN´s disease
- Patient with intestinal stenosis length equal or less than 5cm previously confirmed with bowel magnetic resonance imaging (3 stenosis as maximum)
- Stenosis no permeable for endoscopy(12mm in case of accessible stenosis with conventional colonoscopy and 10mm in case of accessible stenosis with balloon enteroscopy)
- Dilated stenosis according to endoscopist criteria (pass or no the endoscopy)
- Patient capable of participate in the examinations required by the study
- Patient after being informed, give his/her informed consent in writing
Who cannot join
- Patients with large intestinal stenosis (more than 6cm) and multiples
- Patients with previous or actual treatment with anti-tumor necrosis factor (anti-TNF) drugs
- Patients with positive serology to hepatitis B virus(HBV),hepatitis C virus (HCV), or HIV
- Patients with positive screening to Tuberculosis(positive PPD)
- Established contraindication to anti-TNF drugs
- Existence of fistulous tracts associated with intestinal stenosis
- Neoplastic process associated with stenosis or in another location
- Pregnancy or breastfeeding
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Spain13 sites
Hospital General Universitario de Alicante
Alicante, 03010
Hospital Clinic of Barcelona
Barcelona, 08036
Hospital del Mar
Barcelona
Complejo asistencial universitario de Burgos
Burgos, 09005
Complexo Hospitalario Arquitecto Marcide -Novoa Santos
Ferrol, A Coruña, 15405
Hospital Josep Trueta
Girona, 17007
Hospital La Paz
Madrid, 28046
Hospital Universitario Puerta del Hierro
Majadahonda, Madrid, 28222
Hospital Universitari Son Espases
Palma de Mallorca, Mallorca, 07120
Hospital Moises Broggi
Sant Joan Despí, Barcelona, 08970
Complexo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruña, 15706
Hospital Mutua de Terrassa
Terrassa, Barcelona, 08221
Hospital La Fe
Valencia, 46026
About this study
Official title: A Randomized, Double-blinded, Placebo-controlled Study on the Effects of Adalimumab Intralesional Intestinal Strictures of Crohn's Disease Patients
We study if the administration of intralesional Adalimumab (directly injected in the stricture) associated to endoscopic dilatation has a higher success rate at week 8 compared with placebo in patients with Crohn's disease who had confirmed intestinal stenosis (3 stenosis as maximum)
- Conditions
- Crohn's Disease
- Being tested
- Adalimumab, placebo
- Keywords
- Crohn disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
single intralesional administration during endoscopy process
placeboDrug
single intralesional administration during endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab | Experimental | single administration of Adalimumab 80mg diluted in 5ml saline Receives: Drug: Adalimumab |
| saline | Placebo comparator | 5 ml of saline Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of endoscopic dilatation
Successful dilatation means the passage of the endoscope (or enteroscopy colonoscope) through the stenosis
Measured: at week 8
Secondary outcomes (6)
Stenosis measure
The endoscopic stenosis diameter will be estimated pre and post-dilatation
Measured: baseline
success of endoscopic dilatation
The success of endoscopic dilatation at week 52 means absence of clinical subocclusion, no necessity of surgical nor endoscopic dilatation
Measured: at week 52
Mucosal healing
- Anastomotic strictures: We define mucosal healing as a Rutgeerts < or equal 2 with at least 1 point of improvement (añadir el score)
- Primary strictures: Absence of ulcers after treatment
Measured: at week 8
Histological cure
We consider histological cure if:
- Epithelial damage is < or equal 1
- Architectural changes is < or equal 1
- Infiltration of mononuclear cells in lamina propria is < or equal 1
- Polymorphonuclear cells in the lamina propria = 0
- Polymorphonuclear cells in epithelium = 0
- Absence of erosions and ulcers (based ib scoring system for Histologic Abnormalities in Crohn's disease Mucosal Biopsy Specimens - Title: Early lesions of recurrent Crohn's disease caused by infusion of intestinal contents in excluded ileum Author(s): D'Haens, Geert R.; Geboes, Karel; Peeters, Mark; et al. Source: Gastroenterology Volume: 114 Issue: 2 Pages: 262-267 Published: Feb., 1998)
Measured: at week 8
proportion of patients that develop anti-adalimumab antibodies
Measured: at the end of the study
adverse events
Measured: at the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study start14 Feb 2014
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Why it stopped: slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Varea
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Responsible party
- Sponsor-investigator, Sara Varea, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Begoña González Suarez, MD, Principal investigator, Hospital Clinic of BarcelonaLucía Márquez, MD, Principal investigator, Hospital del MarAlfredo Mata, MD, Principal investigator, Hospital de Sant Joan Despí Moisès BroggiCarlos Huertas, MD, Principal investigator, Hospital Josep TruetaLidia Argüello, MD, Principal investigator, Hospital La FeCecilia González, MD, Principal investigator, Gregorio Marañón HospitalAna Echarri, MD, Principal investigator, Complexo Hospitalario Arquitecto Marcide-Novoa SantosCarme Loras, Principal investigator, Hospital Mútua Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986127
- Sponsor's protocol ID
- CSAI
- Other IDs
- 2012-001723-12
- Status last verified
- Dec 2018
- First submitted
- 9 Oct 2013
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-controlled Study on the Effects of Adalimumab Intralesional Intestinal Strictures of Crohn's Disease Patients
- ClinicalTrials.gov ID
- NCT01986127
- Acronym / sponsor ID
- CSAI
- Conditions
- Crohn's Disease
- Keywords
- Crohn disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sara VareaUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Study start
- 14 Feb 2014
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 18 Nov 2013 (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.
We study if the administration of intralesional Adalimumab (directly injected in the stricture) associated to endoscopic dilatation has a higher success rate at week 8 compared with placebo in patients with Crohn's disease who had confirmed intestinal stenosis (3 stenosis as maximum)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | Experimental | Drug: Adalimumabsingle administration of Adalimumab 80mg diluted in 5ml saline |
| saline | Placebo comparator | Drug: placebo5 ml of saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients of both sexes older than 18 years
- Patient diagnosed of CROHN´s disease
- Patient with intestinal stenosis length equal or less than 5cm previously confirmed with bowel magnetic resonance imaging (3 stenosis as maximum)
- Stenosis no permeable for endoscopy(12mm in case of accessible stenosis with conventional colonoscopy and 10mm in case of accessible stenosis with balloon enteroscopy)
- Dilated stenosis according to endoscopist criteria (pass or no the endoscopy)
Key exclusion criteria (8 listed)
- Patients with large intestinal stenosis (more than 6cm) and multiples
- Patients with previous or actual treatment with anti-tumor necrosis factor (anti-TNF) drugs
- Patients with positive serology to hepatitis B virus(HBV),hepatitis C virus (HCV), or HIV
- Patients with positive screening to Tuberculosis(positive PPD)
- Established contraindication to anti-TNF drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adalimumabsingle intralesional administration during endoscopy process | Drug | Adalimumab |
| placebosingle intralesional administration during endoscopy | Drug | saline |
Primary outcome
Success of endoscopic dilatation
Time frame: at week 8
Successful dilatation means the passage of the endoscope (or enteroscopy colonoscope) through the stenosis
6 secondary outcomes
Stenosis measure
Time frame: baseline
success of endoscopic dilatation
Time frame: at week 52
Mucosal healing
Time frame: at week 8
Histological cure
Time frame: at week 8
proportion of patients that develop anti-adalimumab antibodies
Time frame: at the end of the study
adverse events
Time frame: at the end of the study
Results and safety
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
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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.
Begoña González Suarez, MD principal investigator
Hospital Clinic of Barcelona
Lucía Márquez, MD principal investigator
Hospital del Mar
Alfredo Mata, MD principal investigator
Hospital de Sant Joan Despí Moisès Broggi
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adalimumab in people with Crohn's Disease, run by Sara Varea at 13 sites in Spain.
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 7 inclusion and 8 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: stopped early, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
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?
Success of endoscopic dilatation (time frame: at week 8). 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 13 Dec 2018.