Crohn's Disease With Perianal FistulasPhase 3AdafiNCT00736983
Adalimumab in Combination With Ciprofloxacin/Placebo Treatment of Perianal Fistulas in Crohn's
A Phase 3 study testing adalimumab and ciprofloxacin in people with Crohn's Disease With Perianal Fistulas, run by Foundation for Liver Research at 13 sites in Netherlands.
Trial summary
To assess whether a combination of ciprofloxacin and adalimumab is more effective than adalimumab alone for the treatment of perianal fistulas in Crohn's disease Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn's Disease With Perianal Fistulas
- What is being tested?
- adalimumab and ciprofloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 13 sitesNetherlands
- Study dates
- Sep 2008to Dec 2011
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- proven Crohn's disease
- Single or multiple draining perianal fistulas
Who cannot join
- Abscesses
- Infliximab, cyclosporine, tacrolimus and antibiotics for Crohn's disease within past 3 months
- active viral infection
- significate cardiovascular dysfunction
- Pregnancy, Lactation
- Surgical bowel resection to be expected within 6 months
- Positive stool culture for enteric pathogens
- Total parental nutrition
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Netherlands13 sites
AMC
Amsterdam
VU
Amsterdam
Deventer ziekenhuis
Deventer
Albert Schweitzer ziekenhuis
Dordrecht
Medisch Spectrum Twente
Enschede
UMC Gronigen
Groningen
LUMC
Leiden
AZ Maastricht
Maastricht
St Antonius ziekenhuis
Nieuwegein
UMC Radboud
Nijmegen
Erasmus MC
Rotterdam
Haga ziekenhuis
The Hague
UMC Utrecht
Utrecht
About this study
Official title: Adalimumab for the Treatment of Perianal Fistulas in Crohn's Disease More Effective Alone or Combined to Ciprofloxacin
To assess whether a combination of ciprofloxacin and adalimumab is more effective than adalimumab alone for the treatment of perianal fistulas in Crohn's disease
Read the detailed description
Dutch multicenter, randomized, double-blind study with two arms. 146 patients will be included.
- Conditions
- Crohn's Disease With Perianal Fistulas
- Being tested
- adalimumab, ciprofloxacin
- Keywords
- Perianal fistulas, Crohn's 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
Also called Humira
24 weeks: 160 mg, 80 mg, and than 40mg every 2 weeks
ciprofloxacinDrug
Also called Cipro
12 weeks; daily 2 x 500mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Adalimumab Receives: Drug: adalimumab |
| 2 | Placebo comparator | ciprofloxacin Receives: Drug: ciprofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas.
Measured: 12 week
Secondary outcomes (1)
Proportion of patients in remission
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's Disease With Perianal FistulasStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Liver Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- C.J. van der Woude, MD PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736983
- Sponsor's protocol ID
- IBD 08-01
- Other IDs
- EudraCT#: 2007-005832-10
- Acronym
- Adafi
- Status last verified
- Apr 2012
- First submitted
- 15 Aug 2008
- Last updated
- 17 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Dewint P, Hansen BE, Verhey E, Oldenburg B, Hommes DW, Pierik M, Ponsioen CI, van Dullemen HM, Russel M, van Bodegraven AA, van der Woude CJ. Adalimumab combined with ciprofloxacin is superior to adalimumab monotherapy in perianal fistula closure in Crohn's disease: a randomised, double-blind, placebo controlled trial (ADAFI). Gut. 2014 Feb;63(2):292-9. doi: 10.1136/gutjnl-2013-304488. Epub 2013 Mar 23.
PubMed 23525574
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adalimumab for the Treatment of Perianal Fistulas in Crohn's Disease More Effective Alone or Combined to Ciprofloxacin
- ClinicalTrials.gov ID
- NCT00736983
- Acronym / sponsor ID
- Adafi / IBD 08-01
- Conditions
- Crohn's Disease With Perianal Fistulas
- Keywords
- Perianal fistulas, Crohn's disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Foundation for Liver ResearchUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 18 Aug 2008 (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.
To assess whether a combination of ciprofloxacin and adalimumab is more effective than adalimumab alone for the treatment of perianal fistulas in Crohn's disease
Detailed description
Dutch multicenter, randomized, double-blind study with two arms. 146 patients will be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: adalimumabAdalimumab |
| 2 | Placebo comparator | Drug: ciprofloxacinciprofloxacin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- proven Crohn's disease
- Single or multiple draining perianal fistulas
Key exclusion criteria (8 listed)
- Abscesses
- Infliximab, cyclosporine, tacrolimus and antibiotics for Crohn's disease within past 3 months
- active viral infection
- significate cardiovascular dysfunction
- Pregnancy, Lactation
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 |
|---|---|---|
| adalimumabAlso: Humira24 weeks: 160 mg, 80 mg, and than 40mg every 2 weeks | Drug | 1 |
| ciprofloxacinAlso: Cipro12 weeks; daily 2 x 500mg | Drug | 2 |
Primary outcome
Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas.
Time frame: 12 week
1 secondary outcome
Proportion of patients in remission
Time frame: 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2012.
- Derived from this study: PubMed 23525574Dewint P, Hansen BE, Verhey E, Oldenburg B, Hommes DW, Pierik M, Ponsioen CI, van Dullemen HM, Russel M, van Bodegraven AA, van der Woude CJ. Adalimumab combined with ciprofloxacin is superior to adalimumab monotherapy in perianal fistula closure in Crohn's disease: a randomised, double-blind, placebo controlled trial (ADAFI). Gut. 2014 Feb;63(2):292-9. doi: 10.1136/gutjnl-2013-304488. Epub 2013 Mar 23.
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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.
C.J. van der Woude, MD PhD principal investigator
Erasmus Medical Center
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 and ciprofloxacin in people with Crohn's Disease With Perianal Fistulas, run by Foundation for Liver Research at 13 sites in Netherlands.
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 2 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: finished, as of the sponsor's last update on 17 Apr 2012. 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 Netherlands. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas. (time frame: 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00736983, which also lists 1 linked publication.
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 17 Apr 2012.