Ulcerative ColitisPhase 3ADAPNCT01670240
Adalimumab in the Treatment of Chronic Pouchitis
A Phase 3 study testing Adalimumab in people with Ulcerative Colitis and Pouchitis, run by Odense University Hospital at 1 site in Denmark.
Trial summary
This study wants to investigate the efficiency of biological treatment for chronic pouchitis. Chronic pouchitis is inflammation in a reconstruction after removal of the colon, a pouch. It is examined in patients with ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Pouchitis
- What is being tested?
- Adalimumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2012to Jan 2016
- 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
- Operated with proctocolectomy and construction of an IPAA
- Prior to surgery diagnosed with ulcerative colitis according to established clinically, radiologic, endoscopic and histological criteria.
- Diagnosed with chronic pouchitis as defined above
- PDAI ≥ 7, with the clinically part of PDAI >2 and the endoscopic part of PDAI >3
- Age >18 years
- Negative stool cultures for bacterial bowel pathogens and negative stool microscopy for parasites
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- Serology negative for chronic hepatitis B
- Negative examination for tuberculosis (including x-ray of thorax and a interferon gamma test)
- Signed informed consent
Who cannot join
- Treatment with glucocorticoids within the last 4 weeks
- Diagnosed with Crohn's disease
- Need of an interpreter or if patients do not understand oral or written information.
- Surgical complications as anal stenosis, leak of the anastomosis, or fistula arising from the pouch
- Abuse of medicine, alcohol or drugs
- Ongoing treatment with NSAID (non steroid anti inflammatory drug)
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- Pregnancy or nursing
- A diverting stoma
- Malignancy or other severe chronic disease or expected longevity less than one year
- Patients diagnosed with immune deficiency
- Ongoing infectious disease
- Contraindications against treatment with tumor necrosis factor-alpha antibody, such as heart disease, former cancer disease, in vivo vaccination within the last 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adalimumab (Humira) in the Treatment of Chronic Pouchitis
This study wants to investigate the efficiency of biological treatment for chronic pouchitis. Chronic pouchitis is inflammation in a reconstruction after removal of the colon, a pouch. It is examined in patients with ulcerative colitis.
The primary objective evaluation is to evaluate the clinically effect of biological therapy (adalimumab) in patients with chronic pouchitis.
Secondary objective is to evaluate the effect of biological therapy on the endoscopical and histological inflammatory activity.
It is a double-blinded randomized placebo controlled study.
- Conditions
- Ulcerative Colitis, Pouchitis
- Being tested
- Adalimumab, Placebo
- Keywords
- IPAA, Pouchitis, Ulcerative colitis, Pouch, Adalimumab, Humira
- Medical subject headings
- Colitis, Ulcerative, Pouchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Also called Humira
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab | Active comparator | Every second week, mg: 160-80-40-40-40-40 12 weeks in all Receives: Drug: Adalimumab |
| Placebo | Placebo comparator | Given as the active comparator, every second week Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response on treatment with Adalimumab
The number of patients with chronic pouchitis achieving a clinical improvement, defined as a reduction in clinically PDAI ≥ 2 at any time within the 12 weeks of treatment with adalimumab (Humira).
Clinical PDAI (0-6 points)(pouchitis disease activity index)refers to fewer (0-1 point), number of bowel movements(0-2 points), rectal bleeding(0-1 point) and fecal urgency(0-2 points).
Measured: 12 weeks
Secondary outcomes (3)
Clinical improvement after 12 weeks of treatment
The number of patients with a clinical improvement (PDAI reduction ≥ 2)at week 12 See the description of clinical improvement and PDAI under primary endpoint
Measured: 12 weeks
Clinical remission after 12 weeks
The number of patients with pouchitis in remission at week 12 (total PDAI ≤4)
Measured: 12 weeks
Endoscopic and histologic response after treatment with Adalimumab
Effect (reduction in PDAI)of adalimumab (Humira) on the endoscopical and histological activity in chronic pouchitis Endoscopical and histological activity is defined from PDAI (pouchitis disease activity index). Endoscopically the presence of Edema, Granularity, Friability, Loss of vascular pattern, Mucous exudates or Ulceration, gives 1 point each (max 6 points). Histological the presence of polymorphic nuclear leukocyte infiltration and ulceration each gives 1-3 points regarding severity (max 6 points)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Hvidovre University Hospital, Aarhus University Hospital, AbbVie
- Responsible party
- Principal investigator, Mie Dilling Kjaer, Odense University Hospital
- Investigators
- Jens Kjeldsen, Phd, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670240
- Sponsor's protocol ID
- 2011-004268-31
- Acronym
- ADAP
- Status last verified
- Jan 2016
- First submitted
- 8 Aug 2012
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adalimumab (Humira) in the Treatment of Chronic Pouchitis
- ClinicalTrials.gov ID
- NCT01670240
- Acronym / sponsor ID
- ADAP / 2011-004268-31
- Conditions
- Ulcerative Colitis, Pouchitis
- Keywords
- IPAA, Pouchitis, Ulcerative colitis, Pouch, Adalimumab, Humira
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Hvidovre University Hospital, Aarhus University Hospital, AbbVie
- Study start
- Aug 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 22 Aug 2012 (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.
This study wants to investigate the efficiency of biological treatment for chronic pouchitis. Chronic pouchitis is inflammation in a reconstruction after removal of the colon, a pouch. It is examined in patients with ulcerative colitis.
The primary objective evaluation is to evaluate the clinically effect of biological therapy (adalimumab) in patients with chronic pouchitis.
Secondary objective is to evaluate the effect of biological therapy on the endoscopical and histological inflammatory activity.
It is a double-blinded randomized placebo controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | Active comparator | Drug: AdalimumabEvery second week, mg: 160-80-40-40-40-40 12 weeks in all |
| Placebo | Placebo comparator | Drug: PlaceboGiven as the active comparator, every second week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Operated with proctocolectomy and construction of an IPAA
- Prior to surgery diagnosed with ulcerative colitis according to established clinically, radiologic, endoscopic and histological criteria.
- Diagnosed with chronic pouchitis as defined above
- PDAI ≥ 7, with the clinically part of PDAI >2 and the endoscopic part of PDAI >3
- Age >18 years
Key exclusion criteria (12 listed)
- Treatment with glucocorticoids within the last 4 weeks
- Diagnosed with Crohn's disease
- Need of an interpreter or if patients do not understand oral or written information.
- Surgical complications as anal stenosis, leak of the anastomosis, or fistula arising from the pouch
- Abuse of medicine, alcohol or 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 |
|---|---|---|
| AdalimumabAlso: Humira | Drug | Adalimumab |
| Placebo | Drug | Placebo |
Primary outcome
Clinical response on treatment with Adalimumab
Time frame: 12 weeks
The number of patients with chronic pouchitis achieving a clinical improvement, defined as a reduction in clinically PDAI ≥ 2 at any time within the 12 weeks of treatment with adalimumab (Humira). Clinical PDAI (0-6 points)(pouchitis disease activity index)refers to fewer (0-1 point), number of bowel movements(0-2 points), rectal bleeding(0-1 point) and fecal urgency(0-2 points).
3 secondary outcomes
Clinical improvement after 12 weeks of treatment
Time frame: 12 weeks
Clinical remission after 12 weeks
Time frame: 12 weeks
Endoscopic and histologic response after treatment with Adalimumab
Time frame: 12 weeks
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 28 Jan 2016.
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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.
Jens Kjeldsen, Phd principal investigator
Odense University Hospital
1 site 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 Ulcerative Colitis and Pouchitis, run by Odense University Hospital at 1 site in Denmark.
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 9 inclusion and 12 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 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Clinical response on treatment with Adalimumab (time frame: 12 weeks). 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 28 Jan 2016.