Plaque PsoriasisPhase 4NCT01556672
Adalimumab-psoriasis and Small Bowel Lesions
A Phase 4 study testing Adalimumab and Capsule endoscopy in people with Plaque Psoriasis and Crohn's Disease, run by Innovaderm Research Inc. at 3 sites in Canada.
Trial summary
This study will determine the prevalence of small bowel lesions suggestive of Crohn's disease (CD) in patients with moderate to severe plaque psoriasis using capsule endoscopy. The study also aims to determine if the treatment of psoriasis with adalimumab will have an effect on the healing of the small bowel for… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Plaque Psoriasis, Crohn's Disease
- What is being tested?
- Adalimumab and Capsule endoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesCanada
- Study dates
- Apr 2012to Apr 2016
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women are 18 to 80 years of age at time of consent
- At least a 6-month history of chronic moderate to severe plaque psoriasis and is a candidate for systemic therapy
- BSA covered with psoriasis of at least 5% or more at Day 0
- Unless subject or subject's partner is in a menopausal state for at least a year, surgically sterile, clinically diagnosed infertile, having a same-sex partner or abstinent, female of childbearing potential or male patient (or his partner) is willing to use effective contraceptive method for at least 30 days before Day 0 and at least 6 months after the last study drug administration
- Is judged not to have contraindications to adalimumab as determined by the principal investigator based upon the results of medical history, laboratory profile, physical examination and chest X ray (CXR) performed at screening
- Negative results for latent TB infection with a PPD or QuantiFERON®-TB Gold test and a CXR
- Capable of giving informed consent and the consent must be obtained prior to any study related procedures
- Must be able and willing to self-administer SC injections or have a qualified person available to administer SC injections
Who cannot join
- Diagnosis of inflammatory bowel's disease
- Presence of any evidence of gastrointestinal obstruction, strictures and/or fistulas
- Presence of highly suspected or documented gastroparesis
- Known presence of gastrointestinal motility disorders
- Known presence of delayed gastric emptying
- Prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator
Show all 32Show fewer
- Presence of pacemaker, defibrillator or other electromedical device
- Expected to undergo a MRI examination within 7 days after ingestion of the capsule
- Swallowing disorder
- Presence of other skin diseases or skin infections that may interfere with evaluation of psoriasis or with patient's safety at Day 0
- History of an allergic reaction or significant sensitivity to constituents of study drug, including latex
- Use of any biological therapy for the treatment of psoriasis less than 90 days before Day 0
- Use of any other non-biological systemic therapy for the treatment of psoriasis within 28 days before Day 0
- Is planning to intentionally increase exposure to ultraviolet light at any time during the study period
- Is taking or requires systemic (i.e., oral or injectable) corticosteroids within 28 days of Day 0 or during the study
- Used any topical treatments for psoriasis or phototherapy within two weeks prior to Day 0
- Received Anakinra/Kineret within the last 2 weeks prior to Day 0
- Used any investigational non-biological agent within 30 days prior to Day 0, or within 5 half lives of the investigational agent prior to day 0
- Used NSAIDs for 28 days before Day 0
- Has a poorly controlled medical condition in the opinion of the investigator, would put the patient at risk if participating in the study
- Multiple sclerosis or presents with or has a history of neurologic symptoms suggestive of CNS demyelinating disease
- Current signs or symptoms of or a history of systemic lupus erythematosus or lupus like syndrome
- History of cancer or lymphoproliferative disease other than a successfully treated non metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix
- History of listeriosis, treated or untreated TB, persistent chronic infections, or recent active infections requiring hospitalization or treatment with intravenous anti-infectives within 30 days or oral anti-infectives within 14 days prior to Day 0
- Received any live attenuated vaccine 28 days or less before Day 0 or plans to receive one during the study
- Hepatitis B or hepatitis C
- Clinically significant abnormal results for hemoglobin, white blood cell count, platelet count, ALT, AST, total bilirubin or creatinine
- Current use or plan to use anti-retroviral therapy at any time during the study
- Known immune deficiency or is immunocompromised
- Current pregnancy or lactation or considering becoming pregnant during the study or for 150 days after the last dose of study medication
- History of clinically significant drug or alcohol abuse in the last year
- Is considered by the investigator, for any reason, to be an unsuitable candidate for the study
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Lynderm Research
Markham, Ontario, L3P 1A8
Innovaderm Research Inc.
Montreal, Quebec, H2K 4L5
Dr Isabelle Delorme
Saint-Hyacinthe, Quebec, J2S 6L6
About this study
Official title: Open-label Study on Small Bowel Lesions Suggestive of Crohn's Disease in Patients With Moderate to Severe Plaque Psoriasis Treated With Adalimumab
This study will determine the prevalence of small bowel lesions suggestive of Crohn's disease (CD) in patients with moderate to severe plaque psoriasis using capsule endoscopy. The study also aims to determine if the treatment of psoriasis with adalimumab will have an effect on the healing of the small bowel for patients who have lesions suggestive of CD.
Patients with psoriasis are at increased risk of developing Crohn's disease (CD), but the exact prevalence of CD in patients with psoriasis at this time is unknown as many patients probably have undiagnosed disease as the early signs will often cause no symptoms. CD is therefore receiving very little attention from dermatologists who are treating patients with psoriasis. For example, very few dermatologists will actively question patients with psoriasis about symptoms of CD. This lack of knowledge may induce delays in diagnosis. By the time the diagnosis is made and patients receive their first treatment, they may already have significant fibrosis and stenosis of the intestine. Current treatments, including adalimumab, cannot reverse small bowel anomalies to normal in the presence of fibrosis. Therefore, many patients with a late diagnosis will still have symptoms or will eventually require surgery despite good control of the inflammation. Treatment of CD should start as early as possible, as early treatment has been associated with an increased rate of complete healing. Complete control of the disease at its early stages may prevent complications.
Read the detailed description
This open-label, phase IV, 24-week study will recruit a total of 100 patients with moderate to severe plaque psoriasis without a diagnosis of inflammatory bowel disease. All patients will undergo capsule endoscopy at the beginning of the study to detect the presence of small bowel lesions suggestive of CD such as erosions and ulcers. All patients will receive adalimumab 80 mg followed by 40 mg at week 1 and 40 mg every other week (EOW) thereafter. Patients for whom no small bowel lesions suggestive of CD were detected will remain in the study and under adalimumab therapy until week 12. A second capsule endoscopy will be performed 24 weeks after initiation of adalimumab for patients who had small bowel lesions suggestive of CD to evaluate changes in bowel inflammation.
- Conditions
- Plaque Psoriasis, Crohn's Disease
- Being tested
- Adalimumab, Capsule endoscopy
- Keywords
- small bowel lesions, Crohn's Disease, Plaque psoriasis, adalimumab, capsule endoscopy
- 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
Adalimumab will be administered sub-cutaneously to all patients entering the study with a loading dose of 80 mg followed by 40 mg at week 1 and 40 mg every other week. Patients who did not have small bowel lesions detected will be in the study and receive adalimumab until week 12. Patients who had small bowel lesions detected will be in the study and receive adalimumab until week 24.
Capsule endoscopyDevice
Also called EndoCapsule EC-1, OLYMPUS EC TYPE 1
All patients will undergo capsule endoscopy (EndoCapsule EC type 1; Olympus) to treatment initiation (adalimumab) in order to detect the presence of small bowel lesions suggestive of Crohn's disease. Twenty-four (24) weeks after treatment with adalimumab was initiated, patients for whom small bowel lesions were detected will undergo a second capsule endoscopy to evaluate changes in bowel inflammation.
| Study group | Role | What they receive |
|---|---|---|
| adalimumab | Experimental | All patients will receive adalimumab 80 mg followed by 40 mg at week 1 and 40 mg every other week (EOW) thereafter. Receives: Drug: Adalimumab; Device: Capsule endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of small bowel lesions suggestive of Crohn's disease in patients with moderate to severe plaque psoriasis as visualized by capsule endoscopy
Measured: Day 0
Secondary outcomes (5)
Induction of mucosal healing at week 24 after initiation of adalimumab in patients with small bowel lesions suggestive of Crohn's disease and psoriasis as defined by absence of villous edema, erosions and ulcers
Measured: 24 weeks
Study the relationship between mucosal healing and plaque psoriasis improvement in patients with small bowel lesions suggestive of Crohn's disease and psoriasis
as evaluated by the absence of villous edema, erosions and ulcers and mean change from baseline in PASI at week 24
Measured: 24 weeks
Study the relationship between levels of fecal calprotectin and endoscopy findings
Measured: Day 0 and week 24
Change from baseline in PASI at Week 12 for patients who had presence of small bowel lesions suggestive of CD as compared to patients who did not have small bowel lesions suggestive of CD
Measured: 12 weeks
Proportion of patients reaching Psoriasis Area and Severity Index (PASI) 75 at Week 12 for patients who had small bowel lesions suggestive of CD as compared to patients who did not have small bowel lesions suggestive of CD.
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 posted16 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionJan 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovaderm Research Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Robert Bissonnette, MD, FRCPC, Principal investigator, Innovaderm Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556672
- Sponsor's protocol ID
- Inno-6021
- Other IDs
- IMM-11-0110
- Status last verified
- Jun 2016
- First submitted
- 15 Mar 2012
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Study on Small Bowel Lesions Suggestive of Crohn's Disease in Patients With Moderate to Severe Plaque Psoriasis Treated With Adalimumab
- ClinicalTrials.gov ID
- NCT01556672
- Acronym / sponsor ID
- Inno-6021
- Conditions
- Plaque Psoriasis, Crohn's Disease
- Keywords
- small bowel lesions, Crohn's Disease, Plaque psoriasis, adalimumab, capsule endoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Innovaderm Research Inc.University, hospital or other
- Collaborators
- Abbott
- Study start
- Apr 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 16 Mar 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 will determine the prevalence of small bowel lesions suggestive of Crohn's disease (CD) in patients with moderate to severe plaque psoriasis using capsule endoscopy. The study also aims to determine if the treatment of psoriasis with adalimumab will have an effect on the healing of the small bowel for patients who have lesions suggestive of CD.
Patients with psoriasis are at increased risk of developing Crohn's disease (CD), but the exact prevalence of CD in patients with psoriasis at this time is unknown as many patients probably have undiagnosed disease as the early signs will often cause no symptoms. CD is therefore receiving very little attention from dermatologists who are treating patients with psoriasis. For example, very few dermatologists will actively question patients with psoriasis about symptoms of CD. This lack of knowledge may induce delays in diagnosis. By the time the diagnosis is made and patients receive their first treatment, they may already have significant fibrosis and stenosis of the intestine. Current treatments, including adalimumab, cannot reverse small bowel anomalies to normal in the presence of fibrosis. Therefore, many patients with a late diagnosis will still have symptoms or will eventually require surgery despite good control of the inflammation. Treatment of CD should start as early as possible, as early treatment has been associated with an increased rate of complete healing. Complete control of the disease at its early stages may prevent complications.
Detailed description
This open-label, phase IV, 24-week study will recruit a total of 100 patients with moderate to severe plaque psoriasis without a diagnosis of inflammatory bowel disease. All patients will undergo capsule endoscopy at the beginning of the study to detect the presence of small bowel lesions suggestive of CD such as erosions and ulcers. All patients will receive adalimumab 80 mg followed by 40 mg at week 1 and 40 mg every other week (EOW) thereafter. Patients for whom no small bowel lesions suggestive of CD were detected will remain in the study and under adalimumab therapy until week 12. A second capsule endoscopy will be performed 24 weeks after initiation of adalimumab for patients who had small bowel lesions suggestive of CD to evaluate changes in bowel inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adalimumab | Experimental | Drug: Adalimumab, Device: Capsule endoscopyAll patients will receive adalimumab 80 mg followed by 40 mg at week 1 and 40 mg every other week (EOW) thereafter. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men or women are 18 to 80 years of age at time of consent
- At least a 6-month history of chronic moderate to severe plaque psoriasis and is a candidate for systemic therapy
- BSA covered with psoriasis of at least 5% or more at Day 0
- Unless subject or subject's partner is in a menopausal state for at least a year, surgically sterile, clinically diagnosed infertile, having a same-sex partner or abstinent, female of childbearing potential or male patient (or his partner) is willing to use effective contraceptive method for at least 30 days before Day 0 and at least 6 months after the last study drug administration
- Is judged not to have contraindications to adalimumab as determined by the principal investigator based upon the results of medical history, laboratory profile, physical examination and chest X ray (CXR) performed at screening
Key exclusion criteria (32 listed)
- Diagnosis of inflammatory bowel's disease
- Presence of any evidence of gastrointestinal obstruction, strictures and/or fistulas
- Presence of highly suspected or documented gastroparesis
- Known presence of gastrointestinal motility disorders
- Known presence of delayed gastric emptying
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: HumiraAdalimumab will be administered sub-cutaneously to all patients entering the study with a loading dose of 80 mg followed by 40 mg at week 1 and 40 mg every other week. Patients who did not have small bowel lesions detected will be in the study and receive adalimumab until week 12. Patients who had small bowel lesions detected will be in the study and receive adalimumab until week 24. | Drug | adalimumab |
| Capsule endoscopyAlso: EndoCapsule EC-1, OLYMPUS EC TYPE 1All patients will undergo capsule endoscopy (EndoCapsule EC type 1; Olympus) to treatment initiation (adalimumab) in order to detect the presence of small bowel lesions suggestive of Crohn's disease. Twenty-four (24) weeks after treatment with adalimumab was initiated, patients for whom small bowel lesions were detected will undergo a second capsule endoscopy to evaluate changes in bowel inflammation. | Device | adalimumab |
Primary outcome
Prevalence of small bowel lesions suggestive of Crohn's disease in patients with moderate to severe plaque psoriasis as visualized by capsule endoscopy
Time frame: Day 0
5 secondary outcomes
Induction of mucosal healing at week 24 after initiation of adalimumab in patients with small bowel lesions suggestive of Crohn's disease and psoriasis as defined by absence of villous edema, erosions and ulcers
Time frame: 24 weeks
Study the relationship between mucosal healing and plaque psoriasis improvement in patients with small bowel lesions suggestive of Crohn's disease and psoriasis
Time frame: 24 weeks
Study the relationship between levels of fecal calprotectin and endoscopy findings
Time frame: Day 0 and week 24
Change from baseline in PASI at Week 12 for patients who had presence of small bowel lesions suggestive of CD as compared to patients who did not have small bowel lesions suggestive of CD
Time frame: 12 weeks
Proportion of patients reaching Psoriasis Area and Severity Index (PASI) 75 at Week 12 for patients who had small bowel lesions suggestive of CD as compared to patients who did not have small bowel lesions suggestive of CD.
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 29 Jun 2016.
- Individual participant dataSharing planned: No
Related trials for Plaque Psoriasis
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Plaque Psoriasis Involving Special Areas (Scalp, Genital, and/or Palms of the Hands and the Soles of the Feet)
Plaque Psoriasis
RecruitingObservational study
A Study of Persistence to Guselkumab Treatment in Participants With Moderate-to-Severe Plaque Psoriasis in Romania
Psoriasis
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
Psoriasis
Active, not recruitingObservational study
A Safety Study of Ustekinumab in the Treatment of Pediatric Participants Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis
Psoriasis
Active, not recruitingPhase 3
A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
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.
Robert Bissonnette, MD, FRCPC principal investigator
Innovaderm Research Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adalimumab and Capsule endoscopy in people with Plaque Psoriasis and Crohn's Disease, run by Innovaderm Research Inc. at 3 sites in Canada.
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 8 inclusion and 32 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 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Prevalence of small bowel lesions suggestive of Crohn's disease in patients with moderate to severe plaque psoriasis as visualized by capsule endoscopy (time frame: Day 0). 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 29 Jun 2016.