Adalimumab-psoriasis and Small Bowel Lesions
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.
Device: Capsule endoscopy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]as evaluated by the absence of villous edema, erosions and ulcers and mean change from baseline in PASI at week 24
- Study the relationship between levels of fecal calprotectin and endoscopy findings [ Time Frame: Day 0 and week 24 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||April 2012|
|Study Completion Date:||April 2016|
|Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
All patients will receive adalimumab 80 mg followed by 40 mg at week 1 and 40 mg every other week (EOW) thereafter.
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.
Other Name: HumiraDevice: Capsule endoscopy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556672
|Markham, Ontario, Canada, L3P 1A8|
|Innovaderm Research Inc.|
|Montreal, Quebec, Canada, H2K 4L5|
|Dr Isabelle Delorme|
|St-Hyacinthe, Quebec, Canada, J2S 6L6|
|Principal Investigator:||Robert Bissonnette, MD, FRCPC||Innovaderm Research Inc.|