NCT01556672

Adalimumab-psoriasis and Small Bowel Lesions

Open-label Study on Small Bowel Lesions Suggestive of Crohn's Disease in Patients With Moderate to Severe Plaque Psoriasis Treated With Adalimumab

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Innovaderm Research Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Plaque Psoriasis
• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Adalimumab	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.
DEVICE	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.

Timeline

• Start date: 2012-04-01
• Primary completion: 2016-01-01
• Completion: 2016-04-01
• First posted: 2012-03-16
• Last updated: 2016-06-29

Locations

3 sites across 1 country: Canada