Adalimumab-psoriasis and Small Bowel Lesions

NCT01556672 | Completed Phase 4

• 2 other identifiers: Inno-6021IMM-11-0110
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Plaque Psoriasis; Crohn's Disease

Keywords

small bowel lesions; Crohn's Disease; Plaque psoriasis; adalimumab; capsule endoscopy

Outcome Measures

Primary Outcomes (1)

• Prevalence of small bowel lesions suggestive of Crohn's disease in patients with moderate to severe plaque psoriasis as visualized by capsule endoscopy

  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

  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

  24 weeks

• Study the relationship between levels of fecal calprotectin and endoscopy findings

  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

  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.

  12 weeks

Study Arms (1)

adalimumab

EXPERIMENTAL

All patients will receive adalimumab 80 mg followed by 40 mg at week 1 and 40 mg every other week (EOW) thereafter.

Drug: Adalimumab; Device: Capsule endoscopy

Interventions

Adalimumab DRUG

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.

Also known as: Humira

adalimumab

Capsule endoscopy DEVICE

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.

Also known as: EndoCapsule EC-1, OLYMPUS EC TYPE 1

adalimumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Innovaderm Research Inc.: lead
• Abbott: collaborator

Study Sites (3)

Lynderm Research

Markham, Ontario, L3P 1A8, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2K 4L5, Canada

Location

Dr Isabelle Delorme

Saint-Hyacinthe, Quebec, J2S 6L6, Canada

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Adalimumab; Capsule Endoscopy

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Robert Bissonnette, MD, FRCPC

  Innovaderm Research Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2012
• First Posted: March 16, 2012
• Study Start: April 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 29, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)