Advertisement

Topics

Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy

2014-07-24 14:01:00 | BioPortfolio

Summary

The study hypothesis is that adalimumab induces mucosal healing in the small bowel and that mucosal healing correlates with disease activity. 30 Patients with isolated active small bowel Crohn's disease which are candidates to receive anti-TNF treatment will be included in the study. All patients will undergo patency capsule examination and capsule endoscopy afterwards. Small bowel endoscopic disease severity will be assessed by the capsule endoscopy Crohn's disease activity index (CECDAI). The patients will receive Adalimumab (Humira)injections (160mg,80mg and 40mg every 2 weeks ) for 12 weeks. on week 14 a second capsule endoscopy will be performed and CECDAI calculated again. The patients clinical condition, CDAI,IBDQ and laboratory results including CRP, CBC and fecal calprotectin will be assessed on weeks o, 7 and 14 and results will be compared with the endoscopic score.

Study Design

Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Crohn's Disease

Intervention

Treatment with Adalimumab

Location

Rabin Medical Center - Beilinson Hospital
Petach Tikva
Israel
4910

Status

Not yet recruiting

Source

Rabin Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:01:00-0400

Clinical Trials [731 Associated Clinical Trials listed on BioPortfolio]

Study of Adalimumab Treatment for Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease

The purpose of this study is to evaluate the safety of adalimumab for treatment of patients with moderate to severe Crohn's Disease (CD) and to measure the effects of treatment on patient ...

Pediatric Crohn's Disease AdalImumab Level-based Optimization Treatment (PAILOT) Trial

Objectives: To examine the effect of drug level-based personalized treatment of adalimumab in children with Crohn's disease. Design: A prospective, randomized, open label study. Setting: P...

Treatment of the Human Anti-TNF Monoclonal Antibody Adalimumab in Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab (CHOICE)

The primary objective of this study is to make adalimumab available to patients suffering from moderately to severely active Crohn's Disease who have failed to respond to, lost response to...

Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)

To make adalimumab available to subjects suffering from moderately to severely active Crohn's Disease (CD) and to expand the safety information on adalimumab. The study also assessed chang...

A Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease

Purpose of the study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease when compared to placebo (an inactive substance)

PubMed Articles [29644 Associated PubMed Articles listed on BioPortfolio]

Efficacy of switching to infliximab in patients with Crohn's disease with loss of response to adalimumab.

Anti-TNF monoclonal antibodies are a cornerstone in the treatment of Crohn's disease. Prospective data on switching from the subcutaneous and human adalimumab (ADM) to the intravenous and chimeric inf...

Explaining Interpatient Variability in Adalimumab Pharmacokinetics in Patients With Crohn's Disease.

A significant proportion of patients with Crohn's disease (CD) require dose escalation or fail adalimumab (ADL) therapy over time. ADL, a monoclonal antibody directed against tumor necrosis factor, is...

Influence of early adalimumab serum levels on immunogenicity and long-term outcome of anti-TNF naive Crohn's disease patients: the usefulness of rapid testing.

Proactive testing of adalimumab serum levels is debated.

Etanercept-induced Crohn's disease in ankylosing spondylitis: a case report and review of the literature.

Tumor necrosis factor (TNF)-α is a cytokine that plays a well-established, key role as a central mediator of inflammation and immune regulation. TNF-α and its receptors are suggested to play a criti...

Clinical disease activity and endoscopic severity correlate poorly in children newly diagnosed with Crohn's Disease.

/Aims: Treatment goals in Crohn's disease (CD) have evolved to target mucosal healing. There is now a drive to determine if non-invasive measures can adequately identify the attainment and persistence...

Medical and Biotech [MESH] Definitions

A humanized monoclonal antibody that binds specifically to TNF-ALPHA and blocks its interaction with endogenous TNF RECEPTORS to modulate INFLAMMATION. It is used in the treatment of RHEUMATOID ARTHRITIS; PSORIATIC ARTHRITIS; CROHN'S DISEASE and ULCERATIVE COLITIS.

A chronic transmural inflammation that may involve any part of the DIGESTIVE TRACT from MOUTH to ANUS, mostly found in the ILEUM, the CECUM, and the COLON. In Crohn disease, the inflammation, extending through the intestinal wall from the MUCOSA to the serosa, is characteristically asymmetric and segmental. Epithelioid GRANULOMAS may be seen in some patients.

A condition characterized by persistent or recurrent labial enlargement, ORAL ULCER, and other orofacial manifestations in the absence of identifiable CROHN DISEASE; or SARCOIDOSIS. There is no consensus on whether orofacial granulomatosis is a distinct clinical disorder or an initial presentation of Crohn disease.

A chimeric monoclonal antibody to TNF ALPHA that is used in the treatment of RHEUMATOID ARTHRITIS; ANKYLOSING SPONDYLITIS; PSORIATIC ARTHRITIS and CROHN'S DISEASE.

A humanized monoclonal immunoglobulin G4 antibody to human INTEGRIN ALPHA4 that binds to the alpha4 subunit of INTEGRIN ALPHA4BETA1 and integrin alpha4beta7. It is used as an IMMUNOLOGIC FACTOR in the treatment of RELAPSING-REMITTING MULTIPLE SCLEROSIS and CROHN'S DISEASE.

More From BioPortfolio on "Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Cytokine Tumour Necrosis Factor (TNF)
TNF is a compound that is classified as a cytokine which plays a central role in the cellular mechanisms of apoptosis or cell death. However, there are a number of different kinds of TNF, just under twenty, but the family of molecules have very similar a...


Searches Linking to this Trial