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Crohn's Disease clinical trials

View clinical trials related to Crohn's Disease.

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NCT ID: NCT00077779 Completed - Crohn's Disease Clinical Trials

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

CHARM
Start date: July 2003
Phase: Phase 3
Study type: Interventional

The purpose of this study is to test whether Adalimumab (at two different doses) can induce and maintain clinical remission in subjects with active Crohn's disease when compared to placebo (a substance containing no medication)

NCT ID: NCT00074542 Completed - Crohn's Disease Clinical Trials

An Efficacy and Safety Study of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's Disease

Start date: September 2002
Phase: Phase 3
Study type: Interventional

The purpose of this study is to see if Epanova™ is able to maintain the symptomatic remission in subjects with Crohn's Disease who are responding to steroid induction therapy. Patient safety and quality of life will also be monitored throughout the study.

NCT ID: NCT00072943 Completed - Crohn's Disease Clinical Trials

A Humanized Anti-Interferon-γ Monoclonal Antibody (HuZAF) for Moderate to Severe Crohn's Disease

Start date: March 2002
Phase: Phase 2
Study type: Interventional

The purpose of the HARMONY study is to assess the safety and efficacy of an investigational drug called HuZAF, in patients with moderate to severe Crohn's disease (CD). HuZAF is a humanized anti-Interferon-gamma (anti-IFN-γ) monoclonal antibody, which binds and blocks IFN-γ, a protein in the immune system that is involved in inflammation. Antibodies are proteins normally produced by our immune system to help fight off foreign substances. Scientists have been able to make therapeutic humanized monoclonal antibodies, similar to the antibodies in our bodies, to target diseases.

NCT ID: NCT00072839 Completed - Crohn's Disease Clinical Trials

Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease

Start date: November 12, 2003
Phase: Phase 2
Study type: Interventional

The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.

NCT ID: NCT00061737 Completed - Ulcerative Colitis Clinical Trials

Quality of Life in Pediatric Inflammatory Bowel Disease

Start date: January 2003
Phase: N/A
Study type: Observational

Measurement of the quality of life (QoL) of children and adolescents with inflammatory bowel diseases (IBD) has had little attention, despite the importance of understanding key factors affecting QoL, especially for measuring the effects of clinical trials to improve IBD outcomes. The main purpose of this pilot study is to examine the impact of clinical severity and treatment social factors on the quality of life (QoL) of a diverse population of children and adolescents with inflammatory bowel disease (IBD). Secondary purposes include determining the effects of sociodemographic factors on QoL and exploring the concordance of views of parents and children of QoL. The study aims are to 1) determine the associations of of clinical characteristics (condition type, activity/severity, and treatment) with specific components of general health-related quality of life and IBD-specific QoL; 2) describe the effects of sociodemographic characteristics (SES, age, and gender) on these measures; and 3) compare the views of different observers (parent and child with IBD) of the child's QoL. The study will apply both general and condition-specific QoL measures among a random sample of 250 children and adolescents with IBD, ages 5-18 years, in six clinical sites. We will obtain measures of QoL from both the child and a parent in each case. The study will obtain additional data regarding the subjects' clinical condition (condition type, severity/activity, treatment [including surgery], age of onset) and socioeconomic status (household structure and income). Main analyses will compare general and specific measures of QoL and examine the influence of clinical and sociodemographic variables on QoL, through multivariate regression techniques. We will also examine the differences in child and parent assessments of QoL. The information from this study will provide a stronger base for future studies of treatment and natural history of IBD. It will help to clarify the life domains that are affected by IBD and will inform interventions to improve QoL for children with IBD.

NCT ID: NCT00055536 Completed - Crohn's Disease Clinical Trials

Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease

Start date: April 2002
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety, tolerability, and efficacy of natalizumab in individuals diagnosed with active Crohn's Disease that are not in remission (CDAI greater than/equal to 150) and are currently taking Remicade. It is thought that natalizumab may stop the movement of certain cells, known as white blood cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the symptoms of Crohn's disease. Patients who complete this study may be eligible for long-term natalizumab therapy via extension protocol ELN100226-351.

NCT ID: NCT00055523 Completed - Crohn's Disease Clinical Trials

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

Start date: April 2002
Phase: Phase 2
Study type: Interventional

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)

NCT ID: NCT00055497 Completed - Crohn's Disease Clinical Trials

Remission in Subjects With Crohn's Disease, 1 Year Phase

CLASSICII
Start date: August 2002
Phase: Phase 3
Study type: Interventional

The objectives were: (1) To demonstrate the efficacy of adalimumab in the maintenance of clinical remission up to 56 weeks in participants with Crohn's disease who participated in NCT00055523; (2) To delineate the safety of adalimumab when administered to participants with Crohn's disease up to 56 weeks.

NCT ID: NCT00055367 Completed - Crohn's Disease Clinical Trials

Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's Disease

Start date: April 2002
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and tolerability of natalizumab in adolescents (ages 12-17) diagnosed with moderately to severely active Crohn's disease (CD). It is thought that natalizumab may stop the movement of certain cells, known as white blood cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the symptoms of Crohn's disease. Patients who complete this study may be eligible for long-term natalizumab therapy via extension protocol ELN100226-352.

NCT ID: NCT00048295 Completed - Crohn's Disease Clinical Trials

Alicaforsen (ISIS 2302) in Patients With Active Crohn's Disease

Start date: May 2002
Phase: Phase 3
Study type: Interventional

ISIS 2302 is an antisense oligonucleotide drug that reduces the production of a specific protein called intercellular adhesion molecule (ICAM-1), a substance that plays a significant role in the increase of inflammation. People with Crohn's disease have been shown to over-produce ICAM-1 in their gut tissues. Alicaforsen works by blocking ICAM-1 messenger RNA, the "instruction" molecule that is required for the production of ICAM-1 protein. This trial will examine effects of alicaforsen delivered by 2-hour intravenous infusion over a four-week period, compared to a placebo. Patients may remain on stable background 5-ASA, antibiotic, or immunosuppressive drugs, and prednisone (or equivalent) at </= 30 mg per day.