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Completed

NCT Number: NCT00105300

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

The goal of this study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a result of intolerance to the drug.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Imelda Ziekenhuis, Bonheiden, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females between the ages of 18 and 75 who are diagnosed with mild to moderate Crohn's disease (defined by a CDAI [Crohn's Disease Activity Index] score of 220 and 450)
  • Normal lab parameters
  • Are willing to give informed consent
  • Have previously used and either were intolerant to or lost response to infliximab

Exclusion criteria

  • History of certain types of cancer
  • Diagnosis of ulcerative colitis
  • Pregnant female or breast feeding subjects
  • Known obstructive strictures
  • Surgical bowel resection in the past 6 months
  • History of listeria, human immunodeficiency virus (HIV), central nervous system demyelinating disease or untreated TB (tuberculosis)
  • History of poorly controlled medical conditions
  • Specific doses and durations of Crohn's medications
  • Subjects that have previously used infliximab and have never clinically responded unless primary non-response was due to a treatment limiting reaction to infliximab

Treatment and study plan

Adalimumab

Drug

Primary outcomes

  1. Induction of clinical remission (CDAI score < 150 at Week 4)

Secondary outcomes

  1. Clinical response measured as

  2. Decrease in Baseline CDAI score >= 70 points at Week 4

  3. Decrease in Baseline CDAI score >= 100 points at Week 4

  4. Changes in IBDQ scores at Week 4

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to Infliximab

Important dates

Study start
2004
First posted
Mar 14, 2005
Registry last updated
Aug 15, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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