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OpenTrials
Completed

NCT Number: NCT00055523

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)

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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 2

Primary location

Gastroenterology Associates of the East Bay, Berkeley, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion:

  • Diagnosis of Crohn's disease
  • CDAI score at baseline of between 220 and 450
  • Normal laboratory parameters
  • Willing and able to give informed consent

Exclusion:

  • Diagnosis of ulcerative colitis
  • Women cannot be pregnant or breastfeeding
  • No previous use of infliximab or other anti-TNF antagonists
  • No previous history of tuberculosis or listeria infection
  • No previous history of cancer other than successfully treated skin cancer

Treatment and study plan

Adalimumab (D2E7)

Drug

Primary outcomes

  1. comparison of the induction of clinical remission

  2. (achievement of a CDAI <150) of adalimumab 40 mg and 80 mg vs. placebo at Week 4.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Important dates

Study start
2002
First posted
Mar 6, 2003
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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