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

A Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00077779
Acronym
CHARM
Enrollment
854
Registered
2004-02-16
Start date
2003-07-31
Completion date
Unknown
Last updated
2007-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Brief summary

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)

Interventions

DRUGAdalimumab

Sponsors

Abbott
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Inclusion: * Males and females between the ages of 18 and 75 who are diagnosed with moderate to severe Crohn's Disease defined by a CDAI score of \>= 220 and \<= 450, normal laboratory parameters, * are willing and able to give informed consent, and * are able to self-inject or have a designee or healthcare professional who can inject the study medication. Exclusion: * History of certain types of cancer, diagnosis of ulcerative colitis, * female or breast feeding subjects, * surgical bowel resection(s) with in the past 6 months, * history of listeria, * human immunodeficiency virus (HIV), * central nervous system demyelinating disease or untreated TB, * history of a poorly controlled medical condition, * unsuccessful response to infliximab or any anti-TNF agent use in the past.

Design outcomes

Primary

MeasureTime frame
Clinical remission (CDAI<150).56 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026