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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00055523

Enrollment

300

Registered

2003-03-06

Start date

2002-04-30

Completion date

Unknown

Last updated

2006-08-15

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

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)

Interventions

DRUGAdalimumab (D2E7)

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
comparison of the induction of clinical remission	—
(achievement of a CDAI <150) of adalimumab 40 mg and 80 mg vs. placebo at Week 4.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026