Effects of Adalimumab on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon

Condition(s) targeted: Crohn's Disease

Intervention: adalimumab (Biological); placebo (Biological); adalimumab (Biological)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Beverly A Paperiello, Study Director, Affiliation: Abbott

The goal of this study is to test whether adalimumab can induce mucosal healing in subjects with moderate to severe ileocolonic Crohn's Disease.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Presence of absence of mucosal ulceration by endoscopy relative to Screening endoscopy

Proportion of subjects without mucosal ulceration on endoscopy relative to Screening endoscopy

Secondary outcome:

Safety Parameters

Patient Reported Outcomes

Clinical response indicators

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of Crohn's Disease for greater than 4 months.

- A diagnosis of ileocolonic Crohn's Disease confirmed by endoscopy or radiologic

evaluation within 3 years of Baseline.

- For subjects who have had operations in the ileocolonic region of the intestine after

documented diagnosis of ileocolonic disease, postoperative recurrence of the disease must be documented.

- Endoscopic documentation of ulceration at Screening corresponding to a score of 2 or 3

in at least one of the five segments of the colon on the Ulcerated Surface subscore of the SES-CD.

- Crohn's Disease Activity Index (CDAI) score of >= 220 and <= 450.

- Males and females >= 18 and <= 75 years of age at the Baseline visit.

- Adequate cardiac, renal and hepatic function as determined by the Principal

Investigator and demonstrated by Screening laboratory evaluations, questionnaires, and physical examination results that do not indicate an abnormal clinical condition which would place the subject at undue risk and thus preclude subject participation in the study.

- Subjects must be able to self-inject study medication or have a designee or healthcare

professional who can inject the study medication.

- Subjects must agree to undergo up to 4 endoscopies.

Exclusion Criteria:

- History of cancer or lymphoproliferative disease other than a successfully and

completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma − in-situ of the cervix.

- History of listeria, human immunodeficiency virus (HIV), hepatitis B, an

immunodeficiency syndrome, central nervous system (CNS) demyelinating disease, or untreated TB.

- Subject with a current diagnosis of ulcerative colitis or indeterminate colitis as

determined by the Investigator and Abbott Medical Monitor.

- Subject who has had surgical bowel resections within the past 6 months or is planning

any resection at any time point while enrolled in the study.

- Subject with an ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal

anastomosis are not excluded).

- Subject who has received any investigational biological agent in the past 3 months or

5 half-lives prior to Baseline (whichever is longer).

- Subjects with a poorly controlled medical condition and any other condition which, in

the opinion of the Investigator or the sponsor, would put the subject at risk by participation in the protocol.

- Subject who has previously used infliximab or any anti-TNF, even investigational,

within 8 weeks of Baseline.

- Subject who has previously used infliximab or any anti-TNF agent and has not

clinically responded.

- Previous treatment with adalimumab or previous participation in an adalimumab clinical

study.

- Subjects on prednisone > 40 mg/day (or equivalent).

- Subjects on budesonide > 9 mg/day.

- Subjects with any prior exposure to Tysabri® (natalizumab).

- Subjects with a previous history of dysplasia of the gastrointestinal tract, or found

to have dysplasia in any biopsy performed during the Screening endoscopy.

Wien A - 1090, Austria

Roeselare 8800, Belgium

Bonheiden 2820, Belgium

Leuven B 3000, Belgium

Lille Cedex 59 037, France

Hamburg 22559, Germany

Kiel 24105, Germany

Berlin 12200, Germany

Torino 10128, Italy

Amsterdam 1105 AZ, Netherlands

Calgary, Alberta T2N 4N1, Canada

Vancouver, British Columbia V6Z 2K5, Canada

Atlanta, Georgia 30342, United States

Chicago, Illinois 60637, United States

Chevy Chase, Maryland 20815, United States

Plymouth, Minnesota 55446, United States

Rochester, Minnesota 55905-0002, United States

Mexico, Missouri 65265-3726, United States

Great Neck, New York 11021, United States

Halifax, Nova Scotia B3H 1V7, Canada

Toronto, Ontario M3N 2V7, Canada

Starting date: August 2006
Ending date: February 2009
Last updated: June 11, 2008