Clinical trial NCT00348283: Effects of Adalimumab on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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 Simple Endoscopic Score for Crohn's Disease (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 tuberculosis (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 (anti tumor necrosis factor), 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.

Primary outcomes:
measure: Number of Subjects Without Mucosal Ulceration at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Number of Subjects With Clinical Remission Crohn's Disease Activity Index (CDAI) < 150 at Week 12
timeFrame: Week 12
measure: Number of Subjects Without Mucosal Ulceration at Week 52
timeFrame: Week 52
measure: Number of Subjects With Clinical Remission (CDAI < 150) at Week 52
timeFrame: Week 52
measure: Number of Subjects Without Mucosal Ulceration at Both Week 12 and Week 52
timeFrame: Weeks 12 and 52
measure: Number of Subjects With Clinical Remission (CDAI < 150) at Both Week 12 and Week 52
timeFrame: Weeks 12 and 52
Other outcomes:
Locations:
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chevy Chase
country: United States
state: Maryland
city: Plymouth
country: United States
state: Minnesota
city: Rochester
country: United States
state: Minnesota
city: Mexico
country: United States
state: Missouri
city: Great Neck
country: United States
state: New York
city: Wien
country: Austria
city: Bonheiden
country: Belgium
city: Leuven
country: Belgium
city: Roeselare
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Halifax
country: Canada
state: Nova Scotia
city: Toronto
country: Canada
state: Ontario
city: Lille Cedex
country: France
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Kiel
country: Germany
city: Torino
country: Italy
city: Amsterdam
country: Netherlands
Study officials:
affiliation: Abbott
name: Anne Andrée Camez
role: STUDY_DIRECTOR
References:
citation: Sandborn WJ, Lewis JD, Panes J, Loftus EV, D'Haens G, Yu Z, Huang B, Lacerda AP, Pangan AL, Feagan BG. Association Between Proposed Definitions of Clinical Remission/Response and Well-Being in Patients With Crohn's Disease. J Crohns Colitis. 2022 Mar 14;16(3):444-451. doi: 10.1093/ecco-jcc/jjab161.
citation: Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.
citation: Rutgeerts P, Reinisch W, Colombel JF, Sandborn WJ, D'Haens G, Petersson J, Zhou Q, Iezzi A, Thakkar RB. Agreement of site and central readings of ileocolonoscopic scores in Crohn's disease: comparison using data from the EXTEND trial. Gastrointest Endosc. 2016 Jan;83(1):188-97.e1-3. doi: 10.1016/j.gie.2015.06.018. Epub 2015 Jul 30.
citation: Colombel JF, Rutgeerts PJ, Sandborn WJ, Yang M, Camez A, Pollack PF, Thakkar RB, Robinson AM, Chen N, Mulani PM, Chao J. Adalimumab induces deep remission in patients with Crohn's disease. Clin Gastroenterol Hepatol. 2014 Mar;12(3):414-22.e5. doi: 10.1016/j.cgh.2013.06.019. Epub 2013 Jul 12.