Effects of Adalimumab on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon
NCT ID: NCT00348283
Last Updated: 2011-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
135 participants
INTERVENTIONAL
2006-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Double Blind
Blinded study through Week 52. Adalimumab compared to placebo during blinded portion.
adalimumab
At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Adalimumab 40 mg eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8.
placebo
At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Placebo SC eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8.
Open Label
Note: No comparator was used in Open-Label portion of study. From Week 8, subjects could have switched to open-label (OL) adalimumab 40mg administered subcutaneously (SC) every other week (eow)or OL adalimumab 40 mg SC every week (ew) dosing to treat disease flare or non-response. At Week 52, all remaining subjects were allowed to switch to the Open-Label portion of the study.
adalimumab
At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Adalimumab or placebo SC eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8. In the Open-Label arm, interventions were either adalimumab 40 mg SC eow or adalimumab 40 mg SC weekly. There was no placebo intervention post Week 52.
Interventions
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adalimumab
At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Adalimumab 40 mg eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8.
placebo
At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Placebo SC eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8.
adalimumab
At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Adalimumab or placebo SC eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8. In the Open-Label arm, interventions were either adalimumab 40 mg SC eow or adalimumab 40 mg SC weekly. There was no placebo intervention post Week 52.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Principal Investigators
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Anne Andrée Camez
Role: STUDY_DIRECTOR
Abbott
Locations
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Atlanta, Georgia, United States
Chicago, Illinois, United States
Chevy Chase, Maryland, United States
Plymouth, Minnesota, United States
Rochester, Minnesota, United States
Mexico, Missouri, United States
Great Neck, New York, United States
Vienna, , Austria
Bonheiden, , Belgium
Leuven, , Belgium
Roeselare, , Belgium
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Halifax, Nova Scotia, Canada
Toronto, Ontario, Canada
Lille, , France
Berlin, , Germany
Hamburg, , Germany
Kiel, , Germany
Torino, , Italy
Amsterdam, , Netherlands
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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M05-769
Identifier Type: -
Identifier Source: org_study_id
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