NCT00348283

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
8 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
28 days until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 11, 2010

Completed
Last Updated

April 11, 2011

Status Verified

April 1, 2011

Enrollment Period

2.1 years

First QC Date

June 30, 2006

Results QC Date

September 15, 2009

Last Update Submit

April 7, 2011

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects Without Mucosal Ulceration at Week 12

    Subjects were to have undergone up to 4 endoscopies to evaluate the presence or absence of mucosal ulceration: at Screening, at Week 12 (subjects who moved to open label (OL) drug between Week 8 and Week 12 because of disease flare or non-response were evaluated by endoscopy prior to receiving OL dosing), at the time of switch from blinded study drug to OL adalimumab at any time after Week 12, and at Week 52 or Early Termination. Subjects who remained blinded for the entire 52-week trial or switched to OL adalimumab between Week 8 and Week 12 were to have undergone 3 endoscopies.

    Week 12

Secondary Outcomes (5)

  • Number of Subjects With Clinical Remission Crohn's Disease Activity Index (CDAI) < 150 at Week 12

    Week 12

  • Number of Subjects Without Mucosal Ulceration at Week 52

    Week 52

  • Number of Subjects With Clinical Remission (CDAI < 150) at Week 52

    Week 52

  • Number of Subjects Without Mucosal Ulceration at Both Week 12 and Week 52

    Weeks 12 and 52

  • Number of Subjects With Clinical Remission (CDAI < 150) at Both Week 12 and Week 52

    Weeks 12 and 52

Study Arms (2)

Double Blind

PLACEBO COMPARATOR

Blinded study through Week 52. Adalimumab compared to placebo during blinded portion.

Biological: adalimumabBiological: placebo

Open Label

OTHER

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.

Biological: adalimumab

Interventions

adalimumabBIOLOGICAL

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.

Also known as: ABT-D2E7, Humira
Double Blind
placeboBIOLOGICAL

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.

Double Blind

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Unknown Facility

Atlanta, Georgia, 30342, United States

Location

Unknown Facility

Chicago, Illinois, 60637, United States

Location

Unknown Facility

Chevy Chase, Maryland, 20815, United States

Location

Unknown Facility

Plymouth, Minnesota, 55446, United States

Location

Unknown Facility

Rochester, Minnesota, 55905-0002, United States

Location

Unknown Facility

Mexico, Missouri, 65265-3726, United States

Location

Unknown Facility

Great Neck, New York, 11021, United States

Location

Unknown Facility

Vienna, A - 1090, Austria

Location

Unknown Facility

Bonheiden, 2820, Belgium

Location

Unknown Facility

Leuven, B 3000, Belgium

Location

Unknown Facility

Roeselare, 8800, Belgium

Location

Unknown Facility

Calgary, Alberta, T2N 4N1, Canada

Location

Unknown Facility

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Unknown Facility

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Unknown Facility

Toronto, Ontario, M3N 2V7, Canada

Location

Unknown Facility

Lille, 59 037, France

Location

Unknown Facility

Berlin, 12200, Germany

Location

Unknown Facility

Hamburg, 22559, Germany

Location

Unknown Facility

Kiel, 24105, Germany

Location

Unknown Facility

Torino, 10128, Italy

Location

Unknown Facility

Amsterdam, 1105 AZ, Netherlands

Location

Related Publications (4)

  • 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.

    PMID: 34546360DERIVED

  • 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.

    PMID: 29380251DERIVED

  • 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.

    PMID: 26234693DERIVED

  • 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.

    PMID: 23856361DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Medical Information Specialist
Organization
Abbott
800-633-9110

Study Officials

  • Anne Andrée Camez

    Abbott

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Study Start

August 1, 2006

Primary Completion

September 1, 2008

Last Updated

April 11, 2011

Results First Posted

February 11, 2010

Record last verified: 2011-04

Locations

AU(1)NL(1)DE(3)IT(1)CA(4)FR(1)US(7)BE(3)