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Trial record 1 of 1 for:    Crohn's Disease | Abbvie [Lead] | M14-115
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Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease

This study is currently recruiting participants.
Verified October 2017 by AbbVie
Sponsor:
ClinicalTrials.gov Identifier:
NCT02065570
First Posted: February 19, 2014
Last Update Posted: October 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie
  Purpose
This study will evaluate higher versus standard adalimumab dosing regimens for induction and maintenance therapy in subjects with moderately to severely active Crohn's Disease and evidence of mucosal ulceration.

Condition Intervention Phase
Crohn's Disease Drug: Adalimumab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Proportion of subject who achieve clinical remission [ Time Frame: At Week 4 ]
    Clinical remission will be scored using Crohn's Disease Activity Index (CDAI).

  • Proportion of subjects who achieve endoscopic improvement [ Time Frame: At Week 12 ]
    Endoscopic improvement will be scored using Simplified Endoscopic Score for Crohn's Disease (SES CD).


Secondary Outcome Measures:
  • Proportion of subjects who achieve clinical remission [ Time Frame: At Week 12 ]
    Clinical remission will be scored using Crohn's Disease Activity Index (CDAI).

  • Proportion of subjects who achieve clinical remission and endoscopic improvement [ Time Frame: Clinical remission at Week 4 and endoscopic improvement at Week 12 ]
    Clinical remission will be scored using Crohn's Disease Activity Index (CDAI) and endoscopic improvement will be scored using Simplified Endoscopic Score for Crohn's Disease (SES-CD).

  • Proportion of subjects who discontinued corticosteroid use and achieved clinical remission [ Time Frame: At Week 12 ]
    Clinical remission will be scored using Crohn's Disease Activity Index (CDAI).

  • Proportion of subjects with endoscopic response [ Time Frame: At Week 12 ]
    Endoscopic improvement will be scored using Simplified Endoscopic Score for Crohn's Disease (SES CD).

  • Change in fecal calprotectin level [ Time Frame: From Week 0 to Week 12 ]

Estimated Enrollment: 600
Study Start Date: April 9, 2014
Estimated Study Completion Date: March 15, 2019
Estimated Primary Completion Date: March 15, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1 - Induction
Subjects are randomized to receive a higher induction regimen of adalimumab. After the induction regimen is provided, subjects in this arm will receive blinded adalimumab until Week 12. No placebo arm is planned.
Drug: Adalimumab
Other Name: Humira
Arm 2 - Induction
Subjects are randomized to receive a standard induction regimen of adalimumab. After the induction regimen is provided, subjects in this arm will receive blinded adalimumab until Week 12. No placebo arm is planned.
Drug: Adalimumab
Other Name: Humira
Arm 1 Maintenance
Subjects are re-randomized at Week 14 to a clinically adjusted regimen.
Drug: Adalimumab
Other Name: Humira
Arm 2 Maintenance
Subjects are re-randomized at Week 14 to the therapeutic drug monitoring regimen.
Drug: Adalimumab
Other Name: Humira

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Crohn's disease (CD) for at least 90 days, confirmed by endoscopy during the Screening Period.
  • Active CD with a Crohn's Disease Activity Index (CDAI) despite treatment with oral corticosteroids and/or immunosuppressants.
  • Mucosal ulceration on endoscopy.

Exclusion Criteria:

  • Subject with ulcerative colitis or indeterminate colitis.
  • Subject who has had surgical bowel resections in the past 6 months or is planning resection.
  • Subjects with an ostomy or ileoanal pouch.
  • Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.
  • Subject who has short bowel syndrome.
  • Chronic recurring infections or active Tuberculosis (TB).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065570


Contacts
Contact: AbbVie_Call Center 847-283-8955 abbvieclinicaltrials@abbvie.com

  Show 150 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Alexandra Song, MD AbbVie
  More Information

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02065570     History of Changes
Other Study ID Numbers: M14-115
2013-001746-33 ( EudraCT Number )
First Submitted: February 17, 2014
First Posted: February 19, 2014
Last Update Posted: October 11, 2017
Last Verified: October 2017

Keywords provided by AbbVie:
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents