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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

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ClinicalTrials.gov Identifier: NCT02065570
Recruitment Status : Recruiting
First Posted : February 19, 2014
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
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 or disease Intervention/treatment Phase
Crohn's Disease Drug: Adalimumab Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
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
Actual Study Start Date : April 9, 2014
Estimated Primary Completion Date : December 11, 2020
Estimated Study Completion Date : December 11, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Adalimumab

Arm Intervention/treatment
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 2 Maintenance
Subjects are re-randomized at Week 14 to the therapeutic drug monitoring regimen.
Drug: Adalimumab
Other Name: Humira

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 1 Maintenance
Subjects are re-randomized at Week 14 to a clinically adjusted regimen.
Drug: Adalimumab
Other Name: Humira




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

  2. 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 :
  1. 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).

  2. Change in fecal calprotectin level [ Time Frame: From Week 0 to Week 12 ]
  3. 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).

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

  5. 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).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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).

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 143 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02065570     History of Changes
Other Study ID Numbers: M14-115
2013-001746-33 ( EudraCT Number )
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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