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Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02065570
Recruitment Status : Active, not recruiting
First Posted : February 19, 2014
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE February 17, 2014
First Posted Date  ICMJE February 19, 2014
Last Update Posted Date February 18, 2019
Actual Study Start Date  ICMJE April 9, 2014
Estimated Primary Completion Date February 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2018)
  • Proportion of participants who achieve clinical remission [ Time Frame: At Week 4 ]
    Clinical remission will be scored using Crohn's Disease Activity Index (CDAI).
  • Proportion of participants who achieve endoscopic response [ Time Frame: At Week 12 ]
    Endoscopic response will be scored using Simplified Endoscopic Score for Crohn's Disease.
Original Primary Outcome Measures  ICMJE
 (submitted: February 17, 2014)
  • 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).
Change History Complete list of historical versions of study NCT02065570 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2018)
  • Proportion of participants with sustained clinical remission [ Time Frame: Week 4 and Week 12 ]
    Clinical remission will be scored using Crohn's Disease Activity Index (CDAI).
  • Change in fecal calprotectin level [ Time Frame: From Week 0 to Week 4 ]
    Change in fecal calprotectin level from baseline is determined.
  • Proportion of participants who achieve clinical remission and endoscopic response. [ Time Frame: At Week 12 ]
    Clinical remission will be scored using Crohn's Disease Activity Index (CDAI). Endoscopic response will be scored using Simplified Endoscopic Score for Crohn's Disease
  • Proportion of participants with clinical remission [ Time Frame: At Week 12 ]
    Clinical remission will be scored using Crohn's Disease Activity Index (CDAI).
  • Proportion of participants 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 participants with endoscopic remission [ Time Frame: At Week 12 ]
    Endoscopic remission will be scored using Simplified Endoscopic Score for Crohn's Disease.
  • Proportion of participants with hs-CRP<5 mg/L and fecal calprotectin <250 microgram/gram [ Time Frame: At Week 4 ]
    hs-CRP and fecal calprotectin levels are monitored.
  • Proportion of participants with clinical remission, hs-C Reactive Protein (CRP)<5 mg/L and fecal calprotectin <250 microgram/gram [ Time Frame: At Week 4 ]
    Clinical remission will be scored using Crohn's Disease Activity Index (CDAI).
  • Proportion of participants with clinical remission, hs-CRP<5 mg/L and fecal calprotectin<250 microgram/gram and endoscopic remission [ Time Frame: At Week 12 ]
    Clinical remission will be scored using Crohn's Disease Activity Index (CDAI). Endoscopic remission will be scored using Simplified Endoscopic Score for Crohn's Disease.
  • Proportion of participants who achieve an SES-CD <=2 [ Time Frame: At Week 12 ]
    Participants who achieve SES-CD <=2 are determined
  • Proportion of participants with clinical response [ Time Frame: At Week 4 and week 12 ]
    Clinical response will be scored using Crohn's Disease Activity Index (CDAI).
  • Proportion of participants achieving response in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom domain [ Time Frame: At Week 4 and week 12 ]
    Response will be scored using IBDQ symptom domain score.
  • Proportion of participants achieving response in IBDQ fatigue item [ Time Frame: At Week 12 ]
    Response will be scored using IBDQ fatigue item score.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2014)
  • Proportion of subjects that show clinical remission [ Time Frame: At Week 12 ]
    Clinical remission will be scored using Crohn's Disease Activity Index (CDAI).
  • 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).
  • Change in proportion of subjects with clinical response [ Time Frame: From Week 4 to Week 12 ]
    Clinical response will be scored measuring for a decrease in 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 Inflammatory Bowel disease Questionnaire (IBDQ) [ Time Frame: From Week 0 to Week 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE Drug: Adalimumab
Other Name: Humira
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Adalimumab
  • Arm 2 Maintenance
    Subjects are re-randomized at Week 14 to the therapeutic drug monitoring regimen.
    Intervention: Drug: Adalimumab
  • 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.
    Intervention: Drug: Adalimumab
  • Arm 1 Maintenance
    Subjects are re-randomized at Week 14 to a clinically adjusted regimen.
    Intervention: Drug: Adalimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 30, 2018)
514
Original Estimated Enrollment  ICMJE
 (submitted: February 17, 2014)
310
Estimated Study Completion Date  ICMJE February 3, 2020
Estimated Primary Completion Date February 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Canada,   Czechia,   Denmark,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   Poland,   Puerto Rico,   Romania,   Slovakia,   Spain,   Switzerland,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02065570
Other Study ID Numbers  ICMJE M14-115
2013-001746-33 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP