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Study to Evaluate the Safety and Efficacy of Two Drug Regimens in Subjects With Moderate to Severe Ulcerative Colitis

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: NCT02065622
Recruitment Status : Active, not recruiting
First Posted : February 19, 2014
Last Update Posted : October 14, 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 October 14, 2019
Actual Study Start Date  ICMJE March 27, 2014
Actual Primary Completion Date September 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2018)
  • Proportion of week 8 responders (per full Mayo Score) achieving clinical remission (per full Mayo score) [ Time Frame: week 52 ]
  • Proportion of subjects achieving clinical remission (per full Mayo Score) [ Time Frame: Week 8 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 17, 2014)
Proportion of subjects achieving clinical remission (per full Mayo Score) [ Time Frame: Week 8 ]
Change History Complete list of historical versions of study NCT02065622 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2018)
  • Proportion of subjects achieving endoscopic improvement (endoscopic subscore of 0 or 1) [ Time Frame: week 8 ]
  • Proportion of Week 8 responders (per full Mayo Score) achieving endoscopic improvement (endoscopic subscore of 0 or 1) [ Time Frame: Week 52 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2014)
  • Proportion of subjects achieving endoscopic improvement (endoscopic subscore of 0 or 1) [ Time Frame: week 8 ]
  • Proportion of Week 8 responders (per full Mayo Score) achieving clinical remission (per full Mayo Score) [ Time Frame: Week 52 ]
  • Proportion of Week 8 responders (per full Mayo Score) achieving endoscopic improvement (endoscopic subscore of 0 or 1) [ Time Frame: Week 52 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Efficacy of Two Drug Regimens in Subjects With Moderate to Severe Ulcerative Colitis
Official Title  ICMJE A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Brief Summary To evaluate safety and efficacy of two dosing regimens in achieving clinical remission in subjects with moderately to severely active Ulcerative Colitis.
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 Ulcerative Colitis (UC)
Intervention  ICMJE
  • Drug: Adalimumab
    Other Name: Humira
  • Other: Placebo
Study Arms  ICMJE
  • Experimental: Experimental Maintenance Dose
    Experimental Maintenance Dose
    Intervention: Drug: Adalimumab
  • Experimental: Higher Induction Dose
    Higher Induction Dose
    Intervention: Drug: Adalimumab
  • Active Comparator: Standard Induction Dose
    Standard Induction Dose
    Interventions:
    • Drug: Adalimumab
    • Other: Placebo
  • Active Comparator: Standard Maintenance Dose
    Standard Maintenance Dose
    Interventions:
    • Drug: Adalimumab
    • Other: Placebo
  • Experimental: Higher Maintenance Dose
    Higher Maintenance Dose
    Interventions:
    • Drug: Adalimumab
    • Other: Placebo
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: December 17, 2018)
952
Original Estimated Enrollment  ICMJE
 (submitted: February 17, 2014)
525
Estimated Study Completion Date  ICMJE November 15, 2019
Actual Primary Completion Date September 6, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of Ulcerative Colitis (UC) for at least 90 days, confirmed by endoscopy during Screening period.
  • Active UC with Mayo Score of 6 to 12 points and endoscopy subscore of 2 to 3 despite concurrent or prior treatment with a full and adequate course, in the opinion of the Investigator, with oral corticosteroids or immunosuppressants or both.

Exclusion Criteria:

  • Subject with Crohn's disease (CD) or indeterminate colitis (IC).
  • Current diagnosis of fulminant colitis and/or toxic megacolon.
  • Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.
  • 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,   Japan,   Netherlands,   Poland,   Romania,   Slovakia,   Spain,   Switzerland,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02065622
Other Study ID Numbers  ICMJE M14-033
2013-001682-16 ( 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 October 2019

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