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

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ClinicalTrials.gov Identifier: NCT02065622
Recruitment Status : Recruiting
First Posted : February 19, 2014
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
To evaluate safety and efficacy of two dosing regimens in achieving clinical remission in subjects with moderately to severely active Ulcerative Colitis.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis (UC) Drug: Adalimumab Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 940 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 27, 2014
Estimated Primary Completion Date : December 18, 2019
Estimated Study Completion Date : December 18, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Experimental Maintenance Dose
Experimental Maintenance Dose
Drug: Adalimumab
Other Name: Humira
Experimental: Higher Induction Dose
Higher Induction Dose
Drug: Adalimumab
Other Name: Humira
Active Comparator: Standard Induction Dose
Standard Induction Dose
Drug: Adalimumab
Other Name: Humira
Other: Placebo
Active Comparator: Standard Maintenance Dose
Standard Maintenance Dose
Drug: Adalimumab
Other Name: Humira
Other: Placebo
Experimental: Higher Maintenance Dose
Higher Maintenance Dose
Drug: Adalimumab
Other Name: Humira
Other: Placebo



Primary Outcome Measures :
  1. Proportion of week 8 responders (per full Mayo Score) achieving clinical remission (per full Mayo score) [ Time Frame: week 52 ]
  2. Proportion of subjects achieving clinical remission (per full Mayo Score) [ Time Frame: Week 8 ]

Secondary Outcome Measures :
  1. Proportion of subjects achieving endoscopic improvement (endoscopic subscore of 0 or 1) [ Time Frame: week 8 ]
  2. Proportion of Week 8 responders (per full Mayo Score) achieving endoscopic improvement (endoscopic subscore of 0 or 1) [ Time Frame: Week 52 ]


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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 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).

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): NCT02065622


Contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

  Show 176 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02065622     History of Changes
Other Study ID Numbers: M14-033
2013-001682-16 ( EudraCT Number )
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Ulcerative Colitis

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents