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Trial record 2 of 9 for:    adalimumab | Crohn Disease | Italy
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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 : Completed
First Posted : February 19, 2014
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 514 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
Actual Primary Completion Date : January 30, 2020
Actual Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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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


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

  2. 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.

  3. Number of Participants With Adverse Events [ Time Frame: From first dose of study drug until 70 days following last dose of study drug (up to 65 weeks). ]
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.


Secondary Outcome Measures :
  1. Proportion of participants achieving response in IBDQ fatigue item [ Time Frame: At Week 12 ]
    Response will be scored using IBDQ fatigue item score.

  2. 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.

  3. 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).

  4. Proportion of participants who achieve an SES-CD <=2 [ Time Frame: At Week 12 ]
    Participants who achieve SES-CD <=2 are determined

  5. 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.

  6. 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).

  7. 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.

  8. Proportion of participants with endoscopic remission [ Time Frame: At Week 12 ]
    Endoscopic remission will be scored using Simplified Endoscopic Score for Crohn's Disease.

  9. 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).

  10. Proportion of participants with clinical remission [ Time Frame: At Week 12 ]
    Clinical remission will be scored using Crohn's Disease Activity Index (CDAI).

  11. 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

  12. Change in fecal calprotectin level [ Time Frame: From Week 0 to Week 4 ]
    Change in fecal calprotectin level from baseline is determined.

  13. 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).


Eligibility Criteria
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Information from the National Library of Medicine

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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).
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
More Information
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Additional Information:

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02065570    
Other Study ID Numbers: M14-115
2013-001746-33 ( EudraCT Number )
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
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

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