Effectiveness and Safety in Patients With Crohn´s Disease in Clinical Routine

NCT01083680 | Completed Results

• 1 other identifier: P10-278
• Study Type: observational
• Target: 4,107
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was intended to evaluate the long-term safety and effectiveness of adalimumab in participants with Crohn's disease (CD) who are treated as recommended in the product label.

Conditions

Crohn's Disease

Keywords

Routine clinical setting; Long-term efficacy and safety; Crohn's Disease; Humira®; Adalimumab

Outcome Measures

Primary Outcomes (4)

• Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit

  The CDAI is a measure of clinical response and remission that was developed for use in clinical trials. The CDAI includes 8 variables encompassing both patient-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, patients keep track of daily symptoms on a diary card, and the daily symptom scores are summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; 0 would the lower limit with no set upper limit. The scale for the scores is as follows: \< 150 to indicate remission, 150 - 219 to define mildly active disease, 220 - 450 to define moderately active disease, and \> 450 to define severely active disease. Negative changes indicate reductions (improvement) in disease activity.

  Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60

• Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time

  The CDAI is a measure of clinical response and remission that was developed for use in clinical trials. The CDAI includes 8 variables encompassing both participant-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, patients keep track of daily symptoms on a diary card, and the daily symptom scores are summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; there is no set upper limit. The scale for the scores is as follows: \< 150 to indicate remission, 150 - 219 to define mildly active disease, 220 - 450 to define moderately active disease, and \> 450 to define severely active disease.

  Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60

• Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants

  The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is an abbreviated version of the Inflammatory Bowel Disease (IBD) Questionnaire, a Health-related quality of life (HRQOL) assessment tool for patients with IBD. The SIBDQ utilizes 10 items concerning patient well-being during the last 2 weeks, each of which is scored on a scale of 1 (poor HRQOL) to 7 (optimum HRQOL). The individual sub scores are added to produce the total SIBDQ score. SIBDQ scores range from 10 to 70 with higher values indicating better HRQOL. Positive changes indicate reductions in disease activity.

  Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60

• Percentage of Participants With Adverse Events (Excluding Serious Adverse Events)

  An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product. For more details on adverse events please see the AE section below.

  Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60

Secondary Outcomes (2)

• 4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time

  Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60

• Compliance With the Self-injection Via the Humira®-PEN

  Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60

Study Arms (1)

Participants with Crohn's Disease (CD)

Participants with Crohn's Disease treated with adalimumab (HUMIRA®) in routine clinical practice.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population consisted of participants with Crohn's Disease (CD) who were treated with adalimumab.

You may qualify if:

• \- Severe, active Crohn's Disease in patients with insufficient response to a complete and adequate therapy of glucocorticoid and/or immunosuppressive drug and/or hypersensitivity against such a therapy or in patients where such a therapy is contraindicated.

You may not qualify if:

• \- Hypersensitivity against the drug or one of the other ingredients.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Related Links

• Related Info

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Global Medical Information
• Organization: AbbVie

800-633-9110

Study Officials

• Sandra Bloch, MD

  AbbVie Deutschland GmbH & Co. KG, Medical Department

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2010
• First Posted: March 10, 2010
• Study Start: May 1, 2007
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 4, 2017
• Results First Posted: April 4, 2017

Record last verified: 2017-03