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

• ClinicalTrials.gov Identifier: NCT01083680
• Recruitment Status: Completed
• First Posted: March 10, 2010
• Results First Posted: April 4, 2017
• Last Update Posted: April 4, 2017
• Sponsor: AbbVie (prior sponsor, Abbott)
• Information provided by (Responsible Party): AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Description

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.

Condition or disease
Crohn's Disease

Detailed Description:

This study was a 60-month prospective, multicenter, observational study of adalimumab in adult participants with CD who resided in Germany. Visits were scheduled every 3 months for the first year and every 6 months thereafter. Participants continued in the study for a maximum of 60 months or until discontinuation from adalimumab therapy.

Study Design

• Study Type: Observational
• Actual Enrollment: 4107 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Post-marketing Observational Study to Evaluate the Safety and Efficacy of HUMIRA® (Adalimumab SC) for the Treatment of Moderate to Severe Crohn's Disease in Daily Clinical Practice
• Study Start Date: May 2007
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: December 2015

Groups and Cohorts

Group/Cohort
Participants with Crohn's Disease (CD); Participants with Crohn's Disease treated with adalimumab (HUMIRA®) in routine clinical practice.

Outcome Measures

Primary Outcome Measures :

1. Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit [ Time Frame: Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 ]
   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.
2. Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time [ Time Frame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 ]
   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.
3. Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants [ Time Frame: Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 ]
   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.
4. Percentage of Participants With Adverse Events (Excluding Serious Adverse Events) [ Time Frame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 ]

   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.

Secondary Outcome Measures :

1. 4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time [ Time Frame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 ]
   The HBI is a simplified version of the CDAI; HBI scores correlate well with CDAI scores. The HBI consists of 5 items encompassing patient-reported (well-being, symptoms)and objective (presence of abdominal mass or complications) variables. Symptom scores are based on symptom status on the previous day rather than the total of 7 days as for the CDAI. The total HBI score is the sum of the values for each of the five items. Higher HBI scores indicate greater disease activity; 0 would the lower limit with no set upper limit. Scores < 5 indicate remission, 5 - 7 indicate mild disease, 8 - 16 indicate moderate disease, and 16 indicate severe disease. Each HBI unit is equivalent to approximately 27 CDAI units. Higher scores indicate greater disease activity.
2. Compliance With the Self-injection Via the Humira®-PEN [ Time Frame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 ]
   Adalimumab will be self-administered by participants using Humira®-PEN. Analysis of compliance was not performed as outlined in the protocol.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

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

Contacts and Locations

Sponsors and Collaborators

AbbVie (prior sponsor, Abbott)

Investigators

• Study Director: Sandra Bloch, MD; AbbVie Deutschland GmbH & Co. KG, Medical Department

More Information

Additional Information:

Related Info 

• Responsible Party: AbbVie (prior sponsor, Abbott)
• ClinicalTrials.gov Identifier: NCT01083680
• Other Study ID Numbers: P10-278
• First Posted: March 10, 2010
• Results First Posted: April 4, 2017
• Last Update Posted: April 4, 2017
• Last Verified: March 2017

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

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

Additional relevant MeSH terms:

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