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

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.

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.

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.

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.