Clinical Remission is defined as a Crohn's Disease Activity Index (CDAI) score of ≤150 when evaluated at Week 12

All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT was used for effectiveness analysis. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or with a major violation on prohibited medications were considered a treatment failure.

All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis.

All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis.

601-point, ordinal scale which quantifies the symptoms of patients with Crohn's Disease from 0 (complete remission) to 600 (most severe active disease). Mean change=Week 12 Mean CDAI-Baseline Mean CDAI

All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score was used for the analysis. If no week 12 score, then the week 9 score was be used. If no week 9 score, the subject was considered a treatment failure.

Clinical Response is defined as a ≥ 100-point reduction in the CDAI scores at Week 12

All subjects who received at least one apheresis session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 CDAI score or Last Observation Carried Forward was used for the analysis. Subjects with a major violation on prohibited medications were considered a treatment failure.

101-point, ordinal scale measuring general health of patients from 0 (low quality of life) to 100 (high quality of life), Mean change=Week 12 Mean -Baseline Mean

All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.

101-point, ordinal scale measuring general health of patients from 0 (low quality of life) to 100 (high quality of life), Mean change=Week 12 Mean -Baseline Mean

All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.

193-point, ordinal scale measuring disease-specific quality of life from 32 (low quality of life) to 224 (high quality of life). Mean change= Week 12 Mean-Baseline Mean

All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.

A continuous scale that is a cardinal index of health from 0 (no impairment) to 1 (most impairment), Mean change=Week 12 Mean -Baseline Mean

All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.

101-point, ordinal scale which measures non-disease specific health-related quality of life from 0 (Worst imaginable health state) to 100 (best imaginable health state)

All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.

101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean

All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.

101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean

All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.

101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean

All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.

101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean

All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.

101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean

All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.

26-point,ordinal scale that assesses the severity of Crohn's Disease from 0 (least severe) to 26 (most severe), Mean change=Week 12 Mean -Baseline Mean

Endoscopic evaluations were to be performed at baseline and Week 12 on a subset of study subjects.

7-point,ordinal scale that measures the subject's state of Crohn's Disease from 0 (totally inactive) to 7 (as bad as it gets), Mean change=Week 12 Mean -Baseline Mean

All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.

All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 value or Last Observation Carried Forward was used for the analysis.

A clinical response is defined as a 70-point decrease in CDAI score.

All subjects who received at least one apheresis treatment session and had a CDAI score greater than 300 at baseline were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or subjects with a major violation on prohibited medications were considered a treatment failure.

A clinical response is defined as a 70-point decrease in CDAI score

All subjects who received at least one apheresis treatment session and had a CDAI score less than or equal to 300 at baseline were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or with a major violation on prohibited medications were considered a treatment failure.

A clinical response is defined as a 70-point decrease in CDAI score

All subjects who received at least one apheresis treatment session and previously used TNFa-inhibitors were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or subjects with a major violation on prohibited medications were considered a treatment failure.

A clinical response is defined as a 70-point decrease in CDAI score

All subjects who received at least one apheresis treatment session and who have not used TNFa-inhibitors were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or subjects with a major violation on prohibited medications were considered a treatment failure.

A clinical response is defined as a 70-point decrease in CDAI score

All subjects who received at least one apheresis treatment session and who used 5-aminosylisalates during the study were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or subjects with a major violation on prohibited medication were considered a treatment failure.

A clinical response is defined as a 70-point decrease in CDAI score

All subjects who received at least one apheresis treatment session and who did not use 5-aminosylisalates during the study were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or subjects with a major violation on prohibited medications were considered a treatment failure.