Trial Outcomes & Findings for Study for the Treatment of Crohn's Disease With Adacolumn (NCT NCT00162942)

NCT ID: NCT00162942

Last Updated: 2009-04-07

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 235 participants
• Primary outcome timeframe: Baseline to Week 12
• Results posted on: 2009-04-07

Participant Flow

Participant milestones

Measure	Adacolumn Adacolumn, ten apheresis sessions within 9 weeks	Sham Sham, ten apheresis sessions within 9 weeks
Overall Study STARTED	157	78
Overall Study Week 12	127	61
Overall Study COMPLETED	51	26
Overall Study NOT COMPLETED	106	52

Reasons for withdrawal

Measure	Adacolumn Adacolumn, ten apheresis sessions within 9 weeks	Sham Sham, ten apheresis sessions within 9 weeks
Overall Study Adverse Event	10	6
Overall Study Death	1	0
Overall Study Withdrawal by Subject	3	6
Overall Study Physician Decision	1	0
Overall Study Enter Open-Label Study	76	35
Overall Study Alternate Therapy	6	2
Overall Study Lack of Efficacy	1	0
Overall Study Flare During Active Treatment	7	3
Overall Study 2 or more consecutive treatments missed	1	0

Baseline Characteristics

Study for the Treatment of Crohn's Disease With Adacolumn

Baseline characteristics by cohort

Measure	Adacolumn n=157 Participants Adacolumn, ten apheresis sessions within 9 weeks	Sham n=78 Participants Sham, ten apheresis sessions within 9 weeks	Total n=235 Participants Total of all reporting groups
Race/Ethnicity, Customized Hispanic	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Age Continuous	40.6 years STANDARD_DEVIATION 12.5 • n=5 Participants	41.4 years STANDARD_DEVIATION 13.6 • n=7 Participants	40.9 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	81 Participants n=5 Participants	44 Participants n=7 Participants	125 Participants n=5 Participants
Sex: Female, Male Male	76 Participants n=5 Participants	34 Participants n=7 Participants	110 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	142 participants n=5 Participants	75 participants n=7 Participants	217 participants n=5 Participants
Race/Ethnicity, Customized African American	8 participants n=5 Participants	2 participants n=7 Participants	10 participants n=5 Participants
Race/Ethnicity, Customized Asian/Pacific Islander	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Other	4 participants n=5 Participants	1 participants n=7 Participants	5 participants n=5 Participants
Alcohol Use Consumes Alcohol	85 participants n=5 Participants	54 participants n=7 Participants	139 participants n=5 Participants
Alcohol Use Previously Drank	33 participants n=5 Participants	12 participants n=7 Participants	45 participants n=5 Participants
Alcohol Use Never Drank	39 participants n=5 Participants	12 participants n=7 Participants	51 participants n=5 Participants
Smoking Status Current Smoker	46 participants n=5 Participants	26 participants n=7 Participants	72 participants n=5 Participants
Smoking Status Ex-Smoker	39 participants n=5 Participants	23 participants n=7 Participants	62 participants n=5 Participants
Smoking Status Non-Smoker	72 participants n=5 Participants	29 participants n=7 Participants	101 participants n=5 Participants
Baseline Crohn's Disease Activity Index Score	309.6 units on a scale STANDARD_DEVIATION 55.7 • n=5 Participants	314.7 units on a scale STANDARD_DEVIATION 53.5 • n=7 Participants	311.3 units on a scale STANDARD_DEVIATION 54.9 • n=5 Participants
Crohn's Disease History	139.5 months STANDARD_DEVIATION 125.1 • n=5 Participants	129.9 months STANDARD_DEVIATION 123.1 • n=7 Participants	136.3 months STANDARD_DEVIATION 124.3 • n=5 Participants
Height	170.3 centimeter STANDARD_DEVIATION 9.7 • n=5 Participants	169.9 centimeter STANDARD_DEVIATION 10.3 • n=7 Participants	170.2 centimeter STANDARD_DEVIATION 9.9 • n=5 Participants
Inflammatory Bowel Disease Flares in the Past 12 Months	2.2 flares STANDARD_DEVIATION 2.2 • n=5 Participants	2.5 flares STANDARD_DEVIATION 2.8 • n=7 Participants	2.3 flares STANDARD_DEVIATION 2.4 • n=5 Participants
Weight	74.89 kilogram STANDARD_DEVIATION 16.22 • n=5 Participants	72.29 kilogram STANDARD_DEVIATION 19.23 • n=7 Participants	74.03 kilogram STANDARD_DEVIATION 17.28 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: 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.

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

Outcome measures

Measure	Adacolumn n=157 Participants Adacolumn, ten apheresis sessions within 9 weeks	Sham n=78 Participants Sham, ten apheresis sessions within 9 weeks
Clinical Remission	17.8 percentage of participants	19.2 percentage of participants

PRIMARY outcome

Timeframe: Baseline through Week 12 Visit

Population: 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.

Outcome measures

Measure	Adacolumn n=157 Participants Adacolumn, ten apheresis sessions within 9 weeks	Sham n=78 Participants Sham, ten apheresis sessions within 9 weeks
Frequency and Severity of Adverse Events Through Week 12 Any Adverse Event	93 percentage of participants	93.6 percentage of participants
Frequency and Severity of Adverse Events Through Week 12 Severe Adverse Event	19.7 percentage of participants	19.2 percentage of participants
Frequency and Severity of Adverse Events Through Week 12 Device-Related Adverse Event	61.1 percentage of participants	75.6 percentage of participants
Frequency and Severity of Adverse Events Through Week 12 Serious Adverse Event	8.3 percentage of participants	6.4 percentage of participants
Frequency and Severity of Adverse Events Through Week 12 Device-Related Serious Adverse Event	0.6 percentage of participants	0.0 percentage of participants
Frequency and Severity of Adverse Events Through Week 12 Adverse Event Leading to Device Discontinuation	10.8 percentage of participants	11.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: 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.

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

Outcome measures

Measure	Adacolumn n=152 Participants Adacolumn, ten apheresis sessions within 9 weeks	Sham n=73 Participants Sham, ten apheresis sessions within 9 weeks
CDAI Score Change From Baseline	-65.6 units on a scale Standard Deviation 96.6	-62.3 units on a scale Standard Deviation 103

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: 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.

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

Outcome measures

Measure	Adacolumn n=157 Participants Adacolumn, ten apheresis sessions within 9 weeks	Sham n=78 Participants Sham, ten apheresis sessions within 9 weeks
Clinical Response	28.0 percentage of participants	26.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: 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

Outcome measures

Measure	Adacolumn n=145 Participants Adacolumn, ten apheresis sessions within 9 weeks	Sham n=71 Participants Sham, ten apheresis sessions within 9 weeks
Mean Change in Short-Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score	3.84 units on a scale Standard Deviation 8.76	3.29 units on a scale Standard Deviation 9.19

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: 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

Outcome measures

Measure	Adacolumn n=145 Participants Adacolumn, ten apheresis sessions within 9 weeks	Sham n=71 Participants Sham, ten apheresis sessions within 9 weeks
Mean Change in Short-Form 36 Questionnaire (SF-36) Mental Component Summary (MCS) Score	2.52 units on a scale Standard Deviation 10.13	2.48 units on a scale Standard Deviation 11.23

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: 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

Outcome measures

Measure	Adacolumn n=148 Participants Adacolumn, ten apheresis sessions within 9 weeks	Sham n=74 Participants Sham, ten apheresis sessions within 9 weeks
Mean Change in Inflammatory Bowel Diseases Questionnaire (IBDQ)	18.5 units on a scale Standard Deviation 32.1	16.8 units on a scale Standard Deviation 37.9

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: 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

Outcome measures

Measure	Adacolumn n=147 Participants Adacolumn, ten apheresis sessions within 9 weeks	Sham n=72 Participants Sham, ten apheresis sessions within 9 weeks
Mean Change in EuroQol Score (Single Index)	0.0392 units on a scale Standard Deviation 0.2239	0.0917 units on a scale Standard Deviation 0.2648

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: 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)

Outcome measures

Measure	Adacolumn n=148 Participants Adacolumn, ten apheresis sessions within 9 weeks	Sham n=73 Participants Sham, ten apheresis sessions within 9 weeks
Mean Change in EuroQol Score (Visual Analog Scale)	4.4 units on a scale Standard Deviation 19.8	5.5 units on a scale Standard Deviation 18.6

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: 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

Outcome measures

Measure	Adacolumn n=132 Participants Adacolumn, ten apheresis sessions within 9 weeks	Sham n=63 Participants Sham, ten apheresis sessions within 9 weeks
Mean Change in Work Limitations Questionnaire (Time Management)	-9.9 units on a scale Standard Deviation 25.5	-6.6 units on a scale Standard Deviation 31.7

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: 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

Outcome measures

Measure	Adacolumn n=136 Participants Adacolumn, ten apheresis sessions within 9 weeks	Sham n=68 Participants Sham, ten apheresis sessions within 9 weeks
Mean Change in Work Limitations Questionnaire (Physical Demands)	-5.2 units on a scale Standard Deviation 23.1	2.3 units on a scale Standard Deviation 22.7

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: 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

Outcome measures

Measure	Adacolumn n=136 Participants Adacolumn, ten apheresis sessions within 9 weeks	Sham n=66 Participants Sham, ten apheresis sessions within 9 weeks
Mean Change in Work Limitations Questionnaire (Mental-Interpersonal Demands)	-5.5 units on a scale Standard Deviation 20.5	-2.7 units on a scale Standard Deviation 20.8

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: 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

Outcome measures

Measure	Adacolumn n=132 Participants Adacolumn, ten apheresis sessions within 9 weeks	Sham n=63 Participants Sham, ten apheresis sessions within 9 weeks
Mean Change in Work Limitations Questionnaire (Output Demands)	-7.4 units on a scale Standard Deviation 25.8	-3.8 units on a scale Standard Deviation 28.7

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: 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

Outcome measures

Measure	Adacolumn n=123 Participants Adacolumn, ten apheresis sessions within 9 weeks	Sham n=59 Participants Sham, ten apheresis sessions within 9 weeks
Mean Change in Work Limitations Questionnaire (WLQ Index)	-1.8 units on a scale Standard Deviation 5.6	-0.5 units on a scale Standard Deviation 6.9

SECONDARY outcome

Timeframe: Baseline to Week 12

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

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

Outcome measures

Measure	Adacolumn n=25 Participants Adacolumn, ten apheresis sessions within 9 weeks	Sham n=8 Participants Sham, ten apheresis sessions within 9 weeks
Mean Change in Crohn's Disease Endoscopic Index of Severity	2 units on a scale Standard Deviation 7.73	-4.63 units on a scale Standard Deviation 13.20

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: 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.

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

Outcome measures

Measure	Adacolumn n=149 Participants Adacolumn, ten apheresis sessions within 9 weeks	Sham n=71 Participants Sham, ten apheresis sessions within 9 weeks
Mean Change in Subject Global Rating	-0.7 units on a scale Standard Deviation 1.6	-0.6 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline to week 12

Population: 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.

Outcome measures

Measure	Adacolumn n=147 Participants Adacolumn, ten apheresis sessions within 9 weeks	Sham n=71 Participants Sham, ten apheresis sessions within 9 weeks
Mean Change in C-Reactive Protein	-1.75 milligrams/liter Standard Deviation 22.67	0.24 milligrams/liter Standard Deviation 12.59

POST_HOC outcome

Timeframe: Baseline to Week 12

Population: 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.

Outcome measures

Measure	Adacolumn n=80 Participants Adacolumn, ten apheresis sessions within 9 weeks	Sham n=48 Participants Sham, ten apheresis sessions within 9 weeks
Clinical Response in Subjects With a CDAI Score Greater Than 300 Baseline CDAI Score>300	43.8 percentage of participants	27.1 percentage of participants

POST_HOC outcome

Timeframe: Baseline to Week 12

Population: 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

Outcome measures

Measure	Adacolumn n=77 Participants Adacolumn, ten apheresis sessions within 9 weeks	Sham n=30 Participants Sham, ten apheresis sessions within 9 weeks
Clinical Response in Subjects With a CDAI Score Less Than or Equal to 300	39.0 percentage of participants	43.3 percentage of participants

POST_HOC outcome

Timeframe: Baseline to Week 12

Population: 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

Outcome measures

Measure	Adacolumn n=28 Participants Adacolumn, ten apheresis sessions within 9 weeks	Sham n=19 Participants Sham, ten apheresis sessions within 9 weeks
Clinical Response Based on Previous Use of Tumor Necrosis Factor-Alpha (TNF-a) Inhibitors	50.0 percentage of participants	21.1 percentage of participants

POST_HOC outcome

Timeframe: Baseline to Week 12

Population: 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

Outcome measures

Measure	Adacolumn n=129 Participants Adacolumn, ten apheresis sessions within 9 weeks	Sham n=59 Participants Sham, ten apheresis sessions within 9 weeks
Clinical Response Based on No Previous Use of Tumor Necrosis Factor-Alpha (TNF-a) Inhibitors	39.5 percentage of participants	37.3 percentage of participants

POST_HOC outcome

Timeframe: Baseline to Week 12

Population: 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

Outcome measures

Measure	Adacolumn n=64 Participants Adacolumn, ten apheresis sessions within 9 weeks	Sham n=23 Participants Sham, ten apheresis sessions within 9 weeks
Clinical Response Based on Use of 5-Aminosylisalates During the Study	48.4 percentage of participants	21.7 percentage of participants

POST_HOC outcome

Timeframe: Baseline to Week 12

Population: 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.

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

Outcome measures

Measure	Adacolumn n=93 Participants Adacolumn, ten apheresis sessions within 9 weeks	Sham n=55 Participants Sham, ten apheresis sessions within 9 weeks
Clinical Response Based on no Use of 5-Aminosylisalates During the Study	36.6 percentage of participants	38.2 percentage of participants

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tao Wang

Otsuka America Pharmaceutical, Inc

Phone: 240-683-3213

Email: tao.wang@otsuka-us.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60