Crohn's Disease
Conditions
Keywords
Crohn's Disease
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of the Adacolumn Apheresis System as a treatment for the signs and symptoms of Crohn's disease.
Detailed description
Trial Features: * Medical device (Non-drug option) * Most patients can remain on current treatment regimen throughout the study Components of the Study: * Study length is 24 weeks, which includes a screening visit, ten treatment visits over nine weeks and 4 follow-up appointments * Physical exams, laboratory tests and disease assessments conducted at no charge to the patient * 2:1 Randomization (treatment:sham) * Open-Label extension offered to eligible patients
Interventions
DEVICEAdacolumn
Ten apheresis sessions: One hour of Adacolumn Apheresis System procedure per visit. Patient had two procedures per week for the first two weeks followed by one apheresis session per weeks for two weeks (Weeks 1-4). then a week break occurs for rest followed by one apheresis session per week for 4 weeks (weeks 6-9).
DEVICESham
Sham, ten apheresis sessions within 9 weeks
Sponsors
Otsuka America Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Moderate to severe Crohn's disease * Adequate peripheral venous access * Agree to participate in the required follow-up visits * Able to complete a diary * Signed written informed consent document and authorization for use of protected health information Key
Exclusion criteria
* Extremely severe Crohn's disease * Known obstructive symptoms within the past 3 months * Presence of toxic megacolon * Major surgery within the past 6 weeks or anticipated need for surgery within 12 weeks * Total colectomy, ileostomy, stoma or 100 cm of resected small bowel * Requiring in-patient hospitalization * A history of allergic reaction to heparin or heparin-induced thrombocytopenia * A history of hypersensitivity reaction associated with an apheresis procedure or intolerance of apheresis procedures * A history of severe cardiovascular or peripheral arterial diseases * A history of cerebral vascular diseases * Liver diseases * Renal insufficiency * Known bleeding disorder or use of concomitant anticoagulant therapy for purposes other than apheresis treatment * Any hypercoagulable disorder * Known infection with Hepatitis B or C, or HIV * Severe anemia * Leukopenia or granulocytopenia * Evidence of current systemic infection * Malignancy * Pregnant, lactating or planning to become pregnant during the course of the investigational study * Used within the last 30 days, an investigational drug, biologic or device or 5 half-lives, if known, for any investigational drug or biologic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Remission | Baseline to Week 12 | Clinical Remission is defined as a Crohn's Disease Activity Index (CDAI) score of ≤150 when evaluated at Week 12 |
| Frequency and Severity of Adverse Events Through Week 12 | Baseline through Week 12 Visit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Short-Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score | Baseline to Week 12 | 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 |
| Mean Change in Short-Form 36 Questionnaire (SF-36) Mental Component Summary (MCS) Score | Baseline to Week 12 | 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 |
| Mean Change in Work Limitations Questionnaire (Physical Demands) | Baseline to Week 12 | 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 |
| Mean Change in Inflammatory Bowel Diseases Questionnaire (IBDQ) | Baseline to Week 12 | 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 |
| Mean Change in EuroQol Score (Single Index) | Baseline to Week 12 | 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 |
| Mean Change in EuroQol Score (Visual Analog Scale) | Baseline to Week 12 | 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) |
| CDAI Score Change From Baseline | Baseline to Week 12 | 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 |
| Mean Change in Work Limitations Questionnaire (Mental-Interpersonal Demands) | Baseline to Week 12 | 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 |
| Mean Change in Work Limitations Questionnaire (Output Demands) | Baseline to Week 12 | 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 |
| Mean Change in Work Limitations Questionnaire (WLQ Index) | Baseline to Week 12 | 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 |
| Mean Change in Crohn's Disease Endoscopic Index of Severity | Baseline to Week 12 | 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 |
| Mean Change in Subject Global Rating | Baseline to Week 12 | 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 |
| Mean Change in C-Reactive Protein | Baseline to week 12 | — |
| Mean Change in Work Limitations Questionnaire (Time Management) | Baseline to Week 12 | 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 |
| Clinical Response | Baseline to Week 12 | Clinical Response is defined as a ≥ 100-point reduction in the CDAI scores at Week 12 |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adacolumn Adacolumn, ten apheresis sessions within 9 weeks | 157 |
| Sham Sham, ten apheresis sessions within 9 weeks | 78 |
| Total | 235 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | 2 or more consecutive treatments missed | 1 | 0 |
| Overall Study | Adverse Event | 10 | 6 |
| Overall Study | Alternate Therapy | 6 | 2 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Enter Open-Label Study | 76 | 35 |
| Overall Study | Flare During Active Treatment | 7 | 3 |
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 6 |
Baseline characteristics
| Characteristic | Sham | Total | Adacolumn |
|---|---|---|---|
| Age Continuous | 41.4 years STANDARD_DEVIATION 13.6 | 40.9 years STANDARD_DEVIATION 12.8 | 40.6 years STANDARD_DEVIATION 12.5 |
| Alcohol Use Consumes Alcohol | 54 participants | 139 participants | 85 participants |
| Alcohol Use Never Drank | 12 participants | 51 participants | 39 participants |
| Alcohol Use Previously Drank | 12 participants | 45 participants | 33 participants |
| Baseline Crohn's Disease Activity Index Score | 314.7 units on a scale STANDARD_DEVIATION 53.5 | 311.3 units on a scale STANDARD_DEVIATION 54.9 | 309.6 units on a scale STANDARD_DEVIATION 55.7 |
| Crohn's Disease History | 129.9 months STANDARD_DEVIATION 123.1 | 136.3 months STANDARD_DEVIATION 124.3 | 139.5 months STANDARD_DEVIATION 125.1 |
| Height | 169.9 centimeter STANDARD_DEVIATION 10.3 | 170.2 centimeter STANDARD_DEVIATION 9.9 | 170.3 centimeter STANDARD_DEVIATION 9.7 |
| Inflammatory Bowel Disease Flares in the Past 12 Months | 2.5 flares STANDARD_DEVIATION 2.8 | 2.3 flares STANDARD_DEVIATION 2.4 | 2.2 flares STANDARD_DEVIATION 2.2 |
| Race/Ethnicity, Customized African American | 2 participants | 10 participants | 8 participants |
| Race/Ethnicity, Customized Asian/Pacific Islander | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Caucasian | 75 participants | 217 participants | 142 participants |
| Race/Ethnicity, Customized Hispanic | 0 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized Other | 1 participants | 5 participants | 4 participants |
| Sex: Female, Male Female | 44 Participants | 125 Participants | 81 Participants |
| Sex: Female, Male Male | 34 Participants | 110 Participants | 76 Participants |
| Smoking Status Current Smoker | 26 participants | 72 participants | 46 participants |
| Smoking Status Ex-Smoker | 23 participants | 62 participants | 39 participants |
| Smoking Status Non-Smoker | 29 participants | 101 participants | 72 participants |
| Weight | 72.29 kilogram STANDARD_DEVIATION 19.23 | 74.03 kilogram STANDARD_DEVIATION 17.28 | 74.89 kilogram STANDARD_DEVIATION 16.22 |
Outcome results
Primary
Clinical Remission
Clinical Remission is defined as a Crohn's Disease Activity Index (CDAI) score of ≤150 when evaluated at Week 12
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adacolumn | Clinical Remission | 17.8 percentage of participants |
| Sham | Clinical Remission | 19.2 percentage of participants |
p-value: 0.858Fisher Exact
Primary
Frequency and Severity of Adverse Events Through Week 12
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adacolumn | Frequency and Severity of Adverse Events Through Week 12 | Any Adverse Event | 93 percentage of participants |
| Adacolumn | Frequency and Severity of Adverse Events Through Week 12 | Device-Related Adverse Event | 61.1 percentage of participants |
| Adacolumn | Frequency and Severity of Adverse Events Through Week 12 | Serious Adverse Event | 8.3 percentage of participants |
| Adacolumn | Frequency and Severity of Adverse Events Through Week 12 | Device-Related Serious Adverse Event | 0.6 percentage of participants |
| Adacolumn | Frequency and Severity of Adverse Events Through Week 12 | Adverse Event Leading to Device Discontinuation | 10.8 percentage of participants |
| Adacolumn | Frequency and Severity of Adverse Events Through Week 12 | Severe Adverse Event | 19.7 percentage of participants |
| Sham | Frequency and Severity of Adverse Events Through Week 12 | Adverse Event Leading to Device Discontinuation | 11.5 percentage of participants |
| Sham | Frequency and Severity of Adverse Events Through Week 12 | Any Adverse Event | 93.6 percentage of participants |
| Sham | Frequency and Severity of Adverse Events Through Week 12 | Device-Related Serious Adverse Event | 0.0 percentage of participants |
| Sham | Frequency and Severity of Adverse Events Through Week 12 | Device-Related Adverse Event | 75.6 percentage of participants |
| Sham | Frequency and Severity of Adverse Events Through Week 12 | Severe Adverse Event | 19.2 percentage of participants |
| Sham | Frequency and Severity of Adverse Events Through Week 12 | Serious Adverse Event | 6.4 percentage of participants |
Secondary
CDAI Score Change From Baseline
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adacolumn | CDAI Score Change From Baseline | -65.6 units on a scale | Standard Deviation 96.6 |
| Sham | CDAI Score Change From Baseline | -62.3 units on a scale | Standard Deviation 103 |
p-value: 0.813Student's t-test
Secondary
Clinical Response
Clinical Response is defined as a ≥ 100-point reduction in the CDAI scores at Week 12
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adacolumn | Clinical Response | 28.0 percentage of participants |
| Sham | Clinical Response | 26.9 percentage of participants |
p-value: 1Fisher Exact
Secondary
Mean Change in C-Reactive Protein
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adacolumn | Mean Change in C-Reactive Protein | -1.75 milligrams/liter | Standard Deviation 22.67 |
| Sham | Mean Change in C-Reactive Protein | 0.24 milligrams/liter | Standard Deviation 12.59 |
p-value: 0.35Wilcoxon (Mann-Whitney)
Secondary
Mean Change in Crohn's Disease Endoscopic Index of Severity
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
Time frame: Baseline to Week 12
Population: Endoscopic evaluations were to be performed at baseline and Week 12 on a subset of study subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adacolumn | Mean Change in Crohn's Disease Endoscopic Index of Severity | 2 units on a scale | Standard Deviation 7.73 |
| Sham | Mean Change in Crohn's Disease Endoscopic Index of Severity | -4.63 units on a scale | Standard Deviation 13.2 |
p-value: 0.256Wilcoxon (Mann-Whitney)
Secondary
Mean Change in EuroQol Score (Single Index)
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adacolumn | Mean Change in EuroQol Score (Single Index) | 0.0392 units on a scale | Standard Deviation 0.2239 |
| Sham | Mean Change in EuroQol Score (Single Index) | 0.0917 units on a scale | Standard Deviation 0.2648 |
p-value: 0.17Wilcoxon (Mann-Whitney)
Secondary
Mean Change in EuroQol Score (Visual Analog Scale)
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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adacolumn | Mean Change in EuroQol Score (Visual Analog Scale) | 4.4 units on a scale | Standard Deviation 19.8 |
| Sham | Mean Change in EuroQol Score (Visual Analog Scale) | 5.5 units on a scale | Standard Deviation 18.6 |
p-value: 0.0773Wilcoxon (Mann-Whitney)
Secondary
Mean Change in Inflammatory Bowel Diseases Questionnaire (IBDQ)
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adacolumn | Mean Change in Inflammatory Bowel Diseases Questionnaire (IBDQ) | 18.5 units on a scale | Standard Deviation 32.1 |
| Sham | Mean Change in Inflammatory Bowel Diseases Questionnaire (IBDQ) | 16.8 units on a scale | Standard Deviation 37.9 |
p-value: 0.67Wilcoxon (Mann-Whitney)
Secondary
Mean Change in Short-Form 36 Questionnaire (SF-36) Mental Component Summary (MCS) Score
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adacolumn | Mean Change in Short-Form 36 Questionnaire (SF-36) Mental Component Summary (MCS) Score | 2.52 units on a scale | Standard Deviation 10.13 |
| Sham | Mean Change in Short-Form 36 Questionnaire (SF-36) Mental Component Summary (MCS) Score | 2.48 units on a scale | Standard Deviation 11.23 |
p-value: 0.977Wilcoxon (Mann-Whitney)
Secondary
Mean Change in Short-Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adacolumn | Mean Change in Short-Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score | 3.84 units on a scale | Standard Deviation 8.76 |
| Sham | Mean Change in Short-Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score | 3.29 units on a scale | Standard Deviation 9.19 |
p-value: 0.67Student's t-test
Secondary
Mean Change in Subject Global Rating
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adacolumn | Mean Change in Subject Global Rating | -0.7 units on a scale | Standard Deviation 1.6 |
| Sham | Mean Change in Subject Global Rating | -0.6 units on a scale | Standard Deviation 1.3 |
p-value: 0.87Wilcoxon (Mann-Whitney)
Secondary
Mean Change in Work Limitations Questionnaire (Mental-Interpersonal Demands)
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adacolumn | Mean Change in Work Limitations Questionnaire (Mental-Interpersonal Demands) | -5.5 units on a scale | Standard Deviation 20.5 |
| Sham | Mean Change in Work Limitations Questionnaire (Mental-Interpersonal Demands) | -2.7 units on a scale | Standard Deviation 20.8 |
p-value: 0.441Wilcoxon (Mann-Whitney)
Secondary
Mean Change in Work Limitations Questionnaire (Output Demands)
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adacolumn | Mean Change in Work Limitations Questionnaire (Output Demands) | -7.4 units on a scale | Standard Deviation 25.8 |
| Sham | Mean Change in Work Limitations Questionnaire (Output Demands) | -3.8 units on a scale | Standard Deviation 28.7 |
p-value: 0.759Wilcoxon (Mann-Whitney)
Secondary
Mean Change in Work Limitations Questionnaire (Physical Demands)
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adacolumn | Mean Change in Work Limitations Questionnaire (Physical Demands) | -5.2 units on a scale | Standard Deviation 23.1 |
| Sham | Mean Change in Work Limitations Questionnaire (Physical Demands) | 2.3 units on a scale | Standard Deviation 22.7 |
p-value: 0.379Wilcoxon (Mann-Whitney)
Secondary
Mean Change in Work Limitations Questionnaire (Time Management)
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adacolumn | Mean Change in Work Limitations Questionnaire (Time Management) | -9.9 units on a scale | Standard Deviation 25.5 |
| Sham | Mean Change in Work Limitations Questionnaire (Time Management) | -6.6 units on a scale | Standard Deviation 31.7 |
p-value: 0.261Wilcoxon (Mann-Whitney)
Secondary
Mean Change in Work Limitations Questionnaire (WLQ Index)
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adacolumn | Mean Change in Work Limitations Questionnaire (WLQ Index) | -1.8 units on a scale | Standard Deviation 5.6 |
| Sham | Mean Change in Work Limitations Questionnaire (WLQ Index) | -0.5 units on a scale | Standard Deviation 6.9 |
p-value: 0.222Wilcoxon (Mann-Whitney)
Post Hoc
Clinical Response Based on No Previous Use of Tumor Necrosis Factor-Alpha (TNF-a) Inhibitors
A clinical response is defined as a 70-point decrease in CDAI score
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adacolumn | Clinical Response Based on No Previous Use of Tumor Necrosis Factor-Alpha (TNF-a) Inhibitors | 39.5 percentage of participants |
| Sham | Clinical Response Based on No Previous Use of Tumor Necrosis Factor-Alpha (TNF-a) Inhibitors | 37.3 percentage of participants |
p-value: 0.8721Fisher Exact
Post Hoc
Clinical Response Based on no Use of 5-Aminosylisalates During the Study
A clinical response is defined as a 70-point decrease in CDAI score
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adacolumn | Clinical Response Based on no Use of 5-Aminosylisalates During the Study | 36.6 percentage of participants |
| Sham | Clinical Response Based on no Use of 5-Aminosylisalates During the Study | 38.2 percentage of participants |
p-value: 0.8618Fisher Exact
Post Hoc
Clinical Response Based on Previous Use of Tumor Necrosis Factor-Alpha (TNF-a) Inhibitors
A clinical response is defined as a 70-point decrease in CDAI score
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adacolumn | Clinical Response Based on Previous Use of Tumor Necrosis Factor-Alpha (TNF-a) Inhibitors | 50.0 percentage of participants |
| Sham | Clinical Response Based on Previous Use of Tumor Necrosis Factor-Alpha (TNF-a) Inhibitors | 21.1 percentage of participants |
p-value: 0.0676Fisher Exact
p-value: 0.0506Fisher Exact (Mid-P-Value)
Post Hoc
Clinical Response Based on Use of 5-Aminosylisalates During the Study
A clinical response is defined as a 70-point decrease in CDAI score
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adacolumn | Clinical Response Based on Use of 5-Aminosylisalates During the Study | 48.4 percentage of participants |
| Sham | Clinical Response Based on Use of 5-Aminosylisalates During the Study | 21.7 percentage of participants |
p-value: 0.0289Fisher Exact
Post Hoc
Clinical Response in Subjects With a CDAI Score Greater Than 300
A clinical response is defined as a 70-point decrease in CDAI score.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adacolumn | Clinical Response in Subjects With a CDAI Score Greater Than 300 | Baseline CDAI Score>300 | 43.8 percentage of participants |
| Sham | Clinical Response in Subjects With a CDAI Score Greater Than 300 | Baseline CDAI Score>300 | 27.1 percentage of participants |
p-value: 0.0632Fisher Exact
p-value: 0.0504Fisher Exact (Mid-P-Value)
Post Hoc
Clinical Response in Subjects With a CDAI Score Less Than or Equal to 300
A clinical response is defined as a 70-point decrease in CDAI score
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adacolumn | Clinical Response in Subjects With a CDAI Score Less Than or Equal to 300 | 39.0 percentage of participants |
| Sham | Clinical Response in Subjects With a CDAI Score Less Than or Equal to 300 | 43.3 percentage of participants |
p-value: 0.8265Fisher Exact