Phase 3
Completed N=235
Study for the Treatment of Crohn's Disease With Adacolumn
Source: ClinicalTrials.gov NCT00162942 ↗Enrolled (actual)
235
Serious AEs
—
Results posted
Apr 2009
Primary outcomePrimary: Clinical Remission — 17.8; 19.2 percentage of participants — p=.858
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Remission |
17.8; 19.2 | .858 |
| PRIMARY Frequency and Severity of Adverse Events Through Week 12 |
93; 93.6; 19.7; 19.2; 61.1; 75.6 | — |
| SECONDARY CDAI Score Change From Baseline |
-65.6; -62.3 | 0.813 |
| SECONDARY Clinical Response |
28.0; 26.9 | 1.000 |
| SECONDARY Mean Change in Short-Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score |
3.84; 3.29 | 0.670 |
| SECONDARY Mean Change in Short-Form 36 Questionnaire (SF-36) Mental Component Summary (MCS) Score |
2.52; 2.48 | 0.977 |
| SECONDARY Mean Change in Inflammatory Bowel Diseases Questionnaire (IBDQ) |
18.5; 16.8 | 0.670 |
| SECONDARY Mean Change in EuroQol Score (Single Index) |
0.0392; 0.0917 | 0.170 |
| SECONDARY Mean Change in EuroQol Score (Visual Analog Scale) |
4.4; 5.5 | 0.0773 |
| SECONDARY Mean Change in Work Limitations Questionnaire (Time Management) |
-9.9; -6.6 | 0.261 |
| SECONDARY Mean Change in Work Limitations Questionnaire (Physical Demands) |
-5.2; 2.3 | 0.379 |
| SECONDARY Mean Change in Work Limitations Questionnaire (Mental-Interpersonal Demands) |
-5.5; -2.7 | 0.441 |
| SECONDARY Mean Change in Work Limitations Questionnaire (Output Demands) |
-7.4; -3.8 | 0.759 |
| SECONDARY Mean Change in Work Limitations Questionnaire (WLQ Index) |
-1.8; -0.5 | 0.222 |
| SECONDARY Mean Change in Crohn's Disease Endoscopic Index of Severity |
2; -4.63 | 0.256 |
| SECONDARY Mean Change in Subject Global Rating |
-0.7; -0.6 | 0.870 |
| SECONDARY Mean Change in C-Reactive Protein |
-1.75; 0.24 | 0.350 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00162942). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.