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| Name | Class |
|---|---|
| Aase and Ejnar Danielsens Foundation | OTHER |
| Beckett Foundation | OTHER |
| the Danish Biotechnology Program | UNKNOWN |
| Colitis-Crohn Foreningen |
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To compare treatment outcome in patients with Crohn's disease with secondary loss of response to infliximab (i.e. initial good response follow by loss of response) treated according to current standards based only on clinical features versus treatment based on serum levels of infliximab and anti-infliximab antibody (Ab) status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Patients with Crohn's disease with secondary loss of response to infliximab. |
|
| 2 | Active Comparator | Patients with Crohn's disease with secondary loss of response to infliximab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measurement of serum infliximab and anti-infliximab antibodies | Procedure | In the intervention group treatment of patients with Crohn's disease with secondary loss of response to infliximab is based on serum infliximab and anti-infliximab Ab levels according to following algorithm:
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with response at week 12, i.e. CDAI decrease of 70 or more for patients with luminal disease, or reduction of 50 percent or more from base line in the number of draining fistulas for patients with fistulising disease. | Clinical response rates at week 12 should be non-inferior in the intervention group as compared to the control group. Both primary end-points should be met in order to declare the primary end-points succesfully archived. | 12 weeks |
| Total expenses related to Crohn's disease during the study (inclusion to week 12). | Crohn related expenses at week 12 should be less in the intervention group as compared to the control group. Both primary end-points should be met in order to declare the primary end-points succesfully archived. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change compared to baseline in WPAI score at week 12. | 12 weeks | |
| Mean change compared to baseline in IBDQ score at week 12. | 12 weeks | |
| Mean change compared to baseline in CDAI score at week 4,8, 12,20. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Ainsworth, M.D., Ph.D. DMSci | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Medical Gastroenterology, Ålborg University Hospital | Aalborg | 9000 | Denmark | |||
| Dept of Hepatology and Medical Gastroenterology, Århus University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18028512 | Background | Ainsworth MA, Bendtzen K, Brynskov J. Tumor necrosis factor-alpha binding capacity and anti-infliximab antibodies measured by fluid-phase radioimmunoassays as predictors of clinical efficacy of infliximab in Crohn's disease. Am J Gastroenterol. 2008 Apr;103(4):944-8. doi: 10.1111/j.1572-0241.2007.01638.x. Epub 2007 Nov 19. | |
| 19140087 |
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| OTHER |
| Danish Medical Association | OTHER |
| Frode V. Nyegaard and wife's Foundation | UNKNOWN |
| Health Science Research Foundation of Region of Copenhagen | UNKNOWN |
| Herlev Hospital Research Council | UNKNOWN |
| Lundbeck Foundation | OTHER |
| P. Carl Petersens Fund | OTHER |
| Biomonitor A/S | UNKNOWN |
| Prometheus Inc. | INDUSTRY |
| The Danish Institute for Health Services Research | UNKNOWN |
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| Treatment according to current standards without knowledge of serum infliximab and anti-infliximab Ab status | Procedure | In the control group patients with Crohn's disease with secondary loss of response to infliximab is treated according to current standard of care which is to increase dose of infliximab to 5 mg/kg every 4 weeks without knowledge of serum infliximab levels and anti-infliximab Ab status. |
|
| 4, 8, 12, 20 weeks |
| Mean change compared to baseline in PDAI score at week 4, 8, 12, and 20. | 4, 8, 12, 20 weeks |
| Clinical response at week 4, 8, 20 | Clinical response is defined as decrease of 70 in CDAI (luminal disease) or 50% reduction of active fistulas (fistulizing disease). | Week 4, 8, 20 |
| Laboratory parameters | Change in laboratory parameters (hemoglobin, crp, albumin) from inclusion to week 12. | Week 12 |
| Days with subjective feeling of disability due to Crohn's disease | Total number of days with subjective feelinhg of disability due to Crohn's disease from inclusion to week 12. | week 12 |
| Serious adverse drug reactions | Total number of serious adverse drug reactions from inclusion to week 12. | week 12 |
| Expenses related to Crohn's diseae at week 20 | week 20 |
| Expenses related to Crohn's disease compared to change in CDAI-score (luminal disease) or PDAI-score (fistulizing disease), and IBD-score at week 12 and 20 | week 12 and 20 |
| Aarhus |
| 8000 |
| Denmark |
| Institute for Inflammation Research, Copenhagen University Hospital, Rigshospitalet | Copenhagen | 2100 | Denmark |
| Esbjerg Hospital | Esbjerg | 6700 | Denmark |
| Herlev University Hospital | Herlev | 2730 | Denmark |
| Department of Gastroenterology, Hvidovre University Hospital | Hvidovre | 2650 | Denmark |
| Department of Medical Gastroenterology, Køge University Hospital | Køge | 4600 | Denmark |
| Dept of Medical Gastroenterology, Odense University Hospital | Odense | 5000 | Denmark |
| Bendtzen K, Ainsworth M, Steenholdt C, Thomsen OO, Brynskov J. Individual medicine in inflammatory bowel disease: monitoring bioavailability, pharmacokinetics and immunogenicity of anti-tumour necrosis factor-alpha antibodies. Scand J Gastroenterol. 2009;44(7):774-81. doi: 10.1080/00365520802699278. |
| 17133559 | Background | Bendtzen K, Geborek P, Svenson M, Larsson L, Kapetanovic MC, Saxne T. Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor alpha inhibitor infliximab. Arthritis Rheum. 2006 Dec;54(12):3782-9. doi: 10.1002/art.22214. |
| 18032541 | Background | Svenson M, Geborek P, Saxne T, Bendtzen K. Monitoring patients treated with anti-TNF-alpha biopharmaceuticals: assessing serum infliximab and anti-infliximab antibodies. Rheumatology (Oxford). 2007 Dec;46(12):1828-34. doi: 10.1093/rheumatology/kem261. |
| 26245216 | Derived | Steenholdt C, Brynskov J, Thomsen OO, Munck LK, Christensen LA, Pedersen G, Kjeldsen J, Ainsworth MA. Implications of Infliximab Treatment Failure and Influence of Personalized Treatment on Patient-reported Health-related Quality of Life and Productivity Outcomes in Crohn's Disease. J Crohns Colitis. 2015 Nov;9(11):1032-42. doi: 10.1093/ecco-jcc/jjv139. Epub 2015 Aug 5. |
| 25576753 | Derived | Steenholdt C, Bendtzen K, Brynskov J, Thomsen OO, Munck LK, Christensen LA, Pedersen G, Kjeldsen J, Ainsworth MA. Changes in serum trough levels of infliximab during treatment intensification but not in anti-infliximab antibody detection are associated with clinical outcomes after therapeutic failure in Crohn's disease. J Crohns Colitis. 2015 Mar;9(3):238-45. doi: 10.1093/ecco-jcc/jjv004. Epub 2015 Jan 9. |
| 23878167 | Derived | Steenholdt C, Brynskov J, Thomsen OO, Munck LK, Fallingborg J, Christensen LA, Pedersen G, Kjeldsen J, Jacobsen BA, Oxholm AS, Kjellberg J, Bendtzen K, Ainsworth MA. Individualised therapy is more cost-effective than dose intensification in patients with Crohn's disease who lose response to anti-TNF treatment: a randomised, controlled trial. Gut. 2014 Jun;63(6):919-27. doi: 10.1136/gutjnl-2013-305279. Epub 2013 Jul 22. |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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