Use of Combined Measurements of Serum Infliximab and Anti-infliximab Antibodies in the Treatment of Patients With Crohns Disease Failing Infliximab Therapy
NCT ID: NCT00851565
Last Updated: 2011-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2009-06-30
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Patients with Crohn's disease with secondary loss of response to infliximab.
Measurement of serum infliximab and anti-infliximab antibodies
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:
1. Low s-infliximab in the presence of anti-infliximab Ab: Adalimumab 80 mg s.c. followed by 40 mg every 2 weeks.
2. Low s-infliximab without anti-infliximab Ab: Infliximab 10 mg/kg i.v. every 8 weeks.
3. High s-infliximab without anti-infliximab Ab: Stop infliximab treatment. Review history. Steroids or surgery.
4. High s-infliximab in the presence of anti-infliximab Ab: Same as number 3.
2
Patients with Crohn's disease with secondary loss of response to infliximab.
Treatment according to current standards without knowledge of serum infliximab and anti-infliximab Ab status
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.
Interventions
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Measurement of serum infliximab and anti-infliximab antibodies
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:
1. Low s-infliximab in the presence of anti-infliximab Ab: Adalimumab 80 mg s.c. followed by 40 mg every 2 weeks.
2. Low s-infliximab without anti-infliximab Ab: Infliximab 10 mg/kg i.v. every 8 weeks.
3. High s-infliximab without anti-infliximab Ab: Stop infliximab treatment. Review history. Steroids or surgery.
4. High s-infliximab in the presence of anti-infliximab Ab: Same as number 3.
Treatment according to current standards without knowledge of serum infliximab and anti-infliximab Ab status
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.
Eligibility Criteria
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Inclusion Criteria
2. Definitive diagnosis of Crohn's disease (confirmed by recent radiological, endoscopic and/or histological evidence according to international criteria) .
3. Age minimum 18 years.
4. Previous good response to at least 3 doses (5mg/kg) of infliximab (as judged by the treating physician).
5. Loss of response to standard doses of infliximab (as judged by the treating physician).
6. Last infliximab infusion given at least 4 weeks before inclusion.
7. For patients with luminal disease, the CDAI should be above 220 points at inclusion.
8. For patients with fistulising disease only, at least one draining perianal fistula (confirmed by radiography, MR, ultrasound or physical examination) should be present.
Exclusion Criteria
2. Short bowel syndrome
3. Bowel resection within 12 weeks of inclusion.
4. Current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease.
5. Pregnancy
6. History of alcohol or drug abuse within the prior year
7. Patients who do not meet concomitant medication criteria.
8. Any other condition, which in the Investigator's judgment would make the patient unsuitable for inclusion in the study.
18 Years
ALL
No
Sponsors
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Aase and Ejnar Danielsens Foundation
OTHER
Beckett Foundation
OTHER
the Danish Biotechnology Program
UNKNOWN
Colitis-Crohn Foreningen
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
Copenhagen University Hospital at Herlev
OTHER
Responsible Party
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Department of Medical Gastroenterology, Copenhagen University Hospital Herlev
Principal Investigators
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Mark Ainsworth, M.D., Ph.D. DMSci
Role: PRINCIPAL_INVESTIGATOR
Locations
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Dept of Medical Gastroenterology, Ålborg University Hospital
Aalborg, , Denmark
Dept of Hepatology and Medical Gastroenterology, Århus University Hospital
Aarhus, , Denmark
Institute for Inflammation Research, Copenhagen University Hospital, Rigshospitalet
Copenhagen, , Denmark
Esbjerg Hospital
Esbjerg, , Denmark
Herlev University Hospital
Herlev, , Denmark
Department of Gastroenterology, Hvidovre University Hospital
Hvidovre, , Denmark
Department of Medical Gastroenterology, Køge University Hospital
Køge, , Denmark
Dept of Medical Gastroenterology, Odense University Hospital
Odense, , Denmark
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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01MA
Identifier Type: -
Identifier Source: org_study_id