Use of Combined Measurements of Serum Infliximab and Anti-infliximab Antibodies in the Treatment of Patients With Crohns Disease Failing Infliximab Therapy
Information source: Copenhagen University Hospital at Herlev
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Crohn's Disease
Intervention: Measurement of serum infliximab and anti-infliximab antibodies (Procedure); Treatment according to current standards without knowledge of serum infliximab and anti-infliximab Ab status (Procedure)
Phase: Phase 4
Status: Recruiting
Sponsored by: Copenhagen University Hospital at Herlev Official(s) and/or principal investigator(s):
Mark Ainsworth, M.D., Ph.D. DMSci, Principal Investigator, Affiliation: Unaffiliated
Overall contact:
Mark Ainsworth, M.D., Ph.D. DMSci, Phone: +4544884488, Email: marain01@heh.regionh.dk
Summary
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.
Clinical Details
Official title: Use of Combined Measurements of Serum Infliximab and Anti-infliximab Antibodies in the Treatment of Patients With Crohns Disease Failing Infliximab Therapy
Study design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: 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.Total expenses during the study.
Secondary outcome: Mean change compared to baseline in WPAI score at week 12.Mean change compared to baseline in IBDQ score at week 12. Mean change compared to baseline in CDAI score at week 12. Mean change compared to baseline in PDAI score at week 12. Proportion of patients in remission (CDAI less than 150 for luminal disease, closure of all fistulas for fistulising disease) at week 12.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patient must be able to understand the information given to him/her and give written
informed consent.
2. Definitive diagnosis of Crohn's disease (confirmed by recent radiological, endoscopic
and/or histological evidence according to international criteria) .
3. Age between 18 and 65 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:
1. Any contraindication to continued infliximab treatment
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.
Locations and Contacts
Mark Ainsworth, M.D., Ph.D. DMSci, Phone: +4544884488, Email: marain01@heh.regionh.dk
Herlev University Hospital, Herlev 2730, Denmark; Recruiting
Mark Ainsworth, M.D., Ph.D. DMSci, Phone: +4544884488, Email: marain01@heh.regionh.dk
Casper Steenholdt, MD, Ph.D-student, Phone: +4540529577, Email: steenholdt@brygge.dk
Mark Ainsworth, M.D., Ph.D. DMSci, Principal Investigator
Casper Steenholdt, MD, PhD-student, Sub-Investigator
Jørn Brynskov, M.D., DMSci, Sub-Investigator
Ole Østergaard Thomsen, M.D., DMSci, Sub-Investigator
Institute for Inflammation Research, Copenhagen University Hospital, Rigshospitalet, Copenhagen 2100, Denmark; Active, not recruiting
Department of Gastroenterology, Hvidovre University Hospital, Hvidovre 2650, Denmark; Not yet recruiting
Gitte Pedersen, MD, Chief Physician, Phone: +45 36326713, Email: giped@dadlnet.dk
Gitte Pedersen, giped@dadlnet.dk, Principal Investigator
Department of Medical Gastroenterology, Køge University Hospital, Køge 4600, Denmark; Not yet recruiting
Lars Kristian Munck, MD, DMSc, Chief Physician, Phone: +45 56631500, Email: lkmu@regionsjaelland.dk
Lars Kristian Munck, MD, DMSc, Chief Physician, Principal Investigator
Dept of Medical Gastroenterology, Odense University Hospital, Odense 5000, Denmark; Not yet recruiting
Jens Kjeldsen, MD, PhD, Chief Physician, Phone: +45 65411286, Email: jakjeldsen@dadlnet.dk
Jens Kjeldsen, MD, PhD, Chief Physician, Principal Investigator
Dept of Hepatology and Medical Gastroenterology, Århus University Hospital, Århus 8000, Denmark; Not yet recruiting
Lisbet Ambrosius, MD, DMSc, Chief Physician, Phone: +45 89493898, Email: lac@dadlnet.dk
Lisbet Ambrosius, MD, DMSc, Chief Physician, Principal Investigator
Dept of Medical Gastroenterology, Ålborg University Hospital, Ålborg 9000, Denmark; Not yet recruiting
Jan Fallingborg, MD, DMSc, Chief Physician, Phone: +45 99321111, Email: jaf@rn.dk
Jan Fallingborg, MD, DMSc, Chief Physician, Principal Investigator
Additional Information
Related publications: 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. 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 Jan 13;:1-8 [Epub ahead of print] 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. 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.
Starting date: June 2009
Ending date: February 2014
Last updated: August 25, 2009
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