Inflammatory Bowel DiseasesAPRILNCT02503514
Autoimmune Paradoxical Reactions in IBD Longitudinal Cohort
An observational study of Inflammatory Bowel Diseases and Crohns Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: Inflammatory bowel disease patients undergoing treatment with varying biologic agents will be evaluated for incidences of paradoxical immune reactions, the risk factors associated with those paradoxical immune reactions, and whether the paradoxical immune reactions and their associated risk factors differ… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohns Disease, Ulcerative Colitis
- How many people
- 380 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Aug 2017
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with confirmed IBD on a biologic agent or with plans to initiate this within 1 month.
Who may be able to join
- Ability to understand and sign informed consent.
- Adults (male or female) with confirmed IBD diagnosed by routine clinical, radiographic, endoscopic and pathological criteria.
- Adults age 18 or older.
- Adults on a new biologic agent or with plans to initiate a biologic agent, within 1 month for the treatment of their IBD.
Who cannot join
- Inability to understand and sign informed consent.
- Inability to confirm diagnosis of IBD from medical records
- Inability to confirm time of initial biologic start, and prior specific formulations from medical records.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill- CGIBD
Chapel Hill, North Carolina, 27514
About this study
Official title: Autoimmune Paradoxical Reactions in IBD Longitudinal Cohort - APRIL Cohort
Purpose: Inflammatory bowel disease patients undergoing treatment with varying biologic agents will be evaluated for incidences of paradoxical immune reactions, the risk factors associated with those paradoxical immune reactions, and whether the paradoxical immune reactions and their associated risk factors differ based on formulation of biologic agent.
Participants: All adults (≥18 year) with confirmed IBD on a biologic agent or with plans to initiate treatment in 1 month
Procedures (methods): Subjects undergoing treatment with a biologic agent will be followed indefinitely for paradoxical immune reactions. Data will be collected at baseline as well as serum and plasma for banking. Subjects will be followed at 6 month intervals either via email, telephone interviews or at the time of clinic follow-up visits. In the event of a de-novo paradoxical reaction, specific information will be collected from sites in an event capture form, with data abstracted from routine clinical care for the paradoxical reaction. Subjects will continue to be followed every 3 months after the event via email, telephone contact to determine whether resolution and/or recurrence occurred, and to determine any changes in medical therapy. Serum and plasma will be re-collected at the time of first event for comparison to baseline samples and to samples from controls (those on biologics without study documented paradoxical immune reactions). At resolution of the event, patient will return to 6 month follow up schedule. Subjects can discontinue and/or fail a particular biologic treatment; therefore they will also be followed for paradoxical immune reactions, on any new biologic treatment they undergo while in the study.
Read the detailed description
Inclusion/Exclusion Criteria: All adults (≥18 year) with confirmed IBD on a biologic agent or with plans to initiate this within 1 month (defined as any anti-TNF, natalizumab, vedolizumab or ustekinumab) will be enrolled into a prospective cohort (initially in a pilot setting at 5 sites, later with full funding involving all sites of the CRA). Individuals with current biologic use will be included (i.e. prevalent users), with records collected as to time of initial biologic start, and prior specific formulations. Ideally, new initiators of biologic agents will be recruited at the visit where the decision is made to start a biologic agent. Those with a prior history of one of the 4 described paradoxical outcomes associated with a biologic agent will also be included as prevalent cases in order to increase the sample size, with appropriate clinical information collected per medical record. All data on prevalent cases will be entered historically prospective follow up with still occur to ensure that paradoxical reaction does not recur.
Exposures: Data will be collected at baseline including demographic and disease specific factors, concomitant medications, laboratory data, as well as serum and plasma for banking.
Follow up: Individuals will be followed at 6 month intervals either via email, telephone interviews or at the time of clinic follow-up visits. Data event forms for outcomes occurring at any point during follow up will be collected real-time in clinic, or if triggered by standard follow-up at 6 months.
Outcome of paradoxical immune reaction: Outcomes are defined as a) psoriaform skin lesion, b) drug-induced lupus c) demyelinating disorder or d) vasculitis. In the event of a de-novo paradoxical reaction, specific information will be collected from sites in an event capture form, with data abstracted from routine clinical care for the paradoxical reaction. Medical records will be obtained confirming the response, with copies of pathology (dermatologic biopsy)or radiology (MRI) reports when applicable. For specific event capture forms. Individuals will continue to be followed every 3 months after the outcome via telephone contact to determine whether resolution and/or recurrence occurred and changes in medical therapy. At resolution of the event, patient will return to 6 month follow up. Serum and plasma will also be re-collected at the time of first outcome in cases for exposure to baseline samples and to those of controls (those on biologics without paradoxical immune reaction). Serum and plasma will be collected at the time of event diagnosis, when possible (within 2 months). If not possible, blood draw can be "missed" in circumstances where patient is not seen in clinic in this window.
Timeline for study contacts:
The top timeline is for an individual who does not develop an event, baseline in-person consent and serum collection, contact every 6 months for telephone contact visit or follow up visit during the time of routine clinic follow-up. The bottom line is for someone who does develop an event, with closer follow-up until event resolution, and repeat serum collection. Contacts therefore range from 3-6 months, with the vast majority having follow up at 6 month intervals.
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Colitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with specific paradoxical Adverse Events Using Biologic therapies as a part of routine care for the treatment of IBD
Investigator will assess autoimmune reactions such as skin lesions (psoriasis), vasculitis, demyelinating disorders or drug-induced lupus in patients on biologic therapies for IBD. These reactions have been described as "paradoxical inflammation."
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 380 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Responsible party
- Sponsor
- Investigators
- Millie D Long, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503514
- Sponsor's protocol ID
- 15-0167
- Acronym
- APRIL
- Status last verified
- Dec 2017
- First submitted
- 17 Jul 2015
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Benchimol EI, Cook SF, Erichsen R, Long MD, Bernstein CN, Wong J, Carroll CF, Froslev T, Sampson T, Kappelman MD. International variation in medication prescription rates among elderly patients with inflammatory bowel disease. J Crohns Colitis. 2013 Dec;7(11):878-89. doi: 10.1016/j.crohns.2012.09.001. Epub 2012 Sep 25.
PubMed 23018106van Deen WK, van Oijen MG, Myers KD, Centeno A, Howard W, Choi JM, Roth BE, McLaughlin EM, Hollander D, Wong-Swanson B, Sack J, Ong MK, Ha CY, Esrailian E, Hommes DW. A nationwide 2010-2012 analysis of U.S. health care utilization in inflammatory bowel diseases. Inflamm Bowel Dis. 2014 Oct;20(10):1747-53. doi: 10.1097/MIB.0000000000000139.
PubMed 25137415Cleynen I, Vermeire S. Paradoxical inflammation induced by anti-TNF agents in patients with IBD. Nat Rev Gastroenterol Hepatol. 2012 Sep;9(9):496-503. doi: 10.1038/nrgastro.2012.125. Epub 2012 Jul 3.
PubMed 22751454Fiorino G, Danese S, Pariente B, Allez M. Paradoxical immune-mediated inflammation in inflammatory bowel disease patients receiving anti-TNF-alpha agents. Autoimmun Rev. 2014 Jan;13(1):15-9. doi: 10.1016/j.autrev.2013.06.005. Epub 2013 Jun 15.
PubMed 23777821Rahier JF, Buche S, Peyrin-Biroulet L, Bouhnik Y, Duclos B, Louis E, Papay P, Allez M, Cosnes J, Cortot A, Laharie D, Reimund JM, Lemann M, Delaporte E, Colombel JF; Groupe d'Etude Therapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Severe skin lesions cause patients with inflammatory bowel disease to discontinue anti-tumor necrosis factor therapy. Clin Gastroenterol Hepatol. 2010 Dec;8(12):1048-55. doi: 10.1016/j.cgh.2010.07.022. Epub 2010 Aug 20.
PubMed 20728573Afzali A, Wheat CL, Hu JK, Olerud JE, Lee SD. The association of psoriasiform rash with anti-tumor necrosis factor (anti-TNF) therapy in inflammatory bowel disease: a single academic center case series. J Crohns Colitis. 2014 Jun;8(6):480-8. doi: 10.1016/j.crohns.2013.10.013. Epub 2013 Nov 21.
PubMed 24268978Baumgart DC, Grittner U, Steingraber A, Azzaro M, Philipp S. Frequency, phenotype, outcome, and therapeutic impact of skin reactions following initiation of adalimumab therapy: experience from a consecutive cohort of inflammatory bowel disease patients. Inflamm Bowel Dis. 2011 Dec;17(12):2512-20. doi: 10.1002/ibd.21643. Epub 2011 Feb 23.
PubMed 21351201Cullen G, Kroshinsky D, Cheifetz AS, Korzenik JR. Psoriasis associated with anti-tumour necrosis factor therapy in inflammatory bowel disease: a new series and a review of 120 cases from the literature. Aliment Pharmacol Ther. 2011 Dec;34(11-12):1318-27. doi: 10.1111/j.1365-2036.2011.04866.x. Epub 2011 Sep 29.
PubMed 21957906Denadai R, Teixeira FV, Steinwurz F, Romiti R, Saad-Hossne R. Induction or exacerbation of psoriatic lesions during anti-TNF-alpha therapy for inflammatory bowel disease: a systematic literature review based on 222 cases. J Crohns Colitis. 2013 Aug;7(7):517-24. doi: 10.1016/j.crohns.2012.08.007. Epub 2012 Sep 7.
PubMed 22960136Guerra I, Algaba A, Perez-Calle JL, Chaparro M, Marin-Jimenez I, Garcia-Castellanos R, Gonzalez-Lama Y, Lopez-Sanroman A, Mancenido N, Martinez-Montiel P, Quintanilla E, Taxonera C, Villafruela M, Romero-Mate A, Lopez-Serrano P, Gisbert JP, Bermejo F. Induction of psoriasis with anti-TNF agents in patients with inflammatory bowel disease: a report of 21 cases. J Crohns Colitis. 2012 Jun;6(5):518-23. doi: 10.1016/j.crohns.2011.10.007. Epub 2011 Nov 13.
PubMed 22398059Sherlock ME, Walters T, Tabbers MM, Frost K, Zachos M, Muise A, Pope E, Griffiths AM. Infliximab-induced psoriasis and psoriasiform skin lesions in pediatric Crohn disease and a potential association with IL-23 receptor polymorphisms. J Pediatr Gastroenterol Nutr. 2013 May;56(5):512-8. doi: 10.1097/MPG.0b013e31828390ba.
PubMed 23274341Buisson A, Cuny JF, Barbaud A, Schmutz JL, Bigard MA, Gueant JL, Peyrin-Biroulet L. Methotrexate for psoriasiform lesions associated with anti-tumour necrosis factor therapy in inflammatory bowel disease. Aliment Pharmacol Ther. 2012 May;35(10):1175-80. doi: 10.1111/j.1365-2036.2012.05082.x. Epub 2012 Apr 2.
PubMed 22469155Torres J, Buche S, Delaporte E, Colombel JF. Skin side effects of inflammatory bowel disease therapy. Inflamm Bowel Dis. 2013 Apr;19(5):1086-98. doi: 10.1097/MIB.0b013e3182802c07.
PubMed 23474780Niess JH, Danese S. Anti-TNF and skin inflammation in IBD: a new paradox in gastroenterology? Gut. 2014 Apr;63(4):533-5. doi: 10.1136/gutjnl-2013-304683. Epub 2013 Apr 9. No abstract available.
PubMed 23570743Moran GW, Lim AW, Bailey JL, Dubeau MF, Leung Y, Devlin SM, Novak K, Kaplan GG, Iacucci M, Seow C, Martin L, Panaccione R, Ghosh S. Review article: dermatological complications of immunosuppressive and anti-TNF therapy in inflammatory bowel disease. Aliment Pharmacol Ther. 2013 Nov;38(9):1002-24. doi: 10.1111/apt.12491. Epub 2013 Sep 25.
PubMed 24099467
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autoimmune Paradoxical Reactions in IBD Longitudinal Cohort - APRIL Cohort
- ClinicalTrials.gov ID
- NCT02503514
- Acronym / sponsor ID
- APRIL / 15-0167
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Study start
- Aug 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 21 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: Inflammatory bowel disease patients undergoing treatment with varying biologic agents will be evaluated for incidences of paradoxical immune reactions, the risk factors associated with those paradoxical immune reactions, and whether the paradoxical immune reactions and their associated risk factors differ based on formulation of biologic agent.
Participants: All adults (≥18 year) with confirmed IBD on a biologic agent or with plans to initiate treatment in 1 month
Procedures (methods): Subjects undergoing treatment with a biologic agent will be followed indefinitely for paradoxical immune reactions. Data will be collected at baseline as well as serum and plasma for banking. Subjects will be followed at 6 month intervals either via email, telephone interviews or at the time of clinic follow-up visits. In the event of a de-novo paradoxical reaction, specific information will be collected from sites in an event capture form, with data abstracted from routine clinical care for the paradoxical reaction. Subjects will continue to be followed every 3 months after the event via email, telephone contact to determine whether resolution and/or recurrence occurred, and to determine any changes in medical therapy. Serum and plasma will be re-collected at the time of first event for comparison to baseline samples and to samples from controls (those on biologics without study documented paradoxical immune reactions). At resolution of the event, patient will return to 6 month follow up schedule. Subjects can discontinue and/or fail a particular biologic treatment; therefore they will also be followed for paradoxical immune reactions, on any new biologic treatment they undergo while in the study.
Detailed description
Inclusion/Exclusion Criteria: All adults (≥18 year) with confirmed IBD on a biologic agent or with plans to initiate this within 1 month (defined as any anti-TNF, natalizumab, vedolizumab or ustekinumab) will be enrolled into a prospective cohort (initially in a pilot setting at 5 sites, later with full funding involving all sites of the CRA). Individuals with current biologic use will be included (i.e. prevalent users), with records collected as to time of initial biologic start, and prior specific formulations. Ideally, new initiators of biologic agents will be recruited at the visit where the decision is made to start a biologic agent. Those with a prior history of one of the 4 described paradoxical outcomes associated with a biologic agent will also be included as prevalent cases in order to increase the sample size, with appropriate clinical information collected per medical record. All data on prevalent cases will be entered historically prospective follow up with still occur to ensure that paradoxical reaction does not recur.
Exposures: Data will be collected at baseline including demographic and disease specific factors, concomitant medications, laboratory data, as well as serum and plasma for banking.
Follow up: Individuals will be followed at 6 month intervals either via email, telephone interviews or at the time of clinic follow-up visits. Data event forms for outcomes occurring at any point during follow up will be collected real-time in clinic, or if triggered by standard follow-up at 6 months.
Outcome of paradoxical immune reaction: Outcomes are defined as a) psoriaform skin lesion, b) drug-induced lupus c) demyelinating disorder or d) vasculitis. In the event of a de-novo paradoxical reaction, specific information will be collected from sites in an event capture form, with data abstracted from routine clinical care for the paradoxical reaction. Medical records will be obtained confirming the response, with copies of pathology (dermatologic biopsy)or radiology (MRI) reports when applicable. For specific event capture forms. Individuals will continue to be followed every 3 months after the outcome via telephone contact to determine whether resolution and/or recurrence occurred and changes in medical therapy. At resolution of the event, patient will return to 6 month follow up. Serum and plasma will also be re-collected at the time of first outcome in cases for exposure to baseline samples and to those of controls (those on biologics without paradoxical immune reaction). Serum and plasma will be collected at the time of event diagnosis, when possible (within 2 months). If not possible, blood draw can be "missed" in circumstances where patient is not seen in clinic in this window.
Timeline for study contacts:
The top timeline is for an individual who does not develop an event, baseline in-person consent and serum collection, contact every 6 months for telephone contact visit or follow up visit during the time of routine clinic follow-up. The bottom line is for someone who does develop an event, with closer follow-up until event resolution, and repeat serum collection. Contacts therefore range from 3-6 months, with the vast majority having follow up at 6 month intervals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with confirmed IBD on a biologic agent or with plans to initiate this within 1 month.
Key inclusion criteria (4 listed)
- Ability to understand and sign informed consent.
- Adults (male or female) with confirmed IBD diagnosed by routine clinical, radiographic, endoscopic and pathological criteria.
- Adults age 18 or older.
- Adults on a new biologic agent or with plans to initiate a biologic agent, within 1 month for the treatment of their IBD.
Key exclusion criteria (3 listed)
- Inability to understand and sign informed consent.
- Inability to confirm diagnosis of IBD from medical records
- Inability to confirm time of initial biologic start, and prior specific formulations from medical records.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with specific paradoxical Adverse Events Using Biologic therapies as a part of routine care for the treatment of IBD
Time frame: 1 year
Investigator will assess autoimmune reactions such as skin lesions (psoriasis), vasculitis, demyelinating disorders or drug-induced lupus in patients on biologic therapies for IBD. These reactions have been described as "paradoxical inflammation."
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Background: PubMed 23018106Benchimol EI, Cook SF, Erichsen R, Long MD, Bernstein CN, Wong J, Carroll CF, Froslev T, Sampson T, Kappelman MD. International variation in medication prescription rates among elderly patients with inflammatory bowel disease. J Crohns Colitis. 2013 Dec;7(11):878-89. doi: 10.1016/j.crohns.2012.09.001. Epub 2012 Sep 25.
- Background: PubMed 25137415van Deen WK, van Oijen MG, Myers KD, Centeno A, Howard W, Choi JM, Roth BE, McLaughlin EM, Hollander D, Wong-Swanson B, Sack J, Ong MK, Ha CY, Esrailian E, Hommes DW. A nationwide 2010-2012 analysis of U.S. health care utilization in inflammatory bowel diseases. Inflamm Bowel Dis. 2014 Oct;20(10):1747-53. doi: 10.1097/MIB.0000000000000139.
- Background: PubMed 22751454Cleynen I, Vermeire S. Paradoxical inflammation induced by anti-TNF agents in patients with IBD. Nat Rev Gastroenterol Hepatol. 2012 Sep;9(9):496-503. doi: 10.1038/nrgastro.2012.125. Epub 2012 Jul 3.
- Background: PubMed 23777821Fiorino G, Danese S, Pariente B, Allez M. Paradoxical immune-mediated inflammation in inflammatory bowel disease patients receiving anti-TNF-alpha agents. Autoimmun Rev. 2014 Jan;13(1):15-9. doi: 10.1016/j.autrev.2013.06.005. Epub 2013 Jun 15.
- Background: PubMed 20728573Rahier JF, Buche S, Peyrin-Biroulet L, Bouhnik Y, Duclos B, Louis E, Papay P, Allez M, Cosnes J, Cortot A, Laharie D, Reimund JM, Lemann M, Delaporte E, Colombel JF; Groupe d'Etude Therapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Severe skin lesions cause patients with inflammatory bowel disease to discontinue anti-tumor necrosis factor therapy. Clin Gastroenterol Hepatol. 2010 Dec;8(12):1048-55. doi: 10.1016/j.cgh.2010.07.022. Epub 2010 Aug 20.
- Background: PubMed 24268978Afzali A, Wheat CL, Hu JK, Olerud JE, Lee SD. The association of psoriasiform rash with anti-tumor necrosis factor (anti-TNF) therapy in inflammatory bowel disease: a single academic center case series. J Crohns Colitis. 2014 Jun;8(6):480-8. doi: 10.1016/j.crohns.2013.10.013. Epub 2013 Nov 21.
- Background: PubMed 21351201Baumgart DC, Grittner U, Steingraber A, Azzaro M, Philipp S. Frequency, phenotype, outcome, and therapeutic impact of skin reactions following initiation of adalimumab therapy: experience from a consecutive cohort of inflammatory bowel disease patients. Inflamm Bowel Dis. 2011 Dec;17(12):2512-20. doi: 10.1002/ibd.21643. Epub 2011 Feb 23.
- Background: PubMed 21957906Cullen G, Kroshinsky D, Cheifetz AS, Korzenik JR. Psoriasis associated with anti-tumour necrosis factor therapy in inflammatory bowel disease: a new series and a review of 120 cases from the literature. Aliment Pharmacol Ther. 2011 Dec;34(11-12):1318-27. doi: 10.1111/j.1365-2036.2011.04866.x. Epub 2011 Sep 29.
- Background: PubMed 22960136Denadai R, Teixeira FV, Steinwurz F, Romiti R, Saad-Hossne R. Induction or exacerbation of psoriatic lesions during anti-TNF-alpha therapy for inflammatory bowel disease: a systematic literature review based on 222 cases. J Crohns Colitis. 2013 Aug;7(7):517-24. doi: 10.1016/j.crohns.2012.08.007. Epub 2012 Sep 7.
- Background: PubMed 22398059Guerra I, Algaba A, Perez-Calle JL, Chaparro M, Marin-Jimenez I, Garcia-Castellanos R, Gonzalez-Lama Y, Lopez-Sanroman A, Mancenido N, Martinez-Montiel P, Quintanilla E, Taxonera C, Villafruela M, Romero-Mate A, Lopez-Serrano P, Gisbert JP, Bermejo F. Induction of psoriasis with anti-TNF agents in patients with inflammatory bowel disease: a report of 21 cases. J Crohns Colitis. 2012 Jun;6(5):518-23. doi: 10.1016/j.crohns.2011.10.007. Epub 2011 Nov 13.
- Background: PubMed 23274341Sherlock ME, Walters T, Tabbers MM, Frost K, Zachos M, Muise A, Pope E, Griffiths AM. Infliximab-induced psoriasis and psoriasiform skin lesions in pediatric Crohn disease and a potential association with IL-23 receptor polymorphisms. J Pediatr Gastroenterol Nutr. 2013 May;56(5):512-8. doi: 10.1097/MPG.0b013e31828390ba.
- Background: PubMed 22469155Buisson A, Cuny JF, Barbaud A, Schmutz JL, Bigard MA, Gueant JL, Peyrin-Biroulet L. Methotrexate for psoriasiform lesions associated with anti-tumour necrosis factor therapy in inflammatory bowel disease. Aliment Pharmacol Ther. 2012 May;35(10):1175-80. doi: 10.1111/j.1365-2036.2012.05082.x. Epub 2012 Apr 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Millie D Long, MD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Crohns Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with specific paradoxical Adverse Events Using Biologic therapies as a part of routine care for the treatment of IBD (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02503514, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2017.