Arthritis, RheumatoidNCT04731831
Characterization of Immunogenicity of TNF Inhibitors in Arthritis Patients With Poorer Treatment Response.
An observational study of Arthritis, Rheumatoid and Arthritis, Psoriatic, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
The aim of the study is to explore whether the influence of gender, tobacco smoking and obesity on treatment response in tumor necrosis factor inhibitors (TNFIs) can be explained by high degree of inflammation, human leucocyte antigen (HLA) type, autoantibodies, TNF and TNFI concentration and presence of ADA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondylitis, Ankylosing
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2020to 30 Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients at department of Rheumatology in Aalborg Universityhospital, Denmark. Other sites in Jutland, Denmark may be inkluded later.
Who may be able to join
- Patients > 18 years
- Diagnosed with RA, PsA or AS.
- Starting treatment with infliximab or adalimumab.
- Co- treatment with csDMARD or glucocorticoid is acceptable.
- No new bDMARD is initiated at the time of sampling.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of rheumatology
Aalborg, 8000
About this study
Official title: Characterization of Immunogenicity of Tumor Necrosis Factor Inhibitors in Arthritis Patients With Poorer Treatment Response Due to Gender, Obesity and Smoking Status.
The aim of the study is to explore whether the influence of gender, tobacco smoking and obesity on treatment response in tumor necrosis factor inhibitors (TNFIs) can be explained by high degree of inflammation, human leucocyte antigen (HLA) type, autoantibodies, TNF and TNFI concentration and presence of ADA.
Read the detailed description
Tumor necrosis factor inhibitors (TNFIs) have been uses with success since 1999 in Denmark in treatment of various inflammatory diseases, eg. rheumatoid arthritis (RA), Chrohn's disease, psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS).
TNFIs block a central cytokine in the inflammatory process, tumor necrosis factor (TNF).
Because the drugs are large proteins, they are prone to trigger an immune response and elicit anti-drug antibodies(ADA).
Epidemiologic studies have revealed that groups of patients (women, tobacco smokers, obese patients) with inflammatory rheumatic diseases have a lower response to TNFIs. The reasons for this are not fully elucidated. The hypothesis is that immunogenicity and changed pharmacokinetic of TNFI are causes of the inferior response.
The investigators will carry out a prospective clinical studies of 120 arthritis patients (RA, PsA and AS) initiating treatment with adalimumab or infliximab. The patients will be followed for 12 months and will be registered in DANBIO as normal praxis. Blood samples will be collected at baseline, 2, 4 and 12 months or at termination of the treatment.
Genotypes, autoantibodies, inflammation markers, TNFI and ADA will be measured.
The aim of the study is to explore:
A: If differences between men and women with respect to different markers of inflammation, human leucocyte antigen (HLA), autoantibodies, TNFI concentration and presence of ADAs can explain the lower response and adherence to the treatment among women.
B: If differences between smokers and non-smokers with respect to different markers of inflammation, HLA, autoantibodies, TNFI concentration and presence of ADAs can explain the lower response and adherence to the treatment among patients with arthritis who smoke tobacco.
C: If differences between obese and normal weight patients with respect to different markers of inflammation, HLA, autoantibodies, TNFI concentration and presence of ADAs can explain the lower response and adherence to the treatment.
The study will contribute with new knowledge, which hopefully can make the treatment more personalized and efficient.
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient with arthritis starting infliximab or adalimumab | Patients with Rheumatoid Artritis, Psoriatic Arthritis, Anchylosing Spondylitis starting treament with infliximab or adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response
Changes in disease activity score according to the diagnose. A reduction in the disease activity score indicates a good treatment response.
- Disease Activity Score 28 joints with C-reactive protein (DAS28-CRP)
- Disease Activity in Psoriasis Arthritis (DAPSA)
- Ankylosing Spondylitis Activity Score (ASDAS)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
- Bath Ankylosin Spondylitis Functional Index (BASFI)
Measured: 12 months
Secondary outcomes (5)
Immunogenesity
Antibodies directed against infliximab or adalimumab. Concentration of anti-drug-antibodies
Measured: 12 months
Drug koncentration
Plasma koncentration of infliximab or adalimumab
Measured: 12 months
Concentration of markers of inflammation
C-reactive protein (CRP), IL1, .
Measured: 12 months
Concentration of autoantibodies
ANA, ACPA, IgM-RF
Measured: Day 1
HLA-type
Genomic determination of Human Leucocyte antigens
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start1 Aug 2020
- Primary completion1 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Buch Lauridsen, Aalborg University Hospital
- Investigators
- Lene Dreyer, MD, Prof., Principal investigator, Department of Clinical Medicine, Aalborg University and Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731831
- Sponsor's protocol ID
- N-20200063
- Status last verified
- Jun 2024
- First submitted
- 19 Dec 2020
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tracey D, Klareskog L, Sasso EH, Salfeld JG, Tak PP. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol Ther. 2008 Feb;117(2):244-79. doi: 10.1016/j.pharmthera.2007.10.001. Epub 2007 Oct 26.
PubMed 18155297Elliott MJ, Maini RN, Feldmann M, Kalden JR, Antoni C, Smolen JS, Leeb B, Breedveld FC, Macfarlane JD, Bijl H, et al. Randomised double-blind comparison of chimeric monoclonal antibody to tumour necrosis factor alpha (cA2) versus placebo in rheumatoid arthritis. Lancet. 1994 Oct 22;344(8930):1105-10. doi: 10.1016/s0140-6736(94)90628-9.
PubMed 7934491Steenholdt C, Bendtzen K, Brynskov J, Ainsworth MA. Optimizing Treatment with TNF Inhibitors in Inflammatory Bowel Disease by Monitoring Drug Levels and Antidrug Antibodies. Inflamm Bowel Dis. 2016 Aug;22(8):1999-2015. doi: 10.1097/MIB.0000000000000772.
PubMed 27135483van Schie KA, Hart MH, de Groot ER, Kruithof S, Aarden LA, Wolbink GJ, Rispens T. The antibody response against human and chimeric anti-TNF therapeutic antibodies primarily targets the TNF binding region. Ann Rheum Dis. 2015 Jan;74(1):311-4. doi: 10.1136/annrheumdis-2014-206237. Epub 2014 Oct 23.
PubMed 25342759Kalden JR, Schulze-Koops H. Immunogenicity and loss of response to TNF inhibitors: implications for rheumatoid arthritis treatment. Nat Rev Rheumatol. 2017 Nov 21;13(12):707-718. doi: 10.1038/nrrheum.2017.187.
PubMed 29158574Meroni PL, Valentini G, Ayala F, Cattaneo A, Valesini G. New strategies to address the pharmacodynamics and pharmacokinetics of tumor necrosis factor (TNF) inhibitors: A systematic analysis. Autoimmun Rev. 2015 Sep;14(9):812-29. doi: 10.1016/j.autrev.2015.05.001. Epub 2015 May 15.
PubMed 25985765Mould DR. The Pharmacokinetics of Biologics: A Primer. Dig Dis. 2015;33 Suppl 1:61-69. doi: 10.1159/000437077. Epub 2015 Sep 14.
PubMed 26367860Zandman-Goddard G, Peeva E, Shoenfeld Y. Gender and autoimmunity. Autoimmun Rev. 2007 Jun;6(6):366-72. doi: 10.1016/j.autrev.2006.10.001. Epub 2006 Nov 13.
PubMed 17537382Hojgaard P, Ballegaard C, Cordtz R, Zobbe K, Clausen M, Glintborg B, Kristensen LE, Dreyer L. Gender differences in biologic treatment outcomes-a study of 1750 patients with psoriatic arthritis using Danish Health Care Registers. Rheumatology (Oxford). 2018 Sep 1;57(9):1651-1660. doi: 10.1093/rheumatology/key140.
PubMed 29893926Chimenti MS, Triggianese P, Conigliaro P, Tonelli M, Gigliucci G, Novelli L, Teoli M, Perricone R. A 2-year observational study on treatment targets in psoriatic arthritis patients treated with TNF inhibitors. Clin Rheumatol. 2017 Oct;36(10):2253-2260. doi: 10.1007/s10067-017-3769-4. Epub 2017 Jul 31.
PubMed 28762060Kennedy NA, Heap GA, Green HD, Hamilton B, Bewshea C, Walker GJ, Thomas A, Nice R, Perry MH, Bouri S, Chanchlani N, Heerasing NM, Hendy P, Lin S, Gaya DR, Cummings JRF, Selinger CP, Lees CW, Hart AL, Parkes M, Sebastian S, Mansfield JC, Irving PM, Lindsay J, Russell RK, McDonald TJ, McGovern D, Goodhand JR, Ahmad T; UK Inflammatory Bowel Disease Pharmacogenetics Study Group. Predictors of anti-TNF treatment failure in anti-TNF-naive patients with active luminal Crohn's disease: a prospective, multicentre, cohort study. Lancet Gastroenterol Hepatol. 2019 May;4(5):341-353. doi: 10.1016/S2468-1253(19)30012-3. Epub 2019 Feb 27.
PubMed 30824404Gladman DD, Antoni C, Mease P, Clegg DO, Nash P. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005 Mar;64 Suppl 2(Suppl 2):ii14-7. doi: 10.1136/ard.2004.032482.
PubMed 15708927Egeberg A, Kristensen LE, Thyssen JP, Gislason GH, Gottlieb AB, Coates LC, Jullien D, Gisondi P, Gladman DD, Skov L, Mallbris L. Incidence and prevalence of psoriatic arthritis in Denmark: a nationwide register linkage study. Ann Rheum Dis. 2017 Sep;76(9):1591-1597. doi: 10.1136/annrheumdis-2016-210963. Epub 2017 May 8.
PubMed 28483767Kvien TK, Uhlig T, Odegard S, Heiberg MS. Epidemiological aspects of rheumatoid arthritis: the sex ratio. Ann N Y Acad Sci. 2006 Jun;1069:212-22. doi: 10.1196/annals.1351.019.
PubMed 16855148Rifbjerg-Madsen S, Christensen AW, Christensen R, Hetland ML, Bliddal H, Kristensen LE, Danneskiold-Samsoe B, Amris K. Pain and pain mechanisms in patients with inflammatory arthritis: A Danish nationwide cross-sectional DANBIO registry survey. PLoS One. 2017 Jul 7;12(7):e0180014. doi: 10.1371/journal.pone.0180014. eCollection 2017.
PubMed 28686639
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Immunogenicity of Tumor Necrosis Factor Inhibitors in Arthritis Patients With Poorer Treatment Response Due to Gender, Obesity and Smoking Status.
- ClinicalTrials.gov ID
- NCT04731831
- Acronym / sponsor ID
- N-20200063
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 1 Feb 2021 (actual)
- 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.
The aim of the study is to explore whether the influence of gender, tobacco smoking and obesity on treatment response in tumor necrosis factor inhibitors (TNFIs) can be explained by high degree of inflammation, human leucocyte antigen (HLA) type, autoantibodies, TNF and TNFI concentration and presence of ADA.
Detailed description
Tumor necrosis factor inhibitors (TNFIs) have been uses with success since 1999 in Denmark in treatment of various inflammatory diseases, eg. rheumatoid arthritis (RA), Chrohn's disease, psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS).
TNFIs block a central cytokine in the inflammatory process, tumor necrosis factor (TNF).
Because the drugs are large proteins, they are prone to trigger an immune response and elicit anti-drug antibodies(ADA).
Epidemiologic studies have revealed that groups of patients (women, tobacco smokers, obese patients) with inflammatory rheumatic diseases have a lower response to TNFIs. The reasons for this are not fully elucidated. The hypothesis is that immunogenicity and changed pharmacokinetic of TNFI are causes of the inferior response.
The investigators will carry out a prospective clinical studies of 120 arthritis patients (RA, PsA and AS) initiating treatment with adalimumab or infliximab. The patients will be followed for 12 months and will be registered in DANBIO as normal praxis. Blood samples will be collected at baseline, 2, 4 and 12 months or at termination of the treatment.
Genotypes, autoantibodies, inflammation markers, TNFI and ADA will be measured.
The aim of the study is to explore:
A: If differences between men and women with respect to different markers of inflammation, human leucocyte antigen (HLA), autoantibodies, TNFI concentration and presence of ADAs can explain the lower response and adherence to the treatment among women.
B: If differences between smokers and non-smokers with respect to different markers of inflammation, HLA, autoantibodies, TNFI concentration and presence of ADAs can explain the lower response and adherence to the treatment among patients with arthritis who smoke tobacco.
C: If differences between obese and normal weight patients with respect to different markers of inflammation, HLA, autoantibodies, TNFI concentration and presence of ADAs can explain the lower response and adherence to the treatment.
The study will contribute with new knowledge, which hopefully can make the treatment more personalized and efficient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with arthritis starting infliximab or adalimumab | – | –Patients with Rheumatoid Artritis, Psoriatic Arthritis, Anchylosing Spondylitis starting treament with infliximab or adalimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at department of Rheumatology in Aalborg Universityhospital, Denmark. Other sites in Jutland, Denmark may be inkluded later.
Key inclusion criteria (5 listed)
- Patients > 18 years
- Diagnosed with RA, PsA or AS.
- Starting treatment with infliximab or adalimumab.
- Co- treatment with csDMARD or glucocorticoid is acceptable.
- No new bDMARD is initiated at the time of sampling.
Key exclusion criteria (1 listed)
- -
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
Treatment response
Time frame: 12 months
Changes in disease activity score according to the diagnose. A reduction in the disease activity score indicates a good treatment response. * Disease Activity Score 28 joints with C-reactive protein (DAS28-CRP) * Disease Activity in Psoriasis Arthritis (DAPSA) * Ankylosing Spondylitis Activity Score (ASDAS) * Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) * Bath Ankylosin Spondylitis Functional Index (BASFI)
5 secondary outcomes
Immunogenesity
Time frame: 12 months
Drug koncentration
Time frame: 12 months
Concentration of markers of inflammation
Time frame: 12 months
Concentration of autoantibodies
Time frame: Day 1
HLA-type
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Background: PubMed 18155297Tracey D, Klareskog L, Sasso EH, Salfeld JG, Tak PP. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol Ther. 2008 Feb;117(2):244-79. doi: 10.1016/j.pharmthera.2007.10.001. Epub 2007 Oct 26.
- Background: PubMed 7934491Elliott MJ, Maini RN, Feldmann M, Kalden JR, Antoni C, Smolen JS, Leeb B, Breedveld FC, Macfarlane JD, Bijl H, et al. Randomised double-blind comparison of chimeric monoclonal antibody to tumour necrosis factor alpha (cA2) versus placebo in rheumatoid arthritis. Lancet. 1994 Oct 22;344(8930):1105-10. doi: 10.1016/s0140-6736(94)90628-9.
- Background: PubMed 27135483Steenholdt C, Bendtzen K, Brynskov J, Ainsworth MA. Optimizing Treatment with TNF Inhibitors in Inflammatory Bowel Disease by Monitoring Drug Levels and Antidrug Antibodies. Inflamm Bowel Dis. 2016 Aug;22(8):1999-2015. doi: 10.1097/MIB.0000000000000772.
- Background: PubMed 25342759van Schie KA, Hart MH, de Groot ER, Kruithof S, Aarden LA, Wolbink GJ, Rispens T. The antibody response against human and chimeric anti-TNF therapeutic antibodies primarily targets the TNF binding region. Ann Rheum Dis. 2015 Jan;74(1):311-4. doi: 10.1136/annrheumdis-2014-206237. Epub 2014 Oct 23.
- Background: PubMed 29158574Kalden JR, Schulze-Koops H. Immunogenicity and loss of response to TNF inhibitors: implications for rheumatoid arthritis treatment. Nat Rev Rheumatol. 2017 Nov 21;13(12):707-718. doi: 10.1038/nrrheum.2017.187.
- Background: PubMed 25985765Meroni PL, Valentini G, Ayala F, Cattaneo A, Valesini G. New strategies to address the pharmacodynamics and pharmacokinetics of tumor necrosis factor (TNF) inhibitors: A systematic analysis. Autoimmun Rev. 2015 Sep;14(9):812-29. doi: 10.1016/j.autrev.2015.05.001. Epub 2015 May 15.
- Background: PubMed 26367860Mould DR. The Pharmacokinetics of Biologics: A Primer. Dig Dis. 2015;33 Suppl 1:61-69. doi: 10.1159/000437077. Epub 2015 Sep 14.
- Background: PubMed 17537382Zandman-Goddard G, Peeva E, Shoenfeld Y. Gender and autoimmunity. Autoimmun Rev. 2007 Jun;6(6):366-72. doi: 10.1016/j.autrev.2006.10.001. Epub 2006 Nov 13.
- Background: PubMed 29893926Hojgaard P, Ballegaard C, Cordtz R, Zobbe K, Clausen M, Glintborg B, Kristensen LE, Dreyer L. Gender differences in biologic treatment outcomes-a study of 1750 patients with psoriatic arthritis using Danish Health Care Registers. Rheumatology (Oxford). 2018 Sep 1;57(9):1651-1660. doi: 10.1093/rheumatology/key140.
- Background: PubMed 28762060Chimenti MS, Triggianese P, Conigliaro P, Tonelli M, Gigliucci G, Novelli L, Teoli M, Perricone R. A 2-year observational study on treatment targets in psoriatic arthritis patients treated with TNF inhibitors. Clin Rheumatol. 2017 Oct;36(10):2253-2260. doi: 10.1007/s10067-017-3769-4. Epub 2017 Jul 31.
- Background: PubMed 30824404Kennedy NA, Heap GA, Green HD, Hamilton B, Bewshea C, Walker GJ, Thomas A, Nice R, Perry MH, Bouri S, Chanchlani N, Heerasing NM, Hendy P, Lin S, Gaya DR, Cummings JRF, Selinger CP, Lees CW, Hart AL, Parkes M, Sebastian S, Mansfield JC, Irving PM, Lindsay J, Russell RK, McDonald TJ, McGovern D, Goodhand JR, Ahmad T; UK Inflammatory Bowel Disease Pharmacogenetics Study Group. Predictors of anti-TNF treatment failure in anti-TNF-naive patients with active luminal Crohn's disease: a prospective, multicentre, cohort study. Lancet Gastroenterol Hepatol. 2019 May;4(5):341-353. doi: 10.1016/S2468-1253(19)30012-3. Epub 2019 Feb 27.
- Background: PubMed 15708927Gladman DD, Antoni C, Mease P, Clegg DO, Nash P. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005 Mar;64 Suppl 2(Suppl 2):ii14-7. doi: 10.1136/ard.2004.032482.
- Individual participant dataSharing planned: No
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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.
Lene Dreyer, MD, Prof. principal investigator
Department of Clinical Medicine, Aalborg University and Aalborg University Hospital
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 Arthritis, Rheumatoid and Arthritis, Psoriatic, run by Aalborg University Hospital at 1 site in Denmark.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Jun 2024. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen B Lauridsen, MD (0045 097665595, kabula@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response (time frame: 12 months). 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 NCT04731831, which also lists 29 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 28 Jun 2024.