- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04399382
A Clinical Study to Evaluate the Efficacy of Biologics in SpA
June 1, 2022 updated by: The University of Hong Kong-Shenzhen Hospital
A Clinical Study Using Damage-associated Molecular Pattern and Apparent Diffusion Coefficient to Evaluate the Efficacy of Biologics for Treating Spondyloarthritis
Spondyloarthritis (SpA) is one of the potentially debilitating inflammatory diseases that affect the whole body, primarily burdening the sacroiliac joints and the spine.
It mostly affects young and middle aged adults.
SpA can be classified to non-radiographic axial SpA (nr-axSpA) and radiographic axSpA (r-axSpA).
The latter is ankylosing spondylitis (AS).
The key to its early treatment is the radiological detection and management of sacroiliitis.
To date, biologics is the most powerful anti-inflammatory drug.
Recent research has shown that diffusion-weighted imaging (DWI) outperforms the sequence recommended by the Guidelines in diagnosing inflammation and assessing disease activity.
Preliminary research conducted by our team has also demonstrated that apparent diffusion coefficient (ADC) is a valuable imaging biomarker.
However, to date, no serum maker of comparable effectiveness has been identified.
Damage-Associated Molecular Pattern (DAMP), including S100A8 and S100A9, high mobility group protein B1 (HMGB1) and Tenascin-C (TNC), may play a role in inflammation by regulating the TLR4/MyD88/NF-κB signaling pathways.
The present study will enroll 20 patients with nr-axSpA and 20 patients with AS.
It will utilize serum DAMP and ADC to assess disease activity before and after treatment as well as the change in and correlations of treatment outcomes, in order to identify objective and quantifiable serum and imaging markers that are beneficial in clinical applications.
ADC is the primary outcome.
The main hypothesis is that disease activity as measured by ADC will be reduced after 1 year of treatment from baseline as compared to before treatment at baseline.
Study findings will indicate the utility of ADC as an objective indicator of disease activity for guiding therapeutic approaches and improving dosage adjustment in clinical applications.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jinxian Huang
- Phone Number: +86-18307555163
- Email: huangjx@hku-szh.org
Study Locations
-
-
Guangdong
-
Shenzhen, Guangdong, China, 518000
- Recruiting
- Jin-Xian
-
Contact:
- Jin-Xian Huang
- Phone Number: +8618307555163
- Email: huangjx@hku-szh.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with axial SpA who attend the rheumatology clinic of The University of Hong Kong-Shenzhen Hospital will be screened consecutively by the PI, her trained nurses, and/or research assistants for eligibility.
Eligible patients will be recruited to participate in the study.
Description
Inclusion Criteria:
- Diagnosed with non-radiographic or radiographic axial SpA
Exclusion Criteria:
- Unable to provide written consent
- Unable to undergo MRI examination
- Pregnancy
- Unable to read and/or write Chinese
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Non-radiographic group
Participants with non-radiographic axial SpA
|
The exposure of interest in this observational study is the biological therapy of Tumor Necrosis Factor (TNF) inhibitor, specifically etanercept biosmilar/ infliximab/ adalimumab/ golimumab.
|
Radiographic group
Participants with radiographic axial SpA (a.k.a.
ankylosing spondylitis)
|
The exposure of interest in this observational study is the biological therapy of Tumor Necrosis Factor (TNF) inhibitor, specifically etanercept biosmilar/ infliximab/ adalimumab/ golimumab.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Apparent Diffusion Coefficient
Time Frame: 1 year
|
Apparent Diffusion Coefficient (ADC)
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lecouvet FE, Vander Maren N, Collette L, Michoux N, Triqueneaux P, Stoenoiu M, Houssiau F, Malghem J, Denis ML, Larbi A, Nzeusseu Toukap A. Whole body MRI in spondyloarthritis (SpA): Preliminary results suggest that DWI outperforms STIR for lesion detection. Eur Radiol. 2018 Oct;28(10):4163-4173. doi: 10.1007/s00330-018-5377-3. Epub 2018 Apr 17.
- Wang F, Chu C, Zhu L, Zhao C, Wei Y, Chen W, He J, Sun L, Zhou Z. Whole-lesion ADC histogram analysis and the spondyloarthritis research consortium of canada (SPARCC) MRI index in evaluating the disease activity of ankylosing spondylitis. J Magn Reson Imaging. 2019 Jul;50(1):114-126. doi: 10.1002/jmri.26568. Epub 2018 Dec 16.
- Bradbury LA, Hollis KA, Gautier B, Shankaranarayana S, Robinson PC, Saad N, Le Cao KA, Brown MA. Diffusion-weighted Imaging Is a Sensitive and Specific Magnetic Resonance Sequence in the Diagnosis of Ankylosing Spondylitis. J Rheumatol. 2018 Jun;45(6):771-778. doi: 10.3899/jrheum.170312. Epub 2018 Feb 15.
- Chung HY, Xu X, Lau VW, Ho G, Lee KL, Li PH, Tsang HH, Kwok SK, Lau CS, Wong CS. Comparing diffusion weighted imaging with clinical and blood parameters, and with short tau inversion recovery sequence in detecting spinal and sacroiliac joint inflammation in axial spondyloarthritis. Clin Exp Rheumatol. 2017 Mar-Apr;35(2):262-269. Epub 2016 Nov 13.
- Chan CWS, Tsang HHL, Li PH, Lee KH, Lau CS, Wong PYS, Chung HY. Diffusion-weighted imaging versus short tau inversion recovery sequence: Usefulness in detection of active sacroiliitis and early diagnosis of axial spondyloarthritis. PLoS One. 2018 Aug 7;13(8):e0201040. doi: 10.1371/journal.pone.0201040. eCollection 2018.
- Lee KH, Chung HY, Xu X, Lau VWH, Lau CS. Apparent Diffusion Coefficient as an Imaging Biomarker for Spinal Disease Activity in Axial Spondyloarthritis. Radiology. 2019 Apr;291(1):121-128. doi: 10.1148/radiol.2019180960. Epub 2019 Feb 5.
- Smolen JS, Braun J, Dougados M, Emery P, Fitzgerald O, Helliwell P, Kavanaugh A, Kvien TK, Landewe R, Luger T, Mease P, Olivieri I, Reveille J, Ritchlin C, Rudwaleit M, Schoels M, Sieper J, Wit Md, Baraliakos X, Betteridge N, Burgos-Vargas R, Collantes-Estevez E, Deodhar A, Elewaut D, Gossec L, Jongkees M, Maccarone M, Redlich K, van den Bosch F, Wei JC, Winthrop K, van der Heijde D. Treating spondyloarthritis, including ankylosing spondylitis and psoriatic arthritis, to target: recommendations of an international task force. Ann Rheum Dis. 2014 Jan;73(1):6-16. doi: 10.1136/annrheumdis-2013-203419. Epub 2013 Jun 8.
- Landewe R, Sieper J, Mease P, Inman RD, Lambert RG, Deodhar A, Marzo-Ortega H, Magrey M, Kiltz U, Wang X, Li M, Zhong S, Mostafa NM, Lertratanakul A, Pangan AL, Anderson JK. Efficacy and safety of continuing versus withdrawing adalimumab therapy in maintaining remission in patients with non-radiographic axial spondyloarthritis (ABILITY-3): a multicentre, randomised, double-blind study. Lancet. 2018 Jul 14;392(10142):134-144. doi: 10.1016/S0140-6736(18)31362-X. Epub 2018 Jun 29.
- Gratacos J, Pontes C, Juanola X, Sanz J, Torres F, Avendano C, Vallano A, Calvo G, de Miguel E, Sanmarti R; REDES-TNF investigators. Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis. Arthritis Res Ther. 2019 Jan 8;21(1):11. doi: 10.1186/s13075-018-1772-z.
- Zhao M, Zhang P, Fang L, Luo Z, Gu J, Lin Z. Possible predictors for relapse from etanercept discontinuation in ankylosing spondylitis patients in remission: a three years' following-up study. Clin Rheumatol. 2018 Jan;37(1):87-92. doi: 10.1007/s10067-017-3763-x. Epub 2017 Aug 7.
- Yang R, Liu H, Fan M. A quick decrease of bone marrow edema in sacroiliac joint could be served as a novel marker for dose tapering of etanercept in ankylosing spondylitis patients. Medicine (Baltimore). 2019 Mar;98(11):e14620. doi: 10.1097/MD.0000000000014620.
- Nefla M, Holzinger D, Berenbaum F, Jacques C. The danger from within: alarmins in arthritis. Nat Rev Rheumatol. 2016 Nov;12(11):669-683. doi: 10.1038/nrrheum.2016.162. Epub 2016 Oct 13.
- Dolcino M, Tinazzi E, Pelosi A, Patuzzo G, Moretta F, Lunardi C, Puccetti A. Gene Expression Analysis before and after Treatment with Adalimumab in Patients with Ankylosing Spondylitis Identifies Molecular Pathways Associated with Response to Therapy. Genes (Basel). 2017 Apr 24;8(4):127. doi: 10.3390/genes8040127.
- Almasi S, Aslani S, Poormoghim H, Jamshidi AR, Poursani S, Mahmoudi M. Gene Expression Profiling of Toll-Like Receptor 4 and 5 in Peripheral Blood Mononuclear Cells in Rheumatic Disorders: Ankylosing Spondylitis and Rheumatoid Arthritis. Iran J Allergy Asthma Immunol. 2016 Feb;15(1):87-92.
- De Rycke L, Vandooren B, Kruithof E, De Keyser F, Veys EM, Baeten D. Tumor necrosis factor alpha blockade treatment down-modulates the increased systemic and local expression of Toll-like receptor 2 and Toll-like receptor 4 in spondylarthropathy. Arthritis Rheum. 2005 Jul;52(7):2146-58. doi: 10.1002/art.21155.
- Yang ZX, Liang Y, Zhu Y, Li C, Zhang LZ, Zeng XM, Zhong RQ. Increased expression of Toll-like receptor 4 in peripheral blood leucocytes and serum levels of some cytokines in patients with ankylosing spondylitis. Clin Exp Immunol. 2007 Jul;149(1):48-55. doi: 10.1111/j.1365-2249.2007.03396.x. Epub 2007 Apr 25.
- Kiyeko GW, Hatterer E, Herren S, Di Ceglie I, van Lent PL, Reith W, Kosco-Vilbois M, Ferlin W, Shang L. Spatiotemporal expression of endogenous TLR4 ligands leads to inflammation and bone erosion in mouse collagen-induced arthritis. Eur J Immunol. 2016 Nov;46(11):2629-2638. doi: 10.1002/eji.201646453. Epub 2016 Sep 6.
- Sode J, Bank S, Vogel U, Andersen PS, Sorensen SB, Bojesen AB, Andersen MR, Brandslund I, Dessau RB, Hoffmann HJ, Glintborg B, Hetland ML, Locht H, Heegaard NH, Andersen V. Genetically determined high activities of the TNF-alpha, IL23/IL17, and NFkB pathways were associated with increased risk of ankylosing spondylitis. BMC Med Genet. 2018 Sep 12;19(1):165. doi: 10.1186/s12881-018-0680-z.
- Schelbergen RF, Blom AB, van den Bosch MH, Sloetjes A, Abdollahi-Roodsaz S, Schreurs BW, Mort JS, Vogl T, Roth J, van den Berg WB, van Lent PL. Alarmins S100A8 and S100A9 elicit a catabolic effect in human osteoarthritic chondrocytes that is dependent on Toll-like receptor 4. Arthritis Rheum. 2012 May;64(5):1477-87. doi: 10.1002/art.33495.
- Voller T, Faust A, Roth J, Schafers M, Vogl T, Hermann S. A Non-Peptidic S100A9 Specific Ligand for Optical Imaging of Phagocyte Activity In Vivo. Mol Imaging Biol. 2018 Jun;20(3):407-416. doi: 10.1007/s11307-017-1148-9.
- Turina MC, Sieper J, Yeremenko N, Conrad K, Haibel H, Rudwaleit M, Baeten D, Poddubnyy D. Calprotectin serum level is an independent marker for radiographic spinal progression in axial spondyloarthritis. Ann Rheum Dis. 2014 Sep;73(9):1746-8. doi: 10.1136/annrheumdis-2014-205506. Epub 2014 May 20. No abstract available.
- Hu H, Du F, Zhang S, Zhang W. Serum calprotectin correlates with risk and disease severity of ankylosing spondylitis and its change during first month might predict favorable response to treatment. Mod Rheumatol. 2019 Sep;29(5):836-842. doi: 10.1080/14397595.2018.1519103. Epub 2019 Jan 3.
- Olofsson T, Lindqvist E, Mogard E, Andreasson K, Marsal J, Geijer M, Kristensen LE, Wallman JK. Elevated faecal calprotectin is linked to worse disease status in axial spondyloarthritis: results from the SPARTAKUS cohort. Rheumatology (Oxford). 2019 Jul 1;58(7):1176-1187. doi: 10.1093/rheumatology/key427.
- Gupta L, Bhattacharya S, Agarwal V, Aggarwal A. Elevated levels of serum MRP8/14 in ankylosing spondylitis: associated with peripheral arthritis and active disease. Clin Rheumatol. 2016 Dec;35(12):3075-3079. doi: 10.1007/s10067-016-3448-x. Epub 2016 Oct 13.
- Levitova A, Hulejova H, Spiritovic M, Pavelka K, Senolt L, Husakova M. Clinical improvement and reduction in serum calprotectin levels after an intensive exercise programme for patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis. Arthritis Res Ther. 2016 Nov 25;18(1):275. doi: 10.1186/s13075-016-1180-1.
- Huang J, Yin Z, Song G, Cui S, Jiang J, Zhang L. Discriminating Value of Calprotectin in Disease Activity and Progression of Nonradiographic Axial Spondyloarthritis and Ankylosing Spondylitis. Dis Markers. 2017;2017:7574147. doi: 10.1155/2017/7574147. Epub 2017 May 24.
- Paramarta JE, Turina MC, Noordenbos T, Heijda TF, Blijdorp IC, Yeremenko N, Baeten D. A proof-of-concept study with the tyrosine kinase inhibitor nilotinib in spondyloarthritis. J Transl Med. 2016 Oct 27;14(1):308. doi: 10.1186/s12967-016-1050-2.
- Schelbergen RF, de Munter W, van den Bosch MH, Lafeber FP, Sloetjes A, Vogl T, Roth J, van den Berg WB, van der Kraan PM, Blom AB, van Lent PL. Alarmins S100A8/S100A9 aggravate osteophyte formation in experimental osteoarthritis and predict osteophyte progression in early human symptomatic osteoarthritis. Ann Rheum Dis. 2016 Jan;75(1):218-25. doi: 10.1136/annrheumdis-2014-205480. Epub 2014 Sep 1.
- Geven EJ, van den Bosch MH, Di Ceglie I, Ascone G, Abdollahi-Roodsaz S, Sloetjes AW, Hermann S, Schafers M, van de Loo FA, van der Kraan PM, Koenders MI, Foell D, Roth J, Vogl T, van Lent PL. S100A8/A9, a potent serum and molecular imaging biomarker for synovial inflammation and joint destruction in seronegative experimental arthritis. Arthritis Res Ther. 2016 Oct 24;18(1):247. doi: 10.1186/s13075-016-1121-z.
- van Lent PL, Blom AB, Schelbergen RF, Sloetjes A, Lafeber FP, Lems WF, Cats H, Vogl T, Roth J, van den Berg WB. Active involvement of alarmins S100A8 and S100A9 in the regulation of synovial activation and joint destruction during mouse and human osteoarthritis. Arthritis Rheum. 2012 May;64(5):1466-76. doi: 10.1002/art.34315.
- van den Bosch MH, Blom AB, Schelbergen RF, Vogl T, Roth JP, Sloetjes AW, van den Berg WB, van der Kraan PM, van Lent PL. Induction of Canonical Wnt Signaling by the Alarmins S100A8/A9 in Murine Knee Joints: Implications for Osteoarthritis. Arthritis Rheumatol. 2016 Jan;68(1):152-63. doi: 10.1002/art.39420.
- Schelbergen RF, van Dalen S, ter Huurne M, Roth J, Vogl T, Noel D, Jorgensen C, van den Berg WB, van de Loo FA, Blom AB, van Lent PL. Treatment efficacy of adipose-derived stem cells in experimental osteoarthritis is driven by high synovial activation and reflected by S100A8/A9 serum levels. Osteoarthritis Cartilage. 2014 Aug;22(8):1158-66. doi: 10.1016/j.joca.2014.05.022. Epub 2014 Jun 10.
- Koenders MI, Marijnissen RJ, Devesa I, Lubberts E, Joosten LA, Roth J, van Lent PL, van de Loo FA, van den Berg WB. Tumor necrosis factor-interleukin-17 interplay induces S100A8, interleukin-1beta, and matrix metalloproteinases, and drives irreversible cartilage destruction in murine arthritis: rationale for combination treatment during arthritis. Arthritis Rheum. 2011 Aug;63(8):2329-39. doi: 10.1002/art.30418.
- Zhu B, Zhu Q, Li N, Wu T, Liu S, Liu S. Association of serum/plasma high mobility group box 1 with autoimmune diseases: A systematic review and meta-analysis. Medicine (Baltimore). 2018 Jul;97(29):e11531. doi: 10.1097/MD.0000000000011531.
- Chen Y, Sun W, Li S, Ni J, Su Y, Wang C, Luo X, Tu W, Shen G, Gong F, Zheng F, Dong L. Preliminary study of high mobility group box chromosomal protein 1(HMGB1) in ankylosing spondylitis patients. Clin Exp Rheumatol. 2015 Mar-Apr;33(2):187-94. Epub 2015 Jan 20.
- Wang C, Miao Y, Wu X, Huang Y, Sun M, Zhu Y, Zheng F, Sun W, Dong L. Serum HMGB1 Serves as a Novel Laboratory Indicator Reflecting Disease Activity and Treatment Response in Ankylosing Spondylitis Patients. J Immunol Res. 2016;2016:6537248. doi: 10.1155/2016/6537248. Epub 2016 Oct 5.
- Oktayoglu P, Em S, Tahtasiz M, Bozkurt M, Ucar D, Yazmalar L, Nas K, Yardimeden I, Cevik F, Celik Y, Mete N. Elevated serum levels of high mobility group box protein 1 (HMGB1) in patients with ankylosing spondylitis and its association with disease activity and quality of life. Rheumatol Int. 2013 May;33(5):1327-31. doi: 10.1007/s00296-012-2578-y. Epub 2012 Nov 10.
- Hou C, Luan L, Ren C. Oxidized low-density lipoprotein promotes osteoclast differentiation from CD68 positive mononuclear cells by regulating HMGB1 release. Biochem Biophys Res Commun. 2018 Jan 1;495(1):1356-1362. doi: 10.1016/j.bbrc.2017.11.083. Epub 2017 Nov 14.
- Hasegawa M, Yoshida T, Sudo A. Role of tenascin-C in articular cartilage. Mod Rheumatol. 2018 Mar;28(2):215-220. doi: 10.1080/14397595.2017.1349560. Epub 2017 Jul 19.
- Okamura N, Hasegawa M, Nakoshi Y, Iino T, Sudo A, Imanaka-Yoshida K, Yoshida T, Uchida A. Deficiency of tenascin-C delays articular cartilage repair in mice. Osteoarthritis Cartilage. 2010 Jun;18(6):839-48. doi: 10.1016/j.joca.2009.08.013. Epub 2009 Sep 6.
- Matsui Y, Hasegawa M, Iino T, Imanaka-Yoshida K, Yoshida T, Sudo A. Tenascin-C Prevents Articular Cartilage Degeneration in Murine Osteoarthritis Models. Cartilage. 2018 Jan;9(1):80-88. doi: 10.1177/1947603516681134. Epub 2016 Dec 4.
- Gupta L, Bhattacharya S, Aggarwal A. Tenascin-C, a biomarker of disease activity in early ankylosing spondylitis. Clin Rheumatol. 2018 May;37(5):1401-1405. doi: 10.1007/s10067-017-3938-5. Epub 2018 Jan 8.
- Midwood K, Sacre S, Piccinini AM, Inglis J, Trebaul A, Chan E, Drexler S, Sofat N, Kashiwagi M, Orend G, Brennan F, Foxwell B. Tenascin-C is an endogenous activator of Toll-like receptor 4 that is essential for maintaining inflammation in arthritic joint disease. Nat Med. 2009 Jul;15(7):774-80. doi: 10.1038/nm.1987. Epub 2009 Jun 28.
- Sofat N, Robertson SD, Hermansson M, Jones J, Mitchell P, Wait R. Tenascin-C fragments are endogenous inducers of cartilage matrix degradation. Rheumatol Int. 2012 Sep;32(9):2809-17. doi: 10.1007/s00296-011-2067-8. Epub 2011 Aug 27.
- Schwenzer A, Jiang X, Mikuls TR, Payne JB, Sayles HR, Quirke AM, Kessler BM, Fischer R, Venables PJ, Lundberg K, Midwood KS. Identification of an immunodominant peptide from citrullinated tenascin-C as a major target for autoantibodies in rheumatoid arthritis. Ann Rheum Dis. 2016 Oct;75(10):1876-83. doi: 10.1136/annrheumdis-2015-208495. Epub 2015 Dec 9.
- Cutolo M, Soldano S, Paolino S. Potential roles for tenascin in (very) early diagnosis and treatment of rheumatoid arthritis. Ann Rheum Dis. 2020 Apr;79(4):e42. doi: 10.1136/annrheumdis-2019-215063. Epub 2019 Feb 1. No abstract available.
- Maksymowych WP. Biomarkers for Diagnosis of Axial Spondyloarthritis, Disease Activity, Prognosis, and Prediction of Response to Therapy. Front Immunol. 2019 Mar 7;10:305. doi: 10.3389/fimmu.2019.00305. eCollection 2019.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 12, 2022
Primary Completion (Anticipated)
October 1, 2022
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
May 19, 2020
First Submitted That Met QC Criteria
May 19, 2020
First Posted (Actual)
May 22, 2020
Study Record Updates
Last Update Posted (Actual)
June 2, 2022
Last Update Submitted That Met QC Criteria
June 1, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HKUSZH201902013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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