Study Results
Results pending
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Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
40 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-05-18
Study Completion Date
2022-09-30
Brief Summary
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Psoriatic arthritis is related with chronic inflammation and progressive radiographic damages, and it in turn lead to disability and loss in function-ability. Recent advance in treatment pathway through anti IL-17 gives promising clinical improvement. Yet, its effect on radiographic progression remains uncertain. This study aimed to ascertain the effect of secukinumab on structural progression in PsA by evaluation through high resolution peripheral quantative computed tomography (HRpqCT).
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Detailed Description
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Psoriatic arthritis (PsA) is a chronic inflammatory joint disease associated with psoriasis. PsA is associated with distinctive clinical features including changes in skin and nails, peripheral arthritis, axial disease, dactylitis and enthesitis. Synovial inflammation in peripheral joints is the most prevalent feature of the disease ranging in severity from mild joint inflammation to disabling peripheral arthritis \[1\]. Within 2 years of diagnosis, radiological erosions were developed in 47% of the patients \[2\]. Without proper monitoring and treatment, it will lead to significant structure damage and loss of physical function, and even arthritis mutilans, which is the most severe destructive form of PsA \[3\]. Prevention of structural damage is one of the primary goals of treating PsA patients to maximise health-related quality of life \[4\].
Detection of bone erosions in PsA patients is usually achieved by conventional radiographs although the sensitivity is low \[5\]. High-resolution peripheral quantitative CT (HR-pQCT) is a novel technique for detailed bone microstructure analysis with high reproducibility in assessing bony erosions \[6\]. With its high spatial resolution of 130 μm, HR-pQCT exhibited a higher sensitivity in detecting erosion compared with radiograph and magnetic resonance imaging (MRI) \[7\]. Recently, Finzel et al. described an indirect method to assess volume based on measurements of the width and depth of the erosions using HR-pQCT \[8\]. Quantitative measurement of erosion volume can also be achieved \[6\]. Using this method, erosion repair under biological disease-modifying antirheumatic drugs (DMARDs) treatment has been demonstrated in patients with rheumatoid arthritis (RA) \[8, 9\]. Bone apposition at the margin of erosions (osteosclerosis) with the formation of a new cortical lining was associated with a decrease in erosion depth or width, which may indicate either periosteal or endosteal repair processes \[8, 9\]. Valid measurement of erosion volume using HR-pQCT will facilitate the testing of treatments that may help to heal erosion. Decrease in erosion volume and the presence of osteosclerosis on HR-pQCT could be promising markers for erosion healing.
Interleukin 17 (IL-17) is a proinflammatory cytokine which produced by type 17 helper T cells (Th17). It is now considered to be a key cytokine in the pathogenesis of a number of autoimmune disorders in humans including PsA \[10\]. IL-17 was also reported to be associated with the presence of joint erosion \[11\]. Recently, secukinumab, an anti-interleukin-17A monoclonal antibody, was reported to be effective in reducing disease activity and decreased the rate of radiographic joint damage compared with placebo \[12\]. However, whether healing of erosion could occur in PsA has never been evaluated.
On the other hand, osteophytes formation at the entheseal regions of the joints in PsA is distinctive feature compared with RA \[13\]. The formation of osteophytes is tightly regulated by anabolic pathways, which resembles the pathogenesis of new bone formation in ankylosing spondylitis (AS). Tumor necrosis factor (TNF) inhibition was unable to halt the structural progression in AS patients \[14-16\], it also lacked efficacy in stopping the progression of osteophytes in PsA patients \[17\]. Inhibition of IL-17 by secukinumab was effective in the treatment of both AS \[18\] and PsA \[12\]. Secukinumab also decreased the rate of radiographic joint damage regarding to erosion and joint space narrowing \[12\]. However, it is unknown if it has any effect in the progression of osteophytes. In an animal model, although over-expression of IL-17 alone failed to induce entheseal and periosteal bone formation, inhibition of IL-17 leaded to significant reduction of such bone formation in an IL-23 overexpression model \[19\]. Moreover, IL-17A accelerates bone formation by stimulating the proliferation and osteoblastic differentiation of mesenchymal progenitor cells after injury \[20\]. It is worth exploring if secukinumab could prevent the progression of osteophytes in PsA patients.
Detection of bone erosions in PsA patients is usually achieved by conventional radiographs although the sensitivity is low \[5\]. High-resolution peripheral quantitative CT (HR-pQCT) is a novel technique for detailed bone microstructure analysis with high reproducibility in assessing bony erosions \[6\]. With its high spatial resolution of 130 μm, HR-pQCT exhibited a higher sensitivity in detecting erosion compared with radiograph and magnetic resonance imaging (MRI) \[7\]. Recently, Finzel et al. described an indirect method to assess volume based on measurements of the width and depth of the erosions using HR-pQCT \[8\]. Quantitative measurement of erosion volume can also be achieved \[6\]. Using this method, erosion repair under biological disease-modifying antirheumatic drugs (DMARDs) treatment has been demonstrated in patients with rheumatoid arthritis (RA) \[8, 9\]. Bone apposition at the margin of erosions (osteosclerosis) with the formation of a new cortical lining was associated with a decrease in erosion depth or width, which may indicate either periosteal or endosteal repair processes \[8, 9\]. Valid measurement of erosion volume using HR-pQCT will facilitate the testing of treatments that may help to heal erosion. Decrease in erosion volume and the presence of osteosclerosis on HR-pQCT could be promising markers for erosion healing.
Interleukin 17 (IL-17) is a proinflammatory cytokine which produced by type 17 helper T cells (Th17). It is now considered to be a key cytokine in the pathogenesis of a number of autoimmune disorders in humans including PsA \[10\]. IL-17 was also reported to be associated with the presence of joint erosion \[11\]. Recently, secukinumab, an anti-interleukin-17A monoclonal antibody, was reported to be effective in reducing disease activity and decreased the rate of radiographic joint damage compared with placebo \[12\]. However, whether healing of erosion could occur in PsA has never been evaluated.
On the other hand, osteophytes formation at the entheseal regions of the joints in PsA is distinctive feature compared with RA \[13\]. The formation of osteophytes is tightly regulated by anabolic pathways, which resembles the pathogenesis of new bone formation in ankylosing spondylitis (AS). Tumor necrosis factor (TNF) inhibition was unable to halt the structural progression in AS patients \[14-16\], it also lacked efficacy in stopping the progression of osteophytes in PsA patients \[17\]. Inhibition of IL-17 by secukinumab was effective in the treatment of both AS \[18\] and PsA \[12\]. Secukinumab also decreased the rate of radiographic joint damage regarding to erosion and joint space narrowing \[12\]. However, it is unknown if it has any effect in the progression of osteophytes. In an animal model, although over-expression of IL-17 alone failed to induce entheseal and periosteal bone formation, inhibition of IL-17 leaded to significant reduction of such bone formation in an IL-23 overexpression model \[19\]. Moreover, IL-17A accelerates bone formation by stimulating the proliferation and osteoblastic differentiation of mesenchymal progenitor cells after injury \[20\]. It is worth exploring if secukinumab could prevent the progression of osteophytes in PsA patients.
Conditions
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Psoriatic Arthritis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Subject will be randomised into secukinumab or placebo group in 1:1 ratio
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Secukinumab
Subject will received secukinumab 150mg at week 0-4, and once monthly till week 48
Group Type
EXPERIMENTAL
Secukinumab
Intervention Type
DRUG
Subject will take secukinumab once weekly in week 0-4, and once monthly till week 48
Placebo
Subject will received placebo 150mg at week 0-4, and once monthly till week 48
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Subject will take placebo once weekly in week 0-4, and once monthly till week 48
Interventions
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Secukinumab
Subject will take secukinumab once weekly in week 0-4, and once monthly till week 48
Intervention Type
DRUG
Placebo
Subject will take placebo once weekly in week 0-4, and once monthly till week 48
Intervention Type
DRUG
Other Intervention Names
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Cosentyx
Eligibility Criteria
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Inclusion Criteria
1. ≥18 years old;
2. without severe deformity in MCP joints which would influence the longitudinal assessment of HR-pQCT;
3. with active disease, which is defined as three or more than tender joints and three or more than swollen joints, despite previous treatment with nonsteroidal anti-inflammatory drugs, disease-modifying antirheumatic drugs.
2. without severe deformity in MCP joints which would influence the longitudinal assessment of HR-pQCT;
3. with active disease, which is defined as three or more than tender joints and three or more than swollen joints, despite previous treatment with nonsteroidal anti-inflammatory drugs, disease-modifying antirheumatic drugs.
Exclusion Criteria
1. limited in ability to perform usual self-care, vocational, and avocational activities;
2. pregnancy;
3. previous therapy with biologic;
4. the presence of active inflammatory diseases other than PsA;
5. active infection in 2 weeks before randomization or a history of ongoing, chronic, or recurrent infections including tuberculosis;
6. history of hepatitis B \& C;
7. history of malignant disease within the past 5 years (excluding basal cell carcinoma or actinic keratosis, in-situ cervical cancer, or non-invasive malignant colon polyps);
8. contraindications to secukinumab.
2. pregnancy;
3. previous therapy with biologic;
4. the presence of active inflammatory diseases other than PsA;
5. active infection in 2 weeks before randomization or a history of ongoing, chronic, or recurrent infections including tuberculosis;
6. history of hepatitis B \& C;
7. history of malignant disease within the past 5 years (excluding basal cell carcinoma or actinic keratosis, in-situ cervical cancer, or non-invasive malignant colon polyps);
8. contraindications to secukinumab.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Chinese University of Hong Kong
OTHER
Sponsor Role
lead
Responsible Party
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Lai-Shan Tam
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Lai Shan Tam, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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Department of Medicine and Therapeutics
Hong Kong, , Hong Kong
Site Status
Countries
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Hong Kong
References
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Mortezavi M, Thiele R, Ritchlin C. The joint in psoriatic arthritis. Clin Exp Rheumatol. 2015 Sep-Oct;33(5 Suppl 93):S20-5. Epub 2015 Oct 15.
Reference Type
BACKGROUND
Kane D, Stafford L, Bresnihan B, FitzGerald O. A prospective, clinical and radiological study of early psoriatic arthritis: an early synovitis clinic experience. Rheumatology (Oxford). 2003 Dec;42(12):1460-8. doi: 10.1093/rheumatology/keg384. Epub 2003 Oct 1.
Reference Type
BACKGROUND
Acosta Felquer ML, FitzGerald O. Peripheral joint involvement in psoriatic arthritis patients. Clin Exp Rheumatol. 2015 Sep-Oct;33(5 Suppl 93):S26-30. Epub 2015 Oct 15.
Reference Type
BACKGROUND
Gossec L, Smolen JS, Ramiro S, de Wit M, Cutolo M, Dougados M, Emery P, Landewe R, Oliver S, Aletaha D, Betteridge N, Braun J, Burmester G, Canete JD, Damjanov N, FitzGerald O, Haglund E, Helliwell P, Kvien TK, Lories R, Luger T, Maccarone M, Marzo-Ortega H, McGonagle D, McInnes IB, Olivieri I, Pavelka K, Schett G, Sieper J, van den Bosch F, Veale DJ, Wollenhaupt J, Zink A, van der Heijde D. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2016 Mar;75(3):499-510. doi: 10.1136/annrheumdis-2015-208337. Epub 2015 Dec 7.
Reference Type
BACKGROUND
Poggenborg RP, Bird P, Boonen A, Wiell C, Pedersen SJ, Sorensen IJ, Madsen OR, Slot O, Moller JM, Boyesen P, Hasselquist M, Ostergaard M. Pattern of bone erosion and bone proliferation in psoriatic arthritis hands: a high-resolution computed tomography and radiography follow-up study during adalimumab therapy. Scand J Rheumatol. 2014;43(3):202-8. doi: 10.3109/03009742.2013.835865. Epub 2013 Dec 19.
Reference Type
BACKGROUND
Fouque-Aubert A, Boutroy S, Marotte H, Vilayphiou N, Bacchetta J, Miossec P, Delmas PD, Chapurlat RD. Assessment of hand bone loss in rheumatoid arthritis by high-resolution peripheral quantitative CT. Ann Rheum Dis. 2010 Sep;69(9):1671-6. doi: 10.1136/ard.2009.114512. Epub 2010 Jun 4.
Reference Type
BACKGROUND
Srikhum W, Virayavanich W, Burghardt AJ, Yu A, Link TM, Imboden JB, Li X. Quantitative and semiquantitative bone erosion assessment on high-resolution peripheral quantitative computed tomography in rheumatoid arthritis. J Rheumatol. 2013 Apr;40(4):408-16. doi: 10.3899/jrheum.120780. Epub 2013 Feb 15.
Reference Type
BACKGROUND
Finzel S, Rech J, Schmidt S, Engelke K, Englbrecht M, Schett G. Interleukin-6 receptor blockade induces limited repair of bone erosions in rheumatoid arthritis: a micro CT study. Ann Rheum Dis. 2013 Mar;72(3):396-400. doi: 10.1136/annrheumdis-2011-201075. Epub 2012 May 14.
Reference Type
BACKGROUND
Finzel S, Rech J, Schmidt S, Engelke K, Englbrecht M, Stach C, Schett G. Repair of bone erosions in rheumatoid arthritis treated with tumour necrosis factor inhibitors is based on bone apposition at the base of the erosion. Ann Rheum Dis. 2011 Sep;70(9):1587-93. doi: 10.1136/ard.2010.148395. Epub 2011 May 27.
Reference Type
BACKGROUND
Miossec P, Korn T, Kuchroo VK. Interleukin-17 and type 17 helper T cells. N Engl J Med. 2009 Aug 27;361(9):888-98. doi: 10.1056/NEJMra0707449. No abstract available.
Reference Type
BACKGROUND
Menon B, Gullick NJ, Walter GJ, Rajasekhar M, Garrood T, Evans HG, Taams LS, Kirkham BW. Interleukin-17+CD8+ T cells are enriched in the joints of patients with psoriatic arthritis and correlate with disease activity and joint damage progression. Arthritis Rheumatol. 2014 May;66(5):1272-81. doi: 10.1002/art.38376.
Reference Type
BACKGROUND
Mease PJ, McInnes IB, Kirkham B, Kavanaugh A, Rahman P, van der Heijde D, Landewe R, Nash P, Pricop L, Yuan J, Richards HB, Mpofu S; FUTURE 1 Study Group. Secukinumab Inhibition of Interleukin-17A in Patients with Psoriatic Arthritis. N Engl J Med. 2015 Oct;373(14):1329-39. doi: 10.1056/NEJMoa1412679.
Reference Type
BACKGROUND
Finzel S, Englbrecht M, Engelke K, Stach C, Schett G. A comparative study of periarticular bone lesions in rheumatoid arthritis and psoriatic arthritis. Ann Rheum Dis. 2011 Jan;70(1):122-7. doi: 10.1136/ard.2010.132423. Epub 2010 Oct 11.
Reference Type
BACKGROUND
van der Heijde D, Salonen D, Weissman BN, Landewe R, Maksymowych WP, Kupper H, Ballal S, Gibson E, Wong R; Canadian (M03-606) study group; ATLAS study group. Assessment of radiographic progression in the spines of patients with ankylosing spondylitis treated with adalimumab for up to 2 years. Arthritis Res Ther. 2009;11(4):R127. doi: 10.1186/ar2794. Epub 2009 Aug 24.
Reference Type
BACKGROUND
van der Heijde D, Landewe R, Baraliakos X, Houben H, van Tubergen A, Williamson P, Xu W, Baker D, Goldstein N, Braun J; Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy Study Group. Radiographic findings following two years of infliximab therapy in patients with ankylosing spondylitis. Arthritis Rheum. 2008 Oct;58(10):3063-70. doi: 10.1002/art.23901.
Reference Type
BACKGROUND
van der Heijde D, Landewe R, Einstein S, Ory P, Vosse D, Ni L, Lin SL, Tsuji W, Davis JC Jr. Radiographic progression of ankylosing spondylitis after up to two years of treatment with etanercept. Arthritis Rheum. 2008 May;58(5):1324-31. doi: 10.1002/art.23471.
Reference Type
BACKGROUND
Finzel S, Kraus S, Schmidt S, Hueber A, Rech J, Engelke K, Englbrecht M, Schett G. Bone anabolic changes progress in psoriatic arthritis patients despite treatment with methotrexate or tumour necrosis factor inhibitors. Ann Rheum Dis. 2013 Jul;72(7):1176-81. doi: 10.1136/annrheumdis-2012-201580. Epub 2012 Aug 21.
Reference Type
BACKGROUND
Baeten D, Sieper J, Braun J, Baraliakos X, Dougados M, Emery P, Deodhar A, Porter B, Martin R, Andersson M, Mpofu S, Richards HB; MEASURE 1 Study Group; MEASURE 2 Study Group. Secukinumab, an Interleukin-17A Inhibitor, in Ankylosing Spondylitis. N Engl J Med. 2015 Dec 24;373(26):2534-48. doi: 10.1056/NEJMoa1505066.
Reference Type
BACKGROUND
Sherlock JP, Joyce-Shaikh B, Turner SP, Chao CC, Sathe M, Grein J, Gorman DM, Bowman EP, McClanahan TK, Yearley JH, Eberl G, Buckley CD, Kastelein RA, Pierce RH, Laface DM, Cua DJ. IL-23 induces spondyloarthropathy by acting on ROR-gammat+ CD3+CD4-CD8- entheseal resident T cells. Nat Med. 2012 Jul 1;18(7):1069-76. doi: 10.1038/nm.2817.
Reference Type
BACKGROUND
Ono T, Okamoto K, Nakashima T, Nitta T, Hori S, Iwakura Y, Takayanagi H. IL-17-producing gammadelta T cells enhance bone regeneration. Nat Commun. 2016 Mar 11;7:10928. doi: 10.1038/ncomms10928.
Reference Type
BACKGROUND
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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PsA secukinumab XCT study 2018
Identifier Type: -
Identifier Source: org_study_id
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