Lead Investigator: Dafne Capelusnik, Care and Public Health Research Institute (CAPHRI), Maastricht University
Title of Proposal Research: Assessment of peripheral arthritis and related disease activity measurement instruments in spondyloarthritis
Vivli Data Request: 10200
Funding Source: Funding from Assessment of SpondyloArthritis International Society (ASAS)
Potential Conflicts of Interest: Dr. Molto reports:
• Honoraria: Abbvie, Amgen, Biogen, BMS, Galapagos, Janssen, Lilly, Novartis, Pfizer, UCB, Viatris
• Grants: Biogen, Pfizer, UCB
This research is not being funded by any of the companies.
Dr. Clementina Lopez Medina reports: AbbVie/Abbott
Eli Lilly
Novartis
UCB Pharma
This research is not being funded by any of the companies.
Dr. Sofia Ramiro reports: -Research grants: AbbVie, Galapagos, Novartis, MSD, Pfizer, UCB;
-Consultancy fees: AbbVie, Eli Lilly, Novartis, MSD, Pfizer, UCB, Sanofi
We will not be assessing the effect of the specific drugs, but the sensitivity to change of the spinal mobility measures. In that sense potential conflicts of interest will not be of influence
When publishing the research findings, the disclosing COIs arising from the study will be presented.
This research is not being funded by any of the companies.
Summary of the Proposed Research:
Spondyloarthritis (SpA) is a chronic disease in which the spine and other areas of the body become inflamed. SpA can present in different physical and clinical forms such as axial SpA (axSpA) which mainly presents as back pain, or peripheral SpA (pSpA) which is characterized by inflammation and pain in joints located outside the spine. The two types can occur together or separately.
A clinician’s instrument called the ASAS-OMERACT core outcome set (The Assessment of Spondylarthritis international Society-Outcomes Measures in Rheumatology core outcome set (COS)) has recently been updated to allow it to be used to assess axSpA, however for pSpA the 44-swollen joint count (SJC44), which looks at 44 joints in the body to assess swelling, was chosen as the preferred instrument recommended for use in clinical trials, but no combination of scoring systems (composite scores – tools that combine several different measures or tests into one overall score) were assessed in that project.
Although scarce, there is some evidence of the good performance of composite scores when assessing disease activity in the pSpA population. For example, in a study addressing the sensitivity to change and discriminatory aspects of different measurement instruments (capacity to discriminate between different groups and scenarios), the combination of Axial Spondyloarthritis Disease Activity (ASDAS), Bath Ankylosing Spondylitis Disease Index (BASDAI), patient global assessment (PGA), and physician global assessment (PhGA) had the highest performance, whereas the SJC, tender joint count (TJC) and C-reactive protein (CRP) performance was not good enough. In another attempt at assessing the validity of measurement instruments in pSpA, good performance was found for the Disease Activity Index for Psoriatic Arthritis (DAPSA), Psoriatic Arthritis (PsA) Disease Activity Score (PASDAS) and Ankylosing spondylitis disease activity score (ASDAS), although the agreement among the three instruments when classifying disease activity states was not sufficient. This finding emphasized the need of further analysis of the existing thresholds (the established cut-off values used to categorize a score into different disease activity states) of those instruments in pSpA.
Recently, a study was conducted, called ASAS-perSpA, which included patients with axSpA, pSpA and PsA, and the validity of several measurement instruments was assessed, including the SJC, but also different composite scores validated for SpA and even in other inflammatory diseases such as the Disease Activity Score (DAS) 28 and 44. Results from this analysis showed that composite scores including joint counts have superior construct (is better at measuring what it is intended to measure) by discriminating better between active/inactive patients. Simultaneously, the psychometric properties of 9 measurement instruments were assessed in the CRESPA trial. In this study, conducted in patients with pSpA, both the ASDAS and DAPSA showed good validity and clinical trial discrimination, with DAPSA exhibiting numerically better results.
The aim of this study is to compare the construct validity (the degree to which an outcome measure measures the construct it purports to measure) and discrimination of different measurement instruments to assess disease activity due to peripheral arthritis in patients with spondyloarthritis (either axSpA or pSpA), with the aim of selecting the most adequate and best performing measurement instrument to be endorsed by Assessment of SpondyloArthritis International Society (ASAS).
Requested Studies:
A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Peripheral Spondyloarthritis
Data Contributor: AbbVie
Study ID: NCT01064856
Sponsor ID: M10-883
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis
Data Contributor: AbbVie
Study ID: NCT03178487
Sponsor ID: M16-098
A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Effect of Golimumab Administered Subcutaneously in Subjects With Active Axial Spondyloarthritis (Protocol No. P07642, Also Known as MK-8259-006-02).
Data Contributor: Johnson & Johnson
Study ID: NCT01453725
Sponsor ID: P07642
A Randomized, Double-blind Trial of the Efficacy of REMICADE (Infliximab) Compared With Placebo in Subjects With Ankylosing Spondylitis Receiving Standard Anti-inflammatory Drug Therapy
Data Contributor: Johnson & Johnson
Study ID: NCT00207701
Sponsor ID: CR004792
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalpha MonoclonalAntibody, Administered Subcutaneously, in Subjects With Active Ankylosing Spondylitis
Data Contributor: Johnson & Johnson
Study ID: NCT00265083
Sponsor ID: CR006337
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFα Monoclonal Antibody, Administered Intravenously, in Subjects With Active Ankylosing Spondylitis
Data Contributor: Johnson & Johnson
Study ID: NCT02186873
Sponsor ID: CR103795
A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD-Naive Patients With Radiographic Axial Spondyloarthritis
Data Contributor: Lilly
Study ID: NCT02696785
Sponsor ID: 16178
A Multicenter, Randomized, Double-Blind, Placebo- Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in TNFi-Experienced Patients With Radiographic Axial Spondyloarthritis
Data Contributor: Lilly
Study ID: NCT02696798
Sponsor ID: 16179
A 52-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD Naive Patients With Nonradiographic Axial Spondyloarthritis
Data Contributor: Lilly
Study ID: NCT02757352
Sponsor ID: 16180
A Multicentre, 12 Week Double Blind Placebo Controlled Randomized Study Of Etanercept On A Background Nsaid In The Treatment Of Adult Subjects With Non Radiographic Axial Spondyloarthritis With A 92 Week Open Label Extension
Data Contributor: Pfizer Inc.
Study ID: NCT01258738
Sponsor ID: B1801031
A Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing Spondylitis
Data Contributor: Pfizer Inc.
Study ID: NCT00247962
Sponsor ID: 0881A3-402
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)
Data Contributor: Pfizer Inc.
Study ID: NCT03502616
Sponsor ID: NCT03502616
Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis (axSpA) Without X-Ray Evidence of Ankylosing Spondylitis (AS) and Objective Signs of Inflammation
Data Contributor: UCB
Study ID: NCT02552212
Sponsor ID: AS0006
Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis
Data Contributor: UCB
Study ID: NCT01087762
Sponsor ID: AS001