In this Investigator Initiated study, the investigators want to explore the potential of an induction therapy with Tumor Necrosis Factor (TNF)-blocking agents in a very early disease stage (less than 3 months of symptom duration) of patients with predominant peripheral spondyloarthritis (SpA), classified according to the new Assessment of SpondyloArthritis (ASAS)-criteria. The hypothesis would be that treatment with a TNF-blocker at this early ("immature") stage of the disease would result in a significant higher number of patients in clinical remission compared to placebo, and that - comparable to the early Rheumatoid Arthritis (RA) patients in the BeSt-study - long-term treatment would not be necessary to maintain this remission in a number of patients. In this placebo-controlled, double blind, randomized study (with open-label phase, starting at week 24) sixty patients fulfilling the Assessment of SpondyloArthritis (ASAS) criteria of peripheral spondylarthritis will be enrolled. Patients will be randomized in a 2:1 ratio (2 golimumab :1 placebo). During the placebo-controlled phase, 50mg golimumab, or placebo will be administrated subcutaneously (SC) every 4 weeks through week 20. Subjects will be treated with open-label Golimumab 50 mg SC injections at weeks 24, 28, 32, 36, 40, 44, and 48. If patients are in 'clinical remission' (clinical remission is defined by the absence of arthritis, enthesitis and dactylitis clinically at two major consecutive visits. Visits are planned at week 12, week 24, week 36 and week 48) then the treatment will be stopped. In case of clinical relapse, patients will be treated with open-label golimumab 50 mg SC. Patients in sustained clinical remission will be observed to assess the possibility of maintaining drug-free remission. The study duration will be 48 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Ghent University Hospital
Ghent, Belgium
Clinical remission
The primary endpoint of the study is the induction of clinical remission (complete resolution of synovitis/dactylitis/enthesitis which was present at baseline) and prevention of newly developing peripheral and/or axial spondylarthritis signs). The primary analysis will be a comparison at 24 weeks of the percentage of patients in clinical remission in the group treated with the Tumor Necrosis Factor (TNF)-blocking agent versus placebo.
Time frame: At 24 weeks
The improvement in the tender and swollen joint count
The key secondary endpoint will be the changes in the tender and swollen joint count (76/78 joint count)at 6 months (week 24) in comparison with baseline.
Time frame: At week 24.
The improvement in dactylitis with obtaining a circumference measurement and clinical picture.
The key secondary endpoint will be the changes in dactylitis at 6 months (week 24) in comparison with baseline.
Time frame: At week 24.
The improvement in enthesitis, using the different scoring systems with inclusion of all relevant entheses.
The key secondary endpoint will be the changes in enthesitis at 6 months (week 24) in comparison with baseline.
Time frame: At 24 weeks.
The improvement in global measurements of disease activity.
The improvement in global measurements of disease activity: patient global assessment of disease activity, patient pain assessment (peripheral and axial pain), physician global assessment of disease activity, ...)
Time frame: At 24 weeks.
The exploration of the utility of conventional ankylosing spondylitis measurements such as BASDAI, BASFI, BASMI
The key secundairy endpoints will be changes in global measurements of disease activity and conventional ankylosing spondylitis measurements (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI),Bath Ankylosing Spondylitis Metrology Index (BASMI)) at 6 months (week 24) in comparison with baseline.
Time frame: At week 24.
The exploration of the safety of (Tumor Necrosis Factor)TNF-α blockade in patients with early peripheral spondyloarthritis.
The improvement in global measurements of disease activity: patient global assessment of disease activity, patient pain assessment (peripheral and axial pain), physician global assessment of disease activity, ...)
Time frame: At 24 weeks.
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