Peripheral Spondylarthritis Clinical Trial
Official title:
Exploration of TNF-alpha Blockade With Golimumab in the Induction of Clinical Remission in Patients With Early Peripheral Spondyloarthritis (SpA) According to ASAS-criteria
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.
n/a