Spondyloarthritis: Inducing Drug-free Remission by Early TNF-alpha Blockade

"At the week 24 timepoint, there are 3 possible scenario's:~1. In patients that do not reach a state of clinical remission at week 24, blinded study medication will be interrupted and all patients will start open-label SC golimumab for an additional 36 weeks (up to max. week 60).~2. In patients that achieve sustained clinical remission at week 24, defined as absence of clinical arthritis, enthesitis and dactylitis at both week 12 and week 24, all study medication will be discontinued and prospective follow-up will be planned in SPARTACUS Phase B.~3. In patients that reach a state of clinical remission at week 24, but that did not yet reach this status at week 12, blinded study medication will be continued without any change in the treatment schedule for another 12 weeks."

"At week 36, patients that have continued the blinded study medication, will be re-assessed regarding sustained clinical remission (at week 24 and 36): if yes, all study medication will again be discontinued and prospective follow-up will be planned in SPARTACUS Phase B. If no, these patients will start open-label SC golimumab for an additional 24 weeks (up to max. week 60).~If patients were in the open-label golimumab treatment arm, effectiveness of the treatment will be assessed by using the PASSI-question. Inadequate responders will be discontinued from the study and will be treated with standard-of-care medication at the discretion of their treating rheumatologist, whereas patients with an acceptable improvement in signs and symptoms will continue with the same (open-label) medication schedule."

"At week 48, all patients still remaining in SPARTACUS Phase A will have been treated with open-label golimumab (for a minimum of 12 weeks, but potentially up to 48 weeks). In patients reaching at this timepoint sustained clinical remission (at week 36 and 48), golimumab will be discontinued and prospective follow-up will be planned in SPARTACUS Phase B. For the other patients there are 3 possible scenarios:~1. If clinical remission for the first time at week 48, continuation without any change in the treatment schedule for another 12 weeks.~2. If an inadequate response (based on the PASSI-question), discontinuation from the study and standard-of-care medication~3. If an acceptable improvement (but no clinical remission), continuation open-label golimumab for an additional 12 weeks, with open-label methotrexate (unless contra-indicated) to fulfil Belgian reimbursement criteria for TNFi."

At week 60 (final study visit of SPARTACUS Phase A), patients reaching sustained clinical remission (at week 48 and 60), will roll-over into SPARTACUS Phase B. All other patients will be discontinued and will be treated with standard-of-care medication (including TNFi, if in accordance with Belgian reimbursement criteria).