Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04435288 | Spondyloarthritis: Inducing Drug-free Remission by Early TNF-alpha Blockade | PHASE3 | ACTIVE NOT_RECRUITING | 90 | — | — | Aug 24, 2020 | Dec 31, 2028 | Sep 26, 2025 | 6 | Belgium |
At week 24 of the study the 2 treatment strategies will be compared with regard to achievement of clinical remission. Clinical remission is defined as complete absence of arthritis, dactylitis or enthesitis on clinical examination.
| Arm | Type | Description |
|---|---|---|
| TNFi-induction group | ACTIVE_COMPARATOR | The patients in the TNFi-induction group will receive golimumab at a standard dose of 50 mg subcutaneously (SC) every 4 weeks (with matching methotrexate (MTX)-placebo). In case of potential intolerance or toxicity to MTX-placebo, the dose will be gradually tapered to a minimum of 7.5 mg per week. When there are no tolerability/toxicity issues, the weekly dose of MTX-placebo will be increased to 20 mg at week 4. At week 12, a "Patient Acceptable Signs \& Symptoms Improvement" ('PASSI') will be assessed by asking the question "Taking into account both efficacy and side effects, did you experience over the past 12 weeks enough improvement in signs and symptoms of your' arthritis-enthesitis-dactylitis to consider continuation of the same treatment schedule for the next 12 weeks?". If yes, all study medication will be kept stable until week 24; if no, oral sulphasalazine at a dose of 2 g per day will be started (escape medication). |
| csDMARD-Step-up group | ACTIVE_COMPARATOR | The patients in the csDMARD-Step-up group will start with oral methotrexate (MTX) at a weekly dose of 15 mg for 4 weeks (with matching TNFi-placebo injections). In case of potential intolerance or toxicity to MTX , the dose will be gradually tapered to a minimum of 7.5 mg per week. When there are no tolerability/toxicity issues, the weekly dose of MTX will be increased to 20 mg at week 4. At week 12, a "Patient Acceptable Signs \& Symptoms Improvement" ('PASSI') will be assessed by asking the question "Taking into account both efficacy and side effects, did you experience over the past 12 weeks enough improvement in signs and symptoms of your' arthritis-enthesitis-dactylitis to consider continuation of the same treatment schedule for the next 12 weeks?". If yes, all study medication will be kept stable until week 24; if no, oral sulphasalazine at a dose of 2 g per day will be started (escape medication). |
| Name | Type | Description |
|---|---|---|
| week 24 | DRUG | 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. |
| week 36 | DRUG | 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. |
| Week 48 | DRUG | 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. |
| Week 60 | DRUG | 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). |
Inclusion Criteria: SPARTACUS Phase A: "Remission-Induction Phase" A subject will be eligible for study participation if all of the following criteria are met: * Subjects must be able and willing to provide written informed consent and comply with the requirements of this study protocol. * Subjec...