(ASLeap) Study Estimating the Clinical Difference Between 300 mg and 150 mg of Secukinumab Following Dose Escalation to 300 mg in Patients With Ankylosing Spondylitis
Escalating the dose of Cosentyx is currently one approach for treating certain rheumatologic conditions. The purpose of this study is to discover if it is beneficial to double the standard dose of the biologic drug Cosentyx for patients with Ankylosing Spondylitis (AS). Patients with an AS diagnosis who have not responded to one biologic drug therapy or who have never been on a biologic, for whom other treatments (such as with NSAIDs) are not effective are invited to contact the study team to see if they could benefit from participating in this study.
- Understand and communicate with the investigator, comply with the requirements of the study and give a written, signed and dated informed consent
- Male or non-pregnant, non-lactating female patients at least 18 years of age
- Diagnosis of moderate to severe Ankylosing Spondylitis (AS) with prior documented radiologic evidence fulfilling the Modified New York criteria for AS
- Active AS assessed by total Bath Ankylosing Spondylitis Disease Activity index (BASDAI) ≥ 4 (0-10) at baseline
- Total back pain as measured by visual analog scale (VAS) ≥ 40 mm (0-100 mm) at baseline
- Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at baseline
- Patients should have been on non-steroidal anti-inflammatory drugs (NSAIDs) at the maximum tolerated dose for at least 4 weeks prior to their Baseline Visit, with an inadequate response or for less than 4 weeks if withdrawn for intolerance, toxicity or contraindications
- Stable dose of NSAIDs including Cyclooxygenase-1 (COX-1) or Cyclooxygenase-2 (COX-2) inhibitors for at least 2 weeks before their Baseline Visit
- Patients who have been on a tumor necrosis factor alpha (TNFα) inhibitor (not more than one) must have experienced an inadequate response to previous or current treatment given at an approved dose for at least 3 months prior to baseline or had been intolerant upon administration of an anti-TNFα agent
Additional inclusion and exclusion criteria apply.
Principal InvestigatorMichael R Bubb, M.D.
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