16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients
- Conditions
- Spondylitis, Ankylosing
- Interventions
- Registration Number
- NCT02008916
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The purpose of this study was to generate 16-week efficacy data, as well as up to 3-year efficacy, safety and tolerability data in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 226
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Secukinumab 10 mg/kg i.v. / 300 mg s.c. Secukinumab Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study. Placebo i.v. and s.c. Placebo secukinumab Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study. Secukinumab 10 mg/kg i.v. / 150 mg s.c. Secukinumab Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
- Primary Outcome Measures
Name Time Method Number of Participants With 20% Improvement in the Assessment of Spondyloarthritis International Society Criteria Scale / ASAS 20 Response 16 weeks ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 was used to assess the efficacy of at least one dose of secukinumab versus placebo.
- Secondary Outcome Measures
Name Time Method ASAS Partial Remission 16 weeks ASAS partial remission is a composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame a value not above 2 units in each of the 4 ASAS domains on a scale of 10. In this study, ASAS partial remission was used to assess the efficacy of at least one dose of secukinumab versus placebo.
ASAS 5/6 Response 16 weeks ASAS 5/6 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 5 of a conventional set of 6 clinical domains relevant to AS and no worsening in the remaining domain. In this study, ASAS 5/6 was used to assess the efficacy of at least one dose of secukinumab versus placebo.
Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe) Week 8 and Week 12 Successful self-administration is defined as success in steps P8 (Removed Needle Cap from Safety Syringe), P10 (Pinched the Skin at Injection Site), P11 (Inserted the Needle into Skin), P12 (Held onto the Finger Flange), P13 (Fully Depressed Plunger until End Point), and P14 (Held Plunger Down and Syringe in Place) of the Instructions for Use, as observed by the site staff at applicable visits.
Prefilled Syringe Patient Satisfaction Assessment Baseline, weeks 8, 12 and 16 The self-injection assessment questionnaire (SIAQ) measures overall patient experience with subcutaneous self-injection at applicable visits. Domain scores ranging from 0 (worst experience) to 10 (best experience) are presented: Feeling about injections, Self-confidence, Satisfaction with self-injection.
ASAS 40 Response 16 weeks ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 40 was used to assess the efficacy of at least one dose of secukinumab versus placebo.
Serum hsCRP Baseline and 16 weeks Blood levels of C-reactive protein (CRP), an acute phase reactant, are indicative of inflammation and of its severity, and can be used to monitor treatment response. A high sensitivity CRP (hsCRP) test was implemented in this study, to assess the efficacy of at least one dose of secukinumab versus placebo in reducing AS elicited systemic inflammation over the time.
Bath Ankylosing Spondylitis Disease Activity Index / BASDAI Baseline and 16 weeks BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating "no problem" and 10 indicating "worst problem"), to characterise six clinical domains pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, the BASDAI index was used to assess the efficacy of at least one dose of secukinumab versus placebo.
Pre-filled Syringe Possible Hazard Week 8 and Week 12 The number and percentage of subjects who experience any of the defined possible hazards are summarized, as defined in the Possible Hazard assessment check list and as observed by the site staff at applicable visits.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇬🇧Torquay, United Kingdom