Psoriatic Arthritis / Axial Spondyloarthritis / Enthesitis
The purpose of this study is to demonstrate efficacy, including effects on inflammation by magnetic resonance imaging (MRI) assessments, of secukinumab on Achilles tendon enthesitis for up to 1 year with a primary focus at Week 24, in patients with active Psoriatic Arthritis and axial Spondyloarthritis despite current or previous non-steroidal anti-inflammatory drugs (NSAID) and/or disease modifying anti-rheumatic drug (DMARD) and/or anti-TNFα therapy.
- Biological: AIN457/SecukinumabInduction: Week 0,1,2,3 150 mg or 300 mg Secukinumab s.c. Maintenance: 150 mg or 300 mg Secukinumab s.c. every 4 weeks starting at Week 4
- Drug: AIN457/Secukinumab PlaceboInduction: Week 0,1,2,3 Secukinumab Placebo s.c. Maintenance: Secukinumab Placebo s.c. every 4 weeks starting at Week 4 until Week 24 followed by 150 or 300 mg Secukinumab s.c. every 4 weeks
|Ages eligible for Study||18 Years and older|
|Genders eligible for Study||All|
|Accepts Healthy Volunteers||No|
- Patients with Psoriatic arthritis: Diagnosis of Psoriatic arthritis as per the Classification criteria for Psoriatic Arthritis (CASPAR criteria) with symptoms for at least 6 months and active Psoriatic arthritis as assessed by ≥ 1 tender joints out of 78 and ≥ 1 swollen joints out of 76 at Baseline (dactylitis of a digit counts as one joint each).
- Patients with Axial Spondyloarthritis: Diagnosis of Axial Spondyloarthritis as per the classification of the Assessment of Spondyloarthritis International Society axial Spondyloarthritis (ASAS) criteria and objective signs of inflammation at Screening (magnetic resonance imaging (MRI) or definite radiographic sacroilitis and/or abnormal C-Reactive Protein) and active disease assessed by total Bath ankylosing spondylitis disease activity index (BASDAI) ≥ 4 (0-10) at Baseline.
- Diagnosis of Achilles tendon enthesitis according to swelling and tenderness at the insertional site of the Achilles tendon into the calcaneus.
- Onset of heel pain ≥ 1 month at Baseline.
- Heel enthesitis that is magnetic resonance imaging (MRI)-positive according to the investigator`s judgement.
- Patients who have been exposed to up to two TNFα inhibitors. Key
- Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process.
- Previous exposure to secukinumab or other biologic drug directly targeting Interleukin (IL)-17 or Interleukin (IL)-17 receptor.
- Ongoing use of psoriasis treatments / medications (e.g. topical corticosteroids, ultraviolet (UV) therapy) at randomization.
- Patients who have previously been exposed to more than two Tumor necrosis factor (TNF) inhibitors (investigational or approved).
- Patients who have ever received biologic immunomodulating agents (investigational or approved), except those targeting Tumor necrosis factor (TNF) inhibitors.
- Pregnant or nursing (lactating) women.
- History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection. Other protocol-defined inclusion/exclusion criteria may apply.
- Novartis Investigative SiterecruitingPlovdiv, Bulgaria, 4002
- Novartis Investigative SiterecruitingSofia, Bulgaria, 1407
- Novartis Investigative SiterecruitingStara Zagora, Bulgaria, 6000
- Novartis Investigative SiterecruitingTargovishte, Bulgaria, 7700
- Novartis Investigative SiterecruitingPraha 4, Czech Republic, Czechia, 140 59
- Novartis Investigative SiterecruitingPrague 2, Czechia, 128 50
- Novartis Investigative SiterecruitingUherske Hradiste, Czechia, 686 01
- Novartis Investigative SiterecruitingBerlin, Germany, 12033
- Novartis Investigative SiterecruitingBerlin, Germany, 14059
- Novartis Investigative SiterecruitingCottbus, Germany, 03042
- Novartis Investigative SiterecruitingErlangen, Germany, 91054
- Novartis Investigative SiterecruitingFrankfurt am Main, Germany, 60528
- Novartis Investigative SiterecruitingHamburg, Germany, 22081
- Novartis Investigative SiterecruitingHamburg, Germany, 22415
- Novartis Investigative SiterecruitingHannover, Germany, 30161
- Novartis Investigative SiterecruitingHerne, Germany, 44649
- Novartis Investigative SiterecruitingMagdeburg, Germany, 39104
- Novartis Investigative SiterecruitingMagdeburg, Germany, 39110
- Novartis Investigative SiterecruitingWuppertal, Germany, 42105
- Novartis Investigative SiterecruitingAthens, Greece, 115 21
- Novartis Investigative SiterecruitingBergamo, BG, Italy, 24128
- Novartis Investigative SiterecruitingSiena, SI, Italy, 53100
- Novartis Investigative SiterecruitingVerona, VR, Italy, 37134
- Novartis Investigative SiterecruitingPiestany, Slovakia, 92101
- Novartis Investigative SiterecruitingTorrelavega, Cantabria, Spain, 39300
- Novartis Investigative SiterecruitingCartagena, Murcia, Spain, 30202
- Novartis Investigative SiterecruitingVigo, Pontevedra, Spain, 36200
- Novartis Investigative SiterecruitingBaracaldo, Vizcaya, Spain, 48903
- Novartis Investigative SiterecruitingMadrid, Spain, 28040
- Novartis Investigative SiterecruitingMadrid, Spain, 28046
- Novartis Investigative SiterecruitingMadrid, Spain, 28944
- Novartis Investigative SiterecruitingMalaga, Spain, 29009
- Novartis Investigative SiterecruitingPontevedra, Spain, 36001
United Kingdom (7)
- Novartis Investigative SiterecruitingTruro, Cornwall, United Kingdom, TR1 3LJ
- Novartis Investigative SiterecruitingLeytonstone, London, United Kingdom, E11 1NR
- Novartis Investigative SiterecruitingBarnsley, United Kingdom, S75 2EP
- Novartis Investigative SiterecruitingHull, United Kingdom, HU3 2JZ
- Novartis Investigative SiterecruitingLondon, United Kingdom, NW3 2QG
- Novartis Investigative SiterecruitingStoke on Trent, United Kingdom, ST6 7AG
- Novartis Investigative SiterecruitingTyne & Wear, United Kingdom, NE29 8NH
30 August, 2016
13 November, 2017