Ankylosing spondylitis MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or non-pregnant, non-nursing female patients at least 18 years of age. - Diagnosis of moderate to severe Ankylosing Spondylitis with radiologic evidence (centrally read X-ray) fulfilling the Modified New York criteria for AS despite previous or current NSAID/non biologic DMARD therapy. - Active AS assessed by total BASDAI = 4 on a scale of 0-10. - Spinal pain as measured by BASDAI question #2 = 4 (0-10). - Total back pain as measured by visual analog scale (VAS) = 40 mm (0-100 mm). - hsCRP = 5mg/L OR presence of at least 1 syndesmophyte on centrally read spinal X-ray. Other protocol-defined inclusion criteria may apply, Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 753 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 84
Exclusion criteria
Exclusion criteria: - Patients with total ankylosis of the spine. - Pregnant or nursing (lactating) women. - Evidence of ongoing infectious or malignant process. - Previous exposure to any biologic immunomodulating agent, including those targeting IL-17, IL-17 receptor or TNFa. - Subjects taking high potency opioid analgesics. - Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents. Other protocol-defined exclusion criteria may apply,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the proportion of subjects on secukinumab (150 mg s.c. or 300 mg s.c.) with no radiographic progression as measured by mSASSS at Week 104 is superior to subjects on GP2017 (adalimumab biosimilar 40 mg s.c.). ;Secondary Objective: To demonstrate the change from baseline in mSASSS in subjects on AIN457 (150mg sc or 300mg sc) is superior to GP2017 at W104 -To demonstrate the proportion of subjects with a syndesmophyte at baseline with no new syndesmophytes at W104 on AIN457 (150mg sc or 300mg sc) is superior to GP2017 -To evaluate the Berlin SI joint edema score in subjects on AIN457 (150mg sc or 300mg sc) at W104 versus GP2017 (in a subset of subjects at selected sites) -To evaluate the ASspiMRI-a Berlin modification score in subjects on AIN457 (150mg sc or 300mg sc) at W104 versus GP2017 (in a subset of subjects at selected sites) -To evaluate ASAS20 response, ASAS40 response, ASAS partial remission and ASDAS inactive disease in subjects on AIN457 150mg sc compared to AIN457 300mg sc at W104 -Overall safety and tolerability of AIN457;Primary end point(s): No radiographic progression as measured by modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) for 150 mg sc or 300 mg sc secukinumab versus GP2017);Timepoint(s) of evaluation of this end point: 104 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from baseline in modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). - No new syndesmophyte as measured by mSASSS. - Assessment of SpondyloArthritis International Society 20 (ASAS20). - ASAS 40. - ASAS partial remission. - Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease. - Berlin sacroiliac (SI) joint edema score. - Ankylosing Spondylitis Spine Magnetic Resonance Imaging - activity (ASspiMRI-a) Berlin modification score.;Timepoint(s) of evaluation of this end point: 104 weeks | — |
Countries
Argentina, Australia, Belgium, Canada, Chile, Colombia, Czechia, Czech Republic, Denmark, Finland, France, Germany, Greece, Israel, Japan, Korea, Republic of, Mexico, Monaco, Netherlands, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Slovakia, Spain, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed