Status:
COMPLETED
Study Estimating the Clinical Difference Between 300 mg and 150 mg of Secukinumab Following Dose Escalation to 300 mg in Patients With Ankylosing Spondylitis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This was a study estimating the clinical difference between 300 mg and 150 mg of secukinumab following dose escalation to 300 mg in patients with ankylosing spondylitis
Detailed Description
The study used a multicenter design which included an initial 16 week open-label period (Treatment Period 1) followed by a randomized, double-blind, parallel-group period (Treatment Period 2), 1. Scr...
Eligibility Criteria
Inclusion
- Key
- 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
- Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at baseline
- Total back pain as measured by visual analog scale (VAS) ≥ 40 mm (0-100 mm) 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dose for at least 4 weeks prior to their Baseline Visit, with an inadequate response or for less than 4 weeks if withdrawn for intolerance, toxicity or contraindications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
- Key
Exclusion
- Total ankylosis of the spine
- Use of other investigational drugs within 5 half-lives of enrollment, or within 4 weeks before the Baseline Visit, whichever is longer.
- History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
- Chest x-ray, computerized tomography (CT) scan, or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician.
- Previous exposure to secukinumab or any other biologic drug directly targeting Interleukin-17 (IL-17), Interleukin-12/23 (IL-12/23), or the IL-17 receptor, or any other biologic immunomodulating agent, except those targeting TNFα
- Patients who have taken more than one anti-TNFα agent
- Any intramuscular or intravenous corticosteroid injection within 2 weeks before baseline
- Any therapy by intra-articular injections (e.g. corticosteroid) within 4 weeks before baseline
- Previous treatment with any cell-depleting therapies
- Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, morphine)
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
March 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2021
Estimated Enrollment :
322 Patients enrolled
Trial Details
Trial ID
NCT03350815
Start Date
March 13 2018
End Date
May 29 2021
Last Update
April 29 2022
Active Locations (65)
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1
Novartis Investigative Site
Jonesboro, Arkansas, United States, 72401
2
Novartis Investigative Site
Fullerton, California, United States, 92835
3
Novartis Investigative Site
Loma Linda, California, United States, 92354
4
Novartis Investigative Site
Palm Desert, California, United States, 92260