Study Estimating the Clinical Difference Between 300 mg and 150 mg of Secukinumab Following Dose Escalation to 300 mg in Patients With Ankylosing Spondylitis
Status: | Recruiting |
---|---|
Conditions: | Arthritis, Neurology, Neurology |
Therapuetic Areas: | Neurology, Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/24/2019 |
Start Date: | March 13, 2018 |
End Date: | August 31, 2020 |
Contact: | Novartis Pharmaceuticals |
Email: | novartis.email@novartis.com |
Phone: | 1-888-669-6682 |
A Randomized, Double-blind, Parallel-group, Multicenter Study of Secukinumab to Compare 300 mg and 150 mg at Week 52 in Patients With Ankylosing Spondylitis Who Are Randomized to Dose Escalation After Not Achieving Inactive Disease During an Initial 16 Weeks of Open-label Treatment With Secukinumab 150 mg (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
dose escalation to 300 mg in patients with ankylosing spondylitis
Key Inclusion Criteria:
1. Understand and communicate with the investigator, comply with the requirements of the
study and give a written, signed and dated informed consent
2. Male or non-pregnant, non-lactating female patients at least 18 years of age
3. Diagnosis of moderate to severe Ankylosing Spondylitis (AS) with prior documented
radiologic evidence fulfilling the Modified New York criteria for AS
4. Active AS assessed by total Bath Ankylosing Spondylitis Disease Activity index
(BASDAI) ≥ 4 (0-10) at baseline
5. Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at baseline
6. Total back pain as measured by visual analog scale (VAS) ≥ 40 mm (0-100 mm) at
baseline
7. 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inadequate response or for less than 4 weeks if withdrawn for intolerance, toxicity or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
8. Stable dose of NSAIDs including Cyclooxygenase-1 (COX-1) or Cyclooxygenase-2 (COX-2)
inhibitors for at least 2 weeks before their Baseline Visit
9. 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 Criteria:
1. Total ankylosis of the spine
2. Use of other investigational drugs within 5 half-lives of enrollment, or within 4
weeks before the Baseline Visit, whichever is longer.
3. History of hypersensitivity to any of the study drugs or its excipients or to drugs of
similar chemical classes.
4. 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.
5. 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
6. Patients who have taken more than one anti-TNFα agent
7. Any intramuscular or intravenous corticosteroid injection within 2 weeks before
baseline
8. Any therapy by intra-articular injections (e.g. corticosteroid) within 4 weeks before
baseline
9. Previous treatment with any cell-depleting therapies
10. Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone,
morphine)
Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
57
sites
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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