Status:
COMPLETED
Study of Efficacy and Safety of Secukinumab in Chinese Subjects With Active PsA Compared to Placebo.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Psoriatic Arthritis
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
The purpose of this study was to assess the efficacy and safety of secukinumab in Chinese participants with active Psoriatic arthritis (PsA ) compared to placebo.
Detailed Description
This study used a randomized, double-blind, placebo-controlled, parallel-group design. A screening period running up to 10 weeks before randomization was used to assess participant eligibility follow...
Eligibility Criteria
Inclusion
- Participant must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed.
- Chinese male or non-pregnant, non-lactating Chinese female participants at least 18 years of age.
- Diagnosis of PsA classified by Classification of Psoriatic Arthritis (CASPAR) criteria and with symptoms for at least 6 months with moderate to severe Psoriatic arthritis (PsA).
- Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies negative at screening.
- Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or a documented history of plaque psoriasis.
- Participants on Methotrexate (MTX) must be on folic acid supplementation at randomization.
- Participants who are on a DMARD other than MTX must discontinue the DMARD 4 weeks prior to randomization visit except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine washout has been performed.
Exclusion
- Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
- Participants taking high potency opioid analgesics (e.g., methadone, hydromorphone, morphine).
- Previous exposure to secukinumab or other biologic drug directly targeting interleukin- 17 (IL-17) or IL-17 receptor
- Participants who have ever received biologic immunomodulating agents except for those targeting Tumor necrosis factor alpha (TNFα).
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective contraception during the entire study (during the entire study).
Key Trial Info
Start Date :
June 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2023
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04711902
Start Date
June 24 2021
End Date
March 10 2023
Last Update
October 9 2024
Active Locations (12)
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1
Novartis Investigative Site
Chongqing, Chongqing Municipality, China, 400010
2
Novartis Investigative Site
Guangzhou, Guangdong, China, 510120
3
Novartis Investigative Site
Zhuzhou, Hunan, China, 412000
4
Novartis Investigative Site
Baotou, Inner Mongolia, China, 014010