Clinical Trials Logo
  1. Home
  2. Ankylosing Spondylitis
  3. NCT04840485
  4. Details
NCT04840485 Clinical Trial

Efficacy and Safety of SHR-1314 in Patients With Active Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

Official title:
A Randomized, Double-blind, Multicenter, Placebo-controlled, Phase II/III Adaptive Study of SHR-1314 to Assess Efficacy and Safety in Patients With Active Ankylosing Spondylitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04840485
Other study ID # SHR-1314-302
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date June 9, 2021
Est. completion date February 28, 2024

Study information
Verified date May 2024
Source Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in patients with active ankylosing spondylitis

Recruitment information / eligibility
Status Completed
Enrollment 548
Est. completion date February 28, 2024
Est. primary completion date November 3, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Active Ankylosing Spondylitis, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response, contraindications or intolerance to NSAIDs Exclusion Criteria: - pregnancy or lactation, serious infectious, malignancy, previous exposure to any biological agent excluding TNF antagonists

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• SHR-1314
SHR-1314 high dose
• SHR-1314
SHR-1314 low-dose
• Placebo
Placebo

Locations
Country Name City State
China Chinese PLA General Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants Responded for Assessment of SpondyloArthritis international Society 20 Criteria (ASAS20) at 16 Weeks 16 Weeks
Secondary Percentage of Participants Responded for ASAS 20 Response at 32 Weeks 32 Weeks
Secondary Percentage of Participants Responded for ASAS 40 Response at 16 and 32 Weeks 16 and 32 Weeks
Secondary Percentage of Participants Responded for ASAS 5/6 Response at 16 and 32 Weeks 16 and 32 Weeks
Secondary Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 and 32 Weeks 16 and 32 Weeks
Secondary Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at 16 and 32 Weeks 16 and 32 Weeks
See also
  Status Clinical Trial Phase
Terminated NCT02685904 - A Multicentre Study to Evaluate the Efficacy and Safety of ENIA11 in Patients With Ankylosing Spondylitis Phase 3
Completed NCT02186873 - A Study of Golimumab in Participants With Active Ankylosing Spondylitis Phase 3
Completed NCT01668004 - The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012) Phase 4
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Completed NCT01934933 - Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis Phase 4
Not yet recruiting NCT04875299 - Optimal Adalimumab Plasma Concentrations in Ankylosing Spondylitis Patients
Completed NCT02758782 - NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of Structural Damage in Ankylosing Spondylitis Phase 4
Completed NCT02763111 - Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of Various Doses of BCD-085 in Patients With Active Ankylosing Spondylitis Phase 2
Active, not recruiting NCT02687620 - Does Immunogenicity Have an Influence on the Efficacy of Anti-TNF Therapy in Patients With AS: An Inception Cohort Study
Completed NCT02154425 - A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers Phase 1
Completed NCT01750528 - Prevalence and Progression of Periodontitis in Ankylosing Spondylitis N/A
Completed NCT01463189 - Web-based Support to Manage Arthritis Pain Phase 2
Completed NCT01091675 - Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis and Inadequate Response to ≥2 NSAIDs Phase 3
Completed NCT00844805 - Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1) Phase 3
Recruiting NCT00747578 - Health-Related Quality of Life and Disease-Related Costs: Comparison Between Ankylosing Spondylitis, Rheumatoid Arthritis and Systemic Lupus Erythematosus in Taiwan N/A
Completed NCT00715091 - Effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) on RAdiographic Damage in Ankylosing Spondylitis Phase 4
Completed NCT01083693 - Quality of Life Outcomes of HUMIRA in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) After Unsustainable Response to Biologicals and Disease Modifying Antirheumatic Drugs N/A
Not yet recruiting NCT00517101 - Presence of IBD Specific Antibodies (ASCA, ALCA, ACCA, AMCA) in the Sera of Patients With Spondyloarthropathy N/A
Completed NCT00367211 - Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers. Phase 3
Completed NCT00133315 - TNFalfa Blocking Treatment of Spondylarthropathies Phase 4