Ankylosing Spondylitis Clinical Trial
Official title:
Safety and Efficacy of Prefilled Liquid Etanercept(Yisaipu) for Active Ankylosing Spondylitis on the Basis of NSAID Therapy: A Multicenter Randomized, Double-blind, Parallel Group Phase III Trial
This randomized, double-blind, phase III parallel-group non-inferiority study aimed to investigate the efficacy and safety of prefilled liquid etanercept (Yisaipu) versus lyophilized etanercept powder (Yisaipu) in active ankylosing spondylitis patients.
The study carried out between March 6, 2014 and July 13, 2015 across multiple medical centers in China enrolled adult active ankylosing spondylitis patients aged between 18 and 65 years. Patients were randomized in a 3:1:1 ratio to receive twice weekly 25 mg prefilled liquid etanercept for totally 24 injections (group I) or once weekly 50 mg prefilled liquid etanercept for totally 48 injections (group II), or 25 mg twice weekly lyophilized etanercept powder for totally 48 injections (group III). The primary efficacy outcome was the proportion of patients who achieved ASAS20 at week 24. ;
| 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 |