Clinical trials: Spondyloarthritis, Axial
Active Non-radiographic Axial Spondyloarthritis
A Trial of SHR-1314 Injection in Adult Patients With Active Non-radiographic Axial Spondyloarthritis
The study is being conducted to evaluate the efficacy and safety of SHR-1314 injection in adult patients with active non-radiographic axial spondyloarthritis.
- Trial name
- NCT06860750
- Testing
- SHR-1314 Injection
- Where
- China
- Volunteers
- 380 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Axial Spondyloarthritis
A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNFα Naive Participants With Active Radiographic Axial Spondyloarthritis
The purpose of this study is to assess the efficacy of ustekinumab, in adult participants with active radiographic axial spondyloarthritis (AxSpA), who are naive to anti-TNF alpha agents, as measured by the reduction in signs and…
- Trial name
- NCT02437162
- Testing
- Ustekinumab 45 mg, Ustekinumab 90 mg, Golimumab 50 mg
- Where
- 57 sites in United States, Czechia and 5 more
- Volunteers
- 347 people
- Sponsor
- Janssen Research & Development, LLC
Axial Spondyloarthritis
A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Participants With Active Radiographic Axial Spondyloarthritis
The purpose of this study is to assess the efficacy of ustekinumab, in adult anti-TNF(alpha) refractory participants with active radiographic axial spondyloarthritis (AxSpA), as measured by the reduction in signs and symptoms of…
- Trial name
- NCT02438787
- Testing
- Ustekinumab 45 mg, Ustekinumab 90 mg, Golimumab 50 mg
- Where
- 148 sites in United States, Argentina and 17 more
- Volunteers
- 315 people
- Sponsor
- Janssen Research & Development, LLC
Axial Spondyloarthritis
AScalate: Treat-to-target in Axial Spondyloarthritis
This was a randomized, parallel-group, open-label, multicenter study in patients with active axSpA. The aim of the study was to demonstrate that the efficacy of a T2T approach (with secukinumab as a first-line biologic) was…
- Trial name
- AScalate (NCT03906136)
- Testing
- Secukinumab/Adalimumab-Biosimilar, Standard-of-care
- Where
- 47 sites in France, Germany
- Volunteers
- 304 people
- Sponsor
- Novartis Pharmaceuticals
Arthritis, Rheumatoid, Spondyloarthritis, Axial
Biologic Treatment Registry Across Canada
This registry is a multi-center, prospective, longitudinal, observational program that will gather and analyse data on participants treated with infliximab, golimumab, golimumab Intravenous (I.V) or ustekinumab.
- Conditions
- Arthritis, Rheumatoid, Spondyloarthritis, Axial, Arthritis, Psoriatic
- Trial name
- BioTRAC (NCT00741793)
- Where
- Canada
- Volunteers
- 2,821 people
- Sponsor
- Janssen Inc.
Axial Spondyloarthritis (AxSpA)
Retrospective Case-Control Study for Developing an Artificial Intelligence (AI) Tool for Lesion Detection Using Magnetic Resonance Imaging (MRI) and Clinical Variables for Early Diagnosis of Axial Spondyloarthritis (axSpA)
The goal of this observational study is to develop and validate an Artificial Intelligence (AI) tool that allows the lesion detection and early diagnosis of axial spondyloarthritis (axSpA) based on Magnetic Resonance Imaging…
- Trial name
- InnovaDetect (NCT06591481)
- Where
- 7 sites in Jordan, Saudi Arabia and 2 more
- Volunteers
- 925 people, healthy volunteers welcome
- Sponsor
- Ángel Alberich Bayarri
Axial Spondyloarthritis
A Study to Evaluate 608 in Patients With Non- Radiographic Axial Spondyloarthritis (Nr-axSpA)
This study will evaluate the effect and safety of 608 in patients with nr-axSpA.
- Trial name
- NCT06222671
- Testing
- 608
- Where
- 6 sites in China
- Volunteers
- 180 people
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Axial Spondyloarthritis
Study of Efficacy and Safety of GR1501 in Patients with Radiographic Axial Spondyloarthritis
The purpose of this trial is to demonstrate the clinical efficacy of GR1501 at week 16; and to demonstrate safety and tolerability of GR1501 compared to placebo in patients with Radiographic Axial Spondyloarthritis at week 16 and…
- Trial name
- NCT05881785
- Testing
- GR1501 low dose, GR1501 high dose
- Where
- China
- Volunteers
- 465 people
- Sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Rheumatoid Arthritis, Psoriatic Arthritis
A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)
The purpose of the study is to assess systemic certolizumab pegol (CZP) exposure, the formation of anti-CZP antibodies and safety of CZP across the course of pregnancy in study participants with chronic inflammatory diseases.
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Crohn's Disease, Axial Spondyloarthritis
- Trial name
- CHERISH (NCT04163016)
- Testing
- Pharmacokinetics of certolizumab pegol
- Where
- 9 sites in United States, France and 4 more
- Volunteers
- 22 people
- Sponsor
- UCB Biopharma SRL
Axial Spondyloarthritis
A Study of Brodalumab in Subjects With Axial Spondyloarthritis (axSpA)
To evaluate the efficacy of Brodalumab in axSpA (ankylosing spondylitis [AS] and non-radiographic axial spondyloarthritis [nr-axSpA]) subjects compared to placebo, as measured by the proportion of axSpA subjects achieving an…
- Trial name
- NCT02985983
- Testing
- Brodalumab
- Where
- 48 sites in Japan, South Korea and 1 more
- Volunteers
- 159 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Ankylosing Spondylitis
Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA
The purpose of this global study was to demonstrate the efficacy, safety, and tolerability of an intravenous (i.v.) regimen of secukinumab compared to placebo in participants with active ankylosing spondylitis (AS) or…
- Trial name
- NCT04156620
- Testing
- Secukinumab
- Where
- 102 sites in United States, Belgium and 16 more
- Volunteers
- 527 people
- Sponsor
- Novartis Pharmaceuticals
Axial Spondyloarthritis
Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis (LEVENTA)
The aim of the study is to evaluate the efficacy, safety, immunogenicity, pharmacokinetics and pharmacodynamics of a fixed dose of study drug (BCD-180) in comparison with placebo in patients with active axial spondyloarthritis…
- Trial name
- NCT06333210
- Testing
- anti-TRBV9 monoclonal antibody infusions, Adalimumab subcutaneous injection
- Where
- 32 sites in Belarus, Russia
- Volunteers
- 421 people
- Sponsor
- Biocad
Rheumatoid Arthritis, Psoriatic Arthritis
Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Non-radiographic Axial Spondyloarthritis
The primary objective of this study is to evaluate the effect of filgotinib on semen parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial…
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Non-Radiographical Axial Spondyloarthritis
- Trial name
- MANTA-RAy (NCT03926195)
- Testing
- Filgotinib, Standard of Care
- Where
- 71 sites in Bulgaria, Czechia and 6 more
- Volunteers
- 109 people
- Sponsor
- Lakefront Biotherapeutics NV
Pharmacokinetics, Safety Issues
A Clinical Study With Adalimumab Biosimilar
The study aims to evaluate the pharmacokinetic profile, safety profile, and immunogenic potential of adalimumab of a new citrate-free formulation of adalimumab (Adalimumab Richmond) [Test Product] vs.
- Trial name
- NCT06291948
- Testing
- Humira® (adalimumab) AC Pen [Reference Product], Adalimumab Richmond [Test Product]
- Where
- Argentina
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Laboratorios Richmond S.A.C.I.F.
Axial Spondyloarthritis
Efficacy and Safety of SCT650C in Participants With Axial Spondyloarthritis
The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SCT650C in patients with Axial Spondyloarthritis
- Trial name
- NCT06197009
- Testing
- SCT650C
- Where
- Turkey (Türkiye)
- Volunteers
- 168 people
- Sponsor
- Sinocelltech Ltd.
Arthritis, Rheumatoid (RA), Axial Spondyloarthritis (axSpA)
A Real-world Study of Imraldi® Use
The primary objective of this study is to evaluate candidate predictors of persistence on adalimumab (Imraldi®) participants diagnosed with immune-mediated inflammatory disease in Europe (EU).
- Conditions
- Arthritis, Rheumatoid (RA), Axial Spondyloarthritis (axSpA), Arthritis, Psoriatic (PsA), Crohn's Disease (CD)
- Trial name
- PROPER (NCT04089514)
- Testing
- Adalimumab
- Where
- 54 sites in Belgium, Germany and 4 more
- Volunteers
- 1,000 people
- Sponsor
- Biogen
Axial Spondyloarthritis
Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis
The aim of the study is to evaluate the efficacy, safety, immunogenicity, pharmacokinetics and pharmacodynamics of two doses of study drug (BCD-180) in comparison with placebo in patients with active radiographic axial…
- Trial name
- ELEFTA (NCT05445076)
- Testing
- anti-TRBV9 monoclonal antibody, low dose, anti-TRBV9 monoclonal antibody, high dose
- Where
- 2 sites in Russia
- Volunteers
- 250 people
- Sponsor
- Biocad
Axial Spondyloarthritis
to Evaluate the Preliminary Efficacy and Safety of GR1501 Injection in Patients With Active Axial Spondyloarthritis
Dosage: 100mg or 200mg or 300mg Administration frequency: Q2W administration in the first 4 weeks (W0, W2, W4), and subsequent Q4W administration (W8, W12) Administration: subcutaneous injection Specifications: 100mg/ 1mL/bottle…
- Trial name
- NCT05162937
- Testing
- IL-17A antibody
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Axial Spondyloarthritis, Psoriatic Arthritis
Secukinumab (Cosentyx®) Effectiveness in Axial Spondyloarthritis and Psoriatic Arthritis Patients Using Artificial Intelligence (SpAINET): Spanish Multicenter, Retrospective, Real World Evidence Study
This was a multicenter, retrospective, and non-interventional study using secondary data captured in the Electronic Health Records (EHRs).
- Trial name
- NCT05677542
- Testing
- secukinumab
- Where
- 3 sites in Spain
- Volunteers
- 758 people
- Sponsor
- Novartis Pharmaceuticals
Non-radiographic Axial Spondyloarthritis
A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Non-Radiographic Axial Spondyloarthritis
This study is to evaluate the efficacy and safety of SHR0302 in subjects with active non-radiographic axial spondyloarthritis.
- Trial name
- NCT05324631
- Testing
- SHR0302
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.