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A prospective, multicenter real-world study of Adalimumab injection (Anjiarun) in the treatment of ankylosing spondylitis

A prospective, multicenter real-world study of Adalimumab injection (Anjiarun) in the treatment of ankylosing spondylitis

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400081637
Enrollment
Unknown
Registered
2024-03-07
Start date
2024-03-26
Completion date
Unknown
Last updated
2024-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing spondylitis

Interventions

Treatment group receiving Adalimumab (Anjiarun):NA

Sponsors

Sichuan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Only cases that meet all of the following inclusion criteria can participate in this study: (1) Age = 18 years old, regardless of gender; (2) Clinically diagnosed as adult severe active ankylosing spondylitis with poor conventional therapy; (3) Doctor's prescription for Adalimumab Injection (Anjiarun); (4) Ability to complete research related evaluations and records; (5) Voluntarily participate in the study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria will be excluded from this trial: (1) Known to be allergic to Adalimumab or formulation excipients; (2) Patients who have previously used Adalimumab treatment but have been ineffective; (3) Active tuberculosis or other serious infectious diseases; (4) Patients with moderate to severe heart failure (NYHA grade III/IV); (5) Malignant tumor patients; (6) Pregnant or lactating women; (7) Other circumstances determined by the researcher to be unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Bath Ankylosing Spondylitis Disease Activity Index, BASDAI;

Secondary

MeasureTime frame
Severity of morning stiffness;Duration of morning stiffness;VAS;Ankylosing Spondylitis Disease Activity Score, ASDAS;Bath AS Function Index, BASFI;ASAS20;BASMI;CRP;erythrocyte sedimentation rate, ESR;ASQoL;TSQM;

Countries

China

Contacts

Public ContactJing Zhu

Sichuan Provincial People's Hospital

zhujingys@sina.com+86 189 8183 8317

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026