A Real-World Study on the Safety and Efficacy of Adalimumab Injection in Patients with Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriasis

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2600118695

Enrollment

Unknown

Registered

2026-02-10

Start date

2026-02-13

Completion date

Unknown

Last updated

2026-02-16

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

Conditions

Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriasis

Interventions

Rheumatoid arthritis patients group:None

Ankylosing spondylitis patients group:None

Patients with moderate-to-severe plaque psoriasis group:None

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years, regardless of gender; 2. Meet the international/domestic diagnostic criteria for the respective diseases:RA: Fulfill the 2010 ACR/EULAR Rheumatoid Arthritis classification criteria.AS: Fulfill the 1984 modified New York criteria for Ankylosing Spondylitis.Ps: Clinically diagnosed with moderate-to-severe plaque psoriasis; 3. Physician's decision to initiate adalimumab treatment (either as a first-line biologic or a switch from another biologic agent); 4. Voluntarily sign the Informed Consent Form.

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity to adalimumab or any of its excipients; 2. Contraindications listed in the adalimumab package insert (e.g., active tuberculosis or other serious infections, moderate-to-severe heart failure (NYHA Class III/IV), etc.); 3. Currently participating in another interventional clinical trial; 4. Any other condition deemed by the Investigator to make the subject unsuitable for this study.

Design outcomes

Primary

Measure	Time frame
The incidence of adverse events of special interest (AESI) associated with adalimumab injection treatment at 24 weeks and throughout the entire observation period;The incidence, severity, and outcomes of adverse events (AEs) and serious adverse events (SAEs) associated with adalimumab injection treatment within 24 weeks;The incidence, severity, and outcomes of adverse events (AEs) and serious adverse events (SAEs) throughout the entire observation period;	—

Measure

Time frame

The incidence of adverse events of special interest (AESI) associated with adalimumab injection treatment at 24 weeks and throughout the entire observation period;The incidence, severity, and outcomes of adverse events (AEs) and serious adverse events (SAEs) associated with adalimumab injection treatment within 24 weeks;The incidence, severity, and outcomes of adverse events (AEs) and serious adverse events (SAEs) throughout the entire observation period;

—

Secondary

Measure	Time frame
Change from baseline in the Short Form Health Survey (SF-36) score;Rheumatoid Arthritis cohort: Change from baseline in Disease Activity Score (DAS28-ESR);Ankylosing Spondylitis cohort: Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score;Psoriasis cohort: Change from baseline in Dermatology Life Quality Index (DLQI) score;	—

Countries

China

Contacts

Public ContactYonghong Cui;Hong Li

Sinopharm Tongmei General Hospital

Chaojituzi_2008@163.com+86 136 5352 7336

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026