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Patient-Reported Outcome Evaluation of Golimumab in the Treatment of Ankylosing Spondylitis: A Prospective Observational Study

Patient-Reported Outcome Evaluation of Golimumab in the Treatment of Ankylosing Spondylitis: A Prospective Observational Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600127221
Enrollment
Unknown
Registered
2026-06-26
Start date
2021-04-16
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

ankylosing spondylitis

Interventions

Observation group:None

Sponsors

Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The patient must be at least 18 years old; 2. Diagnosis meets the 1984 New York criteria for ankylosing spondylitis; 3. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >= 4; 4. The patient can understand and complete self-assessment questionnaires;

Exclusion criteria

Exclusion criteria: 1. Patients who have contraindications to golimumab 2. Patients currently using bDMARDs or who have stopped using bDMARDs for less than 3 months.

Design outcomes

Primary

MeasureTime frame
ASAS20 response rate;ASAS40 response rate;Ankylosing Spondylitis Disease Activity Score (ASDAS);

Secondary

MeasureTime frame
Functional Assessment of Chronic Illness Therapy - Fatigue Score;Bath Ankylosing Spondylitis Disease Activity Index;SPARCC Scores of the Spine and Sacroiliac Joints;Pittsburgh Sleep Quality Index Score;Visual Analogue Scale Score;

Countries

China

Contacts

Public ContactDongyi He

Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

dongyihe@medmail.com.cn+86 21 62805833

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026