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Comparative analysis of adult-onset Still's disease (AOSD) treatments

Comparison of different treatments in adult-onset Still's disease (AOSD): biologics, glucocorticoids, and conventional disease-modifying antirheumatic drugs (DMARDs)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN86135778
Enrollment
500
Registered
2023-12-14
Start date
2008-09-15
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Treatments of Adult-onset Still's Disease (AOSD, rheumatic disease) Musculoskeletal Diseases

Interventions

Retrospective Observational study Data collected: - Epidemiological data (age at onset, sex, height, weight, comorbidities) - Disease activity data (items of the Pouchot Score, CRP, Ferritin, Leuko

Sponsors

St. Elisabeth-Hospital Meerbusch-Lank
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Yamaguchi classification criteria are met 2. Documented clinical visits at onset/flare, by week 12 and week 72

Exclusion criteria

Exclusion criteria: Not matching the inclusion criteria

Design outcomes

Primary

MeasureTime frame
Sustained remission (definition see below) at week 12 and complication free until week 72 (definition see below). For remission, all of the below must be fulfilled: 1. Physician subjective evaluation of “remission” based on chart review 2. CRP below 10 mg/l 3. No fever during last week 4. No arthritis during last week 5. No ASOD-associated rash during last week For Complication-free (none of the following should have been appeared): 1. Complications of GC use 2. Diabetes necessitating insulin therapy 3. Gain in body weight (= 10%) 4. Osteonecrosis of any joint 5. Psychosis or other psychiatric disease requiring psychopharmacological intervention 6. Hypertension > 180 mmHg systolic pressure resulting in change of antihypertensive medication 7. Dyslipidemia requiring therapy with e.g. statins 8. Worsening of bone density > 0,5 SD (T1-4, neck or total hip), preexisting osteoporosis or osteoporosis diagnosed within 2 months of disease onset is not considered to be a GC-related event 9. Clinical diagnosis of steroid myopathy 10. Skin disease attributed to GC, e.g. striae, cutaneous necrosis, relevant subcutaneous bleeding or ulcerations 11. Eye disease attributable to GC (esp. cataract, glaucoma) 12. Serious infection necessitating intravenous antibiotic use 13. Death 14. Development of macrophage activation syndrome, AOSD-associated pneumonitis, ASOD-associated peri myocarditis 15. Ongoing disease activity requiring switch from DMARD-based to biological therapy

Secondary

MeasureTime frame
1. Flare-free survival in patients under remission 2. Rate of remission (definition see below) by week 12 and complication free by week 72 3. Retrospective analysis of differences in the glucocorticoid toxicity index (GTI) 4. GC dose reduction (at week 12 and week 72) 5. GC dose reduction by at least 75% compared to disease onset 6. Time to remission 7. Time to complication (definition see above) 8. Complications (definition see above)

Countries

Germany

Contacts

Public ContactAnna Kernder
anna_kernder@t-online.de+49 02118100

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Sep 6, 2026