UnknownPhase 2

A Clinical Study of Tranilast in the Treatment of Cryopyrin-Associated Periodic Syndrome (CAPS)

China71 participantsStarted 2019-05-23

Plain-language summary

This is a prospective cohort study to observe the efficacy and safety of tranilast in CAPS patients. The investigators would analyze the changes in Auto-Inflammatory Diseases Activity Index (AIDAI) before and after treatment as well as changes in inflammatory markers, patients' and physician's global assessment of disease activity to determine the efficacy and safety of tranilast.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Raised inflammatory markers (CRP/SAA) (mandatory criteria)
✓. ≥2 of 6 CAPS typical signs/symptoms:
✓. Urticaria-like rash;
✓. Cold/stress triggered episodes;
✓. Sensorineural hearing loss;
✓. Musculoskeletal symptoms (arthralgia/arthritis/myalgia);
✓. Chronic aseptic meningitis;
✓. Skeletal abnormalities (epiphyseal overgrowth/frontal bossing).

Exclusion criteria

✕. Being treated with IL-1 inhibitor, other biological agents and immunosuppressants
✕. Pregnant and lactating women
✕. Serious organ function failure, expected life time less than 6 months

What they're measuring

Changes in Auto-Inflammatory Diseases Activity Index score after 6-month treatment over baseline

Timeframe: The previous 1 month before treatment and the 6th month after treatment

Trial details

NCT IDNCT03923140

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04

Contact for this trial

Hongmei Song, Doctor

+86-10-69156271 songhm1021@hotmail.com

View on ClinicalTrials.gov More Cryopyrin-Associated Periodic Syndromes trials