Efficacy and Safety of Tranilast in Patients With Cryopyrin-Associated Periodic Syndrome (CAPS): A Single-Arm Prospective Cohort Study
Sponsor study identifier
interventional
71
1 country
1
Study Start
May 23, 2019
Actual (reported)Primary Completion
April 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 14, 2019
Actual (reported)April 22, 2019
Actual (reported)May 23, 2019
Actual (reported)April 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Changes in Auto-Inflammatory Diseases Activity Index score after 6-month treatment over baseline
Patients or their parents completed a 1-month (31 days) prospective diary with 12 yes/no items( Fever ≥38°C, Overall symptoms, Abdominal pain, Nausea/vomiting, Diarrhoea, Headaches, Chest pain, Painful nodes, Arthralgia or myalgia, Swelling of the joints, Eye manifestations, Skin rash) at the previous 1 month before treatment, and the 6th month after treatment . Each item of this diary was dichotomised as no (0)=absence of symptom or yes (1)=presence of symptom. The calculation of the Auto-Inflammatory Diseases Activity Index score is straightforward, consisting of the sum of all 12 items (0-372 in a month of 31 days). Higher values represent higher disease activity.
The previous 1 month before treatment and the 6th month after treatment
Changes in Auto-Inflammatory Diseases Activity Index score at the 1st and 3rd month over baseline
The previous 1 month before treatment and the 1st and 3rd month after treatment
Changes in inflammatory markers, including C-reactin protein, erythrocyte sedimentation rate, serum amyloid protein, interleukin-1β and interleukin-18， at 1, 3 and 6 months over baseline
Baseline and at 1, 3 and 6 months after treatment
Changes in physician global assessment of disease activity on a 0-10 visual analog scale (VAS) at 1, 3 and 6 months over baseline
Baseline and 1, 3 and 6 months after treatment
Changes in parent/patient global assessment of well-being on a 0-10 visual analogue score (VAS) at 1, 3 and 6 months over baseline
Baseline and 1, 3 and 6 months after treatment
Changes in CSF white blood cell count for CINCA patients
Baseline and 6 months after treatment.
5mg/kg.d for juvenile patients with a maximum dose of 0.3g per day; 0.1g each time, three times a day for adults patients
5mg/kg.d for juvenile patients with a maximum dose of 0.3g per day; 0.1g each time, three times a day for adults patients
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Hongmei Song
Peking Union Medical College Hospital
First Submitted
April 14, 2019
First Posted
April 22, 2019
Study Start
May 23, 2019
Actual (reported)Primary Completion
April 2024
A Study to Evaluate VTX2735 in Patients With Cryopyrin-associated Periodic Syndrome
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 4, 2019
Record last verified: 2019-06
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Source: ClinicalTrials.gov.
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