Ignite Creation Date:
2024-05-05 @ 10:10 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01045772
Status:
COMPLETED
Last Update Posted:
2012-05-31
First Post:
2010-01-07
Brief Title:
Safety and Tolerability of Rilonacept in Muckle-Wells Syndrome MWS or Schnitzler Syndrome SchS
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
A Single-Centre Open Label Study of the Safety and Tolerability of Rilonacept in Subjects Living in Germany With Muckle-Wells Syndrome MWS a Cryopyrin-Associated Periodic Syndrome CAPS or Schnitzler Syndrome SchS
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACCILTRA1
Brief Summary:
This is a single-center open label study of the IL-1 transfusion protein rilonacept in subjects with Muckle-Wells syndrome MWS or Schnitzler syndrome SchS in Germany Prospective subjects will be recruited from a patient population previously characterized in an observational study and from referrals within the German CAPS community SchS subjects will be recruited through the Charité Patient pool
The Baseline phase will begin with the Screening visit day -21 Visit 1 and continue for three weeks DHAFs Daily Health Assessment Forms will be collected from all subjects from Day - 21 to Day 0 DHAF information including MWAS Muckle-Wells Activity Score or SCHAS Schnitzler Activity Score values from this period will be used for the baseline phase evaluation Inclusion to receive rilonacept will occur on day 0 Visit 2
On day 0 eligible subjects will receive a loading dose of two subcutaneous SC injections of rilonacept for a total of 320 mg Subsequent study drug injections of rilonacept 160 mg will be administered once a week for four weeks After subjects complete this initial 4-week treatment phase they will be eligible to receive rilonacept 160 mg once weekly for 48 weeks during the extended treatment phase
DHAFs will be used to assess symptoms throughout the study Overall a max of 12 subjects with either MWS or SchS will be enrolled
The Baseline phase will begin with the Screening visit day -21 Visit 1 and continue for three weeks DHAFs Daily Health Assessment Forms will be collected from all subjects from Day - 21 to Day 0 DHAF information including MWAS Muckle-Wells Activity Score or SCHAS Schnitzler Activity Score values from this period will be used for the baseline phase evaluation Inclusion to receive rilonacept will occur on day 0 Visit 2
On day 0 eligible subjects will receive a loading dose of two subcutaneous SC injections of rilonacept for a total of 320 mg Subsequent study drug injections of rilonacept 160 mg will be administered once a week for four weeks After subjects complete this initial 4-week treatment phase they will be eligible to receive rilonacept 160 mg once weekly for 48 weeks during the extended treatment phase
DHAFs will be used to assess symptoms throughout the study Overall a max of 12 subjects with either MWS or SchS will be enrolled
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT Number 2006-004290-97 | OTHER | EMEA | None |