CIDP07 Rozanolixizumab Post Trial Access Program (the PTA)
1 other identifier
expanded_access
N/A
0 countries
N/A
Brief Summary
This Post Trial Access (PTA) Program enables access to rozanolixizumab for eligible patients who have taken part in the CIDP04 trial (NCT04051944) and are continuing to derive benefit from treatment.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2021
CompletedFirst Posted
Study publicly available on registry
August 20, 2021
CompletedJanuary 25, 2024
January 1, 2024
August 19, 2021
January 23, 2024
Conditions
Keywords
Interventions
Rozanolixizumab is dosed weekly. Patients should continue to receive the dose they were receiving in the CIDP04 (NCT04051944) trial.
Eligibility Criteria
You may qualify if:
- Patient who has taken part in the CIDP04 (NCT04051944) study
- Patient who derives continued benefit from treatment
- All required safety information has been reported as per local laws/regulations, reported to Bionical, as appropriate, and documented in the patient's medical records
- Patient is not pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273 (UCB)
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2021
First Posted
August 20, 2021
Last Updated
January 25, 2024
Record last verified: 2024-01