DDT COA #000135: Cutaneous Lupus Erythematosus Disease Area and Severity Index in Systemic Lupus Erythematosus
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Immunology and Inflammation (OII)
Division of Dermatology and Dentistry (DDD)
DDT COA Number
DDT COA #000135
Instrument Name
Cutaneous Lupus Erythematosus Disease and Severity Index (CLASI)
Disease/Condition
Systemic Lupus Erythematosus (SLE)
Concept of Interest
Presence and severity of signs of cutaneous manifestations
Context of Use
Patients with SLE
COA Type
ClinRO
Qualification Stage
Letter of Intent- Accepted
Requestor(s)
The CLASI Working Group
Contact(s)
Joseph Merola
Alyssa Parks
Victoria Werth
Date Accepted into CDER’s COA Qualification Program
August 5, 2020
Submission and Regulatory Correspondence History
| Qualification Submission | Date | FDA Submission Decision & Recommendations | Date |
|---|---|---|---|
| Letter of Intent Attachment A |
5/4/20 | FDA Response (Accepted) | 8/5/20 |