Anifrolumab Treatment for 24 Weeks in Patients With Primary Sjögren's Syndrome
Not yet recruiting
AstraZeneca
Phase 2
2022-06-01
The ANISE-II study is a randomized, double-blind, placebo-controlled phase IIa
proof-of-concept trial. Thirty patients with primary Sjögren's syndrome (pSS) are randomized
in a 2:1 ratio to either anifrolumab or placebo treatment for 24 weeks. Main inclusion
criteria are fulfilment of the ACR/EULAR classification criteria for pSS, disease duration of
≤10 years, and an ESSDAI and/or ESSPRI of ≥5 (at least 50% of patients need to fulfil the
ESSDAI ≥5 criterion). The primary outcome measure is Composite of Relevant Endpoints for
Sjögren's Syndrome (CRESS) response at week 24.
Anifrolumab Treatment for 24 Weeks in Patients With Primary Sjögren's Syndrome
Not yet recruiting
University Medical Center Groningen
Phase 2
2022-06-01
The ANISE-II study is a randomized, double-blind, placebo-controlled phase IIa
proof-of-concept trial. Thirty patients with primary Sjögren's syndrome (pSS) are randomized
in a 2:1 ratio to either anifrolumab or placebo treatment for 24 weeks. Main inclusion
criteria are fulfilment of the ACR/EULAR classification criteria for pSS, disease duration of
≤10 years, and an ESSDAI and/or ESSPRI of ≥5 (at least 50% of patients need to fulfil the
ESSDAI ≥5 criterion). The primary outcome measure is Composite of Relevant Endpoints for
Sjögren's Syndrome (CRESS) response at week 24.
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