Phase
Condition
Sjogren's Syndrome
Eye Disease
Musculoskeletal Diseases
Treatment
ABBV-319
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Systemic Lupus Erythematosus (SLE) Population - Clinical diagnosis of SLE at least 6months prior to Screening as defined by the 2019 European Alliance of Associationsfor Rheumatology (EULAR)/American College Of Rheumatology (ACR) classificationcriteria for SLE and a positive antinuclear antibody (ANA) >= 1:80 drawn atScreening.
SLE Population - Anti-double stranded DNA (dsDNA), anti-Smith (Sm),anti-ribonucleoprotein (RNP), or anti-Sjogren's syndrome Ag A (SSA) Abs above theupper limit of normal (ULN).
Sjogren's Disease (SjD) Population - Primary diagnosis of SjD at least 6 monthsprior to Screening as defined by the ACR/EULAR 2016 Criteria.
SjD Population - EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) >= 5 atScreening.
SjD Population - EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) >= 5 atScreening.
Rheumatoid Arthritis (RA) Population - Clinical diagnosis of RA and fulfilling the 2010 ACR/EULAR classification criteria for RA.
RA Population - Rheumatoid Factor (RF) or ACPA above the ULN at Screening.
RA Population - Confirmation of at least moderate disease activity at Screening,defined by both of the following disease activity criteria:
Presence of at least 6 swollen and 6 tender joints at Screening using the 68 (tender)/66 (swollen) joint count.
hs-CRP ≥3 mg/L.
Exclusion
Exclusion Criteria:
History of infection as defined in the protocol.
Any of the medical diseases or disorders listed in the protocol.
History of clinically significant (per investigator's judgment) drug or alcoholabuse within the 6 months prior to Screening.
Any planned elective surgery that would impact study procedures or assessmentsthrough the completion of the Day 365 assessments.
Any clinically significant ECG abnormalities at Screening.
RA-Specific Exclusion Criteria - History of RA overlap syndromes, including but notlimited to, SLE, SjD, scleroderma, mixed connective tissue disease, or polymyositis.
Study Design
Connect with a study center
Les Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre /ID# 272692
Strasbourg, Alsace 67200
FranceActive - Recruiting
CHU de Montpellier - Hopital Lapeyronie /ID# 279892
Montpellier, Herault 34090
FranceActive - Recruiting
Amsterdam University Medical Center /ID# 274286
Amsterdam, North Holland 1105 AZ
NetherlandsActive - Recruiting
Universitair Medisch Centrum Utrecht /ID# 273398
Utrecht, 3584 CX
NetherlandsActive - Recruiting
Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 278239
Avon Park, Florida 33825
United StatesSite Not Available
Clinical Research Of West Florida - Phase I Unit /ID# 275834
Clearwater, Florida 33765
United StatesSite Not Available
Life Clinical Trials - Colonial Drive - Margate /ID# 276050
Margate, Florida 33063
United StatesActive - Recruiting
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 275836
Tampa, Florida 33606
United StatesActive - Recruiting
Advanced Quality Medical Research /ID# 278462
Orland Park, Illinois 60462
United StatesActive - Recruiting
Private Practice - Dr. Ramesh C. Gupta /ID# 275826
Memphis, Tennessee 38119
United StatesActive - Recruiting
Integrative Rheumatology of South Texas - Harlingen /ID# 276458
Harlingen, Texas 78550
United StatesActive - Recruiting

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