Sjogren's Syndrome Clinical Trial
Official title:
A Randomized, Phase 2, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib, GS-9876 and GS-4059 in Adult Subjects With Active Sjogren's Syndrome
| Verified date | October 2020 |
| Source | Gilead Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary objective of this study is to assess the efficacy of filgotinib, lanraplenib, and tirabrutinib in adults with active Sjogren's Syndrome (SjS).
| Status | Completed |
| Enrollment | 152 |
| Est. completion date | October 2, 2019 |
| Est. primary completion date | January 10, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | Key Inclusion Criteria: - Diagnosed with primary or secondary SjS according to the 2002 American European Consensus Group (AECG) classification - Active SjS as defined by an European League Against Rheumatism (EULAR) Sjogren's syndrome disease activity index (ESSDAI) = 5 - Seropositivity for antibodies to SjS-associated antigens A and/or B (anti-SSA or anti-SSB) Key Exclusion Criteria: - Concurrent treatment with any biologic disease modifying antirheumatic drug (bDMARD) (prior bDMARD treatment allowed with appropriate washout as per study protocol) Note: Other protocol defined Inclusion/Exclusion criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| Poland | Centrum Kliniczno-Badawcze | Elblag | |
| Poland | Intermedius | Koscian | |
| Poland | Ai Centrum Medyczne | Poznan | |
| Poland | Centrum Badan Klinicznych S.C | Poznan | |
| Poland | Centrum Medyczne Amed Warszawa Targowek | Warszawa | |
| Poland | Centrum Medyczne Oporow | Wroclaw | |
| Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
| Spain | Hospital General Universitario De Elche | Elche | |
| Spain | Hospital Universitario de Fuenlabrada | Fuenlabrada | |
| Spain | Hospital Regional Universitario de Malaga | Málaga | |
| Spain | Hospital De Merida | Mérida | |
| Spain | Corporacio Sanitaria Parc Taulí de Sabadell | Sabadell | |
| Spain | Hospital Clinico Universitario de Salamanca | San Vicente | |
| Spain | Hospital Quironsalud Infanta Luisa | Sevilla | |
| United Kingdom | Doncaster Royal Infirmary | Doncaster | |
| United Kingdom | Western General Hospital | Edinburgh | |
| United Kingdom | Princess Alexandra Hospital | Harlow | |
| United Kingdom | Great Western Hospital | Swindon | |
| United Kingdom | Warrington Hospital | Warrington | |
| United States | Albuquerque Clinical Trials | Albuquerque | New Mexico |
| United States | Diagnostic Group Integrated Healthcare System, Pllc | Beaumont | Texas |
| United States | East Penn Rheumatology Associates, P.C. | Bethlehem | Pennsylvania |
| United States | Joint and Muscle Research Institute | Charlotte | North Carolina |
| United States | ClinSearch | Chattanooga | Tennessee |
| United States | The Center for Arthritis and Rheumatic Diseases, PC | Chesapeake | Virginia |
| United States | Clinical Research of West Florida, Inc. | Clearwater | Florida |
| United States | Medvin Clinical Research | Covina | California |
| United States | Omega Research Consultants LLC | DeBary | Florida |
| United States | Denver Arthritis Clinic | Denver | Colorado |
| United States | Altoona Center for Clinical Research | Duncansville | Pennsylvania |
| United States | Center for Arthritis & Osteoporosis | Elizabethtown | Kentucky |
| United States | Center for Rheumatology Immunology and Arthritis | Fort Lauderdale | Florida |
| United States | Accurate Clinical Research Inc. | Houston | Texas |
| United States | June DO, PC | Lansing | Michigan |
| United States | North Georgia Rheumatology Group, PC | Lawrenceville | Georgia |
| United States | Wasatch Peak Family Practice | Layton | Utah |
| United States | Cape Fear Arthritis Care, PLLC | Leland | North Carolina |
| United States | Physician Research Collaboration, LLC | Lincoln | Nebraska |
| United States | Ramesh C. Gupta, MD | Memphis | Tennessee |
| United States | AARR Arizona Arthritis & Rheumatology Research | Mesa | Arizona |
| United States | Southwest Rheumatology Research | Mesquite | Texas |
| United States | Suncoast Clinical Research, Inc. | New Port Richey | Florida |
| United States | AARR Arizona Arthritis & Rheumatology Research | Phoenix | Arizona |
| United States | Trinity Universal Research Associates | Plano | Texas |
| United States | IRIS Research and Development, LLC | Plantation | Florida |
| United States | Clayton Medical Associates | Saint Louis | Missouri |
| United States | PMG Research of Salisbury | Salisbury | North Carolina |
| United States | Arthritis Northwest | Spokane | Washington |
| United States | Springfield Clinic | Springfield | Illinois |
| United States | North Mississippi Medical Clinics, Inc. - Clinical Research | Tupelo | Mississippi |
| United States | Inland Rheumatology Clinical Trials, Inc. | Upland | California |
| United States | Arthritis & Osteoporosis Clinic | Waco | Texas |
| United States | Clinical Research Center of Reading, LLC | Wyomissing | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Gilead Sciences | Galapagos NV, Ono Pharmaceutical Co. Ltd |
United States, Poland, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline | Response was defined as: Improvement = 20% in = 3 of 5 participant-reported Sjogren's syndrome (SjS) related visual analogue score (VAS) measures (participant's assessment of global disease, pain, oral dryness, ocular dryness and fatigue), with no increase defined as > 30 mm from baseline (Day 1) in any of the above 5 VAS measures, AND either = 20% improvement in high sensitivity C-reactive protein (hsCRP) (if hsCRP = 1.5 x upper limit of normal [ULN] on Day 1) or no increase in hsCRP to = 1.5 x ULN (if hsCRP < 1.5 x ULN on Day 1). | Week 12 | |
| Secondary | Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 12 | The ESSDAI is a physician-administered tool designed to measure disease activity. It consists of 12 organ-specific 'domains' contributing to disease activity associated with the participant's Sjogren's Syndrome only (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. Overall score (ranges from 0 (no activity) to 123 (worst activity)) is calculated as sum of all individual weighted domain scores. A negative change from baseline value indicates improvement. | Baseline; Week 12 | |
| Secondary | Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Week 12 | The ESSPRI is a participant-reported questionnaire to assess subjective participant symptoms and includes 3 domains (dryness, pain, and fatigue). Each domain is scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10. A negative change from baseline value indicates improvement. | Baseline; Week 12 | |
| Secondary | Change From Baseline in ESSDAI at Week 24 | The ESSDAI is a physician-administered tool designed to measure disease activity. It consists of 12 organ-specific 'domains' contributing to disease activity associated with the participant's Sjogren's Syndrome only (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. Overall score (ranges from 0 (no activity) to 123 (worst activity)) is calculated as sum of all individual weighted domain scores. A negative change from baseline value indicates improvement. | Baseline; Week 24 | |
| Secondary | Change From Baseline in ESSPRI at Week 24 | The ESSPRI is a participant-reported questionnaire to assess subjective participant symptoms and includes 3 domains (dryness, pain, and fatigue). Each domain is scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10. A negative change from baseline value indicates improvement. | Baseline; Week 24 |
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