filgotinib phase 3

ASAS core set consists of 6 assessment domains: (1) participant's global assessment of disease activity, (2) spinal pain (derived from the spinal pain questionnaire), (3) function (derived from BASFI score), (4) inflammation (derived from morning stiffness questions from BASDAI), (5) hsCRP, (for these 5 domains, a lower score indicate lower disease activity) and (6) lateral spinal flexion (BASMI question 1) (for this 6th domain; a higher score indicate lower disease activity). Filgotinib in combination with methotrexate or as monotherapy versus methotrexate monotherapy in patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate: the phase 3, … Background/Purpose: Filgotinib (FIL)—an oral, selective Janus kinase 1 inhibitor (JAKi)—improved RA signs and symptoms in three phase 3 trials. Filgotinib in combination with methotrexate or as monotherapy versus methotrexate monotherapy in patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate: the phase 3, … MCS consists of social functioning, vitality, mental health, and role-emotional. Gilead and Galapagos Announce Filgotinib Meets Primary and Key Secondary Endpoints in the Phase 3 FINCH 1 Rheumatoid Arthritis Study. Excellent phase 3 trial data for rheumatoid arthritis drug filgotinib – but long road ahead By GlobalData Healthcare 16 Apr 2019 (Last Updated April 16th, 2019 09:28) On 28 March 2019, Gilead … <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/Annots[ 28 0 R 29 0 R] /MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> ��q��suB��D��n��Z�2E��4�"R"5pE��d�U�o��(_Ƴ�|�Gh�$S��O�+�Lǔ2�� I�dS��ϩH#�4ݿn4qyu��a}��jS�W��_��p}�G߯W��˗ɫo_'�>>v�F$B&�?I��fi&uRde�q-��\$��gY��o�?�u�,��|��g�d�Ъ,O3�� `��Oqk?��@�$߽�\2RyU��̛�>cS�G�q�62չ�8/VU�F��?��̒�r��~��J��Rb FIL was also well tolerated in RA patients with inadequate response to MTX. Patients were … BASDAI consists of 6 items asking participants to report their fatigue, spinal pain, peripheral arthritis, enthesitis, intensity, and duration of morning stiffness during the past week on a 0 to 10 numeric rating scale. According to a press release, in psoriatic arthritis, the therapeutic effectiveness of filgotinib will be evaluated in EQUATOR, a multicenter, double-blind, placebo-controlled Phase … 1 0 obj 8.3% patients on placebo and 6.7% patients on filgotinib had a 50% or more decline in sperm concentration at week 13 No new safety findings were identified Data will be submitted to … ASDAS is a composite score of 5 domains: total back pain, peripheral pain and/or swelling, duration of morning stiffness (derived from BASDAI questionnaire), participant's global assessment of disease activity, and serum high-sensitivity C-reactive protein (hsCRP). The data from the randomized, double-blind, placebo-controlled, Phase 2b/3 SELECTION trial showed that a significantly higher proportion of patients treated with filgotinib 200 mg, versus … FINCH Phase 3 program. Double-blind means the patient and the study doctor will not know what study drug (active or not active) the patient will be taking. BASDAI 50% improvement is achieved when a decrease in BASDAI versus baseline by at least 50%. The BASMI combines 5 measures: lateral spinal flexion, tragus-to-wall distance, lumbar flexion (modified Schober index), maximal intermalleolar distance, and cervical rotation. Filgotinib doses in combination with MTX have shown improved signs, symptoms and physical function in patients with RA and limited or no prior MTX exposure. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Proportion of Participants Who Achieve an Assessment of SpondyloArthritis international Society 40% Improvement (ASAS40) Response at Week 16 [ Time Frame: Week 16 ], Proportion of Participants Who Achieve an ASAS40 Response [ Time Frame: Up to Week 12 ], Proportion of Participants Who Achieve an Assessment of SpondyloArthritis international Society 20% Improvement (ASAS20) Response [ Time Frame: Up to Week 16 ], Proportion of Participants who achieve Ankylosing Spondylitis Disease Activity Score (ASDAS) Low Disease Activity (LDA) (ie, ASDAS < 2.1) [ Time Frame: Week 16 ], Proportion of Participants Who Achieve an ASAS 5/6 Response [ Time Frame: Up to Week 16 ], Change from Baseline in the Individual Components of the ASAS Core Set [ Time Frame: Baseline and up to Week 16 ], Proportion of Participants Who Achieve a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50% Improvement Response [ Time Frame: Up to Week 16 ], Change From Baseline in ASDAS [ Time Frame: Baseline and up to Week 16 ], Change From Baseline in BASDAI [ Time Frame: Baseline and up to Week 16 ], Change From Baseline in Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: Baseline and up to Week 16 ], Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) (Linear Score) [ Time Frame: Baseline and up to Week 16 ], Change From Baseline in Chest Expansion [ Time Frame: Baseline and up to Week 16 ], Change From Baseline in Occiput-to-wall Distance [ Time Frame: Baseline and up to Week 16 ], Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES), in Participants With Enthesitis at Baseline [ Time Frame: Baseline and up to Week 16 ], Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) [ Time Frame: Baseline and up to Week 16 ], Change From Baseline in Assessment of SpondyloArthritis international Society Health Index (ASAS HI) [ Time Frame: Baseline and up to Week 16 ], Change From Baseline in Physical Component Summary Score (PCS) of the 36-Item Short-Form Survey (SF-36) Version 2 [ Time Frame: Baseline and up to Week 16 ], Change From Baseline in Mental Component Summary Score (MCS) of the SF-36 Version 2 [ Time Frame: Baseline and up to Week 16 ], Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) [ Time Frame: Baseline and up to Week 16 ], Change From Baseline in Work Productivity and Activity Impairment for Ankylosing Spondylitis (WPAI-AS) [ Time Frame: Baseline and up to Week 16 ], Change From Baseline in EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) [ Time Frame: Baseline and up to Week 16 ], Change From Baseline in Spinal Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Week 16 [ Time Frame: Baseline; Week 16 ], Change From Baseline in Sacroiliac Joint (SIJ) SPARCC Score at Week 16 [ Time Frame: Baseline; Week 16 ], Ambulatory male or female, ≥ 18 years of age (≥ 20 years of age in Japan) on the day of signing initial informed consent, Have an established diagnosis of radiographic axial spondyloarthritis (SpA)/ ankylosing spondylitis (AS) by a rheumatologist (or other specialist with expertise diagnosing AS), History of back pain ≥ 3 months and age at onset of back pain < 45 years, AND, Radiographic sacroiliitis Grade ≥ 2 bilaterally or Grade 3-4 unilaterally, AND, ≥ 1 SpA feature (refer to protocol; inflammatory back pain, arthritis, heel enthesitis, uveitis anterior, dactylitis, psoriasis, inflammatory bowel disease, good response to nonsteroidal anti-inflammatory drugs (NSAIDs), family history of SpA, historically positive human leukocyte antigen B27 (HLA-B27), elevated C-reactive protein (CRP)), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4, AND, Spinal pain score ≥ 4 (based on BASDAI question 2), Have had an inadequate response to ≥ 2 NSAIDs at a therapeutic dose range for ≥ 2 weeks each (a total duration of NSAID trial ≥ 4 weeks) or intolerance to ≥ 2 NSAIDs for the treatment of AS, If using allowed conventional synthetic disease-modifying antirheumatic drug (csDMARD), NSAID, or corticosteroid therapy, must have been on stable doses (as outlined in protocol) prior to Day 1, Contraindication to magnetic resonance imaging (MRI), Prior exposure to a biologic disease-modifying antirheumatic drug (bioDMARD) (including investigational agents), Prior exposure to a Janus kinase (JAK) inhibitor > 2 doses, Any active/recent infection, as specified in the protocol, Note: Prior history of reactive or other types of inflammatory arthritis is permitted if there is documentation of change in diagnosis to AS or additional diagnosis of AS, Any history of an inflammatory arthritis with onset age before 16 years old. Talk with your doctor and family members or friends about deciding to join a study. All 23 disco-vertebral units (DVUs) will be scored. Across the Phase 3 studies, a significantly higher proportion of patients treated with filgotinib 200 mg plus MTX or other csDMARD achieved low disease activity and/or remission (DAS28-CRP ≤ 3.2 and DAS28-CRP < 2.6) at weeks 12 and 24 as compared to placebo or MTX. 4 0 obj The BASFI evaluates physical function in AS. Information provided by (Responsible Party): The primary objective of this study is to evaluate the effect of filgotinib versus placebo on signs and symptoms of active ankylosing spondylitis (AS), evaluated by Assessment of SpondyloArthritis international Society 40% improvement (ASAS40) response at Week 16 in participants with active AS who are naive to biologic disease-modifying antirheumatic drug therapy. Participants who permanently discontinue treatment in the Main Study will not be eligible for the Long-Term extension. In addition to ulcerative colitis, filgotinib is being evaluated by Gilead for the treatment of other inflammatory conditions including rheumatoid arthritis (FINCH Phase 3 trial), Crohn’s disease (DIVERSITY Phase 3 trial), psoriatic arthritis (PENGUIN phase 3 trials), uveitis (phase 2 trial), and small bowel and fistulizing Crohn’s disease (phase 2 trial). This 52-week, phase 3 study evaluated FIL in 1252 patients with RA. The maximal score for each DVU is 18. A Phase 3 study (NCT02914561) will assess the safety of filgotinib during induction and maintenance treatment of moderately to severely active CD. The SF-36 Version 2 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health perceptions, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). The study consists of 2 parts: Main Study (screening through Week 16) and Long-Term Extension (LTE) (up to 1.5 years after Week 16). To further assess the safety profile of filgotinib, investigators conducted a pooled safety analysis across phase 3 FINCH 1, 2, and 3 studies, which examined filgotinib in 100 and 200 mg doses. Low scores indicate more severe fatigue than high scores. FINCH 3 - Week 52 Data from Phase 3 Study … The ASAS40 calculation involves the analysis of 4 domains: participant's global assessment of disease activity, spinal pain (derived from the spinal pain questionnaire), function (derived from Bath Ankylosing Spondylitis Functional Index (BASFI) score), and inflammation (derived from morning stiffness questions from Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)). Across the Phase 3 studies, a significantly higher proportion of patients treated with filgotinib 200 mg plus MTX or other csDMARD achieved low disease activity and/or remission (DAS28-CRP ≤ 3… PHASE 3, Crohn’s disease, Rheumatoid arthritis, Ulcerative colitis Filgotinib is an orally available inhibitor of JAK1/JAK2 and TYK2 in phase III clinical development at Galapagos and Gilead … A lower score indicates lower disease activity. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. endobj 3 0 obj The distance between the occiput and the wall is assessed and the better of the 2 assessments is to be reported. The SIJ SPARCC score ranges 0 - 72, with higher scores indicating more inflammation. You have reached the maximum number of saved studies (100). In addition to ulcerative colitis, filgotinib is being evaluated by Gilead for the treatment of other inflammatory conditions including rheumatoid arthritis (FINCH Phase 3 trial), Crohn’s disease (DIVERSITY Phase 3 … FIL 200mg plus MTX, but not FIL 100mg plus MTX showed non-inferiority to ADA plus MTX, based on DAS28(CRP) low disease activity. FOSTER CITY, Calif. & MECHELEN, Belgium--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & Nasdaq: GLPG) today announced Week 52 results from the Phase 3 FINCH 1 and FINCH 3 … Listing a study does not mean it has been evaluated by the U.S. Federal Government. Among the 10 items, 8 items evaluate basic activities of daily living (putting on socks, bending, reaching up, 2 items on getting up, standing, climbing steps, and looking over shoulder) and 2 items assess participants' ability to cope with everyday life (physically demanding activities and full day's activities). The FACIT-Fatigue measures an individual's level of fatigue during their usual daily activities during the past week. x��\_s�6�w��_�jfˢ�$q�r��Ď�ֹ��ݦ*ه�4�nf8��~�� Filgotinib, sold under the brand name Jyseleca, is a medication used for the treatment of rheumatoid arthritis (RA). The safety and efficacy of 100 mg and 200 mg filgotinib once daily have been investigated in the FINCH clinical Phase 3 program which was initiated in August 2016 and which includes four Phase 3, randomized, multicenter studies in patients with moderate to severe RA.. Herpes zoster was observed in all treatment groups, with a numeric increase in the filgotinib 200 mg group compared with the filgotinib 100 mg group. The total sum of the ASAS HI ranges 0-17, with a lower score indicating a better health status. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04483700. Three studies addressing a broad population of patients with active rheumatoid arthritis Filgotinib 100 mg and 200 mg, once daily dosing in males and females worldwide in... | May 6, 2021 Each domain will be scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. Gilead and Galapagos Announce Positive Topline Results of Phase 2b/3 Trial of Filgotinib in Moderately to Severely Active Ulcerative Colitis. For general information, Learn About Clinical Studies. Investing News Network - … A phase 3 trial of Gilead and Galapagos’ JAK1 inhibitor filgotinib in rheumatoid arthritis has met its primary endpoint. Safety and efficacy of FIL was … Methods: Eligible patients completing the 24-week DARWIN 1 (filgotinib + MTX) and DARWIN 2 (filgotinib monotherapy) studies entered DARWIN 3, where they received filgotinib 200 mg/day, except for 15 … Gilead Sciences has suspended enrollment in two Phase 3 trials studying the effects of filgotinib, an anti-inflammatory therapy currently being investigated in several inflammatory … These data are particularly encouraging as we look ahead to phase 3 results from the ongoing FINCH 1 and 3 trials, which are exploring filgotinib in other populations of patients with rheumatoid arthritis." A single point will be assigned for each "yes" response, resulting in a total score between 0 and 18, with lower scores indicating a better quality of life.

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