Sjogren's Syndrome News - LARVOL Sigma

Sjogren's Syndrome

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20 Mechanisms of Action

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||||||||||  Actemra IV (tocilizumab) / Roche, JW Pharma
Enrollment change:  ETAP: Efficacy of Tocilizumab in Primary Sj (clinicaltrials.gov) -  Mar 10, 2014
P2/3, N=110, Recruiting,  Sponsor: University Hospital, Strasbourg, France
N=80 --> 110

||||||||||  Actemra IV (tocilizumab) / Roche, JW Pharma
Enrollment open:  ETAP: Efficacy of Tocilizumab in Primary Sj (clinicaltrials.gov) -  Mar 10, 2014
P2/3, N=110, Recruiting,  Sponsor: University Hospital, Strasbourg, France
N=80 --> 110 Not yet recruiting --> Recruiting

||||||||||  pimecrolimus topical / Generic mfg.
Trial completion:  Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca (clinicaltrials.gov) -  Feb 22, 2014
P=N/A, N=440, Completed,  Sponsor: Novartis
Not yet recruiting --> Recruiting No longer recruiting --> Completed

|||||||||| New P2 trial: Laser Therapy to Treat the Dry Mouth of Sjogren's Syndrome (clinicaltrials.gov) - Feb 18, 2014
P2, N=34, Recruiting, Sponsor: Federal University of São Paulo

||||||||||  Orencia (abatacept) / BMS
New P3 trial:  ASAPIII: Efficacy and Safety of Abatacept in Patients With Primary Sj (clinicaltrials.gov) -  Feb 18, 2014
P3, N=88, Not yet recruiting,  Sponsor: University Medical Centre Groningen

||||||||||  FML, FML Forte (fluorometholone ophthalmic suspension) / AbbVie
Enrollment open:  Efficacy and Safety of Fluorometholone (FML) in Dry Eye Disease (Keratoconjunctivitis Sicca) (clinicaltrials.gov) -  Feb 17, 2014
P3, N=40, Recruiting,  Sponsor: Instituto Universitario de Oftalmobiología Aplicada
No longer recruiting --> Completed Not yet recruiting --> Recruiting

||||||||||  FML, FML Forte (fluorometholone ophthalmic suspension) / AbbVie
New P3 trial:  Efficacy and Safety of Fluorometholone (FML) in Dry Eye Disease (Keratoconjunctivitis Sicca) (clinicaltrials.gov) -  Jan 29, 2014
P3, N=40, Recruiting,  Sponsor: Instituto Universitario de Oftalmobiología Aplicada

|||||||||| New P4 trial: A New Oral salIvary equivAlent Compared to Two moisturizinG Mouth sprAys in Patients With xeRostomiA: NIAGARA Study (clinicaltrials.gov) - Jan 27, 2014
P4, N=210, Completed, Sponsor: Unither Pharmaceuticals, France

||||||||||  R 348 / Rigel
New P2 trial:  Safety and Efficacy Study of R932348 Ophthalmic Solution in Chronic Ocular Graft Versus Host Disease Patients(DROPS-2) (clinicaltrials.gov) -  Jan 16, 2014
P2, N=60, Not yet recruiting,  Sponsor: Rigel Pharmaceuticals

||||||||||  Orencia (abatacept) / BMS
New P2 trial, P2 data:  Abatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II Study (clinicaltrials.gov) -  Jan 2, 2014
P2, N=15, Recruiting,  Sponsor: Qingping Yao

||||||||||  cyclosporine ophthalmic emulsion / Generic mfg.
New P4 trial:  Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease (clinicaltrials.gov) -  Dec 4, 2013
P4, N=100, Recruiting,  Sponsor: Federal University of São Paulo

||||||||||  loteprednol etabonate / Generic mfg., cyclosporine ophthalmic emulsion / Generic mfg.
Enrollment closed:  Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease) (clinicaltrials.gov) -  Nov 21, 2013
P2, N=100, Active, not recruiting,  Sponsor: Bausch & Lomb Incorporated
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting

||||||||||  hydroxychloroquine / Generic mfg.
Enrollment change:  Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome (clinicaltrials.gov) -  Oct 15, 2013
P3, N=39, Completed,  Sponsor: Seoul National University Hospital
Recruiting --> Active, not recruiting N=60 --> 39

||||||||||  hydroxychloroquine / Generic mfg.
Trial completion:  Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome (clinicaltrials.gov) -  Oct 15, 2013
P3, N=39, Completed,  Sponsor: Seoul National University Hospital
N=60 --> 39 Recruiting --> Completed

|||||||||| Enrollment open: SAN-BB-01: At-Home Research Study for Patients With Autoimmune, Inflammatory, Genetic, Hematological, Infectious, Neurological, CNS, Oncological, Respiratory, Metabolic Conditions (clinicaltrials.gov) - Aug 25, 2013
P=N/A, N=20000, Recruiting, Sponsor: Sanguine Biosciences
Recruiting --> Completed Not yet recruiting --> Recruiting

|||||||||| Enrollment change: CoRDS: Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford (clinicaltrials.gov) - Aug 12, 2013
P=N/A, N=10000, Recruiting, Sponsor: Sanford Health
Not yet recruiting --> Recruiting N=1000 --> 10000

||||||||||  R 348 / Rigel
Enrollment open:  To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca (clinicaltrials.gov) -  Aug 11, 2013
P2, N=210, Recruiting,  Sponsor: Rigel Pharmaceuticals
N=1000 --> 10000 Not yet recruiting --> Recruiting

||||||||||  R 348 / Rigel
New P2 trial:  To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca (clinicaltrials.gov) -  Jul 14, 2013
P2, N=210, Recruiting,  Sponsor: Rigel Pharmaceuticals

||||||||||  Xolair (omalizumab) / Roche, Novartis
Enrollment change:  Omalizumab for Lupus (clinicaltrials.gov) -  Jun 14, 2013
P1, N=30, Recruiting,  Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Not yet recruiting --> Recruiting N=20 --> 30

|||||||||| New P4 trial: Treatment of Dry Eye Using 0.03% Tacrolimus Eye Drops (clinicaltrials.gov) - May 8, 2013
P4, N=24, Completed, Sponsor: University of Sao Paulo General Hospital

|||||||||| Enrollment change, IO biomarker: Neuro-SGSp: Neurotrophins Implications in Primary Sj (clinicaltrials.gov) - Apr 15, 2013
P=N/A, N=40, Completed, Sponsor: University Hospital, Limoges
N=20 --> 30 N=80 --> 40

|||||||||| Trial completion, IO biomarker: Neuro-SGSp: Neurotrophins Implications in Primary Sj (clinicaltrials.gov) - Apr 15, 2013
P=N/A, N=40, Completed, Sponsor: University Hospital, Limoges
N=80 --> 40 Recruiting --> Completed

||||||||||  loteprednol etabonate / Generic mfg., cyclosporine ophthalmic emulsion / Generic mfg.
New P2 trial:  Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease) (clinicaltrials.gov) -  Mar 21, 2013
P2, N=100, Active, not recruiting,  Sponsor: Bausch & Lomb Incorporated

||||||||||  R 348 / Rigel
Trial completion:  A Safety, Tolerability and Pharmacokinetics Study of R932348 Eye Drops in Patients With Dry Eye Disease (clinicaltrials.gov) -  Mar 20, 2013
P1, N=36, Completed,  Sponsor: Rigel Pharmaceuticals
Recruiting --> Completed Active, not recruiting --> Completed

||||||||||  dexamethasone / Generic mfg.
Clinical:  Effects of Dry Eye Treatments on the Ocular Surface (clinicaltrials.gov) -  Feb 21, 2013
P=N/A, N=30, Recruiting,  Sponsor: Baylor College of Medicine

||||||||||  bupivacaine buccal / Oracain
Enrollment open:  Clinical Trials With a Local Anesthetic Lozenge for the Treatment of Chronic Oral Pain (clinicaltrials.gov) -  Feb 20, 2013
P2, N=60, Recruiting,  Sponsor: Hvidovre University Hospital
Active, not recruiting --> Completed Not yet recruiting --> Recruiting

|||||||||| Clinical: CoRDS: Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford (clinicaltrials.gov) - Feb 13, 2013
P=N/A, N=10000, Recruiting, Sponsor: Sanford Health

||||||||||  Actemra IV (tocilizumab) / Roche, JW Pharma
New P2/3 trial:  ETAP: Efficacy of Tocilizumab in Primary Sj (clinicaltrials.gov) -  Jan 30, 2013
P2/3, N=110, Recruiting,  Sponsor: University Hospital, Strasbourg, France

||||||||||  Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Trial completion:  TEARS: Tolerance and Efficacy of Rituximab in Sjogren's Disease (clinicaltrials.gov) -  Jan 20, 2013
P2/3, N=122, Completed,  Sponsor: University Hospital, Brest
Not yet recruiting --> Recruiting Active, not recruiting --> Completed

||||||||||  Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Trial completion:  Anti-CD20 Antibody Therapy for Sjogren's Syndrome (clinicaltrials.gov) -  Dec 20, 2012
P1, N=12, Completed,  Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  R 348 / Rigel
New P1 trial:  A Safety, Tolerability and Pharmacokinetics Study of R932348 Eye Drops in Patients With Dry Eye Disease (clinicaltrials.gov) -  Nov 25, 2012
P1, N=36, Completed,  Sponsor: Rigel Pharmaceuticals

||||||||||  Xolair (omalizumab) / Roche, Novartis
New P1 trial:  Omalizumab for Lupus (clinicaltrials.gov) -  Oct 25, 2012
P1, N=30, Recruiting,  Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

||||||||||  cyclosporin A microemulsion / Generic mfg.
New P2 trial:  CYPRESS: Low Dose Cyclosporin A in Primary Sjögren Syndrome (clinicaltrials.gov) -  Sep 24, 2012
P2, N=30, Recruiting,  Sponsor: Charite University, Berlin, Germany

||||||||||  Benlysta (belimumab) / GSK
Trial completion:  Efficacy and Safety of Belimumab in Primary Sj (clinicaltrials.gov) -  Sep 2, 2012
P2, N=15, Completed,  Sponsor: University of Udine
Active, not recruiting --> Completed Recruiting --> Completed

||||||||||  baminercept (BG 9924) / Biogen
Enrollment open:  Baminercept, a Lymphotoxin-Beta Receptor Fusion Protein, for Treatment of Sj (clinicaltrials.gov) -  Aug 15, 2012
P2, N=72, Recruiting,  Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Recruiting --> Completed Not yet recruiting --> Recruiting

|||||||||| New P1/2 trial: Green Tea Lozenges for the Management of Dry Mouth (clinicaltrials.gov) - Jul 22, 2012
P1/2, N=60, Recruiting, Sponsor: Georgia Regents University

|||||||||| Biomarker: Regulatory B Cells in Inflammatory Rheumatisms and Biomarkers of Response to Biologic Treatments (clinicaltrials.gov) - Jul 15, 2012
P=N/A, N=200, Recruiting, Sponsor: University Hospital, Montpellier

||||||||||  Benlysta (belimumab) / GSK
Enrollment change, IO biomarker:  BELISS: Efficacy and Safety of Belimumab in Subjects With Primary Sj (clinicaltrials.gov) -  Jun 30, 2012
P2, N=20, Completed,  Sponsor: Assistance Publique - H
Not yet recruiting --> Recruiting N=15 --> 20

||||||||||  Benlysta (belimumab) / GSK
Trial completion, IO biomarker:  BELISS: Efficacy and Safety of Belimumab in Subjects With Primary Sj (clinicaltrials.gov) -  Jun 30, 2012
P2, N=20, Completed,  Sponsor: Assistance Publique - H
N=15 --> 20 Recruiting --> Completed

||||||||||  hydroxychloroquine / Generic mfg.
Trial completion:  JOQUER: Hydroxychloroquine Versus Placebo in Primary Sj (clinicaltrials.gov) -  Jun 30, 2012
P3, N=120, Completed,  Sponsor: Assistance Publique - H
Recruiting --> Completed Recruiting --> Completed

||||||||||  Xiidra (lifitegrast) / Novartis
Trial completion:  Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1) (clinicaltrials.gov) -  May 27, 2012
P3, N=588, Completed,  Sponsor: SARcode Bioscience
Recruiting --> Completed Active, not recruiting --> Completed

||||||||||  hydroxychloroquine / Generic mfg.
New P3 trial:  Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome (clinicaltrials.gov) -  May 15, 2012
P3, N=39, Completed,  Sponsor: Seoul National University Hospital

||||||||||  bupivacaine buccal / Oracain
New P2 trial:  Clinical Trials With a Local Anesthetic Lozenge for the Treatment of Chronic Oral Pain (clinicaltrials.gov) -  Apr 23, 2012
P2, N=60, Recruiting,  Sponsor: Hvidovre University Hospital

||||||||||  Pulmozyme (dornase alfa) / Roche
Trial withdrawal:  Pulmozyme for Sjogren's Associated Cough (clinicaltrials.gov) -  Mar 28, 2012
P1, N=0, Withdrawn,  Sponsor: University of Connecticut Health Center
Active, not recruiting --> Completed Recruiting --> Withdrawn

||||||||||  Pulmozyme (dornase alfa) / Roche
Enrollment change:  Pulmozyme for Sjogren's Associated Cough (clinicaltrials.gov) -  Mar 28, 2012
P1, N=0, Withdrawn,  Sponsor: University of Connecticut Health Center
Recruiting --> Withdrawn N=10 --> 0

|||||||||| Trial termination: Omega-3 Fatty Acid Supplements and Dry Eye (clinicaltrials.gov) - Mar 18, 2012
P=N/A, N=35, Terminated, Sponsor: Ohio State University
N=10 --> 0 Active, not recruiting --> Terminated; Researchers left institution

||||||||||  baminercept (BG 9924) / Biogen
New P2 trial:  Baminercept, a Lymphotoxin-Beta Receptor Fusion Protein, for Treatment of Sj (clinicaltrials.gov) -  Mar 11, 2012
P2, N=72, Recruiting,  Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

|||||||||| Enrollment change: Efficacy and Safety Study of Nutritional Supplements for Treatments of Dry Eye (clinicaltrials.gov) - Feb 15, 2012
P=N/A, N=62, Completed, Sponsor: Virginia Eye Consultants
Active, not recruiting --> Terminated; Researchers left institution N=48 --> 62

|||||||||| Trial completion: Efficacy and Safety Study of Nutritional Supplements for Treatments of Dry Eye (clinicaltrials.gov) - Feb 15, 2012
P=N/A, N=62, Completed, Sponsor: Virginia Eye Consultants
N=48 --> 62 Recruiting --> Completed

||||||||||  Vismed (sodium hyaluronate) / TRB Chemedica
Trial completion:  Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye (clinicaltrials.gov) -  Sep 19, 2011
P4, N=82, Completed,  Sponsor: Allergan
Recruiting --> Completed Active, not recruiting --> Completed