Autoimmune Diseases News - LARVOL Sigma

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198 Mechanisms of Action

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||||||||||  Cosentyx (secukinumab) / Novartis
Biomarker, Enrollment closed:  A Biomarker Study of Secukinumab in Rheumatoid Arthritis (RA) Patients (clinicaltrials.gov) -  Nov 4, 2012
P2, N=500, Active, not recruiting,  Sponsor: Novartis Pharmaceuticals
Recruiting --> Active, not recruiting

||||||||||  teriflunomide / Generic mfg.
Enrollment closed:  TOPIC: Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis (clinicaltrials.gov) -  Nov 4, 2012
P3, N=618, Active, not recruiting,  Sponsor: Sanofi
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting

||||||||||  Victoza (liraglutide) / Novo Nordisk
New P3 trial:  Anti-diabetic Effects of Liraglutide in Adolescents and Young Subjects With Type 1 Diabetes (clinicaltrials.gov) -  Nov 4, 2012
P3, N=45, Recruiting,  Sponsor: Kaleida Health

|||||||||| Trial initiation date: Vitamin D3 Treatment in Pediatric Systemic Lupus Erythematosus (clinicaltrials.gov) - Nov 1, 2012
P2, N=78, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Recruiting --> Active, not recruiting Initiation date: Oct 2012 --> Jun 2013

||||||||||  dalfampridine / Generic mfg.
Enrollment closed:  FAME - Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra (clinicaltrials.gov) -  Nov 1, 2012
P4, N=125, Active, not recruiting,  Sponsor: University of Southern Denmark
Initiation date: Oct 2012 --> Jun 2013 Recruiting --> Active, not recruiting

||||||||||  Jyseleca (filgotinib) / Galapagos, Gilead
Trial completion, Combination therapy:  Dose-ranging Study With GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients (clinicaltrials.gov) -  Nov 1, 2012
P2, N=91, Completed,  Sponsor: Galapagos NV
Recruiting --> Active, not recruiting Active, not recruiting --> Completed

||||||||||  Ersatta (mono-pegylated version of C-peptide) / Cebix
Trial completion:  Safety and Pharmacokinetics of CBX129801 in Patients With Type 1 Diabetes (clinicaltrials.gov) -  Nov 1, 2012
P1/2, N=72, Completed,  Sponsor: Cebix Incorporated
Active, not recruiting --> Completed Active, not recruiting --> Completed

|||||||||| Trial completion: A Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple Sclerosis (clinicaltrials.gov) - Nov 1, 2012
P1, N=40, Completed, Sponsor: Oregon Health and Science University
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  PRT062607 / Biogen, AstraZeneca
Trial withdrawal:  EMBRACE: BIIB057 in Subjects With Rheumatoid Arthritis and Inadequate Response to Disease-Modifying Antirheumatic Drugs (clinicaltrials.gov) -  Oct 31, 2012
P2, N=0, Withdrawn,  Sponsor: Biogen Idec
Active, not recruiting --> Completed Not yet recruiting --> Withdrawn

||||||||||  PRT062607 / Biogen, AstraZeneca
Enrollment change:  EMBRACE: BIIB057 in Subjects With Rheumatoid Arthritis and Inadequate Response to Disease-Modifying Antirheumatic Drugs (clinicaltrials.gov) -  Oct 31, 2012
P2, N=0, Withdrawn,  Sponsor: Biogen Idec
Not yet recruiting --> Withdrawn N=156 --> 0

||||||||||  staphylococcal protein A (PRTX-100) / Protalex
Trial termination:  Phase I Safety and Tolerability Study of Staphylococcal Protein A in Adult Patients With Chronic ITP (clinicaltrials.gov) -  Oct 31, 2012
P1, N=9, Terminated,  Sponsor: Protalex, Inc.
N=156 --> 0 Recruiting --> Terminated; Terminated due to recruitment not meeting expectations.

||||||||||  Actemra IV (tocilizumab) / Roche, JW Pharma
Trial initiation date:  A Long-term Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients With Rheumatoid Arthritis (clinicaltrials.gov) -  Oct 31, 2012
P3, N=538, Completed,  Sponsor: Hoffmann-La Roche
Recruiting --> Terminated; Terminated due to recruitment not meeting expectations. Initiation date: Apr 1909 --> Aug 2005

||||||||||  Actemra IV (tocilizumab) / Roche, JW Pharma
Enrollment change, Combination therapy:  A Study of RoActemra/Actemra (Tocilizumab) Plus DMARDs in Patients With Rheumatoid Arthritis (clinicaltrials.gov) -  Oct 31, 2012
P3, N=30, Completed,  Sponsor: Hoffmann-La Roche
Initiation date: Apr 1909 --> Aug 2005 N=61 --> 30

||||||||||  Rituxan (rituximab) / Roche
Enrollment change:  A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate (clinicaltrials.gov) -  Oct 31, 2012
P4, N=15, Completed,  Sponsor: Hoffmann-La Roche
N=61 --> 30 N=20 --> 15

||||||||||  staphylococcal protein A (PRTX-100) / Protalex
Enrollment change:  Phase I Safety and Tolerability Study of Staphylococcal Protein A in Adult Patients With Chronic ITP (clinicaltrials.gov) -  Oct 31, 2012
P1, N=9, Terminated,  Sponsor: Protalex, Inc.
N=20 --> 15 N=21 --> 9

||||||||||  Actemra IV (tocilizumab) / Roche, JW Pharma
Enrollment open:  RITACT: A Long-term Safety Extension Study of Tocilizumab in Brazilian Participants With Rheumatoid Arthritis (RA) Who Completed the Studies ML21530 and MA21488 (clinicaltrials.gov) -  Oct 31, 2012
P4, N=82, Recruiting,  Sponsor: Hoffmann-La Roche
N=21 --> 9 Active, not recruiting --> Recruiting

||||||||||  Actemra IV (tocilizumab) / Roche, JW Pharma
Enrollment closed:  A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic and/or Biologic DMARDS (clinicaltrials.gov) -  Oct 31, 2012
P4, N=145, Active, not recruiting,  Sponsor: Hoffmann-La Roche
Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting

||||||||||  Plegridy (PEG-interferon ?-1a) / Biogen
Trial completion:  Peginterferon Beta-1a (BIIB017) Autoinjector Pharmacokinetic Study in Healthy Volunteers (clinicaltrials.gov) -  Oct 31, 2012
P1, N=30, Completed,  Sponsor: Biogen Idec
Recruiting --> Active, not recruiting Active, not recruiting --> Completed

|||||||||| Trial completion: ABACUS: ACCU-CHEK (clinicaltrials.gov) - Oct 31, 2012
P=N/A, N=218, Completed, Sponsor: Hoffmann-La Roche
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
New P2 trial:  Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis (clinicaltrials.gov) -  Oct 30, 2012
P2, N=30, Recruiting,  Sponsor: Anders Svenningsson

||||||||||  Nanozora (ozoralizumab) / Sanofi, Taisho
Trial completion:  Study Evaluating Multiple Ascending Doses Of ATN-103 In Japanese Subjects With Rheumatoid Arthritis (clinicaltrials.gov) -  Oct 30, 2012
P1/2, N=60, Completed,  Sponsor: Ablynx
Active, not recruiting --> Completed Active, not recruiting --> Completed

|||||||||| Enrollment change: Autoantibody Specificity and Response to IVIG in ITP (clinicaltrials.gov) - Oct 30, 2012
P=N/A, N=200, Recruiting, Sponsor: Shandong University
Active, not recruiting --> Completed N=138 --> 200

||||||||||  Kevzara (sarilumab) / Asahi Kasei, Regeneron, Sanofi
Enrollment change:  Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-? Blockers (clinicaltrials.gov) -  Oct 30, 2012
P2, N=16, Terminated,  Sponsor: Sanofi
N=138 --> 200 N=250 --> 16

|||||||||| Enrollment open: Autoantibody Specificity and Response to IVIG in ITP (clinicaltrials.gov) - Oct 30, 2012
P=N/A, N=200, Recruiting, Sponsor: Shandong University
N=250 --> 16 Completed --> Recruiting

||||||||||  tabalumab (LY2127399) / Eli Lilly
Biomarker, Enrollment change, Biopsy:  A Study of LY2127399 in Rheumatoid Arthritis (clinicaltrials.gov) -  Oct 29, 2012
P2, N=36, Completed,  Sponsor: Eli Lilly and Company
Completed --> Recruiting N=30 --> 36

|||||||||| New P2 trial: Effect of Melatonin on Multiple Sclerosis Related Fatigue (clinicaltrials.gov) - Oct 29, 2012
P2, N=44, Completed, Sponsor: Isfahan University of Medical Sciences

||||||||||  blisibimod (A-623) / Anthera Pharma
Trial initiation date:  CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus (clinicaltrials.gov) -  Oct 29, 2012
P3, N=400, Recruiting,  Sponsor: Anthera Pharmaceuticals
N=30 --> 36 Initiation date: Nov 2012 --> Feb 2013

||||||||||  blisibimod (A-623) / Anthera Pharma
Enrollment change:  CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus (clinicaltrials.gov) -  Oct 29, 2012
P3, N=400, Recruiting,  Sponsor: Anthera Pharmaceuticals
Initiation date: Nov 2012 --> Feb 2013 N=700 --> 400

||||||||||  Janumet (metformin/sitagliptin) / Merck (MSD)
New P4 trial:  A Pilot Study to Assess the Glucose Lowering Effect of Metformin and Sitagliptin in Adolescents With Type 1 Diabetes (clinicaltrials.gov) -  Oct 29, 2012
P4, N=48, Recruiting,  Sponsor: Baylor College of Medicine

|||||||||| Trial completion: Outpatient Control-to-Range: System and Monitoring Testing (clinicaltrials.gov) - Oct 29, 2012
P=N/A, N=10, Completed, Sponsor: University of Virginia
N=700 --> 400 Recruiting --> Completed

|||||||||| Trial completion: Evaluating Safety of NovoPen (clinicaltrials.gov) - Oct 29, 2012
P=N/A, N=1031, Completed, Sponsor: Novo Nordisk
Recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
New P2a trial:  CEASE-MS: Proof of Concept Study of RHB-104 as Add-On Therapy to Interferon Beta-1a in Relapsing Remitting Multiple Sclerosis (RRMS) (clinicaltrials.gov) -  Oct 28, 2012
P2a, N=16, Recruiting,  Sponsor: RedHill Biopharma Limited

|||||||||| Enrollment open: Brain Functional Connectivity Changes Following Cognitive Rehabilitation in Multiple Sclerosis: an fMRI Study (clinicaltrials.gov) - Oct 28, 2012
P=N/A, N=30, Recruiting, Sponsor: Sina Hospital, Iran
Active, not recruiting --> Completed Not yet recruiting --> Recruiting

|||||||||| Enrollment closed: Low Fat Diet and Multiple Sclerosis (clinicaltrials.gov) - Oct 28, 2012
P1, N=61, Active, not recruiting, Sponsor: Oregon Health and Science University
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting

||||||||||  Actemra IV (tocilizumab) / Roche, JW Pharma
New P4 trial:  RITACT: A Long-term Safety Extension Study of Tocilizumab in Brazilian Participants With Rheumatoid Arthritis (RA) Who Completed the Studies ML21530 and MA21488 (clinicaltrials.gov) -  Oct 25, 2012
P4, N=82, Recruiting,  Sponsor: Hoffmann-La Roche

||||||||||  mavrilimumab (KPL-301) / Kiniksa
New P2 trial:  A Study of Mavrilimumab Versus Anti Tumor Necrosis Factor in Subjects With Rheumatoid Arthritis (clinicaltrials.gov) -  Oct 25, 2012
P2, N=172, Recruiting,  Sponsor: MedImmune LLC

|||||||||| Enrollment closed: Insulin Pump Therapy in Adolescents With Newly Diagnosed Type 1 Diabetes (T1D) (clinicaltrials.gov) - Oct 25, 2012
P=N/A, N=12, Active, not recruiting, Sponsor: Nemours Children's Clinic
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting

||||||||||  Humira (adalimumab) / Eisai, AbbVie
Enrollment change:  HOPE 3: Special Investigation (Follow-up Survey of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859 (NCT00870467)) (clinicaltrials.gov) -  Oct 24, 2012
P=N/A, N=220, Completed,  Sponsor: AbbVie (prior sponsor, Abbott)
Recruiting --> Active, not recruiting N=300 --> 220

||||||||||  fletikumab (NNC109-0012) / Novo Nordisk
Enrollment open:  A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics (clinicaltrials.gov) -  Oct 24, 2012
P2, N=268, Recruiting,  Sponsor: Novo Nordisk A/S
N=300 --> 220 Suspended --> Recruiting

||||||||||  Humira (adalimumab) / Eisai, AbbVie
Trial completion:  HOPE 3: Special Investigation (Follow-up Survey of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859 (NCT00870467)) (clinicaltrials.gov) -  Oct 24, 2012
P=N/A, N=220, Completed,  Sponsor: AbbVie (prior sponsor, Abbott)
Suspended --> Recruiting Active, not recruiting --> Completed

||||||||||  Humira (adalimumab) / Eisai, AbbVie
Enrollment change:  ADMIRE: A Pilot Study of the Feasibility of Discontinuation of Adalimumab in Stable Rheumatoid Arthritis Patients in Clinical Remission (clinicaltrials.gov) -  Oct 23, 2012
P4, N=33, Completed,  Sponsor: AbbVie (prior sponsor, Abbott)
Active, not recruiting --> Completed N=50 --> 33

||||||||||  Orencia (abatacept) / BMS
New P4 trial, Preclinical:  Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and APC Cells in Rheumatoid Arthritis (clinicaltrials.gov) -  Oct 23, 2012
P4, N=24, Not yet recruiting,  Sponsor: University of California, Los Angeles

||||||||||  RNS60 / Revalesio
New P2 trial:  Proof of Concept Study Evaluating RNS60 in the Treatment of Relapsing Remitting Multiple Sclerosis (clinicaltrials.gov) -  Oct 23, 2012
P2, N=270, Not yet recruiting,  Sponsor: Revalesio Corporation

||||||||||  Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
New P1/2 trial:  Clinical Trial of Rituximab in Children and Adolescents With Chronic Idiopathic Thrombocytopenic Purpura (ITP) (clinicaltrials.gov) -  Oct 23, 2012
P1/2, N=36, Completed,  Sponsor: Neufeld, Ellis J, MD, PhD

||||||||||  Humira (adalimumab) / Eisai, AbbVie
Trial completion:  ADMIRE: A Pilot Study of the Feasibility of Discontinuation of Adalimumab in Stable Rheumatoid Arthritis Patients in Clinical Remission (clinicaltrials.gov) -  Oct 23, 2012
P4, N=33, Completed,  Sponsor: AbbVie (prior sponsor, Abbott)
N=50 --> 33 Active, not recruiting --> Completed

||||||||||  Veltucyn (veltuzumab) / Gilead
Trial termination:  VELVET, a Dose Range Finding Trial of Veltuzumab in Subjects With Moderate to Severe Rheumatoid Arthritis (clinicaltrials.gov) -  Oct 23, 2012
P2, N=300, Terminated,  Sponsor: Takeda
Active, not recruiting --> Completed Active, not recruiting --> Terminated; Trial re-design; no safety issues identified

||||||||||  Actemra IV (tocilizumab) / Roche, JW Pharma
New P2 trial:  TENOR: Tocilizumab Effect iN pOlymyalgia Rheumatica (clinicaltrials.gov) -  Oct 23, 2012
P2, N=20, Recruiting,  Sponsor: University Hospital, Brest

||||||||||  Orencia (abatacept) / BMS
Trial completion:  Abatacept in Treating Adults With Mild Relapsing Wegener's Granulomatosis (clinicaltrials.gov) -  Oct 22, 2012
P1/2, N=20, Completed,  Sponsor: University of Pennsylvania
Active, not recruiting --> Terminated; Trial re-design; no safety issues identified Active, not recruiting --> Completed

||||||||||  Lemtrada (alemtuzumab) / Sanofi
New P1/2 trial:  CAM-THY: Keratinocyte Growth Factor to Prevent Autoimmunity After Alemtuzumab Treatment of Multiple Sclerosis (clinicaltrials.gov) -  Oct 22, 2012
P1/2, N=86, Recruiting,  Sponsor: Cambridge University Hospitals NHS Foundation Trust

|||||||||| Trial completion, HEOR: Mobile Phone Applications and Quality of Life (clinicaltrials.gov) - Oct 22, 2012
P=N/A, N=65, Completed, Sponsor: Medical Research Foundation, The Netherlands
Active, not recruiting --> Completed Recruiting --> Completed