{"id":"W4401541812","doi":"10.3389/fneur.2024.1437913","title":"Innovation and optimization in autoimmune encephalitis trials: the design and rationale for the Phase 3, randomized study of satralizumab in patients with NMDAR-IgG-antibody-positive or LGI1-IgG-antibody-positive autoimmune encephalitis (CIELO)","year":2024,"lang":"en","type":"article","venue":"Frontiers in Neurology","topic":"Autoimmune Neurological Disorders and Treatments","field":"Medicine","cited_by":17,"is_retracted":false,"has_abstract":true,"ca_institutions":"SickKids Foundation; Hospital for Sick Children; University of Toronto","funders":"Medical Research Council; F. Hoffmann-La Roche","keywords":"Medicine; Autoimmune encephalitis; Autoantibody; Antibody; Neuromyelitis optica; Immunology; Placebo; Encephalitis; Immunotherapy; Internal medicine; Immune system; Pathology; Virus","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":false,"about_ca":true,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.03081296,0.002672876,0.00355221,0.0007463305,0.00114658,0.002200257,0.001870694,0.005031442,0.00847127],"category_scores_gemma":[0.02251232,0.001289963,0.003926942,0.0008491587,0.002243582,0.002377895,0.001140889,0.005642456,0.002080613],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.001546721,"about_ca_system_score_gemma":0.005080799,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0003932227,"about_ca_topic_score_gemma":0.000966257,"domain_scores_codex":[0.9767311,0.01844904,0.001116797,0.001423856,0.001111378,0.001167842],"domain_scores_gemma":[0.9903554,0.003438591,0.002279582,0.0009354791,0.001168479,0.001822505],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"randomized_trial","study_design_gemma":"randomized_trial","study_design_scores_codex":[0.9621454,0.005809446,0.001788162,0.001230956,0.001909318,0.00008433297,0.0001406651,0.0009921385,0.001966831,0.001489403,0.002357836,0.02008547],"study_design_scores_gemma":[0.9528634,0.03845359,0.001190171,0.000127823,0.0006870558,0.00003680488,0.00002451512,0.001300421,0.0004218843,0.001002256,0.003869749,0.00002231082],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"protocol","genre_gemma":"protocol","genre_scores_codex":[0.2979516,0.009231576,0.01626635,0.00640901,0.003749572,0.6492324,0.003787525,0.0004721743,0.01289987],"genre_scores_gemma":[0.383813,0.001824111,0.02895191,0.006459303,0.001409697,0.5729053,0.001386538,0.00007575363,0.003174402],"genre_candidate":"protocol","genre_consensus":"protocol","teacher_disagreement_score":0.03081296,"threshold_uncertainty_score":0.1629565,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.02606988606134259,"score_gpt":0.3222239131659335,"score_spread":0.2961540271045909,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}