A Double-Blind, Placebo-Controlled, Randomized, Clinical Trial of the TLR-3 Agonist Rintatolimod in Severe Cases of Chronic Fatigue Syndrome
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{"title"=>"A double-blind, placebo-controlled, randomized, clinical trial of the TLR-3 agonist rintatolimod in severe cases of chronic fatigue syndrome", "type"=>"journal", "authors"=>[{"first_name"=>"David R.", "last_name"=>"Strayer", "scopus_author_id"=>"7102332272"}, {"first_name"=>"William A.", "last_name"=>"Carter", "scopus_author_id"=>"7202494117"}, {"first_name"=>"Bruce C.", "last_name"=>"Stouch", "scopus_author_id"=>"55094208700"}, {"first_name"=>"Staci R.", "last_name"=>"Stevens", "scopus_author_id"=>"7201710386"}, {"first_name"=>"Lucinda", "last_name"=>"Bateman", "scopus_author_id"=>"36627054900"}, {"first_name"=>"Paul J.", "last_name"=>"Cimoch", "scopus_author_id"=>"6603142983"}, {"first_name"=>"Charles W.", "last_name"=>"Lapp", "scopus_author_id"=>"7004751468"}, {"first_name"=>"Daniel L.", "last_name"=>"Peterson", "scopus_author_id"=>"57191821705"}, {"first_name"=>"William M.", "last_name"=>"Mitchell", "scopus_author_id"=>"7201632755"}], "year"=>2012, "source"=>"PLoS ONE", "identifiers"=>{"scopus"=>"2-s2.0-84858187358", "pui"=>"364433886", "sgr"=>"84858187358", "isbn"=>"1932-6203", "issn"=>"19326203", "pmid"=>"22431963", "doi"=>"10.1371/journal.pone.0031334"}, "id"=>"b1f3a032-ea53-377c-a229-46061fb7f276", "abstract"=>"BACKGROUND: Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is a severely debilitating disease of unknown pathogenesis consisting of a variety of symptoms including severe fatigue. The objective of the study was to examine the efficacy and safety of a TLR-3 agonist, rintatolimod (Poly I: C(12)U), in patients with debilitating CFS/ME.\\n\\nMETHODS AND FINDINGS: A Phase III prospective, double-blind, randomized, placebo-controlled trial comparing twice weekly IV rintatolimod versus placebo was conducted in 234 subjects with long-standing, debilitating CFS/ME at 12 sites. The primary endpoint was the intra-patient change from baseline at Week 40 in exercise tolerance (ET). Secondary endpoints included concomitant drug usage, the Karnofsky Performance Score (KPS), Activities of Daily Living (ADL), and Vitality Score (SF 36). Subjects receiving rintatolimod for 40 weeks improved intra-patient placebo-adjusted ET 21.3% (p = 0.047) from baseline in an intention-to-treat analysis. Correction for subjects with reduced dosing compliance increased placebo-adjusted ET improvement to 28% (p = 0.022). The improvement observed represents approximately twice the minimum considered medically significant by regulatory agencies. The rintatolimod cohort vs. placebo also reduced dependence on drugs commonly used by patients in an attempt to alleviate the symptoms of CFS/ME (p = 0.048). Placebo subjects crossed-over to receive rintatolimod demonstrated an intra-patient improvement in ET performance at 24 weeks of 39% (p = 0.04). Rintatolimod at 400 mg twice weekly was generally well-tolerated.\\n\\nCONCLUSIONS/SIGNIFICANCE: Rintatolimod produced objective improvement in ET and a reduction in CFS/ME related concomitant medication usage as well as other secondary outcomes.\\n\\nTRIAL REGISTRATION: ClinicalTrials.gov NCT00215800.", "link"=>"http://www.mendeley.com/research/doubleblind-placebocontrolled-randomized-clinical-trial-tlr3-agonist-rintatolimod-severe-cases-chron", "reader_count"=>48, "reader_count_by_academic_status"=>{"Unspecified"=>1, "Student > Doctoral Student"=>4, "Researcher"=>14, "Student > Ph. D. Student"=>4, "Other"=>6, "Student > Master"=>7, "Student > Bachelor"=>8, "Lecturer"=>2, "Professor"=>2}, "reader_count_by_user_role"=>{"Unspecified"=>1, "Student > Doctoral Student"=>4, "Researcher"=>14, "Student > Ph. D. Student"=>4, "Other"=>6, "Student > Master"=>7, "Student > Bachelor"=>8, "Lecturer"=>2, "Professor"=>2}, "reader_count_by_subject_area"=>{"Engineering"=>2, "Unspecified"=>1, "Biochemistry, Genetics and Molecular Biology"=>4, "Nursing and Health Professions"=>1, "Mathematics"=>1, "Medicine and Dentistry"=>19, "Agricultural and Biological Sciences"=>16, "Pharmacology, Toxicology and Pharmaceutical Science"=>1, "Psychology"=>2, "Social Sciences"=>1}, "reader_count_by_subdiscipline"=>{"Engineering"=>{"Engineering"=>2}, "Medicine and Dentistry"=>{"Medicine and Dentistry"=>19}, "Social Sciences"=>{"Social Sciences"=>1}, "Psychology"=>{"Psychology"=>2}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>16}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>4}, "Mathematics"=>{"Mathematics"=>1}, "Unspecified"=>{"Unspecified"=>1}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>1}}, "reader_count_by_country"=>{"Netherlands"=>1, "Sweden"=>1, "Italy"=>1, "United Kingdom"=>1, "Spain"=>1}, "group_count"=>2}

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  • {"files"=>["https://ndownloader.figshare.com/files/667115"], "description"=>"<p>Flow Diagram of Study Patients.</p>", "links"=>[], "tags"=>["diagram"], "article_id"=>337594, "categories"=>["Biochemistry", "Ecology", "Neuroscience", "Immunology"], "users"=>["David R. Strayer", "William A. Carter", "Bruce C. Stouch", "Staci R. Stevens", "Lucinda Bateman", "Paul J. Cimoch", "Charles W. Lapp", "Daniel L. Peterson", "William M. Mitchell"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0031334.g001", "stats"=>{"downloads"=>1, "page_views"=>3, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Flow_Diagram_of_Study_Patients_/337594", "title"=>"Flow Diagram of Study Patients.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2012-03-14 02:06:34"}
  • {"files"=>["https://ndownloader.figshare.com/files/667242"], "description"=>"<p>Safety- Adverse Events (AEs) of Rintatolimod (PolyI:C<sub>12</sub>U).</p>", "links"=>[], "tags"=>["adverse", "events", "rintatolimod"], "article_id"=>337722, "categories"=>["Biochemistry", "Ecology", "Neuroscience", "Immunology"], "users"=>["David R. Strayer", "William A. Carter", "Bruce C. Stouch", "Staci R. Stevens", "Lucinda Bateman", "Paul J. Cimoch", "Charles W. Lapp", "Daniel L. Peterson", "William M. Mitchell"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0031334.t005", "stats"=>{"downloads"=>5, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Safety_Adverse_Events_AEs_of_Rintatolimod_PolyI_C_12_U_/337722", "title"=>"Safety- Adverse Events (AEs) of Rintatolimod (PolyI:C<sub>12</sub>U).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-03-14 02:08:42"}
  • {"files"=>["https://ndownloader.figshare.com/files/341982", "https://ndownloader.figshare.com/files/342049", "https://ndownloader.figshare.com/files/342193", "https://ndownloader.figshare.com/files/342246", "https://ndownloader.figshare.com/files/342323", "https://ndownloader.figshare.com/files/342394", "https://ndownloader.figshare.com/files/342450", "https://ndownloader.figshare.com/files/342513", "https://ndownloader.figshare.com/files/342581", "https://ndownloader.figshare.com/files/342650", "https://ndownloader.figshare.com/files/342710"], "description"=>"<div><h3>Background</h3><p>Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is a severely debilitating disease of unknown pathogenesis consisting of a variety of symptoms including severe fatigue. The objective of the study was to examine the efficacy and safety of a TLR-3 agonist, rintatolimod (Poly I: C<sub>12</sub>U), in patients with debilitating CFS/ME.</p> <h3>Methods and Findings</h3><p>A Phase III prospective, double-blind, randomized, placebo-controlled trial comparing twice weekly IV rintatolimod versus placebo was conducted in 234 subjects with long-standing, debilitating CFS/ME at 12 sites. The primary endpoint was the intra-patient change from baseline at Week 40 in exercise tolerance (ET). Secondary endpoints included concomitant drug usage, the Karnofsky Performance Score (KPS), Activities of Daily Living (ADL), and Vitality Score (SF 36). Subjects receiving rintatolimod for 40 weeks improved intra-patient placebo-adjusted ET 21.3% (p = 0.047) from baseline in an intention-to-treat analysis. Correction for subjects with reduced dosing compliance increased placebo-adjusted ET improvement to 28% (p = 0.022). The improvement observed represents approximately twice the minimum considered medically significant by regulatory agencies. The rintatolimod cohort vs. placebo also reduced dependence on drugs commonly used by patients in an attempt to alleviate the symptoms of CFS/ME (p = 0.048). Placebo subjects crossed-over to receive rintatolimod demonstrated an intra-patient improvement in ET performance at 24 weeks of 39% (p = 0.04). Rintatolimod at 400 mg twice weekly was generally well-tolerated.</p> <h3>Conclusions/Significance</h3><p>Rintatolimod produced objective improvement in ET and a reduction in CFS/ME related concomitant medication usage as well as other secondary outcomes.</p> <h3>Trial Registration</h3><p>ClinicalTrials.gov <a href=\"http://www.clinicaltrials.gov/ct2/show/NCT00215800\">NCT00215800</a></p> </div>", "links"=>[], "tags"=>["tlr-3", "agonist", "rintatolimod", "cases"], "article_id"=>127605, "categories"=>["Biochemistry", "Ecology", "Neuroscience", "Immunology"], "users"=>["David R. Strayer", "William A. Carter", "Bruce C. Stouch", "Staci R. Stevens", "Lucinda Bateman", "Paul J. Cimoch", "Charles W. Lapp", "Daniel L. Peterson", "William M. Mitchell"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0031334.s001", "https://dx.doi.org/10.1371/journal.pone.0031334.s002", "https://dx.doi.org/10.1371/journal.pone.0031334.s003", "https://dx.doi.org/10.1371/journal.pone.0031334.s004", "https://dx.doi.org/10.1371/journal.pone.0031334.s005", "https://dx.doi.org/10.1371/journal.pone.0031334.s006", "https://dx.doi.org/10.1371/journal.pone.0031334.s007", "https://dx.doi.org/10.1371/journal.pone.0031334.s008", "https://dx.doi.org/10.1371/journal.pone.0031334.s009", "https://dx.doi.org/10.1371/journal.pone.0031334.s010", "https://dx.doi.org/10.1371/journal.pone.0031334.s011"], "stats"=>{"downloads"=>38, "page_views"=>18, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/A_Double_Blind_Placebo_Controlled_Randomized_Clinical_Trial_of_the_TLR_3_Agonist_Rintatolimod_in_Severe_Cases_of_Chronic_Fatigue_Syndrome/127605", "title"=>"A Double-Blind, Placebo-Controlled, Randomized, Clinical Trial of the TLR-3 Agonist Rintatolimod in Severe Cases of Chronic Fatigue Syndrome", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2012-03-14 02:06:45"}
  • {"files"=>["https://ndownloader.figshare.com/files/667209"], "description"=>"1<p>p-value derived from a Wilcoxon signed rank test comparing whether the median change from Baseline is equal to 0 within each treatment group.</p>2<p>ns = not significant, p>0.05.</p>", "links"=>[], "tags"=>["endpoint", "improvements"], "article_id"=>337692, "categories"=>["Biochemistry", "Ecology", "Neuroscience", "Immunology"], "users"=>["David R. Strayer", "William A. Carter", "Bruce C. Stouch", "Staci R. Stevens", "Lucinda Bateman", "Paul J. Cimoch", "Charles W. Lapp", "Daniel L. Peterson", "William M. Mitchell"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0031334.t004", "stats"=>{"downloads"=>6, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Secondary_Performance_Endpoint_Improvements_in_Stage_1_/337692", "title"=>"Secondary Performance Endpoint Improvements in Stage 1.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-03-14 02:08:12"}
  • {"files"=>["https://ndownloader.figshare.com/files/667376"], "description"=>"1<p>Mean intra-patient percent improvement.</p>2<p>Student's t-test comparing mean baseline ET between treatment groups.</p>3<p>Analysis of covariance (ANCOVA) with baseline as a covariate comparing the mean ET change from baseline within each treatment group.</p>4<p>Paired t-test comparing whether the change from baseline is equal to zero within each treatment group.</p>5<p>Probability that a difference between treatment groups exists using the chi-square test.</p>", "links"=>[], "tags"=>["rintatolimod"], "article_id"=>337861, "categories"=>["Biochemistry", "Ecology", "Neuroscience", "Immunology"], "users"=>["David R. Strayer", "William A. Carter", "Bruce C. Stouch", "Staci R. Stevens", "Lucinda Bateman", "Paul J. Cimoch", "Charles W. Lapp", "Daniel L. Peterson", "William M. Mitchell"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0031334.t001", "stats"=>{"downloads"=>0, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Analysis_of_the_Effect_of_Rintatolimod_on_the_Primary_Endpoint_Exercise_Tolerance_ET_/337861", "title"=>"Analysis of the Effect of Rintatolimod on the Primary Endpoint, Exercise Tolerance (ET).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-03-14 02:11:01"}
  • {"files"=>["https://ndownloader.figshare.com/files/667289"], "description"=>"1<p>Baseline of Stage 2 is the last non-missing Stage 1 value (last observation carried forward [LOCF]).</p>2<p>Mean intra-patient percent improvement.</p>3<p>p-value for the mean is from a paired t-test; p-value for the median is from the Wilcoxon signed rank test.</p>", "links"=>[], "tags"=>["baseline", "treadmill", "duration", "24"], "article_id"=>337765, "categories"=>["Biochemistry", "Ecology", "Neuroscience", "Immunology"], "users"=>["David R. Strayer", "William A. Carter", "Bruce C. Stouch", "Staci R. Stevens", "Lucinda Bateman", "Paul J. Cimoch", "Charles W. Lapp", "Daniel L. Peterson", "William M. Mitchell"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0031334.t002", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Mean_Median_Baseline_and_Mean_Median_Change_from_Baseline_in_Exercise_Treadmill_Duration_seconds_at_Week_24_Stage_2_ITT_Population_/337765", "title"=>"Mean/Median Baseline and Mean/Median Change from Baseline in Exercise Treadmill Duration (seconds) at Week 24 (Stage 2) (ITT Population).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-03-14 02:09:25"}
  • {"files"=>["https://ndownloader.figshare.com/files/667333"], "description"=>"1<p>Daily average of the number of concomitant medications used during the first 4 weeks of study compared to the daily average of the number used during the final 4 weeks of study.</p>2<p>Chi-square test.</p>", "links"=>[], "tags"=>["rintatolimod", "concomitant", "medications", "cfs", "symptoms"], "article_id"=>337814, "categories"=>["Biochemistry", "Ecology", "Neuroscience", "Immunology"], "users"=>["David R. Strayer", "William A. Carter", "Bruce C. Stouch", "Staci R. Stevens", "Lucinda Bateman", "Paul J. Cimoch", "Charles W. Lapp", "Daniel L. Peterson", "William M. Mitchell"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0031334.t003", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Effect_of_Rintatolimod_PolyI_C_12_U_on_the_Use_of_Concomitant_Medications_for_the_Relief_of_CFS_Symptoms_Stage_I_/337814", "title"=>"Effect of Rintatolimod (PolyI:C<sub>12</sub>U) on the Use of Concomitant Medications for the Relief of CFS Symptoms (Stage I).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-03-14 02:10:14"}

PMC Usage Stats | Further Information

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Relative Metric

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