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Proposal 995

Title of the Proposed Research

Identifying immune modulating patterns across diseases from open clinical trial data

Lead Researcher

Dr Atul J. Butte

Affiliation

Institute for Computational Health Sciences
UCSF School of Medicine

Funding Source

This research will be funded by National Institute of Allergy and Infectious Diseases, Division of Allergy, Immunology and Transplantation, contract HSN272201200028C

Potential Conflicts of Interest

Potential conflicts of interest will be disclosed when the research is presented and published.

Data Sharing Agreement Date

25 June 2015

Lay Summary

Cytokines, key regulators of the immune system, play a central role in both health and disease. These small proteins are secreted from a variety of cell types including, but not limited to, immune cell types and are involved in many biological processes. Cytokines have been implicated both as possible diagnostics markers and therapeutics targets. For example, Interleukin 18 (IL-18) has been identified as an early diagnostic marker for acute kidney injury (Parikh, Abraham et al. 2005) while Tumor Necrosis Factor alpha (TNF-a) is a therapeutic target for rheumatoid arthritis (Feldmann 2002). Another important aspect of immunity in health and disease involves different immune cell types such as lymphocytes, leukocytes, macrophages, basophiles and eosinophils in fighting infections, inflammatory responses, allergic reactions etc.

Examining disease-related immune patterns, such as cytokine levels and immune cell counts, can help gain better insight into disease-related immune characteristics and find immune-related similarities and differences between diseases. This research aims to elucidate immune-related patterns in a verity of different disease based on open clinical trial data. Furthermore, these patterns will be used to validate the accuracy of an immune-related dataset that was created by mining the medical literature. Using the placebo, untreated and control arms of several different clinical trials, we aim to identify those disease related immune patterns such as the variability in different cell types that are routinely measured in standard blood tests and mechanistic assays. These immune patterns will then be used to compare between different diseases and to compare it to similar patterns, which were mined from biomedical texts.

Study Data Provided

Study GSK-VR1111924: A randomized, double-blind, placebo controlled, incomplete block, 3 way cross over study in subjects with allergic rhinitis to assess the effect of intranasal repeat doses of SB-705498 when administered alone or in conjunction with intranasal fluticasone propionate on the symptoms of rhinitis in the Vienna allergen challenge chamber
Study GSK-49653/331: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of Rosiglitazone Maleate in the Treatment of Chronic Plaque Psoriasis
Study ROCHE-BV16052: A phase III open-label, randomized, controlled study assessing the efficacy and safety of T-20/Ro 29-9800 (HIV-1 fusion inhibitor) in combination with an optimized background regimen, versus optimized background regimen alone, in triple class (nucleoside reverse transcriptase, non-nucleoside reverse tanscriptase and protease inhibitors) experienced patients or patients naive to one class
Study ROCHE-WV16240: A phase III partially double blind study evaluating the efficacy and safety of 40KD branched pegylated interferon alfa-2a (PEG-IFN, RO0258310) combined with placebo or lamivudine versus lamivudine in HBeAg positive patients with chronic hepatitis B
Study ROCHE-NV15942: A phase III, randomized, multicenter, efficacy and safety study examining the effects of the duration of treatment and the daily dose of ribavirin in patients with chronic hepatitis C virus infection treated with the combination of pegylated-interferon alpha-2a and ribavirin
Study ROCHE-WA17822: A randomized, double-blind study of safety and reduction in signs and symptoms during treatment with tocilizumab versus placebo, in combination with methotrexate, in patients with moderate to severe rheumatoid arthritis
Study ROCHE-MRA009JP: A randomized, double-blind, parallel-group, comparison study of three doses (placebo, MRA 4 mg/kg, or MRA 8 mg/kg) in patients with rheumatoid arthritis
Study ROCHE-NO25026 (BRIM3): A randomized, open-label, controlled, multicenter, global study on progression-free and overall survival in previously untreated patients with unresectable stage IIIC or stage IV melanoma with V600E BRAF mutation receiving RO5185426 or dacarbazine
Study BI-1218.6: Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes
Study BI-1235.37: Comparison in Japan T80/A5 (Telmisartan 80 mg and Amlodipine 5 mg) and T40/A5 (Telmisartan 40 mg and Amlodipine 5 mg)
Study LILLY-F1D-MC-HGHB: A Double-Blind Randomised Comparison of the Efficacy and Safety of Short Acting Intramuscular Olanzapine, Short Acting Intramuscular Haloperidol and Intramuscular Placebo in Patients with Schizophrenia
Study LILLY-F1D-MC-HGGW: Olanzapine Versus Placebo in the Treatment of Bipolar Disorder, Manic or Mixed
Study LILLY-B1Y-MC-HCEP: Fluoxetine vs Placebo in Obsessive Compulsive Disorder
Study TAKEDA-C13011: A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease
Study UCB-SP650: A multi-center, multinational, Phase 3, randomized, double-blind, parallel group, placebo-controlled trial of the efficacy and safety of rotigotine CDS patch (2 target doses) in subjects with advanced-stage, idiopathic Parkinson?s disease who are not well controlled on levodopa

Statistical Analysis Plan

The statistical analysis plan will be added after the research is published.

Publication Citation