Literature DB >> 28992174

Interstitial lung disease points to consider for clinical trials in systemic sclerosis.

Dinesh Khanna1, James Seibold2, Jonathan Goldin3, Donald P Tashkin4, Daniel E Furst5, Athol Wells6.   

Abstract

Interstitial lung disease causes major morbidity and mortality in patients with systemic sclerosis (SSc-ILD). Large randomized clinical trials in SSc-ILD have provided important information regarding the feasibility, reliability and validity of outcome measures. Forced vital capacity percentage predicted should be considered as a primary outcome measure, with inclusion of appropriate radiological and patient-reported measures. We provide practical recommendations for trial design in SSc-ILD.
© The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Entities:  

Keywords:  interstitial lung disease clinical trials; lung disease; scleroderma

Mesh:

Year:  2017        PMID: 28992174      PMCID: PMC5850349          DOI: 10.1093/rheumatology/kex203

Source DB:  PubMed          Journal:  Rheumatology (Oxford)        ISSN: 1462-0324            Impact factor:   7.580


  35 in total

Review 1.  Biomarkers and surrogate endpoints: preferred definitions and conceptual framework.

Authors: 
Journal:  Clin Pharmacol Ther       Date:  2001-03       Impact factor: 6.875

2.  Forced vital capacity in patients with idiopathic pulmonary fibrosis: test properties and minimal clinically important difference.

Authors:  Roland M du Bois; Derek Weycker; Carlo Albera; Williamson Z Bradford; Ulrich Costabel; Alex Kartashov; Talmadge E King; Lisa Lancaster; Paul W Noble; Steven A Sahn; Michiel Thomeer; Dominique Valeyre; Athol U Wells
Journal:  Am J Respir Crit Care Med       Date:  2011-09-22       Impact factor: 21.405

3.  Randomized, prospective, placebo-controlled trial of bosentan in interstitial lung disease secondary to systemic sclerosis.

Authors:  J R Seibold; C P Denton; D E Furst; L Guillevin; L J Rubin; A Wells; M Matucci Cerinic; G Riemekasten; P Emery; H Chadha-Boreham; P Charef; S Roux; C M Black
Journal:  Arthritis Rheum       Date:  2010-07

Review 4.  Connective Tissue Disease-associated Interstitial Lung Diseases (CTD-ILD) - Report from OMERACT CTD-ILD Working Group.

Authors:  Dinesh Khanna; Shikha Mittoo; Rohit Aggarwal; Susanna M Proudman; Nicola Dalbeth; Eric L Matteson; Kevin Brown; Kevin Flaherty; Athol U Wells; James R Seibold; Vibeke Strand
Journal:  J Rheumatol       Date:  2015-03-01       Impact factor: 4.666

5.  Surfactant protein D and KL-6 as serum biomarkers of interstitial lung disease in patients with scleroderma.

Authors:  Faye N Hant; Anna Ludwicka-Bradley; He-Jing Wang; Ning Li; Robert Elashoff; Donald P Tashkin; Richard M Silver
Journal:  J Rheumatol       Date:  2009-03-13       Impact factor: 4.666

6.  Systemic Sclerosis-Associated Interstitial Lung Disease: Lessons from Clinical Trials, Outcome Measures, and Future Study Design.

Authors:  Dinesh Khanna; James R Seibold; Athol Wells; Oliver Distler; Yannick Allanore; Chris Denton; Daniel E Furst
Journal:  Curr Rheumatol Rev       Date:  2010-05-01

7.  A computer-aided diagnosis system for quantitative scoring of extent of lung fibrosis in scleroderma patients.

Authors:  H G Kim; D P Tashkin; P J Clements; G Li; M S Brown; R Elashoff; D W Gjertson; F Abtin; D A Lynch; D C Strollo; J G Goldin
Journal:  Clin Exp Rheumatol       Date:  2010-11-03       Impact factor: 4.473

Review 8.  Surrogate end points in clinical research: hazardous to your health.

Authors:  David A Grimes; Kenneth F Schulz
Journal:  Obstet Gynecol       Date:  2005-05       Impact factor: 7.661

9.  Treatment of scleroderma-interstitial lung disease with cyclophosphamide is associated with less progressive fibrosis on serial thoracic high-resolution CT scan than placebo: findings from the scleroderma lung study.

Authors:  Jonathan Goldin; Robert Elashoff; Hyun J Kim; Xaiohong Yan; David Lynch; Diane Strollo; Michael D Roth; Philip Clements; Daniel E Furst; Dinesh Khanna; Srainnapha Vasunilashorn; Gang Li; Donald P Tashkin
Journal:  Chest       Date:  2009-11       Impact factor: 9.410

10.  Issues in using progression-free survival when evaluating oncology products.

Authors:  Thomas R Fleming; Mark D Rothmann; Hong Laura Lu
Journal:  J Clin Oncol       Date:  2009-05-04       Impact factor: 44.544

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  10 in total

Review 1.  Points to consider when doing a trial primarily involving the heart.

Authors:  Yannick Allanore; Oliver Distler; Ulrich A Walker; Dinesh Khanna; Daniel E Furst; Christophe Meune
Journal:  Rheumatology (Oxford)       Date:  2017-09-01       Impact factor: 7.580

2.  Outcome measurement instrument selection for lung physiology in systemic sclerosis associated interstitial lung disease: A systematic review using the OMERACT filter 2.1 process.

Authors:  David Roofeh; Shaney L Barratt; Athol U Wells; Leticia Kawano-Dourado; Donald Tashkin; Vibeke Strand; James Seibold; Susanna Proudman; Kevin K Brown; Paul F Dellaripa; Tracy Doyle; Thomas Leonard; Eric L Matteson; Chester V Oddis; Joshua J Solomon; Jeffrey A Sparks; Robert Vassallo; Lara Maxwell; Dorcas Beaton; Robin Christensen; Whitney Townsend; Dinesh Khanna
Journal:  Semin Arthritis Rheum       Date:  2021-08-20       Impact factor: 5.431

3.  Treatment of systemic sclerosis-associated interstitial lung disease: Lessons from clinical trials.

Authors:  David Roofeh; Oliver Distler; Yannick Allanore; Christopher P Denton; Dinesh Khanna
Journal:  J Scleroderma Relat Disord       Date:  2020-03-05

4.  Interstitial lung disease in systemic sclerosis quantification of disease classification and progression with high-resolution computed tomography: An observational study.

Authors:  Johan Clukers; Maarten Lanclus; Dennis Belmans; Cedric Van Holsbeke; Wilfried De Backer; Dharshan Vummidi; Paul Cronin; Ben R Lavon; Jan De Backer; Dinesh Khanna
Journal:  J Scleroderma Relat Disord       Date:  2021-01-10

Review 5.  Drugs in phase I and phase II clinical trials for systemic sclerosis.

Authors:  Melody P Chung; Lorinda Chung
Journal:  Expert Opin Investig Drugs       Date:  2020-03-25       Impact factor: 6.206

6.  Reliability and minimal clinically important differences of forced vital capacity: Results from the Scleroderma Lung Studies (SLS-I and SLS-II).

Authors:  Suzanne Kafaja; Philip J Clements; Holly Wilhalme; Chi-Hong Tseng; Daniel E Furst; Grace Hyun Kim; Jonathan Goldin; Elizabeth R Volkmann; Michael D Roth; Donald P Tashkin; Dinesh Khanna
Journal:  Am J Respir Crit Care Med       Date:  2017-11-03       Impact factor: 30.528

Review 7.  TNIP1 in Autoimmune Diseases: Regulation of Toll-like Receptor Signaling.

Authors:  Rambon Shamilov; Brian J Aneskievich
Journal:  J Immunol Res       Date:  2018-10-03       Impact factor: 4.818

8.  Systemic sclerosis: state of the art on clinical practice guidelines.

Authors:  Vanessa Smith; Carlo Alberto Scirè; Rosaria Talarico; Paolo Airo; Tobias Alexander; Yannick Allanore; Cosimo Bruni; Veronica Codullo; Virgil Dalm; Jeska De Vries-Bouwstra; Alessandra Della Rossa; Oliver Distler; Ilaria Galetti; David Launay; Gemma Lepri; Alexis Mathian; Luc Mouthon; Barbara Ruaro; Alberto Sulli; Angela Tincani; Els Vandecasteele; Amber Vanhaecke; Marie Vanthuyne; Frank Van den Hoogen; Ronald Van Vollenhoven; Alexandre E Voskuyl; Elisabetta Zanatta; Stefano Bombardieri; Gerd Burmester; Fonseca João Eurico; Charissa Frank; Eric Hachulla; Frederic Houssiau; Ulf Mueller-Ladner; Matthias Schneider; Jacob M van Laar; Ana Vieira; Maurizio Cutolo; Marta Mosca; Marco Matucci-Cerinic
Journal:  RMD Open       Date:  2018-10-18

9.  Role of Gas6 and TAM Receptors in the Identification of Cardiopulmonary Involvement in Systemic Sclerosis and Scleroderma Spectrum Disorders.

Authors:  Mattia Bellan; Arnaldo Dimagli; Cristina Piccinino; Ailia Giubertoni; Aurora Ianniello; Federico Grimoldi; Maurizio Sguazzotti; Alessandra Nerviani; Michela Barini; Alessandro Carriero; Carlo Smirne; Michela Emma Burlone; Cristina Rigamonti; Rosalba Minisini; Livia Salmi; Matteo Nazzareno Barbaglia; Luigi Mario Castello; Daniele Sola; Paolo Marino; Gian Carlo Avanzi; Mario Pirisi; Pier Paolo Sainaghi
Journal:  Dis Markers       Date:  2020-05-12       Impact factor: 3.434

Review 10.  Ongoing clinical trials and treatment options for patients with systemic sclerosis-associated interstitial lung disease.

Authors:  Dinesh Khanna; Donald P Tashkin; Christopher P Denton; Martin W Lubell; Cristina Vazquez-Mateo; Stephen Wax
Journal:  Rheumatology (Oxford)       Date:  2019-04-01       Impact factor: 7.580

  10 in total

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