Literature DB >> 28992165

Points to consider for designing trials in systemic sclerosis patients with arthritic involvement.

Philip Clements1, Yannick Allanore2, Daniel E Furst1, Dinesh Khanna3.   

Abstract

Although musculoskeletal involvement is quite common in SSc (arthritic in particular), there have been few trials and even fewer controlled trials of therapeutic agents in arthritis in SSc. In addition, there have been only three outcome measures that have been validated for use in trials of SSc arthritis: the HAQ Disability Index, the Cochin Hand Function Scale and the Hand Mobility in SSc scale. The purpose of this article is to present evidence-based points to consider for the design of trials in SSc patients with musculoskeletal involvement (joints in particular). In addition, we make an argument for including outcome variables that can be validated within a given trial for use in future trials.
© 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:  Cochin Hand Function Scale; Hand Mobility in SSc scale (HAMIS); Health Assessment Questionnaire Disability Index (HAQ-DI); scleroderma; scleroderma arthritis; systemic sclerosis

Mesh：

Year:  2017        PMID： 28992165      PMCID： PMC5850357          DOI： 10.1093/rheumatology/kex194

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


  11 in total

1.  Cyclophosphamide versus placebo in scleroderma lung disease.

Authors:  Donald P Tashkin; Robert Elashoff; Philip J Clements; Jonathan Goldin; Michael D Roth; Daniel E Furst; Edgar Arriola; Richard Silver; Charlie Strange; Marcy Bolster; James R Seibold; David J Riley; Vivien M Hsu; John Varga; Dean E Schraufnagel; Arthur Theodore; Robert Simms; Robert Wise; Fredrick Wigley; Barbara White; Virginia Steen; Charles Read; Maureen Mayes; Ed Parsley; Kamal Mubarak; M Kari Connolly; Jeffrey Golden; Mitchell Olman; Barri Fessler; Naomi Rothfield; Mark Metersky
Journal:  N Engl J Med       Date:  2006-06-22       Impact factor: 91.245

2.  2013 classification criteria for systemic sclerosis: an American College of Rheumatology/European League against Rheumatism collaborative initiative.

Authors:  Frank van den Hoogen; Dinesh Khanna; Jaap Fransen; Sindhu R Johnson; Murray Baron; Alan Tyndall; Marco Matucci-Cerinic; Raymond P Naden; Thomas A Medsger; Patricia E Carreira; Gabriela Riemekasten; Philip J Clements; Christopher P Denton; Oliver Distler; Yannick Allanore; Daniel E Furst; Armando Gabrielli; Maureen D Mayes; Jacob M van Laar; James R Seibold; Laszlo Czirjak; Virginia D Steen; Murat Inanc; Otylia Kowal-Bielecka; Ulf Müller-Ladner; Gabriele Valentini; Douglas J Veale; Madelon C Vonk; Ulrich A Walker; Lorinda Chung; David H Collier; Mary Ellen Csuka; Barri J Fessler; Serena Guiducci; Ariane Herrick; Vivien M Hsu; Sergio Jimenez; Bashar Kahaleh; Peter A Merkel; Stanislav Sierakowski; Richard M Silver; Robert W Simms; John Varga; Janet E Pope
Journal:  Arthritis Rheum       Date:  2013-10-03

3.  High-dose versus low-dose D-penicillamine in early diffuse systemic sclerosis: analysis of a two-year, double-blind, randomized, controlled clinical trial.

Authors:  P J Clements; D E Furst; W K Wong; M Mayes; B White; F Wigley; M H Weisman; W Barr; L W Moreland; T A Medsger; V Steen; R W Martin; D Collier; A Weinstein; E Lally; J Varga; S Weiner; B Andrews; M Abeles; J R Seibold
Journal:  Arthritis Rheum       Date:  1999-06

Review 4.  Handling missing data issues in clinical trials for rheumatic diseases.

Authors:  Weng Kee Wong; W J Boscardin; A E Postlethwaite; D E Furst
Journal:  Contemp Clin Trials       Date:  2010-09-16       Impact factor: 2.226

Review 5.  Arthritis in systemic sclerosis: systematic review of the literature and suggestions for the performance of future clinical trials in systemic sclerosis arthritis.

Authors:  Philip J Clements; Yannick Allanore; Dinesh Khanna; Minjit Singh; Daniel E Furst
Journal:  Semin Arthritis Rheum       Date:  2011-12-15       Impact factor: 5.532

Review 6.  Current status of outcome measure development for clinical trials in systemic sclerosis. Report from OMERACT 6.

Authors:  Peter A Merkel; Philip J Clements; John D Reveille; Maria E Suarez-Almazor; Gabriele Valentini; Daniel E Furst
Journal:  J Rheumatol       Date:  2003-07       Impact factor: 4.666

7.  Reliability and validity of the Duruoz Hand Index in persons with systemic sclerosis (scleroderma).

Authors:  Lisa M Brower; Janet L Poole
Journal:  Arthritis Rheum       Date:  2004-10-15

8.  Course of dermal ulcers and musculoskeletal involvement in systemic sclerosis patients in the scleroderma lung study.

Authors:  Karen Au; Maureen D Mayes; Paul Maranian; Philip J Clements; Dinesh Khanna; Virginia D Steen; Donald Tashkin; Michael D Roth; Robert Elashoff; Daniel E Furst
Journal:  Arthritis Care Res (Hoboken)       Date:  2010-12       Impact factor: 4.794

9.  Recombinant human relaxin in the treatment of systemic sclerosis with diffuse cutaneous involvement: a randomized, double-blind, placebo-controlled trial.

Authors:  Dinesh Khanna; Philip J Clements; Daniel E Furst; Joseph H Korn; Michael Ellman; Naomi Rothfield; Fredrick M Wigley; Larry W Moreland; Richard Silver; Youn H Kim; Virginia D Steen; Gary S Firestein; Arthur F Kavanaugh; Michael Weisman; Maureen D Mayes; David Collier; Mary E Csuka; Robert Simms; Peter A Merkel; Thomas A Medsger; Martin E Sanders; Paul Maranian; James R Seibold
Journal:  Arthritis Rheum       Date:  2009-04

10.  Efficacy of connective tissue massage and Mc Mennell joint manipulation in the rehabilitative treatment of the hands in systemic sclerosis.

Authors:  Susanna Maddali Bongi; Angela Del Rosso; Felice Galluccio; Fabrizio Sigismondi; Irene Miniati; M Letizia Conforti; Francesca Nacci; Marco Matucci Cerinic
Journal:  Clin Rheumatol       Date:  2009-06-25       Impact factor: 2.980
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  3 in total

Review 1.  Inflammatory arthritis in systemic sclerosis: What to do?

Authors:  Rebecca B Blank; Ogonna Kenechi Nwawka; Anna A Yusov; Jessica K Gordon
Journal:  J Scleroderma Relat Disord       Date:  2018-06-19

Review 2.  Assessment of disease outcome measures in systemic sclerosis.

Authors:  Robert Lafyatis; Eleanor Valenzi
Journal:  Nat Rev Rheumatol       Date:  2022-07-20       Impact factor: 32.286

3.  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
  3 in total

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