Document Detail


Course of dermal ulcers and musculoskeletal involvement in systemic sclerosis patients in the scleroderma lung study.
MedLine Citation:
PMID:  20740615     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To evaluate changes in vascular and musculoskeletal involvement in subjects in the Scleroderma Lung Study, a multicenter, double-blind, randomized, controlled trial comparing placebo treatment with oral cyclophosphamide (CYC) for 1 year in systemic sclerosis patients with interstitial lung disease. Subjects were then followed off the study agent for an additional 12 months.
METHODS: The following parameters were noted at baseline and every 6 months for each patient: digital tip ulcers, other dermal ulcers, joint swelling, joint tenderness, large joint contractures, muscle tenderness, muscle weakness, oral aperture, hand extension, and fist closure.
RESULTS: A total of 158 patients were enrolled from 13 centers in the US; 79 were randomized to the CYC group and 79 to the placebo group. There were no differences in dermal ulcer and musculoskeletal measures between the CYC and placebo groups at baseline and 12 and 24 months. Improvement in percent predicted forced vital capacity was associated with improvement in the Rodnan skin thickness score (P<0.05) at 12 and 24 months, and with increased mean oral aperture at 24 months (P=0.005).
CONCLUSION: These data document the frequency and course of these vascular and musculoskeletal features over time, therefore providing essential information for sample size calculations and magnitude of effect in future clinical trials. There was no treatment effect of CYC on the vascular and musculoskeletal features described.
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
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Arthritis care & research     Volume:  62     ISSN:  2151-4658     ISO Abbreviation:  Arthritis Care Res (Hoboken)     Publication Date:  2010 Dec 
Date Detail:
Created Date:  2010-12-01     Completed Date:  2011-01-28     Revised Date:  2014-09-08    
Medline Journal Info:
Nlm Unique ID:  101518086     Medline TA:  Arthritis Care Res (Hoboken)     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1772-8     Citation Subset:  IM    
Copyright Information:
Copyright © 2010 by the American College of Rheumatology.
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Cyclophosphamide / administration & dosage*
Double-Blind Method
Female
Follow-Up Studies
Humans
Immunosuppressive Agents / administration & dosage*
Male
Middle Aged
Prognosis
Scleroderma, Localized / complications*,  diagnosis
Scleroderma, Systemic / complications*,  diagnosis,  drug therapy
Skin Ulcer / diagnosis,  etiology*
Grant Support
ID/Acronym/Agency:
K23 AR053858/AR/NIAMS NIH HHS; K23 AR053858-04/AR/NIAMS NIH HHS; K23-AR053858-03/AR/NIAMS NIH HHS; U01 HL060823-03/HL/NHLBI NIH HHS
Chemical
Reg. No./Substance:
0/Immunosuppressive Agents; 8N3DW7272P/Cyclophosphamide
Comments/Corrections

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