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Rheumatology 2001; 40: 615-622
© 2001 British Society for Rheumatology
Original Papers |
Effects of the American College of Rheumatology systemic sclerosis trial guidelines on the nature of systemic sclerosis patients entering a clinical trial
1 Arthritis Clinical Research Unit, Virginia Mason Research Center,
2 Department of Medicine; University of Washington, WA,
3 UCLA School of Medicine,
4 Public Health–Biostatistics, UCLA,
5 Department of Rheumatology, Hutzel Hospital,
6 Department of Medicine, Johns Hopkins University, Baltimore, MD,
7 Department of Medicine, University of Maryland School of Medicine,
8 Department of Medicine, UCSD Medical Center,
9 Department of Medicine, Stritch School of Medicine, Loyola University,
10 Clinical Research, Department of Medicine, University of Alabama at Birmingham, AL,
11 Department of Medicine, Michigan State University College of Medicine,
12 Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA,
13 Department of Medicine, Georgetown University Medical Center,
14 Department of Rheumatology, Denver Health Medical Center, University of Colorado,
15 Department of Medicine, George Washington University Medical Center,
16 Department of Medicine, Brown University School of Medicine,
17 Section of Rheumatology, University of Illinois at Chicago, Chicago, IL,
18 Department of Medicine, University of California at Irvine, CA,
19 Department of Medicine, University of Connecticut Health Center and
20 Scleroderma Program, UMDNJ–Robert Wood Johnson Medical School, NJ, USA
Objectives. To compare the systemic sclerosis (SSc) patients entered into the d-penicillamine trial with SSc patients entered into previous controlled SSc trials. It was hypothesized that the d-penicillamine trial patients, who conformed to the American College of Rheumatology (ACR) guidelines for clinical trials in SSc were different from patients entered into previous trials.
Methods. Patients entering a double-blind, randomized trial of low- vs high-dose d-penicillamine were described carefully and completely. Their characteristics were then compared with previously published data on SSc and its treatment.
Results. One hundred and thirty-four patients had early [mean duration 9.5 (s.d. 4.2) months], diffuse [skin score 21 (8)] disease. Organ involvement in the patients was as follows: pulmonary 54%, cardiac 20%, joints 38%, muscular 20%. Thirty-three per cent had mild proteinuria and 13% were hypertensive when first seen. Compared with patients in most previous studies, these SSc patients had earlier disease and uniformly had diffuse disease. They had less muscular involvement, less dyspnoea, less abnormal pulmonary function and less cardiac and less renal involvement than patients in earlier studies.
Conclusions. The use of the new ACR guidelines for SSc trials may change the nature of patient populations entering future studies.
KEY WORDS: Systemic sclerosis, Scleroderma, Organ involvement, ACR guidelines for systemic sclerosis trials.
Correspondence to: D. E. Furst, Virginia Mason Research Center, 1000 Seneca Street, Seattle, WA 98101, USA.