Document Detail

Inclusion criteria as widely used for rheumatoid arthritis clinical trials: patient eligibility in a Turkish cohort.
MedLine Citation:
PMID:  16173246     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To identify the proportion of patients fulfilling the inclusion criteria widely used in most clinical trials for rheumatoid arthritis (RA)--including the recent clinical trials of anti-Tumor Necrosis Factor alpha (TNFalpha) agents--in a Turkish cohort. METHODS: 186 consecutive RA patients attending a routine tertiary rheumatology clinic were evaluated in 2 groups: Early RA group (group E): 31 patients with a disease duration of < or = 3 years (mean: 1.9 +/- 0.9 years); late RA group (group L): 155 patients with a disease duration of > 3 years (mean: 13.3 +/- 8.6 years). Patients were evaluated according to 2 different sets of inclusion criteria: (i) The widely used common inclusion criteria for RA clinical studies, as outlined by Sokka and Pincus; (ii) the criteria of two major anti-TNF clinical studies, ERA and ATTRACT. RESULTS: No patients in group E, and 9 (6%) patients in group L fulfilled the common criteria used in clinical studies for RA. In group E, 28 patients had already been started on methotrexate; 2 patients were on sulphasalazine and one patient was on leflunomide. Nevertheless, even if the criterion for previous use of methotrexate was not applied patients did not fulfill the rest of the criteria of ERA study. In group L, 9 out of 155 patients (6%) met the criteria for the ATTRACT study. CONCLUSION: Only few patients met the widely used inclusion criteria for most RA clinical trials and the recent clinical trials of TNFalpha agents in this Turkish cohort. This may be explained by the milder disease activity in this geographical region, which further emphasizes the need to consider development of new criteria for inclusion in clinical trials.
F Gogus; Y Yazici; H Yazici
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Clinical and experimental rheumatology     Volume:  23     ISSN:  0392-856X     ISO Abbreviation:  Clin. Exp. Rheumatol.     Publication Date:    2005 Sep-Oct
Date Detail:
Created Date:  2005-09-21     Completed Date:  2005-12-21     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8308521     Medline TA:  Clin Exp Rheumatol     Country:  Italy    
Other Details:
Languages:  eng     Pagination:  681-4     Citation Subset:  IM    
Gazi Medical Faculty, Department of Physical Medicine and Rehabilitation, Division of Rheumatology, Ankara, Turkey.
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MeSH Terms
Arthritis, Rheumatoid*
Clinical Trials as Topic*
Cohort Studies
Middle Aged
Patient Selection*

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