Benvenuti ad Adobe GoLive 6

Inclusion criteria as widely used for rheumatoid arthritis clinical trials: Patient eligibility in a Turkish cohort

F. Gogus¹, Y. Yazici², H. Yazici³

¹Gazi Medical Faculty, Department of Physical Medicine and Rehabilitation, Division of Rheumatology, Ankara, Tur-key; ²NYU–Hospital for Joint Diseases, New York, NY, USA; ³Cerrahpasa Medical Faculty, Department of Internal Medicine, Division of Rheumatology, Istanbul, Turkey.

ABSTRACT
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 a (TNFa) 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 &Mac178; 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 TNFa 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.

Key words
Rheumatoid arthritis, anti-TNF agents, clinical trial criteria, total joint count.

Please address correspondence to: Dr. Feride Gogus, Atatürk Bulvari No:243, Ilbank B Blok D:21, 06700 Kavaklidere, Ankara, Turkey.
E-mail: mtalat@ttnet.net.tr, fgogus@gazi.edu.tr