European perspective of clinical trials in systemic lupus erythematosus

Strand V , Gladman D , Isenberg DA et al. Outcome measures to be used in clinical trials in SLE . J Rheumatol 1999; 26: 490–497 .

Smolen JS , Strand V , Cardiel M et al. Randomized clinical trials and longitudinal observational studies in SLE: Consensus on a preliminary core set of outcome domains . J Rheumatol 1999; 26: 504–507 .

Smolen JS . Clinical and serological features. In: Smolen JS , Zielinski CC (eds) Systemic Lupus Erythematosus: Clinical and Experimental Aspects. Springer Verlag: Berlin , 1987, pp 170–196.

Vitali C , Bencivelli W , Isenberg DA et al. Disease activity in systemic lupus erythematosus: report of the Consensus Study Group of the European Workshop for Rheumatology Research II. Identification of the variables indicative of disease actvity and their use in the development of an activity score . Clin Exp Rheumatol 1992; 10: 541–547 .

Hay EM , Bacon PA , Gordon C et al. The BILAG index: a reliable and valid instrument for measuring clinical disease activity in systemic lupus erythematosus . Q J Med 1993; 86: 447–458 .

Gladman DD , Goldsmith C , Urowitz MB et al. Crosscultural validation and reliability of 3 disease indices in SLE . J Rheumatol 1992; 19: 608–611 .

Gladman DD , Ginzler E , Goldsmith C et al. The development and initial validation of the SLICC/ACR damage index for SLE . Arthritis Rheum 1996; 39: 363–369 .

Stoll T , Gordon C , Seifert B et al. Consistency and validity of patient administered assessment of quality of life by the MOS-SF 36: its association with disease activity and damage in patients with SLE . J Rheumatol 1997; 24: 1608–1614 .

Charles PJ , van Venrooij WJ , Maini RN . The Consensus Workshops for the detection of autoantibodies to intracellular antigens in rheumatic diseases . Clin Exp Rheumatol 1992; 10 (5): 507–511 .

Van Venrooij WJ , Maini RN (eds). Manual of Biological Markers of Disease. Kluwer: Dordrecht , 1995.

Tan EM , Fritzler MJ , McDougal SJ et al. Reference sera for antinuclear antibodies. I. Antinuclear antibodies to native DNA, Sm, nuclear RNP and SS-B/A . Arthritis Rheum 1982; 25: 1003–1005 .

Smolen JS , Butcher B , Fritzler MJ et al. Reference sera for anti-nuclear antibodies. II. Further definition of antibody specificities in international antinuclear antibody reference sera by immunofluorescence and Western blotting . Arthritis Rheum 1997; 40: 413–418 .

Tan EM , Feltkamp TE , Smolen JS et al. Range of antinuclear antibodies in‘healthy’ individuals . Arthritis Rheum 1997; 40: 1601–1611 .

Tan EM , Smolen JS , McDougal JS et al. A critical evaluation of enzyme immunoassays for detection of antinuclear autoantibodies of defined specificities. I. Precision, sensitivity, and specificity . Arthritis Rheum 1999; 42 (3): 455–464 .

SmolenJS , SteinerG , TanEM . Standardsofcare:Thevalueandimportance of standardization (editorial) . Arthritis Rheum 1997; 40: 410–412 .

Efficacy Working Party, CPMP . Guidelines on clinical investigation of slow-acting anti-rheumatic medicinal products in rheumatoid arthritis, 1998.

Food and Drug Administration . Guidance for Industry. Clinical development programs for drugs, devices and biological products for the treatment of rheumatoid arthritis, 1999.