Ankylosing spondylitis: What is the optimum duration of a clinical study? A one year versus a 6 weeks non-steroidal anti-inflammatory drug trial

Rheumatology

Volumn 38, Issue 3, 1999, Pages 235-244

  Dougados, M ^f,g   Gueguen, A ^a   Nakache, J P ^a   Velicitat, P ^b   Veys, E M ^c   Zeidler, H ^d   Calin, A ^e  

^a INSERM   (France)

^b BOEHRINGER INGELHEIM   (France)

^c GHENT UNIVERSITY   (Belgium)

^d HANNOVER MEDICAL SCHOOL   (Germany)

^e ROYAL NATIONAL HOSPITAL FOR RHEUMATIC DISEASES   (United Kingdom)

^f UNIVERSITÉ PARIS DESCARTES   (France)

^g NONE   (France)

Author keywords

Ankylosing spondylitis; Clinical trial; Meloxicam; NSAIDs; Piroxicam; Placebo

Indexed keywords

MELOXICAM; NONSTEROID ANTIINFLAMMATORY AGENT; PIROXICAM;

ADULT; ANKYLOSING SPONDYLITIS; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG TOLERABILITY; DUODENUM ULCER; FEMALE; FUNCTIONAL DISEASE; GASTROINTESTINAL SYMPTOM; HUMAN; MAJOR CLINICAL STUDY; MALE; MELENA; MULTICENTER STUDY; NEUROLOGIC DISEASE; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; SKIN DISEASE; STOMACH ULCER; TIME; TREATMENT OUTCOME;

EID: 0032731383     PISSN: 14620324     EISSN: None     Source Type: Journal    
DOI: 10.1093/rheumatology/38.3.235     Document Type: Article

References (28)

1. Arnett FC. Seronegative spondylarthropathies. Bull Rheum Dis 1987;37:1-12.
2. Dougados M. Diagnosis and monitoring of spondylarthropathy. Compr Ther 1990;16:52-6.
3. Dougados M, Revel M, Khan MA. Management of spondylarthropathy. In: van de Putte LBA, Furst DE, Williams HJ, van Riel PLCM, eds. Therapy of systemic disorders. New York: Marcel Dekker, 1997;375-406.
4. Godfrey RG, Calabro JJ, Mills D, Maltz BA. A double-blind crossover trial of aspirin, indomethacin and phenylbutazone in ankylosing spondylitis. Arthritis Rheum 1972;15:110.
5. Calin A. Grahame R. Double-blind crossover trial of flurbiprofen and phenylbutazone in ankylosing spondylitis. Br Med J 1974;4:496-9.
6. Liebling MR, Altman RD, Benedek TG et al, A double-blind multicentre trial of sulindac (MG 213) in the treatment of ankylosing spondylitis. Arthritis Rheum 1975;18:411.
7. Calin A, Britton M. Sulindac in ankylosing spondylitis. Double-blind evaluation of sulindac and indomethacin. J Am Med Assoc 1979;242:1885-6.
8. Tannenbaum H, De Coteau WE, Esdaile JM et al. A double blind multicentre trial comparing piroxicam and indomethacin in ankylosing spondylitis with long-term follow-up. Curr Ther Res 1984;36:426-35.
9. Sydnes OA. Comparison of piroxicam with indomethacin in ankylosing spondylitis: a double-blind crossover trial. Br J Clin Pract 1981;35:404-44.
10. Bird HA, Le Gallez P, Astbury C et al. A parallel group comparison of tenoxicam and piroxicam in patients with ankylosing spondylitis. Pharmatherapeutica 1986;4: 457-62.
11. Dougados M, Nguyen M, Caporal R et al. Ximoprofen in ankylosing spondylitis: A double blind placebo controlled dose ranging study. Scand J Rheumatol 1994;23:243-8.
12. Sturrock RD, Hart FD. Double-blind crossover comparison of indomethacin, flurbiprofen and placebo in ankylosing spondylitis. Ann Rheum Dis 1974;33:129-31.
13. Shipley M, Berry H, Bloom B. A double-blind crossover trial of indomethacin, fenoprofen and placebo in ankylosing spondylitis, with comments on patients assessment. Rheumatol Rehabil 1980;19:122-5.
14. Dougados M, Nguyen M, Nakache JP, Alir B. Spondylarthrite ankylosante et antiinflammatoires. Concours Méd 1987;109:2780-6.
15. Langman MJS, Weill J, Wainwright P et al. Risks of bleeding peptic ulcer associated with individual nonsteroidal anti-inflammatory drugs. Lancet 1994;343:1075B.
16. Roth SH, Bennett RE. Nonsteroidal anti-inflammatory drug gastropathy. Arch Intern Med 1987;147:2093-100.
17. Engelhardt G. Pharmacology of meloxicam, a new nonsteroidal anti-inflammatory drug with an improved safety profile through preferential inhibition of Cox-2. Br J Rheumatol 1996;35(suppl. 1):4-12.
18. Reginster JY, Distel M, Bluhmki E. A double-blind, three-week study to compare the efficacy and safety of meloxicam 7.5 mg and meloxicam 15 mg in patients with rheumatoid arthritis. Br J Rheumatol 1996;35(suppl. 1):17-21.
19. Huskisson EC, Ghozlan R, Kurthen R, Degners FL, Bluhmki E. A long-term study to evaluate the safety and efficacy of meloxicam therapy in patients with rheumatoid arthritis. Br J Rheumatol 1996;35(suppl. 1):29-34.
20. Lemmel EM, Bolten W, Bourgos-Vargas R et al. Efficacy and safety of meloxicam in patients with rheumatoid arthritis. J Rheumatol 1997;24:282-90.
21. van der Linden S, Valkenburg HA, Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis: Proposal for modification of the New York criteria. Arthritis Rheum 1984;27:361-8.
22. Dougados M, Gueguen A, Nakache JP et al. Evaluation of a functional index for patients with ankylosing spondylitis. J Rheumatol 1990;17:1254-5.
23. Bellamy N, Buchanan WW, Esdaile JM et al. Ankylosing spondylitis antirheumatic drugs trials. III. Setting the deltafor clinical trials of antirheumatic drugs - results of a consensus development (Delphi) exercise. J Rheumatol 1991;18:1716-22.
24. Fleiss JL. Statistical methods for rates and proportions. New York: Wiley and Sons, 1981.
25. Fleiss JL. The design and analysis of clinical experiments. New York: Wiley and Sons, 1996.
26. Dougados M, Duchesne L, Awada H, Amor B. Appréciation de l'utilité des traitements de fond dans la polyarthrite rhumatoïde par l'analyse du taux de maintenance thérapeutique. Rev Rhum Mal Osteoartic 1989;56:89-92.
27. Situnayake RD, Grindulis KA, McConkey B. Long term treatment of rheumatoid arthritis with sulphasalazine, gold or D-penicillamine: a comparison using life-table methods. Ann Rheum Dis 1987;46:177-83.
28. Fries J. Toward an understanding of NSAID-related adverse events: the contribution of longitudinal data. Scand J Rheumatol 1996;25(suppl. 102):3-8.