Titre du document / Document title

Pilot clinical trial of intravenous doxycycline versus placebo for rheumatoid arthritis

Auteur(s) / Author(s)

PILLEMER Stanley ; GULKO Percio ; LIGIER Sophie ; YARBORO Cheryl ; GOURLEY Mark ; GOLDBACH-MANSKY Raphaela ; SIEGEL Richard ; HIRSCH Rosemarie ; PUCINO Frank ; TILLEY Barbara ; WILDER Ronald L. ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

National Institute of Dental and Craniofacial Research, the National Institute of Arthritis, Musculoskeletal and Skin Diseases, the Clinical Center, and the National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland, ETATS-UNIS
North Shore-Long Island Jewish Research Institute, Manhasset, New York, ETATS-UNIS
Washington Hospital Center, Washington, DC, ETATS-UNIS
Division of Biometry and Epidemiology, Institution, Medical University of South Carolina, Charleston, South Carolina, ETATS-UNIS

Résumé / Abstract

Objective. To screen for potential efficacy and assess the feasibility of intravenous (IV) doxycycline as a treatment for rheumatoid arthritis (RA). Methods. The study was a (stratified, block) randomized, double blind, 12 week, pilot trial of IV doxycycline 300 mg/day versus identical appearing IV placebo given over 2 h for 14 days. The primary comparison was to a hypothesized placebo rate of 20% as described by Paulus. If a total of 14 consecutive subjects receiving doxycycline treatment did not respond, it would be considered futile to proceed to a Phase III trial. We planned a placebo group of 14 subjects to verify the placebo response rate and estimate sample size required for a definitive Phase III trial, if such a trial was warranted based on the pilot study. American College of Rheumatology (ACR) RA response criteria were used. After 23 subjects entered, the study was closed due to recruitment difficulties. Results. At baseline, mean (SD) tender joint count was 37(11.9), swollen joint count 30(9.6), morning stiffness 317 (319) min, and erythrocyte sedimentation rate 72 mm/h (27.5). Randomization resulted in 10 subjects receiving doxycycline and 13 receiving placebo. Treatment was stopped in 8 subjects: in 6, treatment was ineffective (one taking doxycycline, 5 placebo), and in 2, rashes occurred (one taking doxycycline, one placebo). Only one subject met ACR response criteria in the doxycycline group and none in the placebo group. Having no responders in the placebo group was consistent with placebo response rate of 20% or less. Several patients required peripherally inserted central catheters for venous access. Conclusion. The efficacy of IV doxycycline as a treatment for RA could not be ruled out. However, as the proportion of responders was small, it is unlikely that potential efficacy of IV doxycycline would outweigh potential disadvantages of IV administration.

Revue / Journal Title

Journal of rheumatology   ISSN 0315-162X   CODEN JRHUA9 

Source / Source

2003, vol. 30, n^o1, pp. 41-43 [3 page(s) (article)] (21 ref.)

Langue / Language

Anglais

Editeur / Publisher

Journal of Rheumatology Publishing, Toronto, ON, CANADA  (1974) (Revue)

Mots-clés anglais / English Keywords

Autoimmune disease ; Immunopathology ; Inflammatory joint disease ; Diseases of the osteoarticular system ; Tetracycline derivatives ; Chronic ; Human ; Toxicity ; Antirheumatic agent ; Double blind study ; Clinical trial ; Placebo ; Treatment efficiency ; Comparative study ; Route of administration ; Intravenous administration ; Doxycycline ; Chemotherapy ; Treatment ; Rheumatoid arthritis ;

Mots-clés français / French Keywords

Maladie autoimmune ; Immunopathologie ; Rhumatisme inflammatoire ; Système ostéoarticulaire pathologie ; Tétracycline dérivé ; Chronique ; Homme ; Toxicité ; Antirhumatismal ; Etude double insu ; Essai clinique ; Placebo ; Efficacité traitement ; Etude comparative ; Voie administration ; Voie intraveineuse ; Doxycycline ; Chimiothérapie ; Traitement ; Polyarthrite rhumatoïde ;

Mots-clés espagnols / Spanish Keywords

Enfermedad autoinmune ; Inmunopatología ; Reumatismo inflamatorio ; Sistema osteoarticular patología ; Tetraciclina derivado ; Crónico ; Hombre ; Toxicidad ; Antireumático ; Estudio doble ciego ; Ensayo clínico ; Placebo ; Eficacia tratamiento ; Estudio comparativo ; Vía administración ; Vía intravenosa ; Doxiciclina ; Quimioterapia ; Tratamiento ; Poliartritis reumatoidea ;

Localisation / Location

INIST-CNRS, Cote INIST : 16024, 35400010375856.0080