RESEARCH - Pilot clinical trial of intravenous doxycycline versus placebo for RA

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J Rheumatol. 2003 Jan;30(1):41-3.

Pilot clinical trial of intravenous doxycycline versus placebo for

rheumatoid arthritis.

Pillemer S, Gulko P, Ligier S, Yarboro C, Gourley M, Goldbach-Mansky

R, Siegel R, Hirsch R, Pucino F, Tilley B, Wilder RL.

National Institute of Dental and Craniofacial Research, Bethesda,

land 20892, USA.

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

us. 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.

PMID: 12508388

http://www.ncbi.nlm.nih.gov/pubmed/12508388

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