Skip Navigation

This Article
Right arrow Full Text Freely available
Right arrow FREE Full Text (PDF) Freely available
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrow Search for citing articles in:
ISI Web of Science (14)
Right arrowRequest Permissions
Right arrow Disclaimer
Google Scholar
Right arrow Articles by Hemmings, F. J.
Right arrow Articles by Jain, R.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Hemmings, F. J.
Right arrow Articles by Jain, R.
Related Collections
Right arrow Rheumatoid Arthritis
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

Rheumatology 2001; 40: 537-543
© 2001 British Society for Rheumatology

Original Papers

Tolerability and pharmacokinetics of the collagenase-selective inhibitor TrocadeTM in patients with rheumatoid arthritis

F. J. Hemmings, M. Farhan, J. Rowland, L. Banken1 and R. Jain2

Roche Products Ltd, Welwyn Garden City, UK,
1 F. Hoffmann-La Roche, Basel, Switzerland and
2 North Shore University Hospital, New York, USA

Objectives. The purpose of this study was to assess the tolerability and multiple-dose pharmacokinetics of TrocadeTM in rheumatoid arthritis patients.

Methods. Forty-eight patients entered this double-blind, placebo-controlled, multiple ascending dose study. Patients received Trocade (25, 50, 100 or 150 mg) or placebo once daily for 28 days. Tolerability was assessed daily. Plasma pharmacokinetics was assessed on days 1 and 28. Trough blood samples were collected weekly.

Results. Trocade was well tolerated, with no differences in the adverse event profile compared with placebo. There were no relevant changes in laboratory parameters, vital signs or 12-lead ECG recordings. Plasma concentration profiles showed that Trocade was rapidly absorbed and most was eliminated within 24 h. The area under the plasma concentration–time curve and the maximum plasma concentration reached increased with dose, but this increase was not proportional to dose. No relevant accumulation was seen.

Conclusions. Trocade was well tolerated for the 28-day study period. From exposure data, doses of 100 and 150 mg were expected to yield plasma levels associated with efficacy, and from trough concentrations the doses of 25 and 50 mg were also expected to be efficacious.

KEY WORDS: Trocade, Rheumatoid arthritis, Safety, Pharmacokinetics, Collagenase-selective inhibitor.

Correspondence to: F. Hemmings, Roche Products Ltd, Albany Place, Broadwater Road, Welwyn Garden City, Hertfordshire AL7 2JL, UK.


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?


This article has been cited by other articles:


Home page
 Ann Rheum DisHome page
D R Close
Matrix metalloproteinase inhibitors in rheumatic diseases
Ann Rheum Dis, November 1, 2001; 60(90003): iii62 - 67.
[Abstract] [Full Text] [PDF]


Disclaimer: Please note that abstracts for content published before 1996 were created through digital scanning and may therefore not exactly replicate the text of the original print issues. All efforts have been made to ensure accuracy, but the Publisher will not be held responsible for any remaining inaccuracies. If you require any further clarification, please contact our Customer Services Department.