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"Effectiveness After Four and Twentyfour Weeks and Safety of Tocilizumab in Patients With Active RA"
This single arm study will assess the effectiveness of tocilizumab in combination with traditional DMARDs with regard to the clinical improvement in disease activity (achievement of LDAS) after 24 weeks' treatment in patients with active rheumatoid arthritis (RA) who have had an inadequate response to current traditional DMARD and/or anti-TNF therapy. Patients will receive tocilizumab 8mg/kg iv every 4 weeks, in addition to ongoing DMARDs at the stable pre-entry dose prescribed by the physician, for a total of 6 infusions during the regular treatment period and a further 6 infusions during an optional extension phase. The anticipated time on study treatment is 6 to 12 months, and the target sample size is \<500 individuals.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Aachen, Germany
Bad Abbach, Germany
Bad Aibling, Germany
Bad Bramstedt, Germany
Bad Nauheim, Germany
Baden-Baden, Germany
Bayreuth, Germany
Berlin, Germany
Berlin, Germany
Berlin, Germany
Start Date
August 1, 2008
Primary Completion Date
November 1, 2009
Completion Date
November 1, 2009
Last Updated
February 8, 2016
286
ACTUAL participants
Tocilizumab
DRUG
Lead Sponsor
Hoffmann-La Roche
NCT07484243
NCT06647069
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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