A Study Comparing Infusion Rates of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00887341
First received: April 22, 2009
Last updated: July 19, 2011
Last verified: July 2011

April 22, 2009
July 19, 2011
May 2009
Not Provided
Appearance of infusion reactions [ Time Frame: Event driven; monitored throughout study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00887341 on ClinicalTrials.gov Archive Site
  • Clinical remission(DAS28<2.6); ACR20/50/70/90 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Adverse events;laboratory parameters [ Time Frame: Throughout study, at each clinic visit ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study Comparing Infusion Rates of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis
Phase II Multi-centre, Randomized, Parallel Group, Pilot Trial to Compare the Incidence of Tocilizumab Related Infusion Reactions in Moderate to Severe RA Patients When Infusion is Made Over 1 Hour Against 31 Minutes

This 2 arm study will compare the incidence of tocilizumab-related infusion reactions, using 2 different infusion times, in patients with moderate to severe rheumatoid arthritis who have shown an inadequate response to DMARDs (Disease Modifying Anti Rheumatic Drugs) or anti-TNFs.Patients will be randomized to one of 2 groups, to receive tocilizumab 8mg/kg iv every 4 weeks either a)over a 1h infusion time for all administrations or b) a 1h infusion time for the first administration, followed by a 31 minute infusion time for subsequent administrations (unless drug-related infusion reactions occur).The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: tocilizumab [RoActemra/Actemra]
    8mg/kg iv every 4 weeks for 6 infusions; first infusion 1h duration, subsequent infusions 31 minutes duration
  • Drug: tocilizumab [RoActemra/Actemra]
    8mg/kg iv every 4 weeks for 6 infusions; each infusion 1h duration
  • Experimental: 1
    Intervention: Drug: tocilizumab [RoActemra/Actemra]
  • Active Comparator: 2
    Intervention: Drug: tocilizumab [RoActemra/Actemra]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
May 2011
Not Provided

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • active moderate or severe rheumatoid arthritis;
  • active disease for >6 months;
  • inadequate response to a stable dose of non-biologic DMARDs or antiTNFs.

Exclusion Criteria:

  • rheumatic autoimmune disease other than rheumatoid arthritis;
  • prior history of, or current inflammatory joint disease other than rheumatoid arthritis;
  • major surgery (including joint surgery) within 8 weeks prior to screening, or planned major surgery within 6 months following enrollment.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00887341
ML22254, 2008-006443-39
Not Provided
Disclosures Group, Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP