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A Study to Assess the Effect of Tocilizumab on Signs and Symptoms in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00848120
First received: February 19, 2009
Last updated: February 3, 2014
Last verified: February 2014

February 19, 2009
February 3, 2014
December 2008
February 2010   (final data collection date for primary outcome measure)
Proportion of patients with ACR20 response [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00848120 on ClinicalTrials.gov Archive Site
  • Proportion of patients with ACR50 and ACR70 responses; change from baseline in DAS28; proportion of patients with DAS28<2.6;QOL scores (HAQ-DI and FACIT) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Time to onset of ACR20/50/70 response [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: At each visit to week 24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Assess the Effect of Tocilizumab on Signs and Symptoms in Patients With Rheumatoid Arthritis
An Open Label Study to Evaluate the Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis

This single arm, open label study will assess the safety and efficacy, with regard to reduction of signs and symptoms,of treatment with tocilizumab in patients with moderate to severe active rheumatoid arthritis. Patients will receive tocilizumab 8mg/kg iv every 4 weeks for a total of 6 infusions. Patients already receiving methotrexate at entry into the study may continue with their treatment together with tocilizumab.The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks for 24 weeks
Experimental: 1
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
29
February 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients,>=18 years of age;
  • rheumatoid arthritis diagnosed >8 weeks and <4 years prior to baseline;
  • naive to, or not responding well to, methotrexate;
  • swollen joint count >=8 (66 joint count) and tender joint count>=8 (68 joint count) at screening and baseline.

Exclusion Criteria:

  • rheumatic autoimmune disease other than rheumatoid arthritis;
  • patients with functional class IV rheumatoid arthritis;
  • history of, or current, inflammatory joint disease other than rheumatoid arthritis, or other systemic autoimmune disorder.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Philippines
 
NCT00848120
ML22074
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
February 2014

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