A Study of Tocilizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARDs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00810277
First received: December 16, 2008
Last updated: August 4, 2014
Last verified: August 2014

December 16, 2008
August 4, 2014
November 2008
May 2010   (final data collection date for primary outcome measure)
Adverse events;serious adverse events [ Time Frame: Throughout study;assessments made at every 4 week visit ] [ Designated as safety issue: No ]
Adverse events;serious adverse events [ Time Frame: Throughout study; assessments made at every 4 week visit ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00810277 on ClinicalTrials.gov Archive Site
  • DAS28;ACR20,50 and 70 responses;CRP and ESR [ Time Frame: Throughout study;assessments made at every 4 week visit ] [ Designated as safety issue: No ]
  • Premature withdrawals; ALT and AST elevations; no. of patients with lipid elevations; neutrophil count [ Time Frame: Throughout study;assessments made at every 4 week visit ] [ Designated as safety issue: No ]
  • DAS28;ACR20,50 and 70 responses;CRP and ESR [ Time Frame: Throughout study; assessments made at every 4 week visit ] [ Designated as safety issue: No ]
  • Premature withdrawals; ALT and AST elevations; no. of patients with lipid elevations; neutrophil count [ Time Frame: Throughout study; assessments made at every 4 week visit ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Tocilizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARDs
An Open Label Study to Evaluate the Safety and Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARDs.

This single arm study will assess the safety and efficacy of tocilizumab in pati ents with moderate to severe active rheumatoid arthritis who have an inadequate response to current non-biologic DMARDs. Patients will receive iv infusions of t ocilizumab 8mg/kg every 4 weeks for a total of 6 infusions, either as monotherap y or in combination with their current non-biologic DMARDs.The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individual s.

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
14
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • moderate to severe rheumatoid arthritis;
  • inadequate response to current non-biologic DMARDs;
  • <=150kg body weight.

Exclusion Criteria:

  • rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
  • previous treatment with other biologics.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00810277
ML22012, 2008-004126-16
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

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