A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis With an Inadequate Response to DMARDs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00996606
First received: October 15, 2009
Last updated: April 1, 2014
Last verified: April 2014

October 15, 2009
April 1, 2014
October 2009
April 2012   (final data collection date for primary outcome measure)
Effect on synovitis, bone marrow edema and erosions, assessed by MRI of the hand [ Time Frame: weeks 4, 8, 12, 24 and 48 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00996606 on ClinicalTrials.gov Archive Site
  • Early effect on synovitis, bone marrow edema and erosions, assessed by MRI of the hand [ Time Frame: day 15 ] [ Designated as safety issue: No ]
  • Clinical response: DAS 28, HAQ, VAS, ESR, CRP, VGEF, Hb [ Time Frame: assessed every 4 weeks ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters [ Time Frame: throughout study, laboratory parameters assessed every 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis With an Inadequate Response to DMARDs
Open Label, Multicenter Study to Evaluate the Effect of Tocilizumab in Combination With DMARDs in the Inhibition of Progression of Synovitis, Bone Marrow Edema, and Erosions Evaluated by Magnetic Resonance Imaging (MRI) of the Hand of Patients With Rheumatoid Arthritis

This open-label, single arm study will evaluate the efficacy and safety of tocilizumab in combination with DMARDs in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to DMARDs. Patients will receive tocilizumab (8mg/kg iv infusion) every 4 weeks in addition to their current DMARD therapy. Anticipated time on study treatment is 48 weeks, and the target sample size is <100.

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 infusion every 4 weeks for 48 weeks
  • Drug: DMARDs
    stable dose as prescribed
Experimental: Single arm
Interventions:
  • Drug: tocilizumab [RoActemra/Actemra]
  • Drug: DMARDs
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >/=18 years of age
  • moderate to severe active rheumatoid arthritis of >/=6 months duration
  • DAS >/=3.2
  • inadequate response to a stable dose of DMARDs
  • patients receiving oral corticosteroids must have been at stable dose on >/=25 days in the 28 days prior to first study treatment

Exclusion Criteria:

  • rheumatic autoimmune disease other than RA
  • history of or current joint disease other than RA
  • previous treatment with a biologic
  • intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
  • previous treatment with any cell-depleting therapies
  • functional class IV (ACR)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00996606
ML22413, 2009-012185-32
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

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