Text Size

A Study of Tocilizumab + DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00951275
First received: July 30, 2009
Last updated: August 8, 2012
Last verified: August 2012
History of Changes

July 30, 2009
August 8, 2012
October 2009
January 2012   (final data collection date for primary outcome measure)
  • Change in Hb levels from baseline [ Time Frame: Day 14, 28 and every 4 weeks ] [ Designated as safety issue: No ]
  • Change in FACIT-F scale score [ Time Frame: Day 14, 28 and every 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00951275 on ClinicalTrials.gov Archive Site
  • Proportion of patients with ACR20/50/70 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Mean change from baseline in ACR score set [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in ACR score set [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Categorical DAS28 responders [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Proportion of patients with ACR20/50/70 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Mean change from baseline in ACR score set [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in ACR score set [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Categorical DAS28 responders [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Tocilizumab + DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
A Single Arm, Open-label Study of Early Improvement of Anemia and Fatigue During Treatment With Tocilizumab (TCZ) in Combination With DMARDs, in Adult Patients With Moderate to Severe Active Rheumatoid Arthritis.

This single arm study will assess the effect of tocilizumab + DMARDs (Disease Modifying Anti-Rheumatic Drugs)on improvement of anemia and fatigue in patients with moderate to severe active rheumatoid arthritis. Eligible patients who have had an inadequate response to DMARDs will receive tocilizumab 8mg/kg iv every 4 weeks in combination with standard DMARDs, for 6 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 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 6 months
  • Drug: Standard DMARDs (Disease Modifying Anti Rheumatic Drugs)
    As prescribed
Experimental: 1
Interventions:
  • Drug: tocilizumab [RoActemra/Actemra]
  • Drug: Standard DMARDs (Disease Modifying Anti Rheumatic Drugs)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • rheumatoid arthritis >=6 months duration;
  • DAS28>=3.2;
  • inadequate response to prior treatment with a stable dose (>=8 weeks) of DMARD therapy.

Exclusion Criteria:

  • rheumatic autoimmune disease other than rheumatoid arthritis;
  • history of or current inflammatory joint disease other than rheumatoid arthritis;
  • unsuccessful treatment with an anti-TNF agent;
  • previous/concurrent treatment with any cell-depleting therapies.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00951275
ML22462, 2009-011105-17
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2012

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