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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.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: October 15, 2009
Last updated: March 1, 2016
Last verified: March 2016
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.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: DMARDs
Drug: tocilizumab [RoActemra/Actemra]
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 58
Study Start Date: October 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm Drug: DMARDs
stable dose as prescribed
Drug: tocilizumab [RoActemra/Actemra]
8mg/kg iv infusion every 4 weeks for 48 weeks


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00996606

Coppito, Abruzzo, Italy, 67100
Napoli, Campania, Italy, 80131
Roma, Lazio, Italy, 00161
Genova, Liguria, Italy, 16132
Milano, Lombardia, Italy, 20122
Milano, Lombardia, Italy, 20157
Pavia, Lombardia, Italy, 27100
Palermo, Sicilia, Italy, 90127
Pisa, Toscana, Italy, 56100
Cona (Ferrara), Veneto, Italy, 44124
Padova, Veneto, Italy, 35128
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT00996606     History of Changes
Other Study ID Numbers: ML22413  2009-012185-32 
Study First Received: October 15, 2009
Last Updated: March 1, 2016
Health Authority: ITALY: Italian Medicines Agency

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents processed this record on October 21, 2016