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A Study of Tocilizumab Plus Non-biological DMARD in Patients With Moderate to Severe Rheumatoid Arhtritis and an Inadequate Response to Non-biological DMARDs

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: December 16, 2009
Last updated: October 7, 2013
Last verified: October 2013

This randomized, double-blind, placebo-controlled study will use Magnetic Resonance Imaging (MRI) to assess the efficacy of tocilizumab plus non-biological DMARD in patients with moderate to severe rheumatoid arthritis who have had an inadequate response to non-biological DMARDS. Patients will be randomized to receive either intravenous tocilizumab at 8mg/kg (minimal dose 480mg, maximum dose 800mg) or placebo every 4 weeks, in addition to their stable dose of non-biological DMARD. Anticipated time on study treatment is 24 weeks, and target sample size is <100.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: tocilizumab [RoActemra/Actemra]
Drug: placebo
Drug: non-biological DMARDs
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Assess Efficacy of Tocilizumab+Non-biological DMARD in Reducing Synovitis as Measured by MRI at 12 Weeks After Initiation of Treatment in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Non-biological DMARDs

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • MRI-assessed synovial volume in the wrist and/or 2nd to 5th MCP joints of the dominant hand [ Time Frame: week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • efficacy: OMERACT-RAMRIS score, DCE-MRI EE, DAS28 score, C-reactive protein, HAQ questionnaire [ Time Frame: weeks 12 and/or 24 ] [ Designated as safety issue: No ]
  • predictive value of MRI response at week 12 on DAS28 and MRI changes at week 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • safety and tolerability: adverse events, laboratory parameters [ Time Frame: throughout study, laboratory assessments every 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: March 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: tocilizumab [RoActemra/Actemra]
8mg/kg (minimal dose 480mg, maximum dose 800mg) iv infusion every 4 weeks for 24 weeks
Drug: non-biological DMARDs
stable dose at investigator's prescription
Placebo Comparator: 2 Drug: placebo
iv every 4 weeks for 24 weeks
Drug: non-biological DMARDs
stable dose at investigator's prescription


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients, >/=18 years of age
  • moderate to severe rheumatoid arthritis of >/=6 months duration
  • synovitis (swollen and tender joint) in the wrist of the dominant hand
  • non-biologic DMARDs at stable dose for >/=12 weeks prior to baseline
  • oral corticosteroids at stable dose for at least 25 out of 28 days prior to baseline

Exclusion Criteria:

  • rheumatic autoimmune disease other than RA
  • history of or current inflammatory joint disease other than RA
  • functional class IV (ACR classification)
  • intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
  • previous treatment with a biologic agent for RA
  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: NCT01034397

Almada, Portugal, 2801-951
Coimbra, Portugal, 3000-075
Coimbra, Portugal, 3041-801
Lisboa, Portugal, 1069-639
Lisboa, Portugal, 1649-035
Lisboa, Portugal, 1349-019
Lisboa, Portugal, 1050-34
Ponte do Lima, Portugal, 4990-041
Porto, Portugal, 4099-001
Porto, Portugal, 4200-319
Vila Nova de Gaia, Portugal, 4400-129
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01034397     History of Changes
Other Study ID Numbers: ML22648, 2009-012218-30
Study First Received: December 16, 2009
Last Updated: October 7, 2013
Health Authority: Portugal: National Pharmacy and Medicines Institute

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on November 25, 2014