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
ClinicalTrials.gov 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034397

Almada, Portugal, 2801-951
Coimbra, Portugal, 3041-801
Coimbra, Portugal, 3000-075
Lisboa, Portugal, 1649-035
Lisboa, Portugal, 1349-019
Lisboa, Portugal, 1050-34
Lisboa, Portugal, 1069-639
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
ClinicalTrials.gov 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
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014