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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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01034397
First received: December 16, 2009
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

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:

Drug Information available for: Tocilizumab
U.S. FDA Resources

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

  Eligibility

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

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

Locations
Portugal
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
Investigators
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: May 23, 2013
Health Authority: Portugal: National Pharmacy and Medicines Institute

Additional relevant MeSH terms:
Arthritis
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 May 23, 2013