Text Size

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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00996606
First received: October 15, 2009
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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: tocilizumab [RoActemra/Actemra]
Drug: DMARDs
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
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:

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

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: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm Drug: tocilizumab [RoActemra/Actemra]
8mg/kg iv infusion every 4 weeks for 48 weeks
Drug: DMARDs
stable dose as prescribed

  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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00996606

Locations
Italy
Cona (ferrara), Italy, 44124
Coppito, Italy, 67100
Genova, Italy, 16132
Milano, Italy, 20157
Milano, Italy, 20122
Napoli, Italy, 80131
Padova, Italy, 35128
Palermo, Italy, 90127
Pavia, Italy, 27100
Pisa, Italy, 56100
Roma, Italy, 00161
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: NCT00996606     History of Changes
Other Study ID Numbers: ML22413, 2009-012185-32
Study First Received: October 15, 2009
Last Updated: May 7, 2013
Health Authority: to: be added

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 19, 2013