TORPEDO Study: A Study on Rapid Effect of Tocilizumab in Patients With Rheumatoid Arthritis With an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) or Anti-TNF

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00977106
First received: August 18, 2009
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

This study will assess the onset and maintenance of effect of tocilizumab on relief in patients with active moderate or severe rheumatoid arthritis who have had an inadequate response to DMARDs or anti-TNF. For the first, double-blind, part of the study patients will be randomized to receive an iv infusion of either 8mg/kg tocilizumab or placebo. After 4 weeks this will be followed by 11 months treatment with tocilizumab 8mg/kg iv infusion every 4 weeks. Methotrexate or DMARD therapy will be continued throughout study treatment. Target sample size is >100.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Comparative Double Blind Placebo Controlled Clinical Study on Tocilizumab Rapid Efficacy on Patients Relief in rheumatoïd Arthritis With an Inadequate Response to DMARDs or Anti TNF :TORPEDO

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Effect of tocilizumab vs placebo on HAQ reduction [ Time Frame: 4 weeks after 1st infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in global disease activity VAS [ Time Frame: measured daily for 4 weeks after 1st infusion, and after 3, 6 and 12 months of treatment ] [ Designated as safety issue: No ]
  • Effect on synovitis score at ultrasound [ Time Frame: assessed day 7 and at month 1,3,6 and 12 ] [ Designated as safety issue: No ]
  • Effect on inflammation biological parameters [ Time Frame: assessed day 7 and at month 1,3,6 and 12 ] [ Designated as safety issue: No ]
  • Effect on bone density by DEXA and on bone and cartilage markers [ Time Frame: assessed day 7 and at month 1, 3 and 12 ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: June 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: tocilizumab [RoActemra/Actemra]
single iv infusion 8 mg/kg
Placebo Comparator: 2 Drug: placebo
single iv infusion
Experimental: 3 Drug: tocilizumab [RoActemra/Actemra]
iv infusion 8mg/kg every 4 weeks for 11 months

  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
  • active moderate or severe rheumatoid arthritis of <10 years duration with inadequate response to methotrexate or anti-TNF
  • on methotrexate treatment for at least 10 weeks, at least 8 weeks on stable dose
  • patients receiving oral corticosteroids and/or NSAIDs should be at stable dose for 4 weeks

Exclusion Criteria:

  • rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
  • functional class IV by ACR classification
  • history of inflammatory joint disease other than RA
  • previous treatment with cell-depleting therapies, abatacept or rituximab
  • active current or history of recurrent infection, or any major episode of infection requiring hospitalization or treatment with iv antibiotics <4 weeks or oral antibiotics <2 weeks prior to screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977106

Locations
France
Amiens, France, 80054
Amiens, France, 80094
Bayonne, France, 64109
Bois Guillaume, France, 76233
Bordeaux, France, 33076
Brest, France, 29609
Cahors, France, 46005
Chambray Les Tours, France, 37171
Clermont-ferrand, France, 63003
Echirolles, France, 38434
La Roche Sur Yon, France, 85925
Limoges, France, 87042
Lyon, France, 69437
Metz, France, 57077
Nantes, France, 44035
Orleans, France, 45000
Paris, France, 75651
Paris, France, 75877
Paris, France, 75679
Rennes, France, 35203
St Priest En Jarez, France, 42277
Toulouse, France, 31059
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: NCT00977106     History of Changes
Other Study ID Numbers: ML22017, 2008-008309-23
Study First Received: August 18, 2009
Last Updated: October 7, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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 April 15, 2014