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
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
2 other identifiers
interventional
103
1 country
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 rheumatoid-arthritis
Started Jun 2009
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 18, 2009
CompletedFirst Posted
Study publicly available on registry
September 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
September 22, 2014
CompletedSeptember 22, 2014
September 1, 2014
2.3 years
August 18, 2009
June 26, 2014
September 15, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Clinically Significant Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 4
HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. Relevant clinical improvement was defined as a reduction of at least 0.22 points in HAQ-DI.
Week 4
Secondary Outcomes (51)
Patient Global Assessment of Disease Activity During the Double-Blind Treatment Period
Baseline, Weeks 1 and 4
Patient Global Assessment of Disease Activity During the Open Treatment Period
Baseline, Weeks 12, 24, 36 and 48
Physician Global Assessment of Disease Activity During the Double-Blind Treatment Period
Baseline and Week 4
Physician Global Assessment of Disease Activity During the Open Treatment Period
Baseline, Weeks 12, 24, 36, and 48
Patient Global Assessment of Pain During the Double-Blind Treatment Period
Baseline and Week 4
- +46 more secondary outcomes
Study Arms (3)
1
EXPERIMENTAL2
PLACEBO COMPARATOR3
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Unknown Facility
Amiens, 80054, France
Unknown Facility
Amiens, 80094, France
Unknown Facility
Bayonne, 64109, France
Unknown Facility
Bois-Guillaume, 76233, France
Unknown Facility
Bordeaux, 33076, France
Unknown Facility
Brest, 29609, France
Unknown Facility
Cahors, 46005, France
Unknown Facility
Chambray-lès-Tours, 37171, France
Unknown Facility
Clermont-Ferrand, 63003, France
Unknown Facility
Échirolles, 38434, France
Unknown Facility
La Roche-sur-Yon, 85925, France
Unknown Facility
Limoges, 87042, France
Unknown Facility
Lyon, 69437, France
Unknown Facility
Metz, 57077, France
Unknown Facility
Nantes, 44035, France
Unknown Facility
Orléans, 45000, France
Unknown Facility
Paris, 75651, France
Unknown Facility
Paris, 75679, France
Unknown Facility
Paris, 75877, France
Unknown Facility
Rennes, 35203, France
Unknown Facility
Saint-Priest-en-Jarez, 42277, France
Unknown Facility
Toulouse, 31059, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann- LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2009
First Posted
September 15, 2009
Study Start
June 1, 2009
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
September 22, 2014
Results First Posted
September 22, 2014
Record last verified: 2014-09