An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local Environment
Open Label, Multicenter, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Monotherapy or in Combination With MTX in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non Biologic DMARDs
1 other identifier
interventional
51
1 country
6
Brief Summary
This open-label, multi-center study in a local environment will evaluate the safety and the effect on disease activity with regard to reduction in signs and symptoms over 6 months of treatment in patients with moderate to severe active rheumatoid arthritis who experienced an inadequate response to a non-biologic DMARD. Tocilizumab 8 mg/kg will be administered as an intravenous infusion every 4 weeks for a total of 6 infusions as monotherapy or in combination with methotrexate (MTX). The anticipated time of study treatment is 24 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 rheumatoid-arthritis
Started Feb 2011
6 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
First Submitted
Initial submission to the registry
December 3, 2010
CompletedFirst Posted
Study publicly available on registry
December 6, 2010
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
February 26, 2015
CompletedFebruary 26, 2015
February 1, 2015
2 years
December 3, 2010
February 10, 2015
February 10, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Related AEs, Discontinuation Due to AEs, or Death
Baseline, every 4 weeks through Week 52
Secondary Outcomes (14)
Percentage of Participants Who Achieved Clinically Significant Improvement Assessed Using Disease Activity Score Based on 28 Joints (DAS28)
Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
Percentage of Participants Achieving LDA Assessed Using DAS28
Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
Percentage of Participants Achieving Remission Assessed Using DAS28
Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
Percentage of Participants With American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70)
Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
Time To Achieve ACR20/ACR50/ACR70
Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
- +9 more secondary outcomes
Study Arms (1)
Single arm
EXPERIMENTALInterventions
tocilizumab 8 mg/kg intravenous infusion every 4 weeks for a total of 6 infusions
Eligibility Criteria
You may qualify if:
- Adult patients \>/=18 years of age
- Moderate to severe rheumatoid arthritis defined as DAS 28\>3.2
- Body weight \</=150 kg
- Patient on at least 1 non-biologic DMARD on a stable dose for at least 8 weeks at any time prior to study start
- Inadequate clinical response to a stable dose of a non-biologic DMARD
You may not qualify if:
- Major surgery within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
- Rheumatic autoimmune disease other than rheumatoid arthritis (RA)
- Functional class IV as defined by the ACR classification
- History or current inflammatory joint disease other than RA
- Previous treatment with any cell depleting therapy
- Previous treatment with methotrexate
- Previous treatment with tocilizumab
- Previous treatment with any biologic drug that is used in the treatment of RA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
Sfax, 3000, Tunisia
Unknown Facility
Sousse, 4000, Tunisia
Unknown Facility
Tunis, 1007, Tunisia
Unknown Facility
Tunis, 1008, Tunisia
Unknown Facility
Tunis, 2010, Tunisia
Unknown Facility
Tunis, 2046, Tunisia
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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2010
First Posted
December 6, 2010
Study Start
February 1, 2011
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
February 26, 2015
Results First Posted
February 26, 2015
Record last verified: 2015-02