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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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17 June 2013 |
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Main ID: |
EUCTR2010-018331-18-GB |
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Date of registration:
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18/03/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A 52 week, Single center, Open-label Study to Evaluate Neutrophil function and survival effects of Tocilizumab (TCZ) in Patients with Active Rheumatoid Arthritis (RA) on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy
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Scientific title:
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A 52 week, Single center, Open-label Study to Evaluate Neutrophil function and survival effects of Tocilizumab (TCZ) in Patients with Active Rheumatoid Arthritis (RA) on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy |
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Date of first enrolment:
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12/05/2010 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-018331-18 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Adult (= 18 years) patients with moderate to severe active RA of = 6 months duration
DAS28 = 3.2 at screening and baseline
Patients must have discontinued biologic DMARDs prior to receiving tocilizumab (patient must have discontinued etanercept for = 2 weeks, infliximab or adalimumab for = 8 weeks, anakinra for = 1 week, rituximab > 24 weeks [or B-cell count has returned to levels prior to treatment and patient meets requirement for active disease])
If continuing non-biologic DMARDs, the dose must be stable for 8 weeks
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Major surgery (including joint surgery) within 8 weeks prior to screening or not recovered from prior surgery
History of or current inflammatory joint disease or rheumatic autoimmune disease other than RA
Active current infection or history of recurrent bacterial, viral, fungal, or mycobacterial infection
Pregnant women or nursing (breast feeding) mothers
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Adult Rheumatoid Arthritis (RA)
MedDRA version: 12.1
Level: LLT
Classification code 10039073
Term: Rheumatoid arthritis
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Intervention(s)
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Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: R04877533
Other descriptive name: TOCILIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
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Primary Outcome(s)
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Primary end point(s): Neutrophil survival and function results reported descriptively:
Apoptosis:
- Neutrophil morphology by light microscopy (change in proportion of cells apoptotic) utilizing a combination of staining and dynamic confocal microscopy
- Change in cell surface molecules: activation marker CD16, and membrane phosphatidyl serine
Neutrophil function:
- by ex vivo flow cytometry measurement of surface molecule expression, including Fc?-receptor, and
- Phagocytosis markers ex vivo (respiratory burst, labeled bacteria)
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Main Objective: To assess the mechanisms of TCZ effects on neutrophil function and survival.
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Secondary Objective: To assure safety (adverse events, laboratory abnormalities, using risk minimization strategies for AEs of Special Interest, section 7) and benefit:risk of TCZ 8 mg/kg as monotherapy or in combination with allowed non-biologic DMARDs, according to SPC and evaluation of benefit by improvements in DAS28.
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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