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Main
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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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10 December 2019 |
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Main ID: |
EUCTR2009-017443-34-GB |
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Date of registration:
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09/08/2010 |
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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 Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy
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Scientific title:
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A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy |
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Date of first enrolment:
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01/11/2010 |
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Target sample size:
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502 |
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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:2009-017443-34 |
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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: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: This study will be conducted in 2 Parts followed by a common open-label extension phase.
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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Bulgaria
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Czech Republic
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Germany
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Italy
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Lithuania
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Slovakia
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Spain
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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 patients, >/=18 years of age
diagnosis of definite ankylosing spondylitis, defined by modified New York criteria, = 3 months prior to baseline
active disease defined as BASDAI score of = 4.0 and spinal pain assessment score of =40, on a 0-100 mm Visual Analogue Scale (VAS), at screening and baseline
inadequate response or intolerant to 1 or more current or previous NSAIDs
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:
previous treatment with tocilizumab
previous treatment with TNF antagonist therapy
inflammatory rheumatic disease other than AS (psoriatic arthritis is allowed if patient also has definite AS as defined in inclusion criteria)
active, acute uveitis at baseline
major surgery (including joint surgery) within eight weeks prior to screening or planned major surgery within six month after randomisation
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
MedDRA version: 12.1
Level: LLT
Classification code 10002556
Term: Ankylosing spondylitis
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Intervention(s)
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Trade Name: RoActemra®
Product Code: Ro 487-5733/F01
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Other descriptive name: TOCILIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Primary end point(s): The primary endpoint in part 1 and part 2 is the proportion of patients with an ASAS 20 response at week 12.
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Main Objective: To assess the:
• Efficacy of treatment with TCZ 4 mg/kg and 8 mg/kg versus placebo in AS patients
who are naïve to treatment with TNF antagonist therapy with regard to the proportion of patients who achieve an ASAS20 response at week 12 (confirmation at week 24)
• Safety of TCZ 4 mg/kg and 8 mg/kg versus placebo with regard to AEs and
laboratory assessments
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Secondary Objective: To assess the:
• Efficacy of treatment with regard to radiographic benefit and improvement of
physical function over 104 weeks
• Long term safety and efficacy of TCZ in patients with AS
• Pharmacokinetics and pharmacodynamics of TCZ in patients with AS
• Immunogenicity of TCZ in patients with AS
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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