|
Main
|
|
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. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
7 January 2013 |
|
Main ID: |
EUCTR2009-017443-34-IT |
|
Date of registration:
|
28/09/2010 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
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 naìve to TNF antagonist therapy
|
|
Scientific title:
|
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 naìve to TNF antagonist therapy |
|
Date of first enrolment:
|
22/09/2010 |
|
Target sample size:
|
502 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-017443-34 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Belgium
|
Bulgaria
|
Czech Republic
|
Germany
|
Italy
|
Lithuania
|
Spain
|
United Kingdom
|
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
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: 0
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
|
|
Health Condition(s) or Problem(s) studied
|
Ankylosing Spondylitis
MedDRA version: 14.1
Level: PT
Classification code 10002556
Term: Ankylosing spondylitis
System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
|
|
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
|
|
Intervention(s)
|
Trade Name: RoActemra
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: TOCILIZUMAB
CAS Number: 375823-41-9
Concentration unit: mg milligram(s)
Concentration number: 200-
|
|
Primary Outcome(s)
|
|
Secondary Objective: To assess: - 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
|
|
Main Objective: To assess: - Efficacy of treatment with TCZ 4 mg/kg and 8 mg/kg versus placebo in AS patients who are naìve 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
|
|
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.
|
|
Secondary ID(s)
|
|
2009-017443-34-GB
|
|
NA22823
|
|
Source(s) of Monetary Support
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|