|
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:
|
25 November 2019 |
|
Main ID: |
EUCTR2009-015845-21-GB |
|
Date of registration:
|
17/03/2010 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis
|
|
Scientific title:
|
A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis |
|
Date of first enrolment:
|
13/05/2010 |
|
Target sample size:
|
300 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-015845-21 |
|
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: yes
Placebo: no
Other: no
|
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
|
|
|
Countries of recruitment
|
|
Belgium
|
Czech Republic
|
Finland
|
Germany
|
Greece
|
Portugal
|
Spain
|
Sweden
|
|
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
- rheumatoid arthritis of >6 months duration
- intolerant of methotrexate or continued treatment with methotrexate is considered inappropriate
- all DMARDs are to be withdrawn prior to receiving study drug
- weight
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 12 weeks prior to baseline or planned major surgery within 6 months after baseline
- history of or current inflammatory joint disease other than RA
- treatment with a biologic agent at any time prior to baseline
- intraarticular or parenteral corticosteroids
- active current infection or history of recurrent bacterial, viral, fungal or mycobaterial infection
- history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or to latex (due to the needle cover of Humira being made of latex)
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Adult Rheumatoid Arthritis (RA)
MedDRA version: 12.1
Level: LLT
Classification code 10039073
Term: Rheumatoid arthritis
|
|
Intervention(s)
|
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: RO4877533
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: Humira®
Product Code: RO 551-6922
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: RO 551-6922
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
|
|
Primary Outcome(s)
|
|
Main Objective: To compare the change in DAS28 from baseline to Week 24 for patients on tocilizumab (TCZ) vs adalimumab (ADA).
|
Secondary Objective: - To assess efficacy parameters using ACR criteria, EULAR criteria and patient reported health assessments
- To compare adverse events
- To compare laboratory changes
|
|
Primary end point(s): The primary endpoint is the change in DAS28 at Week 24.
|
|
Source(s) of Monetary Support
|
|
Ethics review
|
Status: Approved
Approval date:
Contact:
|
|