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Register:	EUCTR
Last refreshed on:	7 August 2012
Main ID:	EUCTR2009-015845-21-FI
Date of registration:	30/04/2010
Prospective Registration:	Yes
Primary sponsor:	F. Hoffmann-La Roche Ltd.
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:	16/06/2010
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:

Countries of recruitment
Belgium	Czech Republic	Finland	Germany	Greece	Portugal	Spain	Sweden
United Kingdom

Contacts

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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- all DMARDs are to be withdrawn prior to receiving study drug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 hte needel coever 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)

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.

Main Objective: To compare the change in DAS28 from baseline to Week 24 for patients on tocilizumab (TCZ) vs adalimumab (ADA).

Secondary Outcome(s)

Secondary ID(s)

2009-015845-21-GB

WA19924

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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