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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00106574




Registration number
NCT00106574
Ethics application status
Date submitted
25/03/2005
Date registered
28/03/2005
Date last updated
2/11/2016

Titles & IDs
Public title
A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis
Scientific title
A Randomized, Double-blind Study of the Effect of Tocilizumab on Reduction in Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to DMARD Therapy
Secondary ID [1] 0 0
WA18063
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - tocilizumab [RoActemra/Actemra]

Experimental: 1 -

Placebo Comparator: 2 -


Treatment: Drugs: Placebo
iv every 4 weeks

Treatment: Drugs: tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of patients with ACR 20 response
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Percentage of patients with ACR 50 and ACR 70 responses.
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Mean changes in parameters of ACR core set
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
AEs, laboratory parameters, vital signs.
Timepoint [3] 0 0
Throughout study

Eligibility
Key inclusion criteria
- patients at least 18 years of age with moderate to severe active RA for at least 6
months;

- inadequate response to current anti-rheumatic therapies, including 1 or more
traditional DMARDs;

- stable DMARD therapy for at least 8 weeks before entering study;

- patients of reproductive potential must be using reliable methods of contraception.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- major surgery (including joint surgery) within 8 weeks before entering study, or
planned surgery within 6 months after entering study;

- patients who have previously failed treatment with an anti-tumor necrosis factor
agent;

- women who are pregnant or breast-feeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Parkville
Recruitment hospital [2] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment postcode(s) [2] 0 0
2050 - Sydney
Recruitment outside Australia
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Chiang Mai

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and
symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying
Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid
arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will be
randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with
stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target
sample size is 500+ individuals.
Trial website
https://clinicaltrials.gov/show/NCT00106574
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications