Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00965653




Registration number
NCT00965653
Ethics application status
Date submitted
18/08/2009
Date registered
25/08/2009
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis
Scientific title
Open-label, Multicenter, Randomized, Parallel Study to Investigate pk, pd, Efficacy and Safety of Tocilizumab (TCZ, RO4877533) Following Subcutaneous Administration of TCZ 162 mg Weekly or Every Other Week in Combination With Methotrexate in Patients With Rheumatoid Arthritis
Secondary ID [1] 0 0
2009-011349-18
Secondary ID [2] 0 0
NP22623
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

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

Experimental: 1 -

Active Comparator: 2 -


Treatment: Drugs: folic acid
>/= 5 mg po weekly

Treatment: Drugs: methotrexate
7.5 - 25 mg weekly (oral or parenteral)

Treatment: Drugs: tocilizumab [RoActemra/Actemra]
162 mg sc weekly (QW)for 12 weeks

Treatment: Drugs: tocilizumab [RoActemra/Actemra]
162 mg sc every other week (Q2W) for 12 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pharmacokinetics of TCZ after QW or Q2W sc administration
Timepoint [1] 0 0
multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up
Primary outcome [2] 0 0
Pharmacodynamic responses of CRP
Timepoint [2] 0 0
sampling in weeks 1 and 2 and at weekly or bi-weekly intervals throughout treatment
Primary outcome [3] 0 0
Safety and tolerability, including injection site reaction
Timepoint [3] 0 0
laboratory assessments every 2nd week on treatment and after 3 weeks follow-up, injection site evaluation after 1st, 2nd and last injection.
Secondary outcome [1] 0 0
Efficacy according to ACR and DAS-EULAR parameters
Timepoint [1] 0 0
assessments on day 1 of weeks 1, 4, 8 and 12
Secondary outcome [2] 0 0
PD responses of IL-6, sIL-6R and anti TCZ antibody
Timepoint [2] 0 0
multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up

Eligibility
Key inclusion criteria
- adults 18 - 75 years of age

- active rheumatoid arthritis of >/= 6 months duration

- inadequate response to at least 12 weeks of methotrexate, the last 8 prior to baseline
on stable dose

- swollen joint count (SJC)>/=4, tender joint count (TJC)>/=6 at screening and baseline

- DMARDs and anti-TNFs, other than methotrexate, withdrawn prior to baseline

- oral corticosteroids (</= 10mg/day prednisone or equivalent) and NSAIDS on stable dose
</= 4 weeks prior to baseline
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- rheumatic autoimmune disease other than rheumatoid arthritis

- prior history or current inflammatory joint disease other than rheumatoid arthritis

- major surgery (including joint surgery) within 8 weeks prior to screening or planned
major surgery within 6 months following enrollment

- functional class IV by ACR classification

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
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
1/08/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Newfoundland and Labrador
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec
Country [4] 0 0
New Zealand
State/province [4] 0 0
Christchurch
Country [5] 0 0
Spain
State/province [5] 0 0
La Coruña
Country [6] 0 0
Spain
State/province [6] 0 0
Sevilla

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

Ethics approval
Ethics application status

Summary
Brief summary
This open-label randomized 2arm study will investigate the pharmacokinetics,
pharmacodynamics, efficacy and safety of subcutaneously administered tocilizumab in patients
with rheumatoid arthritis who have shown an inadequate response to methotrexate. Patients
will be randomized to receive tocilizumab 162 mg sc either weekly or every other week, in
combination with methotrexate, for 12 weeks. Assessments will be made at regular intervals
during treatment and on the 3 weeks of follow-up.Target sample size is < 50 individuals.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00965653
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00965653