Clinical trial NCT00965653: A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-08-25
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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* DMARDs and anti-TNFs, other than methotrexate, withdrawn prior to baseline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

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

Primary outcomes:
measure: Pharmacokinetics of TCZ after QW or Q2W sc administration
timeFrame: multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up
measure: Pharmacodynamic responses of CRP
timeFrame: sampling in weeks 1 and 2 and at weekly or bi-weekly intervals throughout treatment
measure: Safety and tolerability, including injection site reaction
timeFrame: laboratory assessments every 2nd week on treatment and after 3 weeks follow-up, injection site evaluation after 1st, 2nd and last injection.
Secondary outcomes:
measure: Efficacy according to ACR and DAS-EULAR parameters
timeFrame: assessments on day 1 of weeks 1, 4, 8 and 12
measure: PD responses of IL-6, sIL-6R and anti TCZ antibody
timeFrame: multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up
Other outcomes:
Locations:
city: St John's
country: Canada
state: Newfoundland and Labrador
city: Kitchener
country: Canada
state: Ontario
city: Trois-rivieres
country: Canada
state: Quebec
city: Christchurch
country: New Zealand
city: La Coruna
country: Spain
state: La Coruña
city: Santiago de Compostela
country: Spain
state: La Coruña
city: Sevilla
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: