A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00965653

Enrollment

Registered

2009-08-25

Start date

2009-08-31

Completion date

2011-07-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

DRUGfolic acid

\>/= 5 mg po weekly

DRUGmethotrexate

7.5 - 25 mg weekly (oral or parenteral)

DRUGtocilizumab [RoActemra/Actemra]

162 mg sc weekly (QW)for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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/=6 at screening and baseline * DMARDs and anti-TNFs, other than methotrexate, withdrawn prior to baseline * oral corticosteroids (\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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics of TCZ after QW or Q2W sc administration	multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up
Pharmacodynamic responses of CRP	sampling in weeks 1 and 2 and at weekly or bi-weekly intervals throughout treatment
Safety and tolerability, including injection site reaction	laboratory assessments every 2nd week on treatment and after 3 weeks follow-up, injection site evaluation after 1st, 2nd and last injection.

Secondary

Measure	Time frame
Efficacy according to ACR and DAS-EULAR parameters	assessments on day 1 of weeks 1, 4, 8 and 12
PD responses of IL-6, sIL-6R and anti TCZ antibody	multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up

Countries

Canada, New Zealand, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026