A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis

Hoffmann-La Roche29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

folic acidDRUG

\>/= 5 mg po weekly

methotrexateDRUG

7.5 - 25 mg weekly (oral or parenteral)

tocilizumab [RoActemra/Actemra]DRUG

162 mg sc weekly (QW)for 12 weeks

tocilizumab [RoActemra/Actemra]

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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/=6 at screening and baseline * DMARDs and anti-TNFs, other than methotrexate, withdrawn prior to baseline * oral corticosteroids (\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

Locations (7)

Unnamed facility

St. John's, Newfoundland and Labrador, Canada

Unnamed facility

Kitchener, Ontario, Canada

Unnamed facility

Trois-Rivières, Quebec, Canada

Unnamed facility

Christchurch, New Zealand

Outcomes

Primary Outcomes

Pharmacokinetics of TCZ after QW or Q2W sc administration

Time frame: 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

Time frame: sampling in weeks 1 and 2 and at weekly or bi-weekly intervals throughout treatment

Safety and tolerability, including injection site reaction

Time frame: laboratory assessments every 2nd week on treatment and after 3 weeks follow-up, injection site evaluation after 1st, 2nd and last injection.

Secondary Outcomes

Efficacy according to ACR and DAS-EULAR parameters

Time frame: assessments on day 1 of weeks 1, 4, 8 and 12

PD responses of IL-6, sIL-6R and anti TCZ antibody

Time frame: multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up

Data from ClinicalTrials.gov

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