A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis

Roche

Status and phase

Completed

Phase 1

Conditions

Rheumatoid Arthritis

Treatments

Drug: folic acid

Drug: methotrexate

Drug: tocilizumab [RoActemra/Actemra]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00965653

2009-011349-18

NP22623

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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DMARDs and anti-TNFs, other than methotrexate, withdrawn prior to baseline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