NP22623/B: Randomized,Open-Label SC TCZ QW or Q2W trial in RA patients
Research type
Research Study
Full title
An open-label, multicenter, randomized, parallel study to investigate pharmacokinetics, pharmacodynamics, efficacy and safety of tocilizumab (TCZ, RO4877533) following subcutaneous (SC) administration of TCZ 162 mg weekly (QW) or every other week (Q2W) in combination with methotrexate in patients with active rheumatoid arthritis (RA)
IRAS ID
24823
Contact name
Iain McInnes
Contact email
Eudract number
2009-011349-18
Clinicaltrials.gov Identifier
00965653
Research summary
This study will involve patients identified by their rheumatologist as being suitable to start treatment with SC TCZ therapy and will examine how potential PK and PD parameters change over time.IV Tocilizumab has been studied in patients with Rheumatoid Arthritis as a 4 or 8 mg/kg one hour IV infusion every 4 weeks (Q4W) in phase III pivotal trials and has received marketing approval in several countries. Roche intends to develop a subcutaneous (SC) formulation that can be self-administered by patients. This study will serve as a pilot study to select the dose regimen, weekly or every other week, for Phase III SC program development. Safety and tolerability to the treatment will also be assessed.
REC name
West of Scotland REC 1
REC reference
09/S0703/91
Date of REC Opinion
16 Dec 2009
REC opinion
Further Information Favourable Opinion