A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis

Status:	Completed
Conditions:	Arthritis, Rheumatoid Arthritis
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	Any
Updated:	2/4/2013
Start Date:	September 2010
End Date:	December 2013
Contact:	Please reference Study ID Number: WA22762 www.roche.com/about_roche/roche_worldwide.htm
Email:	genentechclinicaltrials@druginfo.com
Phone:	888-662-6728 (U.S. Only)

A Randomized, Double-blind, Parallel Group Study Study of the Safety and Effect on Clinical Outcome of Tocilizumab SC Versus Tocilizumab IV, in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Active Rheumatoid Arthritis

This randomized, double-blind, parallel group study will compare the efficacy and safety of
subcutaneous (sc) versus intravenous (iv) administration of RoActemra/Actemra (tocilizumab)
in patients with moderate to severe active rheumatoid arthritis. Patients will be randomized
to receive either RoActemra/Actemra 162 mg sc weekly plus iv placebo every 4 weeks, or
RoActemra/Actemra 8 mg/kg iv every 4 weeks plus sc placebo weekly during the double-blind
period from baseline to Week 24. The double-blind period will be followed by a 72-week
open-label treatment with some switching of sc and iv administration. No placebo will be
administered in the open-label phase. Patients will continue on their stable dose of
disease-modifying antirheumatic drugs (DMARDs) throughout the study. Anticipated time on
study treatment is 2 years.

Inclusion Criteria:

- Adult patients, >/=18 years of age

- Rheumatoid arthritis of >/= 6 months duration, according to American College of
Rheumatology (ACR) criteria

- Swollen joint count (SJC) >/= 4 (66 joint count), tender joint count (TJC) >/= 4 (68
joint count) at screening and baseline

- Inadequate response to current DMARD therapy

- Permitted DMARDs must be at stable dose for >/= 8 weeks prior to baseline

- Oral corticosteroids ( maximum recommended dose) must be at stable dose for >/= 4 weeks prior to baseline

Exclusion Criteria:

- Major surgery (including joint surgery) within 8 weeks prior to screening or planned
major surgery within 6 months following randomization

- Rheumatic autoimmune disease other than RA

- Functional class IV (ACR classification)

- Diagnosis of juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis
(JRA) and/or RA before the age of 16

- Prior history of or current inflammatory joint disease other than RA

- Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline

- Previous treatment with RoActemra/Actemra

- Active current or history of recurrent infection

We found this trial at

sites

Clinical Trial Facility in Rochester Minnesota

Rochester, Minnesota 55905

559

from 43215

Rochester, MN