A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One TNF-Inhibitor

Status:	Completed
Conditions:	Arthritis, Rheumatoid Arthritis
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	Any
Updated:	11/18/2012
Start Date:	May 2011
End Date:	February 2013
Contact:	Please reference Study ID Number: MA25522 www.roche.com/about_roche/roche_worldwide.htm
Email:	genentechclinicaltrials@druginfo.com
Phone:	888-662-6728 (U.S. Only)

A Randomized, Open-label, Parallel-group Study of the Reduction of Signs and Symptoms During Treatment With Tocilizumab Versus Adalimumab, Both in Combination With MTX, in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to Treatment With Only One TNF Inhibitor

This randomized, parallel-group study will assess the efficacy and safety of
RoActemra/Actemra (tocilizumab) versus adalimumab in combination with methotrexate in
patients with moderate to severe active rheumatoid arthritis. Patients will be randomized to
receive either RoActemra/Actemra 8 mg/kg intravenously (iv) every 4 weeks or adalimumab 40
mg sc every 2 weeks. All patients will receive methotrexate (10-25 mg weekly) and folate (at
least 5 mg weekly). The anticipated time on study treatment is 24 weeks.

Inclusion Criteria:

- Adult patients, >/= 18 years of age

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

- Inadequate response due to inefficacy of treatment (for at least 3 months) with only
one approved TNF-agent other than adalimumab. Depending on the TNF-inhibitor, last
dose of TNF-inhibitor should have been 1 to 8 weeks before randomization to the study

- On methotrexate treatment for >/=12 weeks immediately prior to baseline, with stable
dose (10-25 mg/week) for the last 8 weeks

- Disease Activity Score (DAS28) >3.2 at baseline

- Oral corticosteroids ( anti-inflammatory drugs (NSAIDs) are permitted if the dose has been stable for >/=6
weeks prior to baseline

Exclusion Criteria:

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

- Rheumatic autoimmune disease other than rheumatoid arthritis

- Prior history of or current inflammatory joint disease other than rheumatoid
arthritis

- Functional class IV (ACR criteria)

- History of severe allergic reaction to human, humanized or murine monoclonal
antibodies

- Known active current or history of recurrent infection (including tuberculosis)

- Primary or secondary immunodeficiency (history of or currently active)

- Body weight >150 kg

- Previous treatment with any cell-depleting therapies

- Previous treatment with tocilizumab

- Intra-articular or parenteral corticosteroids within 6 weeks prior to baseline

We found this trial at

sites

Clinical Trial Facility in Tulsa Oklahoma

Tulsa, Oklahoma 74136

from

Tulsa, OK