A Study on The Safety of Administering MabThera/Rituxan (Rituximab) at A More Rapid Rate in Patients With Rheumatoid Arthritis (RATE-RA)

Status:	Completed
Conditions:	Arthritis, Rheumatoid Arthritis
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	Any
Updated:	11/18/2012
Start Date:	July 2011
End Date:	March 2013
Contact:	Please reference Study ID Number: ML25641 www.roche.com/about_roche/roche_worldwide.htm
Email:	genentechclinicaltrials@druginfo.com
Phone:	888-662-6728 (U.S. Only)

A Multicenter, Open-label, Single-arm Study to Evaluate the Safety Administering Rituximab at a More Rapid Infusion Rate in Patients With Rheumatoid Arthritis

This multicenter, open-label, single arm study will evaluate the safety of administering
MabThera/Rituxan (rituximab) at a more rapid infusion rate in patients with moderate to
severe rheumatoid arthritis who have had an inadequate response to anti-TNF therapy and are
receiving methotrexate. Patients will receive 2 courses of MabThera/Rituxan separated by 24
weeks, a course consisting of two 1000 mg intravenous infusions of MabThera/Rituxan
separated by 2 weeks. The Day 1 infusion will be administered at the labeled rate (4.25
hours), the Day 15 and Week 24 and 26 infusions over a 2-hour period. The anticipated time
on study treatment is 26 weeks with a 4-week follow-up.

Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Rheumatoid arthritis of >/= 6 months duration, diagnosed according to the revised
1987 American College of Rheumatology criteria

- Inadequate response to at least one approved anti-TNF agent (adalimumab, etanercept,
infliximab, golimumab, or certolizumab)

- Patients who have received 1 to 2 prior courses of rituximab (RTX) may be enrolled,
provided their most recent course of RTX occurred over 6 months but no more than 9
months prior to baseline. The RTX dosage must have been two 1000 mg infusions per
course administered at the standard approved rate

- Methotrexate treatment between 10 and 25 mg/week (oral or parenteral) for at least 8
weeks immediately prior to baseline

Exclusion Criteria:

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

- Rheumatic autoimmune disease other than rheumatoid arthritis

- Functional class IV as defined by American College of Rheumatology (ACR) criteria

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

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

- Previous serious infusion reaction to any prior biologic therapy

- Known active current or history of recurrent infection

- Evidence of chronic hepatitis B or C infection

- Pregnant or lactating women

- Body weight of > 150 kg

We found this trial at

sites

Clinical Trial Facility in Santa Clara California

Santa Clara, California 95051

from

Santa Clara, CA