A Study on The Safety of Administering Rituximab at A More Rapid Rate in Patients With Rheumatoid Arthritis
RATE-RA
A Multicenter, Open-label, Single-arm Study to Evaluate the Safety Administering Rituximab at a More Rapid Infusion Rate in Patients With Rheumatoid Arthritis
1 other identifier
interventional
351
1 country
86
Brief Summary
This study was designed to evaluate the safety of administering rituximab at a more rapid infusion rate in patients with moderate to severe rheumatoid arthritis who have had an inadequate response to biopharmaceuticals that treat diseases by interfering with tumor necrosis factor (anti-TNF therapies), and were receiving methotrexate therapy for more than eight weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 rheumatoid-arthritis
Started Jul 2011
Shorter than P25 for phase_4 rheumatoid-arthritis
86 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2011
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedStudy Start
First participant enrolled
July 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 6, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 6, 2013
CompletedResults Posted
Study results publicly available
February 19, 2014
CompletedAugust 1, 2017
July 1, 2017
1.5 years
June 24, 2011
January 6, 2014
July 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Experiencing Any Infusion-related Reaction (IRR) Associated With the Second Rituximab Infusion
The primary criterion for assessing safety of the faster infusion was the incidence of infusion related reaction (IRRs). IRRs were adverse events (AEs) that occurred within 24 hours of beginning infusion that were among a pre-specified list of preferred terms from the Medical Dictionary for Regulatory Activities (MedDRA). "Incidence" is defined as the percentage of participants experiencing an IRR.
Within 24 hours of beginning infusion on Day 15
Secondary Outcomes (6)
Percentage of Participants Experiencing Any Serious IRR (SIRR) Associated With the Second Rituximab Infusion
Within 24 hours of beginning infusion on Day 15
Percentage of Participants Experiencing Any IRR or SIRR Associated With the Third Rituximab Infusion
Within 24 hours of beginning infusion on Day 168
Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Second Rituximab Infusion
Within 24 hours of beginning infusion on Day 15
Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Second Rituximab Infusion
During the infusion (a 2-hour period) on Day 15
Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Third Rituximab Infusion
Within 24 hours of beginning infusion on Day 168
- +1 more secondary outcomes
Study Arms (1)
Rituximab
EXPERIMENTALRituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
Interventions
100 mg methylprednisolone administered by slow intravenous infusion at least 30 minutes prior to the start of each study drug infusion
1 gram acetaminophen administered orally 30 to 60 minutes prior to the start of each study drug infusion
50 mg diphenhydramine hydrochloride or equivalent dose of alternate antihistamine administered orally 30 to 60 minutes prior to the start of each study drug infusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (86)
Uni Of Alabama,Birmingham; Medicine - Rheumatology
Birmingham, Alabama, 35294, United States
Clnical & Translational Reseach Center for Alabama, PC
Tuscaloosa, Alabama, 35406, United States
ArthroCare, Arthritis Care; and Research P.C.
Gilbert, Arizona, 85234, United States
Valley Arthritis Care
Phoenix, Arizona, 85027, United States
Catalina Pointe Rheumatology
Tucson, Arizona, 85704, United States
Medvin Clinical Research
Covina, California, 91723, United States
Triwest Research Associates
La Mesa, California, 91942, United States
Medvin Clinical Research
Los Angeles, California, 90048, United States
Brigid Freyne-Private Practice; Internal Medicine, Rheum
Murrieta, California, 92563, United States
Desert Medical Advances; Rheumatology
Palm Desert, California, 92260, United States
San Diego Arthritis Med Clnc
San Diego, California, 92108, United States
Pacific Arthritis Ctr Med Grp
Santa Maria, California, 93454, United States
Inland Rheumatology; Clinical Trials, Inc.
Upland, California, 91786, United States
Medvin Clinical Research
Whittier, California, 90606, United States
Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs
Colorado Springs, Colorado, 80920, United States
Denver Arthritis Clinic
Denver, Colorado, 80230-7127, United States
Rheum & Internal Med Assoc-Bri
Bridgeport, Connecticut, 06606, United States
Arthritis & Osteoporosis Center Pc
Hamden, Connecticut, 06518, United States
Rheumatolgy Consultants of Deleware
Lewes, Delaware, 19958, United States
Javed Rheumatology Associates, Inc.
Newark, Delaware, 19713, United States
Arthritis & Rheumatism; Disease Specialities
Aventura, Florida, 33180, United States
Florida Arthritis Center, PI
Lake Mary, Florida, 32746, United States
Omega ResearchConsultants LLC
Orlando, Florida, 32804, United States
Millenium Research
Ormond Beach, Florida, 32174, United States
Arthritis Center Palm Harbor
Palm Harbor, Florida, 34684, United States
Arthritis Rsrch of Florida, Inc.
Palm Harbor, Florida, 34684, United States
Center For Arthritis; Research Dept
South Miami, Florida, 33143, United States
University of South Florida
Tampa, Florida, 33612, United States
Florida Medical Clinic; Clinical Research
Zephyrhills, Florida, 33613, United States
Parris & Associates
Lawrenceville, Georgia, 30046, United States
St. Luke's Intermountain Research Center
Boise, Idaho, 83702, United States
Institute of Arthritis Research
Idaho Falls, Idaho, 83404, United States
Quad City Rheumatology, Sc
Moline, Illinois, 61265, United States
Physician'S Clinic of Iowa
Cedar Rapids, Iowa, 52401, United States
Bluegrass Comm Research, Inc.
Lexington, Kentucky, 40515, United States
Klein & Associates, M.D. P.A.
Cumberland, Maryland, 21502, United States
Klein & Associates, M.D., P.A.
Hagerstown, Maryland, 21740, United States
St. Luke's Hospital Association of Duluth
Duluth, Minnesota, 55805, United States
Arthritis and Osteoporosis; Treatment and Research Center
Flowood, Mississippi, 39232, United States
Jackson Arthritis Clinic
Flowood, Mississippi, 39232, United States
North Mississippi Med Clinics, Inc.
Tupelo, Mississippi, 38801, United States
David S Rosenberg
Florissant, Missouri, 63031, United States
Arthritis Center of Reno
Reno, Nevada, 89502, United States
Rheumatology Research Group
Lebanon, New Hampshire, 03756, United States
Rheumatology Associates Of New Jersey
Teaneck, New Jersey, 07666, United States
The Center for Rheumatology
Albany, New York, 12203, United States
Arthritis & Osteoporosis Center
Brooklyn, New York, 11201, United States
NYU Center for Musculoskeletal Care
New York, New York, 10003, United States
Buffalo Rheumatology Associates
Orchard Park, New York, 14127, United States
Office of Premier Chatpar Md
Plainview, New York, 11803, United States
Aair Research Center
Rochester, New York, 14618, United States
Rheumatology Associates of Long Island
Smithtown, New York, 11787, United States
Arthritis Health Associates; Clinical Research
Syracuse, New York, 13210, United States
Arth&OsteoConsof theCarolinas-Charlotte
Charlotte, North Carolina, 28207, United States
Box Arthritis & Rheumatology
Charlotte, North Carolina, 28210, United States
Carolina Bone & Joint P.A.
Charlotte, North Carolina, 28210, United States
Physicians East Pa
Greenville, North Carolina, 27834, United States
Shanahan Rheumatology & Immunology, PLLC
Raleigh, North Carolina, 27617, United States
Crystal Arthritis Center, Inc.
Akron, Ohio, 44333, United States
CarePoint East
Columbus, Ohio, 43203, United States
Stat Research, Inc
Dayton, Ohio, 45402, United States
Paramount Medical Research
Middleburg Heights, Ohio, 44130, United States
LION Research
Norman, Oklahoma, 73069, United States
Arthritis and Rheumatology; Center of Oklahoma PLLC
Oklahoma City, Oklahoma, 73103, United States
East Penn Rheumatology Associates, Pc
Bethlehem, Pennsylvania, 18015, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635, United States
Pivotal Clinical Research, Llc
Perkasie, Pennsylvania, 18944, United States
Arthritis Group
Philadelphia, Pennsylvania, 19152, United States
Rheumatic Disease Associates; Clinical Research Unit
Willow Grove, Pennsylvania, 19090, United States
Clinical Research Center of Reading
Wyomissing, Pennsylvania, 19610, United States
Pennsylvania Regional Center for Arthritis and Osteoporosis Research
Wyomissing, Pennsylvania, 19610, United States
Low Country Rheumatology, PA
Charleston, South Carolina, 29406, United States
Rheumatology Associates
Charleston, South Carolina, 29407, United States
West Tennessee Research Institute
Jackson, Tennessee, 38305, United States
Ramesh Gupta - PP
Memphis, Tennessee, 38119, United States
Amarillo Center For Clinical Research
Amarillo, Texas, 79124, United States
Lovelace Scientific Resources Inc.
Austin, Texas, 78758, United States
Adriana Pop-Moody MD Clinic PA
Corpus Christi, Texas, 78404, United States
Arthritis Centers of Texas
Dallas, Texas, 75246, United States
Southwest Rheumatology
Mesquite, Texas, 75150, United States
Arthritis Clinic of Northern Virginia
Arlington, Virginia, 22205, United States
Apex Clinical Research
Kennewick, Washington, 99336, United States
Seattle Arthritis Clinic
Seattle, Washington, 98133, United States
Arthritis Northwest, Spokane
Spokane, Washington, 99204, United States
Cedar Medical Center
Tacoma, Washington, 98405, United States
Rheumatic Disease Center
Glendale, Wisconsin, 53217, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2011
First Posted
June 27, 2011
Study Start
July 26, 2011
Primary Completion
January 6, 2013
Study Completion
January 6, 2013
Last Updated
August 1, 2017
Results First Posted
February 19, 2014
Record last verified: 2017-07