Clinical trial NCT01382940: A Study on The Safety of Administering Rituximab at A More Rapid Rate in Patients With Rheumatoid Arthritis
Official title: A Multicenter, Open-label, Single-arm Study to Evaluate the Safety Administering Rituximab at a More Rapid Infusion Rate in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-06-27
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Key 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

Key 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

Primary outcomes:
measure: Percentage of Participants Experiencing Any Infusion-related Reaction (IRR) Associated With the Second Rituximab Infusion
timeFrame: Within 24 hours of beginning infusion on Day 15
Secondary outcomes:
measure: Percentage of Participants Experiencing Any Serious IRR (SIRR) Associated With the Second Rituximab Infusion
timeFrame: Within 24 hours of beginning infusion on Day 15
measure: Percentage of Participants Experiencing Any IRR or SIRR Associated With the Third Rituximab Infusion
timeFrame: Within 24 hours of beginning infusion on Day 168
measure: Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Second Rituximab Infusion
timeFrame: Within 24 hours of beginning infusion on Day 15
measure: Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Second Rituximab Infusion
timeFrame: During the infusion (a 2-hour period) on Day 15
measure: Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Third Rituximab Infusion
timeFrame: Within 24 hours of beginning infusion on Day 168
measure: Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Third Rituximab Infusion
timeFrame: During the infusion (a 2-hour period) on Day 168
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Uni Of Alabama,Birmingham; Medicine - Rheumatology
state: Alabama
city: Tuscaloosa
country: United States
facility: Clnical & Translational Reseach Center for Alabama, PC
state: Alabama
city: Gilbert
country: United States
facility: ArthroCare, Arthritis Care; and Research P.C.
state: Arizona
city: Phoenix
country: United States
facility: Valley Arthritis Care
state: Arizona
city: Tucson
country: United States
facility: Catalina Pointe Rheumatology
state: Arizona
city: Covina
country: United States
facility: Medvin Clinical Research
state: California
city: La Mesa
country: United States
facility: Triwest Research Associates
state: California
city: Los Angeles
country: United States
facility: Medvin Clinical Research
state: California
city: Murrieta
country: United States
facility: Brigid Freyne-Private Practice; Internal Medicine, Rheum
state: California
city: Palm Desert
country: United States
facility: Desert Medical Advances; Rheumatology
state: California
city: San Diego
country: United States
facility: San Diego Arthritis Med Clnc
state: California
city: Santa Maria
country: United States
facility: Pacific Arthritis Ctr Med Grp
state: California
city: Upland
country: United States
facility: Inland Rheumatology; Clinical Trials, Inc.
state: California
city: Whittier
country: United States
facility: Medvin Clinical Research
state: California
city: Colorado Springs
country: United States
facility: Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs
state: Colorado
city: Denver
country: United States
facility: Denver Arthritis Clinic
state: Colorado
city: Bridgeport
country: United States
facility: Rheum & Internal Med Assoc-Bri
state: Connecticut
city: Hamden
country: United States
facility: Arthritis & Osteoporosis Center Pc
state: Connecticut
city: Lewes
country: United States
facility: Rheumatolgy Consultants of Deleware
state: Delaware
city: Newark
country: United States
facility: Javed Rheumatology Associates, Inc.
state: Delaware
city: Aventura
country: United States
facility: Arthritis & Rheumatism; Disease Specialities
state: Florida
city: Lake Mary
country: United States
facility: Florida Arthritis Center, PI
state: Florida
city: Orlando
country: United States
facility: Omega ResearchConsultants LLC
state: Florida
city: Ormond Beach
country: United States
facility: Millenium Research
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Center Palm Harbor
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Rsrch of Florida, Inc.
state: Florida
city: South Miami
country: United States
facility: Center For Arthritis; Research Dept
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic; Clinical Research
state: Florida
city: Lawrenceville
country: United States
facility: Parris & Associates
state: Georgia
city: Boise
country: United States
facility: St. Luke's Intermountain Research Center
state: Idaho
city: Idaho Falls
country: United States
facility: Institute of Arthritis Research
state: Idaho
city: Moline
country: United States
facility: Quad City Rheumatology, Sc
state: Illinois
city: Cedar Rapids
country: United States
facility: Physician'S Clinic of Iowa
state: Iowa
city: Lexington
country: United States
facility: Bluegrass Comm Research, Inc.
state: Kentucky
city: Cumberland
country: United States
facility: Klein & Associates, M.D. P.A.
state: Maryland
city: Hagerstown
country: United States
facility: Klein & Associates, M.D., P.A.
state: Maryland
city: Duluth
country: United States
facility: St. Luke's Hospital Association of Duluth
state: Minnesota
city: Flowood
country: United States
facility: Arthritis and Osteoporosis; Treatment and Research Center
state: Mississippi
city: Flowood
country: United States
facility: Jackson Arthritis Clinic
state: Mississippi
city: Tupelo
country: United States
facility: North Mississippi Med Clinics, Inc.
state: Mississippi
city: Florissant
country: United States
facility: David S Rosenberg
state: Missouri
city: Reno
country: United States
facility: Arthritis Center of Reno
state: Nevada
city: Lebanon
country: United States
facility: Rheumatology Research Group
state: New Hampshire
city: Teaneck
country: United States
facility: Rheumatology Associates Of New Jersey
state: New Jersey
city: Albany
country: United States
facility: The Center for Rheumatology
state: New York
city: Brooklyn
country: United States
facility: Arthritis & Osteoporosis Center
state: New York
city: New York
country: United States
facility: NYU Center for Musculoskeletal Care
state: New York
city: Orchard Park
country: United States
facility: Buffalo Rheumatology Associates
state: New York
city: Plainview
country: United States
facility: Office of Premier Chatpar Md
state: New York
city: Rochester
country: United States
facility: Aair Research Center
state: New York
city: Smithtown
country: United States
facility: Rheumatology Associates of Long Island
state: New York
city: Syracuse
country: United States
facility: Arthritis Health Associates; Clinical Research
state: New York
city: Charlotte
country: United States
facility: Arth&OsteoConsof theCarolinas-Charlotte
state: North Carolina
city: Charlotte
country: United States
facility: Box Arthritis & Rheumatology
state: North Carolina
city: Charlotte
country: United States
facility: Carolina Bone & Joint P.A.
state: North Carolina
city: Greenville
country: United States
facility: Physicians East Pa
state: North Carolina
city: Raleigh
country: United States
facility: Shanahan Rheumatology & Immunology, PLLC
state: North Carolina
city: Akron
country: United States
facility: Crystal Arthritis Center, Inc.
state: Ohio
city: Columbus
country: United States
facility: CarePoint East
state: Ohio
city: Dayton
country: United States
facility: Stat Research, Inc
state: Ohio
city: Middleburg Heights
country: United States
facility: Paramount Medical Research
state: Ohio
city: Norman
country: United States
facility: LION Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Arthritis and Rheumatology; Center of Oklahoma PLLC
state: Oklahoma
city: Bethlehem
country: United States
facility: East Penn Rheumatology Associates, Pc
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Perkasie
country: United States
facility: Pivotal Clinical Research, Llc
state: Pennsylvania
city: Philadelphia
country: United States
facility: Arthritis Group
state: Pennsylvania
city: Willow Grove
country: United States
facility: Rheumatic Disease Associates; Clinical Research Unit
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading
state: Pennsylvania
city: Wyomissing
country: United States
facility: Pennsylvania Regional Center for Arthritis and Osteoporosis Research
state: Pennsylvania
city: Charleston
country: United States
facility: Low Country Rheumatology, PA
state: South Carolina
city: Charleston
country: United States
facility: Rheumatology Associates
state: South Carolina
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Memphis
country: United States
facility: Ramesh Gupta - PP
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Center For Clinical Research
state: Texas
city: Austin
country: United States
facility: Lovelace Scientific Resources Inc.
state: Texas
city: Corpus Christi
country: United States
facility: Adriana Pop-Moody MD Clinic PA
state: Texas
city: Dallas
country: United States
facility: Arthritis Centers of Texas
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology
state: Texas
city: Arlington
country: United States
facility: Arthritis Clinic of Northern Virginia
state: Virginia
city: Kennewick
country: United States
facility: Apex Clinical Research
state: Washington
city: Seattle
country: United States
facility: Seattle Arthritis Clinic
state: Washington
city: Spokane
country: United States
facility: Arthritis Northwest, Spokane
state: Washington
city: Tacoma
country: United States
facility: Cedar Medical Center
state: Washington
city: Glendale
country: United States
facility: Rheumatic Disease Center
state: Wisconsin
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: