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Trial record 53 of 117 for:    "Connective Tissue Disease" | "Methylprednisolone"

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

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ClinicalTrials.gov Identifier: NCT01382940
Recruitment Status : Completed
First Posted : June 27, 2011
Results First Posted : February 19, 2014
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: rituximab Drug: methotrexate Drug: methylprednisolone Drug: acetaminophen Drug: antihistamine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 351 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 26, 2011
Actual Primary Completion Date : January 6, 2013
Actual Study Completion Date : January 6, 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: Rituximab
Rituximab 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.
Drug: rituximab
1000 mg in 250 mL intravenous infusion
Other Names:
  • Rituxan®
  • MabThera®

Drug: methotrexate
10 to 25 mg/week (oral or parenteral)

Drug: methylprednisolone
100 mg methylprednisolone administered by slow intravenous infusion at least 30 minutes prior to the start of each study drug infusion

Drug: acetaminophen
1 gram acetaminophen administered orally 30 to 60 minutes prior to the start of each study drug infusion

Drug: antihistamine
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




Primary Outcome Measures :
  1. Percentage of Participants Experiencing Any Infusion-related Reaction (IRR) Associated With the Second Rituximab Infusion [ Time Frame: Within 24 hours of beginning infusion on Day 15 ]
    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.


Secondary Outcome Measures :
  1. Percentage of Participants Experiencing Any Serious IRR (SIRR) Associated With the Second Rituximab Infusion [ Time Frame: Within 24 hours of beginning infusion on Day 15 ]
    A serious infusion-related reaction (SIRR) is an IRR that meets the definition of a serious adverse event. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution.

  2. Percentage of Participants Experiencing Any IRR or SIRR Associated With the Third Rituximab Infusion [ Time Frame: Within 24 hours of beginning infusion on Day 168 ]
    IRRs are AEs that occurred within 24 hours of beginning infusion that were included on a pre-specified list of MedDRA preferred terms, and an SIRR is an IRR that suggests a significant hazard, contraindication, side effect or precaution.

  3. Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Second Rituximab Infusion [ Time Frame: Within 24 hours of beginning infusion on Day 15 ]
    The intensity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v. 4.0), where Grade 1 indicates "Mild" severity and Grade 5 indicates "Death". The CTCAE defines Grades 3 and 4 as follows: - Grade 3 means "Severe", indicating considerable interference with the patient's daily activities; medical intervention/therapy required; and hospitalization possible. - Grade 4 means "Life-threatening, Disabling", based on extreme limitation in activity; significant medical intervention/therapy required, and hospitalization probable.

  4. Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Second Rituximab Infusion [ Time Frame: During the infusion (a 2-hour period) on Day 15 ]
    Participants who experienced a moderate or serious IRR had their infusion interrupted immediately and received aggressive symptomatic treatment. The CTCAE includes the following severity descriptions: - "Moderate" means mild to moderate interference with the patient's daily activities, no or minimal medical intervention/therapy required; - "Severe" means considerable interference with the patient's daily activities, medical intervention/therapy required, hospitalization possible. If the IRR was moderate, the infusion was not to be restarted before all the symptoms disappeared, and then at half the rate. If the participant tolerated the reduced rate for 30 minutes, the infusion rate was increased to the next rate on the protocol-specified infusion schedule. If the symptoms did not resolve with treatment, the participant was withdrawn from the treatment period of the study. Participants who experienced a severe IRR to rituximab treatment were discontinued from the study.

  5. Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Third Rituximab Infusion [ Time Frame: Within 24 hours of beginning infusion on Day 168 ]
    The intensity of AEs experienced within 24 hours of beginning infusion were graded on NCI's CTCAE (v. 4.0) intensity scale from Grade 1 ("Mild") to Grade 5 ("Death"). Grade 3 AEs are "Severe" and Grade 4 AEs are "Life-threatening, Disabling".

  6. Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Third Rituximab Infusion [ Time Frame: During the infusion (a 2-hour period) on Day 168 ]
    Participants who experienced a moderate or serious IRR had their infusion interrupted immediately and received aggressive symptomatic treatment. The CTCAE includes the following severity descriptions: - "Moderate" means mild to moderate interference with the patient's daily activities, no or minimal medical intervention/therapy required; - "Severe" means considerable interference with the patient's daily activities, medical intervention/therapy required, hospitalization possible. If the IRR was moderate, the infusion was not to be restarted before all the symptoms disappeared, and then at half the rate. If the participant tolerated the reduced rate for 30 minutes, the infusion rate was increased to the next rate on the protocol-specified infusion schedule. If the symptoms did not resolve with treatment, the participant was withdrawn from the treatment period of the study. Participants who experienced a severe IRR to rituximab treatment were discontinued from the study.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01382940


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Locations
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United States, Alabama
Uni Of Alabama,Birmingham; Medicine - Rheumatology
Birmingham, Alabama, United States, 35294
Clnical & Translational Reseach Center for Alabama, PC
Tuscaloosa, Alabama, United States, 35406
United States, Arizona
ArthroCare, Arthritis Care; and Research P.C.
Gilbert, Arizona, United States, 85234
Valley Arthritis Care
Phoenix, Arizona, United States, 85027
Catalina Pointe Rheumatology
Tucson, Arizona, United States, 85704
United States, California
Medvin Clinical Research
Covina, California, United States, 91723
Triwest Research Associates
La Mesa, California, United States, 91942
Medvin Clinical Research
Los Angeles, California, United States, 90048
Brigid Freyne-Private Practice; Internal Medicine, Rheum
Murrieta, California, United States, 92563
Desert Medical Advances; Rheumatology
Palm Desert, California, United States, 92260
San Diego Arthritis Med Clnc
San Diego, California, United States, 92108
Pacific Arthritis Ctr Med Grp
Santa Maria, California, United States, 93454
Inland Rheumatology; Clinical Trials, Inc.
Upland, California, United States, 91786
Medvin Clinical Research
Whittier, California, United States, 90606
United States, Colorado
Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs
Colorado Springs, Colorado, United States, 80920
Denver Arthritis Clinic
Denver, Colorado, United States, 80230-7127
United States, Connecticut
Rheum & Internal Med Assoc-Bri
Bridgeport, Connecticut, United States, 06606
Arthritis & Osteoporosis Center Pc
Hamden, Connecticut, United States, 06518
United States, Delaware
Rheumatolgy Consultants of Deleware
Lewes, Delaware, United States, 19958
Javed Rheumatology Associates, Inc.
Newark, Delaware, United States, 19713
United States, Florida
Arthritis & Rheumatism; Disease Specialities
Aventura, Florida, United States, 33180
Florida Arthritis Center, PI
Lake Mary, Florida, United States, 32746
Omega ResearchConsultants LLC
Orlando, Florida, United States, 32804
Millenium Research
Ormond Beach, Florida, United States, 32174
Arthritis Center Palm Harbor
Palm Harbor, Florida, United States, 34684
Arthritis Rsrch of Florida, Inc.
Palm Harbor, Florida, United States, 34684
Center For Arthritis; Research Dept
South Miami, Florida, United States, 33143
University of South Florida
Tampa, Florida, United States, 33612
Florida Medical Clinic; Clinical Research
Zephyrhills, Florida, United States, 33613
United States, Georgia
Parris & Associates
Lawrenceville, Georgia, United States, 30046
United States, Idaho
St. Luke's Intermountain Research Center
Boise, Idaho, United States, 83702
Institute of Arthritis Research
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Quad City Rheumatology, Sc
Moline, Illinois, United States, 61265
United States, Iowa
Physician'S Clinic of Iowa
Cedar Rapids, Iowa, United States, 52401
United States, Kentucky
Bluegrass Comm Research, Inc.
Lexington, Kentucky, United States, 40515
United States, Maryland
Klein & Associates, M.D. P.A.
Cumberland, Maryland, United States, 21502
Klein & Associates, M.D., P.A.
Hagerstown, Maryland, United States, 21740
United States, Minnesota
St. Luke's Hospital Association of Duluth
Duluth, Minnesota, United States, 55805
United States, Mississippi
Arthritis and Osteoporosis; Treatment and Research Center
Flowood, Mississippi, United States, 39232
Jackson Arthritis Clinic
Flowood, Mississippi, United States, 39232
North Mississippi Med Clinics, Inc.
Tupelo, Mississippi, United States, 38801
United States, Missouri
David S Rosenberg
Florissant, Missouri, United States, 63031
United States, Nevada
Arthritis Center of Reno
Reno, Nevada, United States, 89502
United States, New Hampshire
Rheumatology Research Group
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Rheumatology Associates Of New Jersey
Teaneck, New Jersey, United States, 07666
United States, New York
The Center for Rheumatology
Albany, New York, United States, 12203
Arthritis & Osteoporosis Center
Brooklyn, New York, United States, 11201
NYU Center for Musculoskeletal Care
New York, New York, United States, 10003
Buffalo Rheumatology Associates
Orchard Park, New York, United States, 14127
Office of Premier Chatpar Md
Plainview, New York, United States, 11803
Aair Research Center
Rochester, New York, United States, 14618
Rheumatology Associates of Long Island
Smithtown, New York, United States, 11787
Arthritis Health Associates; Clinical Research
Syracuse, New York, United States, 13210
United States, North Carolina
Arth&OsteoConsof theCarolinas-Charlotte
Charlotte, North Carolina, United States, 28207
Box Arthritis & Rheumatology
Charlotte, North Carolina, United States, 28210
Carolina Bone & Joint P.A.
Charlotte, North Carolina, United States, 28210
Physicians East Pa
Greenville, North Carolina, United States, 27834
Shanahan Rheumatology & Immunology, PLLC
Raleigh, North Carolina, United States, 27617
United States, Ohio
Crystal Arthritis Center, Inc.
Akron, Ohio, United States, 44333
CarePoint East
Columbus, Ohio, United States, 43203
Stat Research, Inc
Dayton, Ohio, United States, 45402
Paramount Medical Research
Middleburg Heights, Ohio, United States, 44130
United States, Oklahoma
LION Research
Norman, Oklahoma, United States, 73069
Arthritis and Rheumatology; Center of Oklahoma PLLC
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
East Penn Rheumatology Associates, Pc
Bethlehem, Pennsylvania, United States, 18015
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States, 16635
Pivotal Clinical Research, Llc
Perkasie, Pennsylvania, United States, 18944
Arthritis Group
Philadelphia, Pennsylvania, United States, 19152
Rheumatic Disease Associates; Clinical Research Unit
Willow Grove, Pennsylvania, United States, 19090
Clinical Research Center of Reading
Wyomissing, Pennsylvania, United States, 19610
Pennsylvania Regional Center for Arthritis and Osteoporosis Research
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
Low Country Rheumatology, PA
Charleston, South Carolina, United States, 29406
Rheumatology Associates
Charleston, South Carolina, United States, 29407
United States, Tennessee
West Tennessee Research Institute
Jackson, Tennessee, United States, 38305
Ramesh Gupta - PP
Memphis, Tennessee, United States, 38119
United States, Texas
Amarillo Center For Clinical Research
Amarillo, Texas, United States, 79124
Lovelace Scientific Resources Inc.
Austin, Texas, United States, 78758
Adriana Pop-Moody MD Clinic PA
Corpus Christi, Texas, United States, 78404
Arthritis Centers of Texas
Dallas, Texas, United States, 75246
Southwest Rheumatology
Mesquite, Texas, United States, 75150
United States, Virginia
Arthritis Clinic of Northern Virginia
Arlington, Virginia, United States, 22205
United States, Washington
Apex Clinical Research
Kennewick, Washington, United States, 99336
Seattle Arthritis Clinic
Seattle, Washington, United States, 98133
Arthritis Northwest, Spokane
Spokane, Washington, United States, 99204
Cedar Medical Center
Tacoma, Washington, United States, 98405
United States, Wisconsin
Rheumatic Disease Center
Glendale, Wisconsin, United States, 53217
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01382940     History of Changes
Other Study ID Numbers: ML25641
First Posted: June 27, 2011    Key Record Dates
Results First Posted: February 19, 2014
Last Update Posted: August 1, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
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Connective Tissue Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Acetaminophen
Rituximab
Methotrexate
Histamine Antagonists
Histamine H1 Antagonists
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites