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Rheumatoid ArthritisPhase 4RATE-RANCT01382940

A Study on The Safety of Administering Rituximab at A More Rapid Rate in Patients With Rheumatoid Arthritis

A Phase 4 study testing rituximab, methotrexate and methylprednisolone in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 86 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
rituximab, methotrexate and methylprednisolone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
351 participants
Where
86 sitesUnited States
Study dates
26 Jul 2011to 6 Jan 2013
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

86 sites in 1 country.

86 sites in 1 country

United States86 sites

  • Crystal Arthritis Center, Inc.

    Akron, Ohio, 44333

  • The Center for Rheumatology

    Albany, New York, 12203

  • Amarillo Center For Clinical Research

    Amarillo, Texas, 79124

  • Arthritis Clinic of Northern Virginia

    Arlington, Virginia, 22205

  • Lovelace Scientific Resources Inc.

    Austin, Texas, 78758

  • Arthritis & Rheumatism; Disease Specialities

    Aventura, Florida, 33180

  • East Penn Rheumatology Associates, Pc

    Bethlehem, Pennsylvania, 18015

  • Uni Of Alabama,Birmingham; Medicine - Rheumatology

    Birmingham, Alabama, 35294

  • St. Luke's Intermountain Research Center

    Boise, Idaho, 83702

  • Rheum & Internal Med Assoc-Bri

    Bridgeport, Connecticut, 06606

  • Arthritis & Osteoporosis Center

    Brooklyn, New York, 11201

  • Physician'S Clinic of Iowa

    Cedar Rapids, Iowa, 52401

  • Low Country Rheumatology, PA

    Charleston, South Carolina, 29406

  • Rheumatology Associates

    Charleston, South Carolina, 29407

  • Arth&OsteoConsof theCarolinas-Charlotte

    Charlotte, North Carolina, 28207

  • Box Arthritis & Rheumatology

    Charlotte, North Carolina, 28210

  • Carolina Bone & Joint P.A.

    Charlotte, North Carolina, 28210

  • Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs

    Colorado Springs, Colorado, 80920

  • CarePoint East

    Columbus, Ohio, 43203

  • Adriana Pop-Moody MD Clinic PA

    Corpus Christi, Texas, 78404

  • Medvin Clinical Research

    Covina, California, 91723

  • Klein & Associates, M.D. P.A.

    Cumberland, Maryland, 21502

  • Arthritis Centers of Texas

    Dallas, Texas, 75246

  • Stat Research, Inc

    Dayton, Ohio, 45402

  • Denver Arthritis Clinic

    Denver, Colorado, 80230-7127

  • St. Luke's Hospital Association of Duluth

    Duluth, Minnesota, 55805

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635

  • David S Rosenberg

    Florissant, Missouri, 63031

  • Arthritis and Osteoporosis; Treatment and Research Center

    Flowood, Mississippi, 39232

  • Jackson Arthritis Clinic

    Flowood, Mississippi, 39232

  • ArthroCare, Arthritis Care; and Research P.C.

    Gilbert, Arizona, 85234

  • Rheumatic Disease Center

    Glendale, Wisconsin, 53217

  • Physicians East Pa

    Greenville, North Carolina, 27834

  • Klein & Associates, M.D., P.A.

    Hagerstown, Maryland, 21740

  • Arthritis & Osteoporosis Center Pc

    Hamden, Connecticut, 06518

  • Institute of Arthritis Research

    Idaho Falls, Idaho, 83404

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305

  • Apex Clinical Research

    Kennewick, Washington, 99336

  • Triwest Research Associates

    La Mesa, California, 91942

  • Florida Arthritis Center, PI

    Lake Mary, Florida, 32746

  • Parris & Associates

    Lawrenceville, Georgia, 30046

  • Rheumatology Research Group

    Lebanon, New Hampshire, 03756

  • Rheumatolgy Consultants of Deleware

    Lewes, Delaware, 19958

  • Bluegrass Comm Research, Inc.

    Lexington, Kentucky, 40515

  • Medvin Clinical Research

    Los Angeles, California, 90048

  • Ramesh Gupta - PP

    Memphis, Tennessee, 38119

  • Southwest Rheumatology

    Mesquite, Texas, 75150

  • Paramount Medical Research

    Middleburg Heights, Ohio, 44130

  • Quad City Rheumatology, Sc

    Moline, Illinois, 61265

  • Brigid Freyne-Private Practice; Internal Medicine, Rheum

    Murrieta, California, 92563

  • NYU Center for Musculoskeletal Care

    New York, New York, 10003

  • Javed Rheumatology Associates, Inc.

    Newark, Delaware, 19713

  • LION Research

    Norman, Oklahoma, 73069

  • Arthritis and Rheumatology; Center of Oklahoma PLLC

    Oklahoma City, Oklahoma, 73103

  • Buffalo Rheumatology Associates

    Orchard Park, New York, 14127

  • Omega ResearchConsultants LLC

    Orlando, Florida, 32804

  • Millenium Research

    Ormond Beach, Florida, 32174

  • Desert Medical Advances; Rheumatology

    Palm Desert, California, 92260

  • Arthritis Center Palm Harbor

    Palm Harbor, Florida, 34684

  • Arthritis Rsrch of Florida, Inc.

    Palm Harbor, Florida, 34684

  • Pivotal Clinical Research, Llc

    Perkasie, Pennsylvania, 18944

  • Arthritis Group

    Philadelphia, Pennsylvania, 19152

  • Valley Arthritis Care

    Phoenix, Arizona, 85027

  • Office of Premier Chatpar Md

    Plainview, New York, 11803

  • Shanahan Rheumatology & Immunology, PLLC

    Raleigh, North Carolina, 27617

  • Arthritis Center of Reno

    Reno, Nevada, 89502

  • Aair Research Center

    Rochester, New York, 14618

  • San Diego Arthritis Med Clnc

    San Diego, California, 92108

  • Pacific Arthritis Ctr Med Grp

    Santa Maria, California, 93454

  • Seattle Arthritis Clinic

    Seattle, Washington, 98133

  • Rheumatology Associates of Long Island

    Smithtown, New York, 11787

  • Center For Arthritis; Research Dept

    South Miami, Florida, 33143

  • Arthritis Northwest, Spokane

    Spokane, Washington, 99204

  • Arthritis Health Associates; Clinical Research

    Syracuse, New York, 13210

  • Cedar Medical Center

    Tacoma, Washington, 98405

  • University of South Florida

    Tampa, Florida, 33612

  • Rheumatology Associates Of New Jersey

    Teaneck, New Jersey, 07666

  • Catalina Pointe Rheumatology

    Tucson, Arizona, 85704

  • North Mississippi Med Clinics, Inc.

    Tupelo, Mississippi, 38801

  • Clnical & Translational Reseach Center for Alabama, PC

    Tuscaloosa, Alabama, 35406

  • Inland Rheumatology; Clinical Trials, Inc.

    Upland, California, 91786

  • Medvin Clinical Research

    Whittier, California, 90606

  • Rheumatic Disease Associates; Clinical Research Unit

    Willow Grove, Pennsylvania, 19090

  • Clinical Research Center of Reading

    Wyomissing, Pennsylvania, 19610

  • Pennsylvania Regional Center for Arthritis and Osteoporosis Research

    Wyomissing, Pennsylvania, 19610

  • Florida Medical Clinic; Clinical Research

    Zephyrhills, Florida, 33613

Other trials in United States

About this study

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

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.

Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rituximabDrug

    Also called Rituxan®, MabThera®

    1000 mg in 250 mL intravenous infusion

  • methotrexateDrug

    10 to 25 mg/week (oral or parenteral)

  • methylprednisoloneDrug

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

  • acetaminophenDrug

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

  • antihistamineDrug

    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

Study groups in NCT01382940
Study groupRoleWhat they receive
RituximabExperimentalRituximab 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.
Receives: Drug: rituximab; Drug: methotrexate; Drug: methylprednisolone; Drug: acetaminophen; Drug: antihistamine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 24 hours of beginning infusion on Day 15

Secondary outcomes (6)

  1. Percentage of Participants Experiencing Any Serious IRR (SIRR) Associated With the Second Rituximab Infusion

    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.

    Measured: Within 24 hours of beginning infusion on Day 15

  2. Percentage of Participants Experiencing Any IRR or SIRR Associated With the Third Rituximab Infusion

    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.

    Measured: Within 24 hours of beginning infusion on Day 168

  3. Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Second Rituximab Infusion

    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.

    Measured: Within 24 hours of beginning infusion on Day 15

  4. Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Second Rituximab Infusion

    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.

    Measured: During the infusion (a 2-hour period) on Day 15

  5. Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Third Rituximab Infusion

    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".

    Measured: Within 24 hours of beginning infusion on Day 168

  6. Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Third Rituximab Infusion

    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.

    Measured: During the infusion (a 2-hour period) on Day 168

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2011 (estimated)
  2. Study start26 Jul 2011
  3. Primary completion6 Jan 2013
  4. Study completion6 Jan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01382940
Sponsor's protocol ID
ML25641
Acronym
RATE-RA
Status last verified
Jul 2017
First submitted
24 Jun 2011
Last updated
1 Aug 2017

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing rituximab, methotrexate and methylprednisolone in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 86 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01382940.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.

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