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Rheumatoid ArthritisPhase 2NCT00808210

A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab

A Phase 2 study testing Infliximab, Methotrexate and Methylprednisolone in people with Rheumatoid Arthritis, run by Genentech, Inc. at 53 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a Phase II, randomized, active-controlled, double-blind, double-dummy, parallel-group, multicenter study in the United States enrolling patients with active RA. The study will enroll approximately 290 patients at approximately 130 sites. 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?
Infliximab, Methotrexate and Methylprednisolone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
53 sitesUnited States
Study dates
5 Mar 2009to 14 Nov 2012
Phase
Phase 2
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

  • Age >= 18 years
  • Current treatment for RA on an outpatient basis
  • Active disease
  • Currently receiving 50 mg etanercept subcutaneously (SC) every week or 40 mg adalimumab SC every other week.
  • Considered by Investigator to be a primary non-responder to their first anti-TNFα treatment for efficacy reasons

Who cannot join

  • Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
  • History of, or current, inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or other overlap syndrome)
  • Previous treatment with a any biologic therapy for RA (including investigational products with the exception of etanercept or adalimumab
  • Treatment with more than one prior anti-TNFα therapy

Trial locations and contacts

53 sites in 1 country.

53 sites in 1 country

United States53 sites

  • Lehigh Valley Physicians Group

    Allentown, Pennsylvania, 18103

  • Amarillo Center For Clinical Research

    Amarillo, Texas, 79124

  • Billings Clinic; Research Center

    Billings, Montana, 59101

  • Billings Clinic

    Billings, Montana, 59102

  • Regional Clinical Research

    Binghamton, New York, 13905

  • Rheumatology Associates

    Birmingham, Alabama, 35205

  • RASF-Clinical Research Center

    Boca Raton, Florida, 33486

  • Graves Gilbert Clinic

    Bowling Green, Kentucky, 42101

  • Arthritis & Osteoporosis Center

    Brooklyn, New York, 11201

  • Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs

    Colorado Springs, Colorado, 80920

  • Columbia Arthritis Center (Partnership Practice)

    Columbia, South Carolina, 29204

  • Ohio State Univ Med Center

    Columbus, Ohio, 43210

  • Robert W. Levin MD - PP

    Dunedin, Florida, 34698

  • Barada,Harrell,Toohey&Bellhorn

    Durham, North Carolina, 27704

  • Arthritis Associates

    Erie, Pennsylvania, 16508

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Private Practice - Rosenberg

    Florissant, Missouri, 63031

  • Jackson Arthritis Clinic

    Flowood, Mississippi, 39232

  • Physicians East Pa

    Greenville, North Carolina, 27834

  • Piedmont Arthritis Clinic

    Greenville, South Carolina, 29601

  • Arthritis Associates

    Hixson, Tennessee, 37343

  • Phillip A Waller MD, PA

    Houston, Texas, 77034

  • Institute of Arthritis Research

    Idaho Falls, Idaho, 83404

  • Arthritis Associates of Mississippi

    Jackson, Mississippi, 39202

  • NEA Baptist Clinic

    Jonesboro, Arkansas, 72401

  • Science and Research Institute, Inc.

    Jupiter, Florida, 33458

  • Rheumatology, P.C.; Medical Arts Building

    Kalamazoo, Michigan, 49009

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Fiechtner Research Inc

    Lansing, Michigan, 48910

  • Dartmouth-Hitchcock Medical Center, Rheumatology 5C

    Lebanon, New Hampshire, 03756

  • Arthritis Res & Treatment

    Macon, Georgia, 30281

  • Ramesh Gupta - PP

    Memphis, Tennessee, 38119

  • Southwest Rheumatology

    Mesquite, Texas, 75150

  • Illinois Bone & Joint Inst.

    Morton Grove, Illinois, 60053

  • Dr. Brigid Freyne, MD

    Murrieta, California, 92563

  • South Carolina Research Center

    Myrtle Beach, South Carolina, 29572

  • Ctr for Inflammatory Disease

    Nashville, Tennessee, 37205

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma, 73104

  • Southern Tier Arthritis & Rheumatism

    Olean, New York, 14760

  • Westroads Medical Group

    Omaha, Nebraska, 68114

  • Buffalo Rheumatology Associates

    Orchard Park, New York, 14127

  • Rheumatology Associates of Central Florida

    Orlando, Florida, 32806

  • Providence Arthritis Center

    Portland, Oregon, 97213

  • Arthritis Center of Reno

    Reno, Nevada, 89502

  • Harbin Clinic

    Rome, Georgia, 30165

  • Shores Rheumatology

    Saint Clair Shores, Michigan, 48081

  • Texas Arthritis Research Center

    San Antonio, Texas, 78217

  • Lovelace Scientific Resources

    Sarasota, Florida, 34292

  • Springfield Clinic

    Springfield, Illinois, 62703

  • Clayton Medical Research

    St Louis, Missouri, 63117

  • Healthcare Research Consultants

    Tulsa, Oklahoma, 74135

  • Agilence Arthritis and Osteoporosis Medical Center, Inc.

    Whittier, California, 90606

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts, 01610

Other trials in United States

About this study

Official title: A PHASE II RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN COMBINATION WITH METHOTREXATE, COMPARED TO INFLIXIMAB PLUS METHOTREXATE IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS CURRENTLY RESPONDING INADEQUATELY TO ETANERCEPT OR ADALIMUMAB

This is a Phase II, randomized, active-controlled, double-blind, double-dummy, parallel-group, multicenter study in the United States enrolling patients with active RA. The study will enroll approximately 290 patients at approximately 130 sites.

Being tested
Infliximab, Methotrexate, Methylprednisolone, Ocrelizumab, Placebo
Keywords
RA, Arthritis
Medical subject headings
Arthritis, Rheumatoid, Arthritis

What participants receive

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

  • InfliximabDrug

    Intravenous repeating dose

  • MethotrexateDrug

    Oral or parenteral repeating dose

  • MethylprednisoloneDrug

    Intravenous repeating dose

  • OcrelizumabDrug

    Intravenous repeating dose

  • PlaceboDrug

    Intravenous repeating dose

Study groups in NCT00808210
Study groupRoleWhat they receive
Ocrelizumab 200mgExperimentalParticipants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
Receives: Drug: Methotrexate; Drug: Methylprednisolone; Drug: Ocrelizumab; Drug: Placebo
Infliximab 5mg/kgActive comparatorParticipants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
Receives: Drug: Infliximab; Drug: Methotrexate; Drug: Methylprednisolone; Drug: Placebo

What is being measured

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

  1. Change From Baseline in DAS28(ESR) at Week 20

    Measured: Week 20

Secondary outcomes (7)

  1. Percentage of Participants With Clinical Response of 20% According to ACR Criteria

    Measured: Baseline up to 30 months

  2. Percentage of Participants With Clinical Response of 50% According to ACR Criteria

    Measured: Baseline up to 30 months

  3. Percentage of Participants With Clinical Response of 70% According to ACR Criteria

    Measured: Baseline up to 30 months

  4. European League Against Rheumatism (EULAR) Response Rates

    Measured: Baseline up to 30 months

  5. Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

    Measured: Baseline up to 30 months

  6. Change in Fatigue Visual Analog Scale Score (VAS)

    Measured: Baseline up to 30 months

  7. Percentage of Participants With Adverse Events (AEs)

    Measured: Baseline up to 30 months

Timeline

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

  1. First posted15 Dec 2008 (estimated)
  2. Study start5 Mar 2009
  3. Primary completion14 Nov 2012
  4. Study completion14 Nov 2012

Why it stopped: Based on analysis of results and consideration of available treatments, the overall benefit to risk profile of ocrelizumab was not favorable in RA.

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00808210
Sponsor's protocol ID
ACT4562g
Other IDs
GA00931
Status last verified
Oct 2020
First submitted
11 Dec 2008
Last updated
6 Nov 2020
Individual data sharing
Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Infliximab, Methotrexate and Methylprednisolone in people with Rheumatoid Arthritis, run by Genentech, Inc. at 53 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 4 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: stopped early, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 6 Nov 2020). 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?

Change From Baseline in DAS28(ESR) at Week 20 (time frame: Week 20). 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 NCT00808210.

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 6 Nov 2020; AzTrials last refreshed its copy on 30 Oct 2026.

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