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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

Primary Purpose

Rheumatoid Arthritis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Infliximab
Methotrexate
Methylprednisolone
Ocrelizumab
Placebo
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring RA, Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Rheumatology Associates
  • NEA Baptist Clinic
  • Dr. Brigid Freyne, MD
  • Agilence Arthritis and Osteoporosis Medical Center, Inc.
  • Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs
  • RASF-Clinical Research Center
  • Robert W. Levin MD - PP
  • Science and Research Institute, Inc.
  • Rheumatology Associates of Central Florida
  • Lovelace Scientific Resources
  • Arthritis Res & Treatment
  • Harbin Clinic
  • Institute of Arthritis Research
  • Illinois Bone & Joint Inst.
  • Springfield Clinic
  • University of Kansas Medical Center
  • Graves Gilbert Clinic
  • Clinical Pharmacology Study Group
  • Hurley Medical Center
  • Rheumatology, P.C.; Medical Arts Building
  • Fiechtner Research Inc
  • Shores Rheumatology
  • Jackson Arthritis Clinic
  • Arthritis Associates of Mississippi
  • Private Practice - Rosenberg
  • Clayton Medical Research
  • Billings Clinic; Research Center
  • Billings Clinic
  • Westroads Medical Group
  • Arthritis Center of Reno
  • Dartmouth-Hitchcock Medical Center, Rheumatology 5C
  • Regional Clinical Research
  • Arthritis & Osteoporosis Center
  • Southern Tier Arthritis & Rheumatism
  • Buffalo Rheumatology Associates
  • Barada,Harrell,Toohey&Bellhorn
  • Physicians East Pa
  • Ohio State Univ Med Center
  • Oklahoma Medical Research Foundation
  • Healthcare Research Consultants
  • Providence Arthritis Center
  • Lehigh Valley Physicians Group
  • Arthritis Associates
  • Columbia Arthritis Center (Partnership Practice)
  • Piedmont Arthritis Clinic
  • South Carolina Research Center
  • Arthritis Associates
  • Ramesh Gupta - PP
  • Ctr for Inflammatory Disease
  • Amarillo Center For Clinical Research
  • Phillip A Waller MD, PA
  • Southwest Rheumatology
  • Texas Arthritis Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ocrelizumab 200mg

Infliximab 5mg/kg

Arm Description

Participants 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.

Participants 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.

Outcomes

Primary Outcome Measures

Change From Baseline in DAS28(ESR) at Week 20

Secondary Outcome Measures

Percentage of Participants With Clinical Response of 20% According to ACR Criteria
Percentage of Participants With Clinical Response of 50% According to ACR Criteria
Percentage of Participants With Clinical Response of 70% According to ACR Criteria
European League Against Rheumatism (EULAR) Response Rates
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Change in Fatigue Visual Analog Scale Score (VAS)
Percentage of Participants With Adverse Events (AEs)

Full Information

First Posted
December 11, 2008
Last Updated
October 13, 2020
Sponsor
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00808210
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Based on analysis of results and consideration of available treatments, the overall benefit to risk profile of ocrelizumab was not favorable in RA.
Study Start Date
March 5, 2009 (Actual)
Primary Completion Date
November 14, 2012 (Actual)
Study Completion Date
November 14, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
RA, Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ocrelizumab 200mg
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Infliximab 5mg/kg
Arm Type
Active Comparator
Arm Description
Participants 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.
Intervention Type
Drug
Intervention Name(s)
Infliximab
Intervention Description
Intravenous repeating dose
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Oral or parenteral repeating dose
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
Intravenous repeating dose
Intervention Type
Drug
Intervention Name(s)
Ocrelizumab
Intervention Description
Intravenous repeating dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intravenous repeating dose
Primary Outcome Measure Information:
Title
Change From Baseline in DAS28(ESR) at Week 20
Time Frame
Week 20
Secondary Outcome Measure Information:
Title
Percentage of Participants With Clinical Response of 20% According to ACR Criteria
Time Frame
Baseline up to 30 months
Title
Percentage of Participants With Clinical Response of 50% According to ACR Criteria
Time Frame
Baseline up to 30 months
Title
Percentage of Participants With Clinical Response of 70% According to ACR Criteria
Time Frame
Baseline up to 30 months
Title
European League Against Rheumatism (EULAR) Response Rates
Time Frame
Baseline up to 30 months
Title
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Time Frame
Baseline up to 30 months
Title
Change in Fatigue Visual Analog Scale Score (VAS)
Time Frame
Baseline up to 30 months
Title
Percentage of Participants With Adverse Events (AEs)
Time Frame
Baseline up to 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Rheumatology Associates
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
NEA Baptist Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Dr. Brigid Freyne, MD
City
Murrieta
State/Province
California
ZIP/Postal Code
92563
Country
United States
Facility Name
Agilence Arthritis and Osteoporosis Medical Center, Inc.
City
Whittier
State/Province
California
ZIP/Postal Code
90606
Country
United States
Facility Name
Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80920
Country
United States
Facility Name
RASF-Clinical Research Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Robert W. Levin MD - PP
City
Dunedin
State/Province
Florida
ZIP/Postal Code
34698
Country
United States
Facility Name
Science and Research Institute, Inc.
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Rheumatology Associates of Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Lovelace Scientific Resources
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34292
Country
United States
Facility Name
Arthritis Res & Treatment
City
Macon
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Harbin Clinic
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
Facility Name
Institute of Arthritis Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Illinois Bone & Joint Inst.
City
Morton Grove
State/Province
Illinois
ZIP/Postal Code
60053
Country
United States
Facility Name
Springfield Clinic
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Graves Gilbert Clinic
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Clinical Pharmacology Study Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01610
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Rheumatology, P.C.; Medical Arts Building
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Fiechtner Research Inc
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Shores Rheumatology
City
Saint Clair Shores
State/Province
Michigan
ZIP/Postal Code
48081
Country
United States
Facility Name
Jackson Arthritis Clinic
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Arthritis Associates of Mississippi
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Private Practice - Rosenberg
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63031
Country
United States
Facility Name
Clayton Medical Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Billings Clinic; Research Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Westroads Medical Group
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Arthritis Center of Reno
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center, Rheumatology 5C
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Regional Clinical Research
City
Binghamton
State/Province
New York
ZIP/Postal Code
13905
Country
United States
Facility Name
Arthritis & Osteoporosis Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Southern Tier Arthritis & Rheumatism
City
Olean
State/Province
New York
ZIP/Postal Code
14760
Country
United States
Facility Name
Buffalo Rheumatology Associates
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
Facility Name
Barada,Harrell,Toohey&Bellhorn
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Physicians East Pa
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Ohio State Univ Med Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oklahoma Medical Research Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Healthcare Research Consultants
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Providence Arthritis Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Lehigh Valley Physicians Group
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Arthritis Associates
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16508
Country
United States
Facility Name
Columbia Arthritis Center (Partnership Practice)
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Piedmont Arthritis Clinic
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
South Carolina Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Arthritis Associates
City
Hixson
State/Province
Tennessee
ZIP/Postal Code
37343
Country
United States
Facility Name
Ramesh Gupta - PP
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Ctr for Inflammatory Disease
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Amarillo Center For Clinical Research
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79124
Country
United States
Facility Name
Phillip A Waller MD, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Southwest Rheumatology
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Texas Arthritis Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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).

Learn more about this trial

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

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