Back to resultsA Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®) (REGAIN)
Primary Purpose
Arthritis, Rheumatoid
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Golimumab 2 mg/kg IV
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Arthritis, Rheumatoid
Eligibility Criteria
Major Inclusion Criteria include (but not limited to):
- Have a diagnosis of Rheumatoid Arthritis (according to the revised 1987 criteria of the American Rheumatism Association).
- Treatment with infliximab and methotrexate for >= 9 months, (with stable doses of methotrexate over last 16 weeks of 7.5 mg/week to 25 mg/week) and (anti-TNFα therapy with infliximab 2 - 4 mg/kg every 4 weeks, 2 - 5 mg/kg every 5 weeks, 3 - 6 mg/kg every 6 weeks, 3 - 7mg/kg every 7 weeks, or 4 - 8 mg/kg every 8 weeks).
- Disease Activity Score 28 (DAS28) ≥ 3.2 based on Erythrocyte Sedimentation Rate (ESR) at Week -8 and Week 0.
- Swollen joint count (SJC) ≥ 4 and tender joint count (TJC) ≥ 4 at Week - 8 and at Week 0.
- Prior response confirmed by physician.
Major Exclusion Criteria include (but not limited to):
- Have a history of latent or active granulomatous infection, including histoplasmosis, or Have a history of latent or active granulomatous infection, including histoplasmosis, or coccidioidomycosis, prior to the first screening visit or during the Screening Period.
- Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.
- Have a chest radiograph within 3 months prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis.
- Have previously received more than 1 of the currently approved subcutaneous (SC) administered anti-TNFα agents, etanercept, certolizumab pegol, golimumab, or adalimumab.
- Are pregnant, nursing, or planning a pregnancy or fathering a child within 6 months after receiving the last administration of the study agent.
- Weight less than 35 kg or greater than 110 kg (less than 77 pounds or greater than 242 pounds).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Golimumab 2 mg/kg IV
Arm Description
Study drug (golimumab 2 mg/kg IV) will be administered as an intravenous (IV) infusion at Weeks 0, 4, 12, 20 and 28.
Outcomes
Primary Outcome Measures
Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Response at Week 24
The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and erythrocyte sedimentation rate (ESR).
Secondary Outcome Measures
Percentage of Participants Who Achieved an ACR 20 Response at Week 24 With Confirmed Presence of Antibodies to Infliximab
The ACR 20 Response is defined as >= 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (010 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and ESR.
Percentage of Participants Who Acheived ACR 20 Response at Week 24 With Trough Infliximab Levels Below the Lower Limit of Quantification (LLOQ)
The ACR 20 Response is defined as >= 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (010 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and ESR.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01962974
Brief Title
A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®)
Acronym
REGAIN
Official Title
A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Cancelled due to low enrollment
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Biotech, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Phase 3b, multicenter study of the efficacy of golimumab 2 mg/kg IV in subjects with active rheumatoid arthritis who are receiving methotrexate and have inadequate disease control (defined as an erythrocyte sedimentation rate [ESR]-based Disease Activity Score in 28 joints [DAS28] ≥ 3.2 and ≥ 4 swollen and ≥ 4 tender joints) despite current anti-TNFα therapy with infliximab 2 - 4 mg/kg every 4 weeks, 2 - 5 mg/kg every 5 weeks, 3 - 6 mg/kg every 6 weeks, 3 - 7mg/kg every 7 weeks, or 4 - 8 mg/kg every 8 weeks.
To be eligible for participation, subjects must have previously demonstrated initial and/or temporary improvement in disease signs and symptoms, who have since exhibited a diminished response despite continued treatment. It is estimated that 200 subjects will be enrolled in the study at approximately 85 global sites.
Detailed Description
The study employs an open-label "active switch" design that moves subjects from infliximab to golimumab 2 mg/kg IV. In general, subjects eligible for the study include men or women who are currently receiving infliximab in actual clinical practice who are at least 18 years of age with active rheumatoid arthritis, and have previously demonstrated initial and/or temporary improvement in disease signs and symptoms, but now exhibit a diminished response and inadequate disease control despite continued treatment. Subjects must have received infliximab in combination with methotrexate for a minimum of 9 months prior to the first screening visit.
The screening visit will occur sometime between Week -12 and Week -10. Consenting subjects who meet screening criteria will receive their final dose of infliximab at Week -8 as part of actual clinical practice. Golimumab IV treatment, which will be supplied by the sponsor, will be received at Weeks 0, 4, 12, 20, and 28. The primary endpoint is at Week 24, the final efficacy assessment is at Week 32, and a follow-up safety assessment by telephone is at Week 44. There will be a maximum of 36 weeks between the last infliximab infusion at Week -8 and the last infusion of golimumab at Week 28. The duration of study participation is expected to be a maximum of 56 weeks (including the Screening Period, 32 weeks of golimumab treatment and assessment, and a 12-week safety follow-up).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Arthritis, Rheumatoid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Golimumab 2 mg/kg IV
Arm Type
Experimental
Arm Description
Study drug (golimumab 2 mg/kg IV) will be administered as an intravenous (IV) infusion at Weeks 0, 4, 12, 20 and 28.
Intervention Type
Biological
Intervention Name(s)
Golimumab 2 mg/kg IV
Intervention Description
Study drug (golimumab 2 mg/kg IV) will be administered as an intravenous (IV) infusion at Weeks 0, 4, 12, 20 and 28.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Response at Week 24
Description
The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and erythrocyte sedimentation rate (ESR).
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved an ACR 20 Response at Week 24 With Confirmed Presence of Antibodies to Infliximab
Description
The ACR 20 Response is defined as >= 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (010 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and ESR.
Time Frame
Week 24
Title
Percentage of Participants Who Acheived ACR 20 Response at Week 24 With Trough Infliximab Levels Below the Lower Limit of Quantification (LLOQ)
Description
The ACR 20 Response is defined as >= 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (010 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and ESR.
Time Frame
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Major Inclusion Criteria include (but not limited to):
Have a diagnosis of Rheumatoid Arthritis (according to the revised 1987 criteria of the American Rheumatism Association).
Treatment with infliximab and methotrexate for >= 9 months, (with stable doses of methotrexate over last 16 weeks of 7.5 mg/week to 25 mg/week) and (anti-TNFα therapy with infliximab 2 - 4 mg/kg every 4 weeks, 2 - 5 mg/kg every 5 weeks, 3 - 6 mg/kg every 6 weeks, 3 - 7mg/kg every 7 weeks, or 4 - 8 mg/kg every 8 weeks).
Disease Activity Score 28 (DAS28) ≥ 3.2 based on Erythrocyte Sedimentation Rate (ESR) at Week -8 and Week 0.
Swollen joint count (SJC) ≥ 4 and tender joint count (TJC) ≥ 4 at Week - 8 and at Week 0.
Prior response confirmed by physician.
Major Exclusion Criteria include (but not limited to):
Have a history of latent or active granulomatous infection, including histoplasmosis, or Have a history of latent or active granulomatous infection, including histoplasmosis, or coccidioidomycosis, prior to the first screening visit or during the Screening Period.
Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.
Have a chest radiograph within 3 months prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis.
Have previously received more than 1 of the currently approved subcutaneous (SC) administered anti-TNFα agents, etanercept, certolizumab pegol, golimumab, or adalimumab.
Are pregnant, nursing, or planning a pregnancy or fathering a child within 6 months after receiving the last administration of the study agent.
Weight less than 35 kg or greater than 110 kg (less than 77 pounds or greater than 242 pounds).
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Huntsville
State/Province
Alabama
Country
United States
City
Peoria
State/Province
Arizona
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Fort Smith
State/Province
Arkansas
Country
United States
City
Fremont
State/Province
California
Country
United States
City
Fullerton
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Santa Maria
State/Province
California
Country
United States
City
Thousand Oaks
State/Province
California
Country
United States
City
Whittier
State/Province
California
Country
United States
City
Bridgeport
State/Province
Connecticut
Country
United States
City
Clearwater
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Sarasota
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Coeur D'Alene
State/Province
Idaho
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
South Bend
State/Province
Indiana
Country
United States
City
Eagan
State/Province
Minnesota
Country
United States
City
Edina
State/Province
Minnesota
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
Orchard Park
State/Province
New York
Country
United States
City
Asheville
State/Province
North Carolina
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Greensboro
State/Province
North Carolina
Country
United States
City
Hickory
State/Province
North Carolina
Country
United States
City
Wilmington
State/Province
North Carolina
Country
United States
City
Dayton
State/Province
Ohio
Country
United States
City
Duncansville
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Wyomissing
State/Province
Pennsylvania
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Columbia
State/Province
South Carolina
Country
United States
City
Myrtle Beach
State/Province
South Carolina
Country
United States
City
Hixson
State/Province
Tennessee
Country
United States
City
Jakson
State/Province
Tennessee
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Plano
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Arlington
State/Province
Virginia
Country
United States
City
Spokane
State/Province
Washington
Country
United States
City
Glendale
State/Province
Wisconsin
Country
United States
City
Victoria
State/Province
British Columbia
Country
Canada
City
Saint-John'S
State/Province
Newfoundland and Labrador
Country
Canada
City
St. John'S
State/Province
Newfoundland and Labrador
Country
Canada
City
Hamilton
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Rimouski
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&studyid=4785&filename=CR102117_CSR.pdf
Description
A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment with Infliximab (REMICADE ®) REGAIN
Learn more about this trial
A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®)
We'll reach out to this number within 24 hrs