A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®)

NCT ID: NCT01962974

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-12-31

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).

Conditions

Arthritis, Rheumatoid

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Golimumab 2 mg/kg IV

Study drug (golimumab 2 mg/kg IV) will be administered as an intravenous (IV) infusion at Weeks 0, 4, 12, 20 and 28.

Group Type: EXPERIMENTAL

Golimumab 2 mg/kg IV

Intervention Type: BIOLOGICAL

Study drug (golimumab 2 mg/kg IV) will be administered as an intravenous (IV) infusion at Weeks 0, 4, 12, 20 and 28.

Interventions

Golimumab 2 mg/kg IV

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

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 76 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Biotech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Birmingham, Alabama, United States

Huntsville, Alabama, United States

Peoria, Arizona, United States

Phoenix, Arizona, United States

Fort Smith, Arkansas, United States

Fremont, California, United States

Fullerton, California, United States

Long Beach, California, United States

Santa Maria, California, United States

Thousand Oaks, California, United States

Whittier, California, United States

Bridgeport, Connecticut, United States

Clearwater, Florida, United States

Miami, Florida, United States

Orlando, Florida, United States

Sarasota, Florida, United States

Tampa, Florida, United States

Coeur d'Alene, Idaho, United States

Indianapolis, Indiana, United States

South Bend, Indiana, United States

Eagan, Minnesota, United States

Edina, Minnesota, United States

St Louis, Missouri, United States

Albuquerque, New Mexico, United States

Orchard Park, New York, United States

Asheville, North Carolina, United States

Charlotte, North Carolina, United States

Greensboro, North Carolina, United States

Hickory, North Carolina, United States

Wilmington, North Carolina, United States

Dayton, Ohio, United States

Duncansville, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Wyomissing, Pennsylvania, United States

Charleston, South Carolina, United States

Columbia, South Carolina, United States

Myrtle Beach, South Carolina, United States

Hixson, Tennessee, United States

Jakson, Tennessee, United States

Nashville, Tennessee, United States

Houston, Texas, United States

Plano, Texas, United States

San Antonio, Texas, United States

Arlington, Virginia, United States

Spokane, Washington, United States

Glendale, Wisconsin, United States

Victoria, British Columbia, Canada

St. John's, Newfoundland and Labrador, Canada

Hamilton, Ontario, Canada

Montreal, Quebec, Canada

Rimouski, , Canada

Countries

United States; Canada

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&studyid=4785&filename=CR102117_CSR.pdf

A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment with Infliximab (REMICADE ®) REGAIN

Other Identifiers

CNTO148ART3003

Identifier Type: OTHER

Identifier Source: secondary_id

2013-001809-91

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR102117

Identifier Type: -

Identifier Source: org_study_id