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

NCT01962974 | Terminated Phase 3 Results

• 3 other identifiers: CR102117CNTO148ART30032013-001809-91
• Study Type: interventional
• Target: 7
• Locations: 2 countries
• Sites: 52

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.

Conditions

Arthritis, Rheumatoid

Keywords

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

• 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).

  Week 24

Secondary Outcomes (2)

• Percentage of Participants Who Achieved an ACR 20 Response at Week 24 With Confirmed Presence of Antibodies to Infliximab

  Week 24

• Percentage of Participants Who Acheived ACR 20 Response at Week 24 With Trough Infliximab Levels Below the Lower Limit of Quantification (LLOQ)

  Week 24

Study Arms (1)

Golimumab 2 mg/kg IV

EXPERIMENTAL

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

Biological: Golimumab 2 mg/kg IV

Interventions

Golimumab 2 mg/kg IV BIOLOGICAL

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

Golimumab 2 mg/kg IV

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Janssen Biotech, Inc.: lead

Study Sites (52)

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Peoria, Arizona, United States

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Phoenix, Arizona, United States

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Fort Smith, Arkansas, United States

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Fremont, California, United States

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Fullerton, California, United States

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Long Beach, California, United States

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Santa Maria, California, United States

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Thousand Oaks, California, United States

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Whittier, California, United States

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Bridgeport, Connecticut, United States

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Clearwater, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Sarasota, Florida, United States

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Tampa, Florida, United States

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Coeur d'Alene, Idaho, United States

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Indianapolis, Indiana, United States

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South Bend, Indiana, United States

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Eagan, Minnesota, United States

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Edina, Minnesota, United States

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St Louis, Missouri, United States

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Albuquerque, New Mexico, United States

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Orchard Park, New York, United States

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Asheville, North Carolina, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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Hickory, North Carolina, United States

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Wilmington, North Carolina, United States

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Dayton, Ohio, United States

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Duncansville, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Wyomissing, Pennsylvania, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Myrtle Beach, South Carolina, United States

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Hixson, Tennessee, United States

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Jakson, Tennessee, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Arlington, Virginia, United States

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Spokane, Washington, United States

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Glendale, Wisconsin, United States

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Victoria, British Columbia, Canada

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St. John's, Newfoundland and Labrador, Canada

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Hamilton, Ontario, Canada

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Montreal, Quebec, Canada

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Rimouski, Canada

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Related Links

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

golimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

The primary limitation for this study was the very low enrolment, ie, 7 participants which led to the early termination of the study.

Results Point of Contact

• Title: STRATEGIC LEAD
• Organization: Janssen Pharmaceuticals

ClinicalTrialDisclosure@its.jnj.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: October 16, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 12, 2017
• Results First Posted: April 12, 2017

Record last verified: 2017-03

Locations

CA (5); US (47)