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- Klinische proef NCT01962974
A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®) (REGAIN)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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).
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Rimouski, Canada
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British Columbia
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Victoria, British Columbia, Canada
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Newfoundland and Labrador
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Saint-John'S, Newfoundland and Labrador, Canada
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St. John'S, Newfoundland and Labrador, Canada
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Ontario
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Hamilton, Ontario, Canada
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Quebec
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Montreal, Quebec, Canada
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Alabama
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Birmingham, Alabama, Verenigde Staten
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Huntsville, Alabama, Verenigde Staten
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Arizona
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Peoria, Arizona, Verenigde Staten
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Phoenix, Arizona, Verenigde Staten
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Arkansas
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Fort Smith, Arkansas, Verenigde Staten
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California
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Fremont, California, Verenigde Staten
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Fullerton, California, Verenigde Staten
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Long Beach, California, Verenigde Staten
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Santa Maria, California, Verenigde Staten
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Thousand Oaks, California, Verenigde Staten
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Whittier, California, Verenigde Staten
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Connecticut
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Bridgeport, Connecticut, Verenigde Staten
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Florida
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Clearwater, Florida, Verenigde Staten
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Miami, Florida, Verenigde Staten
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Orlando, Florida, Verenigde Staten
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Sarasota, Florida, Verenigde Staten
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Tampa, Florida, Verenigde Staten
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Idaho
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Coeur D'Alene, Idaho, Verenigde Staten
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Indiana
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Indianapolis, Indiana, Verenigde Staten
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South Bend, Indiana, Verenigde Staten
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Minnesota
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Eagan, Minnesota, Verenigde Staten
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Edina, Minnesota, Verenigde Staten
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Missouri
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Saint Louis, Missouri, Verenigde Staten
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New Mexico
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Albuquerque, New Mexico, Verenigde Staten
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New York
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Orchard Park, New York, Verenigde Staten
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North Carolina
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Asheville, North Carolina, Verenigde Staten
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Charlotte, North Carolina, Verenigde Staten
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Greensboro, North Carolina, Verenigde Staten
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Hickory, North Carolina, Verenigde Staten
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Wilmington, North Carolina, Verenigde Staten
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Ohio
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Dayton, Ohio, Verenigde Staten
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Pennsylvania
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Duncansville, Pennsylvania, Verenigde Staten
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Philadelphia, Pennsylvania, Verenigde Staten
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Pittsburgh, Pennsylvania, Verenigde Staten
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Wyomissing, Pennsylvania, Verenigde Staten
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South Carolina
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Charleston, South Carolina, Verenigde Staten
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Columbia, South Carolina, Verenigde Staten
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Myrtle Beach, South Carolina, Verenigde Staten
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Tennessee
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Hixson, Tennessee, Verenigde Staten
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Jakson, Tennessee, Verenigde Staten
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Nashville, Tennessee, Verenigde Staten
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Texas
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Houston, Texas, Verenigde Staten
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Plano, Texas, Verenigde Staten
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San Antonio, Texas, Verenigde Staten
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Virginia
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Arlington, Virginia, Verenigde Staten
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Washington
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Spokane, Washington, Verenigde Staten
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Wisconsin
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Glendale, Wisconsin, Verenigde Staten
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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Study drug (golimumab 2 mg/kg IV) will be administered as an intravenous (IV) infusion at Weeks 0, 4, 12, 20 and 28.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Response at Week 24
Tijdsspanne: Week 24
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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).
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Week 24
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percentage of Participants Who Achieved an ACR 20 Response at Week 24 With Confirmed Presence of Antibodies to Infliximab
Tijdsspanne: Week 24
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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.
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Week 24
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Percentage of Participants Who Acheived ACR 20 Response at Week 24 With Trough Infliximab Levels Below the Lower Limit of Quantification (LLOQ)
Tijdsspanne: Week 24
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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.
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Week 24
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het immuunsysteem
- Auto-immuunziekten
- Gewrichtsziekten
- Musculoskeletale aandoeningen
- Reumatische aandoeningen
- Bindweefselziekten
- Artritis
- Artritis, reumatoïde
- Fysiologische effecten van medicijnen
- Ontstekingsremmende middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Tumornecrosefactorremmers
- Golimumab
Andere studie-ID-nummers
- CR102117
- CNTO148ART3003 (Andere identificatie: Janssen Biotech, Inc.)
- 2013-001809-91 (EudraCT-nummer)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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