Clinical Trial to Compare Treatment With GP2017 and Humira® in Patients With Rheumatoid Arthritis
NCT ID: NCT02744755
Last Updated: 2018-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
353 participants
INTERVENTIONAL
2016-03-31
2017-09-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GP2017
Group 1 will receive treatment with 40mg GP2017 (Adalimumab - GP2017) by subcutaneous injection every other week up to 24 weeks (Study Period 1) at which patients achieving at least a moderate clinical response continue treatment with 40mg GP2017 subcutaneous injection every other week up to 48 weeks (Study Period 2).
Adalimumab - GP2017
Adalimumab - GP2017
US Licensed Humira
Group 2 will receive treatment with 40mg Humira® (Adalimumab - US licensed Humira®) by subcutaneous injection every other week up to 24 weeks (Study Period 1) at which patients achieving at least a moderate clinical response will be switched to treatment with 40mg GP2017 subcutaneous injection every other week up to 48 weeks (Study Period 2).
Adalimumab - US licensed Humira
Adalimumab - US licensed Humira
Interventions
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Adalimumab - GP2017
Adalimumab - GP2017
Adalimumab - US licensed Humira
Adalimumab - US licensed Humira
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients must have active disease, defined as DAS28-CRP ≥ 3.2 at the time of screening
3. Patients must have CRP levels above 5mg/l or ESR levels above the upper limits of normal
4. Patients must have had inadequate clinical response to MTX 10 - 25 mg/week
Exclusion Criteria
2. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during treatment
3. Nursing (lactating) or pregnant women
4. History of or ongoing inflammatory or autoimmune diseases other than RA, e.g. mixed connective tissue disease, systemic lupus erythematosus etc.
5. Systemic corticosteroids \> 7.5mg/day within 4 weeks prior to baseline
6. History or presence of cancer or lymphoproliferative disease other than a successfully and completely treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix and/or removed non-invasive colon polyps, with no evidence of recurrence
7. History of uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (New York Heart Association III-IV), active peptic ulcer disease, recent stroke (within 3 months)
8. Subject known to have immune deficiency, history of positive human immunodeficiency virus (HIV) status or immunocompromised for other reasons
9. History of clinically significant hematologic (e.g. severe anemia, leucopenia, thrombocytopenia), renal or liver disease (e.g. glomerulonephritis, fibrosis, cirrhosis, hepatitis)
10. History of persistent chronic infection; recurrent infection or active infections
11. History of tuberculosis, presence of active tuberculosis, latent tuberculosis as detected by imaging (e.g. chest X-ray, chest Computerized Tomography(CT) scan, Magnetic Resonance Imaging (MRI)) and/ or positive QuantiFERON-TB Gold test (QFT)
12. History or evidence of opportunistic infections, e.g. histoplasmosis, listeriosis, legionellosis
13. Positive serology Hepatitis B (either HBsAg or anti-HBc) or Hepatitis C (positive HCV-Ab or HCV-RNA) indicative of previous or current infections
18 Years
ALL
No
Sponsors
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Hexal AG
INDUSTRY
Sandoz
INDUSTRY
Responsible Party
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Locations
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Arizona Arthritis & Rheumatology
Mesa, Arizona, United States
Sun Valley Arthritis Center Ltd.
Peoria, Arizona, United States
Medvin Clinical Research
Covina, California, United States
MD Med Corp
Hemet, California, United States
Talbert Medical Group
Huntington Beach, California, United States
Denver Arthritis Clinic
Denver, Colorado, United States
Joao Nascimento (Private Practice)
Bridgeport, Connecticut, United States
Arthritis & Rheumatic Disease Specialties
Aventura, Florida, United States
RASF - Clinical Research Center
Boca Raton, Florida, United States
QPS MRA (Miami Research Associates)
Miami, Florida, United States
Omega Research Consultants Orlando
Orlando, Florida, United States
Family Clinical Trials, LLC.
Pembroke Pines, Florida, United States
West Broward Rheumatology Associates, Inc.
Tamarac, Florida, United States
McIlwain Medical Group, PA
Tampa, Florida, United States
BayCare Medical Group, Inc
Tampa, Florida, United States
Lovelace Scientific Resources, Inc.
Venice, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Marietta Rheumatology Associates, PC
Marietta, Georgia, United States
Center for Arthritis & Osteoporosis
Elizabethtown, Kentucky, United States
Arthritis and Rheumatology Consultants
Edina, Minnesota, United States
Physician Research Collaboration
Lincoln, Nebraska, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Montefiore Medical Center PRIME
Lake Success, New York, United States
Medication Management, LLC
Greensboro, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Low Country Rheumatology, PA
North Charleston, South Carolina, United States
Ramesh C Gupta, MD
Memphis, Tennessee, United States
Austin Regional Clinic, P.A.
Austin, Texas, United States
Tekton Research, Inc.
Austin, Texas, United States
Sentara Medical Group Clinical Research
Norfolk, Virginia, United States
IMEDICA s.r.o.
Brno, , Czechia
Revmatologicka a interni ambulance
Kladno, , Czechia
Revmatologicky Ustav
Prague, , Czechia
MEDICAL PLUS s.r.o.
Uherské Hradiště, , Czechia
Revmacentrum MUDr. Mostera s.r.o.
Židenice, , Czechia
Praxis Dr. Walter
Rendsburg, Schleswig-Holstein, Germany
Rheumatologische Schwerpunktpraxis Steglitz
Berlin, , Germany
HRF Hamburger Rheuma Forschungszentrum
Hamburg, , Germany
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz
Békéscsaba, , Hungary
Sopron Medical Egeszsegugyi Szolgaltato Kft.
Budapest, , Hungary
Hevizgyogyfurdo es Szent Andras Reumakorhaz Reumatologia III
Hévíz, , Hungary
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz Reumatologiai Osztaly
Nyíregyháza, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, , Hungary
Vital Medical Center
Veszprém, , Hungary
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
Milan, , Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte UOC Reumatologia
Siena, , Italy
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, Perak, Malaysia
Hospital Pulau Pinang
George Town, Pulau Pinang, Malaysia
Hospital Sibu
Sibu, Sarawak, Malaysia
Hospital Selayang
Batu Caves, Selangor, Malaysia
Centro Investigacion en Artritis y Osteoporosis S.C.
Mexicali, Baja California Norte, Mexico
Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.
San Luis Potosí City, San Luis Potos, Mexico
Clinical Research Institute S.C.
Tlalnepantla, State of Mexico, Mexico
Investigacion y Biomedicina de Chihuahua, S.C.
Chihuahua City, , Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, , Mexico
RM Pharma Specialists SA de CV
México, , Mexico
Szpital Uniwersytecki nr 2 im.dr J. Biziela Dept of Clinical Reumatology
Bydgoszcz, , Poland
Centrum Kliniczno - Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spółka Partnerska
Elblag, , Poland
Centrum Medyczne Pratia Gdynia ProFamilia Spolka Akcyjna, Oddzial w Gdyni
Gdynia, , Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
Lodz, , Poland
Ai Centrum Medyczne Sp. Z O.O. Sp.K.
Poznan, , Poland
RCMed
Sochaczew, , Poland
Slaskie Centrum Reumatologii,Rehabilitacji i Zapobiegania Niepelnosprawnosci im. Gen. Jerzego Zietka
Ustroń, , Poland
Niepubliczny Zakład Opieki Zdrowotnej "Biogenes" Sp. z o.o.
Wroclaw, , Poland
Spitalul Clinic Judetean de Urgenta Brasov Sectia Reumatologie
Brasov, , Romania
Spitalul Clinic Judetean de Urgenta Cluj Napoca Sectia Reumatologie
Cluj-Napoca, , Romania
Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Galati Sectia Reumatologie
Galati, , Romania
RK Medcenter SRL
Iași, , Romania
Spitalul Municipal Ploiesti Sectia Reumatologie
Ploieşti, , Romania
SBIH of Nizhniy Novgorod region " City Clinical Hospital # 5"
Nizhny Novgorod, , Russia
SPb SBIH "Clinical Rheumatological Hospital # 25"
Saint Petersburg, , Russia
Research Institute of Emergency Medical Care
Saint Petersburg, , Russia
SHI Ulyanovsk Reg Clinical Hospital
Ulyanovsk, , Russia
SBHI of Yaroslavl Region "Clinical Hospital #3"
Yaroslavl, , Russia
Institute of Rheumatology
Belgrade, , Serbia
Special Hospital for Rheumatic Diseases
Novi Sad, , Serbia
Hospital de Cruces
Barakaldo, , Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, , Spain
Corporacio Sanitaria Parc Tauli
Sabadell, , Spain
Hospital Infanta Luisa
Seville, , Spain
Princess Alexandra Hospital; Dept of Rheumatology; Williams Day Unit
Harlow, Essex, United Kingdom
Royal Free Hospital
London, , United Kingdom
Countries
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References
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Blauvelt A, Leonardi CL, Gaylis N, Jauch-Lembach J, Balfour A, Lemke L, Hachaichi S, Brueckmann I, Festini T, Wiland P. Treatment with SDZ-ADL, an Adalimumab Biosimilar, in Patients with Rheumatoid Arthritis, Psoriasis, or Psoriatic Arthritis: Results of Patient-Reported Outcome Measures from Two Phase III Studies (ADMYRA and ADACCESS). BioDrugs. 2021 Mar;35(2):229-238. doi: 10.1007/s40259-021-00470-1. Epub 2021 Mar 2.
Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1.
Wiland P, Jeka S, Dokoupilova E, Brandt-Jurgens J, Miranda Limon JM, Cantalejo Moreira M, Cabello RV, Jauch-Lembach J, Thakur A, Haliduola H, Brueckmann I, Gaylis NB. Switching to Biosimilar SDZ-ADL in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: 48-Week Efficacy, Safety and Immunogenicity Results From the Phase III, Randomized, Double-Blind ADMYRA Study. BioDrugs. 2020 Dec;34(6):809-823. doi: 10.1007/s40259-020-00447-6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-003433-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GP17-302
Identifier Type: -
Identifier Source: org_study_id