Clinical Trial to Compare Treatment With GP2017 and Humira® in Patients With Rheumatoid Arthritis (ADMYRA)
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Patients must have been diagnosed with RA ≥ 6 months prior to screening
- Patients must have active disease, defined as DAS28-CRP ≥ 3.2 at the time of screening
- Patients must have CRP levels above 5mg/l or ESR levels above the upper limits of normal
- Patients must have had inadequate clinical response to MTX 10 - 25 mg/week
Exclusion Criteria:
- Previous treatment with adalimumab, other anti-TNFα therapies or cell depleting agents, e.g. anti-CD20 therapy
- 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
- Nursing (lactating) or pregnant women
- History of or ongoing inflammatory or autoimmune diseases other than RA, e.g. mixed connective tissue disease, systemic lupus erythematosus etc.
- Systemic corticosteroids > 7.5mg/day within 4 weeks prior to baseline
- 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
- 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)
- Subject known to have immune deficiency, history of positive human immunodeficiency virus (HIV) status or immunocompromised for other reasons
- History of clinically significant hematologic (e.g. severe anemia, leucopenia, thrombocytopenia), renal or liver disease (e.g. glomerulonephritis, fibrosis, cirrhosis, hepatitis)
- History of persistent chronic infection; recurrent infection or active infections
- 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)
- History or evidence of opportunistic infections, e.g. histoplasmosis, listeriosis, legionellosis
- Positive serology Hepatitis B (either HBsAg or anti-HBc) or Hepatitis C (positive HCV-Ab or HCV-RNA) indicative of previous or current infections
Sites / Locations
- Arizona Arthritis & Rheumatology
- Sun Valley Arthritis Center Ltd.
- Medvin Clinical Research
- MD Med Corp
- Talbert Medical Group
- Denver Arthritis Clinic
- Joao Nascimento (Private Practice)
- Arthritis & Rheumatic Disease Specialties
- RASF - Clinical Research Center
- QPS MRA (Miami Research Associates)
- Omega Research Consultants Orlando
- Family Clinical Trials, LLC.
- West Broward Rheumatology Associates, Inc.
- McIlwain Medical Group, PA
- BayCare Medical Group, Inc
- Lovelace Scientific Resources, Inc.
- Atlanta Center for Medical Research
- Marietta Rheumatology Associates, PC
- Center for Arthritis & Osteoporosis
- Arthritis and Rheumatology Consultants
- Physician Research Collaboration
- Albuquerque Clinical Trials, Inc.
- Montefiore Medical Center PRIME
- Medication Management, LLC
- PMG Research of Wilmington, LLC
- Low Country Rheumatology, PA
- Ramesh C Gupta, MD
- Austin Regional Clinic, P.A.
- Tekton Research, Inc.
- Sentara Medical Group Clinical Research
- IMEDICA s.r.o.
- Revmatologicka a interni ambulance
- Revmatologicky Ustav
- MEDICAL PLUS s.r.o.
- Revmacentrum MUDr. Mostera s.r.o.
- Praxis Dr. Walter
- Rheumatologische Schwerpunktpraxis Steglitz
- HRF Hamburger Rheuma Forschungszentrum
- Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz
- Sopron Medical Egeszsegugyi Szolgaltato Kft.
- Hevizgyogyfurdo es Szent Andras Reumakorhaz Reumatologia III
- SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz Reumatologiai Osztaly
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
- Vital Medical Center
- Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
- A.O.U. Senese Policlinico Santa Maria alle Scotte UOC Reumatologia
- Hospital Raja Perempuan Zainab II
- Hospital Raja Permaisuri Bainun
- Hospital Pulau Pinang
- Hospital Sibu
- Hospital Selayang
- Centro Investigacion en Artritis y Osteoporosis S.C.
- Clinical Research Institute S.C.
- Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.
- Investigacion y Biomedicina de Chihuahua, S.C.
- Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
- RM Pharma Specialists SA de CV
- Szpital Uniwersytecki nr 2 im.dr J. Biziela Dept of Clinical Reumatology
- Centrum Kliniczno - Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spółka Partnerska
- Centrum Medyczne Pratia Gdynia ProFamilia Spolka Akcyjna, Oddzial w Gdyni
- Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
- Ai Centrum Medyczne Sp. Z O.O. Sp.K.
- RCMed
- Slaskie Centrum Reumatologii,Rehabilitacji i Zapobiegania Niepelnosprawnosci im. Gen. Jerzego Zietka
- Niepubliczny Zakład Opieki Zdrowotnej "Biogenes" Sp. z o.o.
- Spitalul Clinic Judetean de Urgenta Brasov Sectia Reumatologie
- Spitalul Clinic Judetean de Urgenta Cluj Napoca Sectia Reumatologie
- Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Galati Sectia Reumatologie
- RK Medcenter SRL
- Spitalul Municipal Ploiesti Sectia Reumatologie
- SBIH of Nizhniy Novgorod region " City Clinical Hospital # 5"
- SPb SBIH "Clinical Rheumatological Hospital # 25"
- Research Institute of Emergency Medical Care
- SHI Ulyanovsk Reg Clinical Hospital
- SBHI of Yaroslavl Region "Clinical Hospital #3"
- Institute of Rheumatology
- Special Hospital for Rheumatic Diseases
- Hospital de Cruces
- Hospital Universitario de Fuenlabrada
- Corporacio Sanitaria Parc Tauli
- Hospital Infanta Luisa
- Princess Alexandra Hospital; Dept of Rheumatology; Williams Day Unit
- Royal Free Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
GP2017
US Licensed Humira
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).
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).