Clinical Trial to Compare Treatment With GP2017 and Humira® in Patients With Rheumatoid Arthritis

NCT02744755 | Completed Phase 3 Results DMC

• 2 other identifiers: GP17-3022015-003433-10
• Study Type: interventional
• Target: 353
• Locations: 13 countries
• Sites: 83

Brief Summary

Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Study Period 1: Change in DAS28-CRP Score From Baseline at Week 12 in Patients Treated With GP2017 and Patients Treated With Humira

  Disease activity score (DAS) 28-CRP is based on 28-joint count (tender and swollen joints), C-reactive protein and patient's assessment of global disease activity (GDA) or general health (GH), values range from 0.96 to 10.0 while higher values mean a higher disease activity. • A DAS28-CRP value \>5.1 corresponds to a high disease activity • A DAS28-CRP value between 3.2 and 5.1 corresponds to a moderate disease activity • A DAS28-CRP value between 2.6 and 3.2 corresponds to a low disease activity • A DAS28-CRP value \< 2.6 corresponds to remission DAS28-CRP = 0.56 \* sqrt(tender28) + 0.28\* sqrt(swollen28) + 0.36 \* ln(CRP+1) + 0.014 \* GDA or GH + 0.96 where • tender28 and swollen28 are the number of tender and swollen joints as assessed using 28-joint count • CRP is C-reactive protein (mg/l) • GDA is the global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm

  Study period 1: week 12

Secondary Outcomes (22)

• Study Period 1: Time-weighted Averaged Change From Baseline in DAS28-CRP Until Week 24 in Patients Treated With GP2017 and With Humira

  Study period 1: week 24

• Study Period 1- Proportion of Patients Achieving EULAR Criterion for Remission

  week 4, week 12 and week 24

• Study Period 1- Proportion of Patients Achieving EULAR Criterion for Good Response

  week 4, week 12 and week 24

• Study Period 1- Proportion of Patients Achieving EULAR Criterion for Moderate Response

  week 4, week 12 and week 24

• Study Period 1- Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria

  week 4, week 12, week 24

Study Arms (2)

GP2017

EXPERIMENTAL

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).

Biological: Adalimumab - GP2017

US Licensed Humira

ACTIVE COMPARATOR

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).

Biological: Adalimumab - US licensed Humira

Interventions

Adalimumab - GP2017 BIOLOGICAL

Adalimumab - GP2017

Also known as: GP2017

GP2017

Adalimumab - US licensed Humira BIOLOGICAL

Adalimumab - US licensed Humira

Also known as: Humira - Comparator

US Licensed Humira

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sandoz: lead
• Hexal AG: collaborator

Study Sites (83)

Arizona Arthritis & Rheumatology

Mesa, Arizona, 85032, United States

Location

Sun Valley Arthritis Center Ltd.

Peoria, Arizona, 85381, United States

Location

Medvin Clinical Research

Covina, California, 91723, United States

Location

MD Med Corp

Hemet, California, 92543, United States

Location

Talbert Medical Group

Huntington Beach, California, 92646, United States

Location

Denver Arthritis Clinic

Denver, Colorado, 80230, United States

Location

Joao Nascimento (Private Practice)

Bridgeport, Connecticut, 06606, United States

Location

Arthritis & Rheumatic Disease Specialties

Aventura, Florida, 33180, United States

Location

RASF - Clinical Research Center

Boca Raton, Florida, 33486, United States

Location

QPS MRA (Miami Research Associates)

Miami, Florida, 33143, United States

Location

Omega Research Consultants Orlando

Orlando, Florida, 32804, United States

Location

Family Clinical Trials, LLC.

Pembroke Pines, Florida, 33026, United States

Location

West Broward Rheumatology Associates, Inc.

Tamarac, Florida, 33321, United States

Location

McIlwain Medical Group, PA

Tampa, Florida, 33613, United States

Location

BayCare Medical Group, Inc

Tampa, Florida, 33614, United States

Location

Lovelace Scientific Resources, Inc.

Venice, Florida, 34292, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Marietta Rheumatology Associates, PC

Marietta, Georgia, 30060, United States

Location

Center for Arthritis & Osteoporosis

Elizabethtown, Kentucky, 42701, United States

Location

Arthritis and Rheumatology Consultants

Edina, Minnesota, 55435, United States

Location

Physician Research Collaboration

Lincoln, Nebraska, 68516, United States

Location

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, 87102, United States

Location

Montefiore Medical Center PRIME

Lake Success, New York, 10467, United States

Location

Medication Management, LLC

Greensboro, North Carolina, 27410, United States

Location

PMG Research of Wilmington, LLC

Wilmington, North Carolina, 28401, United States

Location

Low Country Rheumatology, PA

North Charleston, South Carolina, 29406, United States

Location

Ramesh C Gupta, MD

Memphis, Tennessee, 38119, United States

Location

Austin Regional Clinic, P.A.

Austin, Texas, 78731, United States

Location

Tekton Research, Inc.

Austin, Texas, 78745, United States

Location

Sentara Medical Group Clinical Research

Norfolk, Virginia, 23502, United States

Location

IMEDICA s.r.o.

Brno, 602 00, Czechia

Location

Revmacentrum MUDr. Mostera s.r.o.

Brno-Židenice, 615 00, Czechia

Location

Revmatologicka a interni ambulance

Kladno, 272 01, Czechia

Location

Revmatologicky Ustav

Prague, 12850, Czechia

Location

MEDICAL PLUS s.r.o.

Uherské Hradiště, 686 01, Czechia

Location

Praxis Dr. Walter

Rendsburg, Schleswig-Holstein, 24768, Germany

Location

Rheumatologische Schwerpunktpraxis Steglitz

Berlin, 12161, Germany

Location

HRF Hamburger Rheuma Forschungszentrum

Hamburg, 20095, Germany

Location

Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz

Békéscsaba, 5600, Hungary

Location

Sopron Medical Egeszsegugyi Szolgaltato Kft.

Budapest, 1039, Hungary

Location

Hevizgyogyfurdo es Szent Andras Reumakorhaz Reumatologia III

Hévíz, 8380, Hungary

Location

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz Reumatologiai Osztaly

Nyíregyháza, 4400, Hungary

Location

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, 6725, Hungary

Location

Vital Medical Center

Veszprém, 8200, Hungary

Location

Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

Milan, 20157, Italy

Location

A.O.U. Senese Policlinico Santa Maria alle Scotte UOC Reumatologia

Siena, 53100, Italy

Location

Hospital Raja Perempuan Zainab II

Kota Bharu, Kelantan, 15586, Malaysia

Location

Hospital Raja Permaisuri Bainun

Ipoh, Perak, 30990, Malaysia

Location

Hospital Pulau Pinang

George Town, Pulau Pinang, 10990, Malaysia

Location

Hospital Sibu

Sibu, Sarawak, 96000, Malaysia

Location

Hospital Selayang

Batu Caves, Selangor, 68100, Malaysia

Location

Centro Investigacion en Artritis y Osteoporosis S.C.

Mexicali, Baja California Norte, 21200, Mexico

Location

Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.

San Luis Potosí City, San Luis Potos, 78213, Mexico

Location

Clinical Research Institute S.C.

Tlalnepantla, State of Mexico, 54055, Mexico

Location

Investigacion y Biomedicina de Chihuahua, S.C.

Chihuahua City, 31000, Mexico

Location

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

Durango, 34000, Mexico

Location

RM Pharma Specialists SA de CV

México, 03100, Mexico

Location

Szpital Uniwersytecki nr 2 im.dr J. Biziela Dept of Clinical Reumatology

Bydgoszcz, 85-168, Poland

Location

Centrum Kliniczno - Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spółka Partnerska

Elblag, 82-300, Poland

Location

Centrum Medyczne Pratia Gdynia ProFamilia Spolka Akcyjna, Oddzial w Gdyni

Gdynia, 81-338, Poland

Location

Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna

Lodz, 90-242, Poland

Location

Ai Centrum Medyczne Sp. Z O.O. Sp.K.

Poznan, 61-113, Poland

Location

RCMed

Sochaczew, 96-500, Poland

Location

Slaskie Centrum Reumatologii,Rehabilitacji i Zapobiegania Niepelnosprawnosci im. Gen. Jerzego Zietka

Ustroń, 43-450, Poland

Location

Niepubliczny Zakład Opieki Zdrowotnej "Biogenes" Sp. z o.o.

Wroclaw, 53-224, Poland

Location

Spitalul Clinic Judetean de Urgenta Brasov Sectia Reumatologie

Brasov, 500365, Romania

Location

Spitalul Clinic Judetean de Urgenta Cluj Napoca Sectia Reumatologie

Cluj-Napoca, 400006, Romania

Location

Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Galati Sectia Reumatologie

Galati, 800578, Romania

Location

RK Medcenter SRL

Iași, 707027, Romania

Location

Spitalul Municipal Ploiesti Sectia Reumatologie

Ploieşti, 100337, Romania

Location

SBIH of Nizhniy Novgorod region " City Clinical Hospital # 5"

Nizhny Novgorod, 603005, Russia

Location

SPb SBIH "Clinical Rheumatological Hospital # 25"

Saint Petersburg, 190068, Russia

Location

Research Institute of Emergency Medical Care

Saint Petersburg, 192242, Russia

Location

SHI Ulyanovsk Reg Clinical Hospital

Ulyanovsk, 432063, Russia

Location

SBHI of Yaroslavl Region "Clinical Hospital #3"

Yaroslavl, 150007, Russia

Location

Institute of Rheumatology

Belgrade, 11000, Serbia

Location

Special Hospital for Rheumatic Diseases

Novi Sad, 21112, Serbia

Location

Hospital de Cruces

Barakaldo, 48903, Spain

Location

Hospital Universitario de Fuenlabrada

Fuenlabrada, 28942, Spain

Location

Corporacio Sanitaria Parc Tauli

Sabadell, 08201, Spain

Location

Hospital Infanta Luisa

Seville, 41010, Spain

Location

Princess Alexandra Hospital; Dept of Rheumatology; Williams Day Unit

Harlow, Essex, CM201QX, United Kingdom

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 33651341 DERIVED

• 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.

  PMID: 33263165 DERIVED

• 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.

  PMID: 33119861 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

GP2017

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Sandoz Biopharma Clinical Development - Strategic Planning
• Organization: Hexal AG/Sandoz Inc.

biopharma.clinicaltrials@sandoz.com

0049(0)80244760

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 20, 2016
• Study Start: March 31, 2016
• Primary Completion: January 31, 2017
• Study Completion: September 26, 2017
• Last Updated: December 19, 2018
• Results First Posted: December 19, 2018

Record last verified: 2018-11

Locations

MY (5); ME (6); HU (6); IT (2); PL (8); RO (5); CZ (5); ES (4); GB (2); SE (2); RU (5); DE (3); US (30)