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

A Randomized, Double-blind, Parallel-group, Multicenter Study to Demonstrate Similar Efficacy and to Compare Safety and Immunogenicity of GP2017 and Humira® in Patients With Moderate to Severe Active Rheumatoid Arthritis

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

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Biological: Adalimumab - GP2017; Biological: Adalimumab - US licensed Humira

Detailed Description

The purpose of this study is to demonstrate similar efficacy and safety of GP2017 and US-licensed Humira® in patients with moderate to severe rheumatoid arthritis (RA) with inadequate response to Disease modifying anti-rheumatic drugs (DMARDs), including methotrexate (MTX).

• Study Type: Interventional
• Enrollment (Actual): 353
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia, 602 00
    • iMedica s.r.o.
  • Kladno, Czechia, 272 01
    • Revmatologicka a interni ambulance
  • Praha 2, Czechia, 12850
    • Revmatologicky ustav
  • Uherske Hradiste, Czechia, 686 01
    • Medical Plus S.R.O.
  • Zidenice, Czechia, 615 00
    • Revmacentrum MUDr. Mostera s.r.o.
• Germany
  • Berlin, Germany, 12161
    • Rheumatologische Schwerpunktpraxis Steglitz
  • Hamburg, Germany, 20095
    • HRF Hamburger Rheuma Forschungszentrum
  • Schleswig Holstein
    • Rendsburg, Schleswig Holstein, Germany, 24768
      • Praxis Dr. Walter
• Hungary
  • Bekescsaba, Hungary, 5600
    • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház
  • Budapest, Hungary, 1039
    • Sopron Medical Egeszsegugyi Szolgaltato Kft.
  • Heviz, Hungary, 8380
    • Hevizgyogyfurdo es Szent Andras Reumakorhaz Reumatologia III
  • Nyiregyhaza, Hungary, 4400
    • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz Reumatologiai Osztaly
  • Szeged, Hungary, 6725
    • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
  • Veszprem, Hungary, 8200
    • Vital Medical Center
• Italy
  • Milano, Italy, 20157
    • Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
  • Siena, Italy, 53100
    • A.O.U. Senese Policlinico Santa Maria alle Scotte UOC Reumatologia
• Malaysia
  • Kelantan
    • Kota Bahru, Kelantan, Malaysia, 15586
      • Hospital Raja Perempuan Zainab II
  • Perak
    • Ipoh, Perak, Malaysia, 30990
      • Hospital Raja Permaisuri Bainun
  • Pulau Pinang
    • George Town, Pulau Pinang, Malaysia, 10990
      • Hospital Pulau Pinang
  • Sarawak
    • Sibu, Sarawak, Malaysia, 96000
      • Hospital Sibu
  • Selangor
    • Batu Caves, Selangor, Malaysia, 68100
      • Hospital Selayang
• Mexico
  • Chihuahua, Mexico, 31000
    • Investigacion y Biomedicina de Chihuahua, S.C.
  • Durango, Mexico, 34000
    • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
  • Mexico, Mexico, 03100
    • RM Pharma Specialists SA de CV
  • Baja California Norte
    • Mexicali, Baja California Norte, Mexico, 21200
      • Centro Investigacion en Artritis y Osteoporosis S.C.
  • Estado De Mexico
    • Tlalnepantla, Estado De Mexico, Mexico, 54055
      • Clinical Research Institute S.C.
  • San Luis Potos
    • San Luis Potosi, San Luis Potos, Mexico, 78213
      • Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
• Poland
  • Bydgoszcz, Poland, 85-168
    • Szpital Uniwersytecki nr 2 im.dr J. Biziela Dept of Clinical Reumatology
  • Elblag, Poland, 82-300
    • Centrum Kliniczno - Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spółka Partnerska
  • Gdynia, Poland, 81-338
    • Centrum Medyczne Pratia Gdynia ProFamilia Spolka Akcyjna, Oddzial w Gdyni
  • Lodz, Poland, 90-242
    • Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
  • Poznan, Poland, 61-113
    • Ai Centrum Medyczne Sp. Z O.O. Sp.K.
  • Sochaczew, Poland, 96-500
    • RCMed
  • Ustron, Poland, 43-450
    • Slaskie Centrum Reumatologii,Rehabilitacji i Zapobiegania Niepelnosprawnosci im. Gen. Jerzego Zietka
  • Wroclaw, Poland, 53-224
    • Niepubliczny Zakład Opieki Zdrowotnej "Biogenes" Sp. z o.o.
• Romania
  • Brasov, Romania, 500365
    • Spitalul Clinic Judetean de Urgenta Brasov Sectia Reumatologie
  • Cluj-napoca, Romania, 400006
    • Spitalul Clinic Judetean de Urgenta Cluj Napoca Sectia Reumatologie
  • Galati, Romania, 800578
    • Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Galati Sectia Reumatologie
  • Iasi, Romania, 707027
    • RK Medcenter SRL
  • Ploiesti, Romania, 100337
    • Spitalul Municipal Ploiesti Sectia Reumatologie
• Russian Federation
  • Nizhny Novgorod, Russian Federation, 603005
    • SBIH of Nizhniy Novgorod region " City Clinical Hospital # 5"
  • Saint Petersburg, Russian Federation, 190068
    • SPb SBIH "Clinical Rheumatological Hospital # 25"
  • Saint Petersburg, Russian Federation, 192242
    • Research Institute of Emergency Medical Care
  • Ul'yanovsk, Russian Federation, 432063
    • SHI Ulyanovsk Reg Clinical Hospital
  • Yaroslavl, Russian Federation, 150007
    • SBHI of Yaroslavl Region "Clinical Hospital #3"
• Serbia
  • Belgrade, Serbia, 11000
    • Institute of Rheumatology
  • Novi Sad, Serbia, 21112
    • Special Hospital for Rheumatic Diseases
• Spain
  • Baracaldo, Spain, 48903
    • Hospital de Cruces
  • Fuenlabrada, Spain, 28942
    • Hospital Universitario de Fuenlabrada
  • Sabadell, Spain, 08201
    • Corporació Sanitària Parc Taulí
  • Sevilla, Spain, 41010
    • Hospital Infanta Luisa
• United Kingdom
  • London, United Kingdom, NW3 2QG
    • Royal Free Hospital
  • Essex
    • Harlow, Essex, United Kingdom, CM201QX
      • Princess Alexandra Hospital; Dept of Rheumatology; Williams Day Unit
• United States
  • Arizona
    • Mesa, Arizona, United States, 85032
      • Arizona Arthritis & Rheumatology
    • Peoria, Arizona, United States, 85381
      • Sun Valley Arthritis Center LTD.
  • California
    • Covina, California, United States, 91723
      • Medvin Clinical Research
    • Hemet, California, United States, 92543
      • MD Med Corp
    • Huntington Beach, California, United States, 92646
      • Talbert Medical Group
  • Colorado
    • Denver, Colorado, United States, 80230
      • Denver Arthritis Clinic
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • Joao Nascimento (Private Practice)
  • Florida
    • Aventura, Florida, United States, 33180
      • Arthritis & Rheumatic Disease Specialties
    • Boca Raton, Florida, United States, 33486
      • RASF - Clinical Research Center
    • Miami, Florida, United States, 33143
      • QPS MRA (Miami Research Associates)
    • Orlando, Florida, United States, 32804
      • Omega Research Consultants Orlando
    • Pembroke Pines, Florida, United States, 33026
      • Family Clinical Trials, LLC.
    • Tamarac, Florida, United States, 33321
      • West Broward Rheumatology Associates, Inc.
    • Tampa, Florida, United States, 33613
      • McIlwain Medical Group, PA
    • Tampa, Florida, United States, 33614
      • BayCare Medical Group, Inc
    • Venice, Florida, United States, 34292
      • Lovelace Scientific Resources, Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
    • Marietta, Georgia, United States, 30060
      • Marietta Rheumatology Associates, PC
  • Kentucky
    • Elizabethtown, Kentucky, United States, 42701
      • Center for Arthritis & Osteoporosis
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Arthritis and Rheumatology Consultants
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Physician Research Collaboration
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials, Inc.
  • New York
    • Lake Success, New York, United States, 10467
      • Montefiore Medical Center PRIME
  • North Carolina
    • Greensboro, North Carolina, United States, 27410
      • Medication Management, LLC
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington, LLC
  • South Carolina
    • North Charleston, South Carolina, United States, 29406
      • Low Country Rheumatology, PA
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Ramesh C Gupta, MD
  • Texas
    • Austin, Texas, United States, 78745
      • Tekton Research, Inc.
    • Austin, Texas, United States, 78731
      • Austin Regional Clinic, P.A.
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Sentara Medical Group Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients must have been diagnosed with RA ≥ 6 months prior to screening
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:

1. Previous treatment with adalimumab, other anti-TNFα therapies or cell depleting agents, e.g. anti-CD20 therapy
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Biological: Adalimumab - GP2017; Adalimumab - GP2017; Other Names: GP2017
Active Comparator: 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).	Biological: Adalimumab - US licensed Humira; Adalimumab - US licensed Humira; Other Names: Humira - Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Period 1: Time-weighted Averaged Change From Baseline in DAS28-CRP Until Week 24 in Patients Treated With GP2017 and 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 24
Study Period 1- Proportion of Patients Achieving EULAR Criterion for Remission	Proportion of patients achieving European League against Rheumatism (EULAR) remission (defined as DAS28 CRP < 2.6 )	week 4, week 12 and week 24
Study Period 1- Proportion of Patients Achieving EULAR Criterion for Good Response	Proportion of patients achieving European League against Rheumatism (EULAR) good response (defined as DAS28<=3.2 at post-baseline assessment timepoint(s) with an improvement of >1.2 in DAS28 from baseline.)	week 4, week 12 and week 24
Study Period 1- Proportion of Patients Achieving EULAR Criterion for Moderate Response	Proportion of patients achieving European League against Rheumatism (EULAR) moderate response (defined as DAS28<=3.2 at post-baseline assessment timepoint(s) with an improvement of >0.6 to <=1.2 from baseline or DAS28 >3.2 to <=5.1 with an improvement of >0.6 to <=1.2 or of >1.2 from baseline or DAS28 >5.1 with an improvement of >1.2 from baseline) ;	week 4, week 12 and week 24
Study Period 1- Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria	Proportion of patients achieving EULAR/American College of Rheumatology (EULAR/ACR) Boolean remission criteria (defined as number of tender joint count 28 <=1 and swollen joint count 28 <=1, CRP level (mg/dL) <=1 and patient's global assessment <=1 on a scale of 1-10 (corresponding to <=10 on a scale of 1-100).	week 4, week 12, week 24
Study Period 1: Change in DAS28-CRP and DAS28-ESR Scores From Baseline to Week 24 in Patients Treated With GP2017 and Patients Treated With Humira	DAS28-CRP is a disease activity score and defined in primary outcome measure. DAS28-ESR is the DAS28 erythrocyte sedimentation rate score. DAS28-CRP and DAS28-ESR: best is 0,; < 2.6 - remission,; ≥ 2.6 to ≤ 3.2 - low disease activity; > 3.2 to ≤ 5.1 - moderate disease activity; > 5.1 - high disease activity DAS28-ESR = 0.56 * sqrt(tender28) + 0.28*sqrt(swollen28) + 0.7 * ln(ESR) + 0.014 * GDA 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) • ESR is erythrocyte sedimentation rate (mm/h) • GDA is the global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm.Values range from 0 to 10. Higher values mean a higher disease activity.	study period 1: week 2, 4, 24
Study Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24	ACR20 response was defined if a patient fulfilled all 3 criteria below: -at least 20% improvement in tender 68 joint count -at least 20% improvement in swollen 66 joint-count; And at least 20% improvement in at least 3 of the following 5 measures: - Patient's assessment of RA pain (visual analogue scale (VAS) 100 mm), -Patient's global assessment of disease activity (VAS 100 mm), -Physician's global assessment of disease activity (VAS 100 mm), -Patient self-assessed disability index(HAQ-DI© score), -Acute phase reactant (CRP or ESR). ACR50 and ACR70 responses were defined as ACR20 response replacing "20% improvement" by "50% improvement" and "70% improvement", respectively.	Week 4, week 12 and week 24
Study Period 1 - Changes From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI©) at Weeks 4, 12 and 24;	Health assessment questionnaire (HAQ-DI) disability index ranges from 0 (best) to 3 (worst).The HAQ© was scored in accordance with the recommendation from the developers outlined in the "HAQ PACK" from Stanford University, California. Ramey Dr, Fries JF, Singh G. in B. Spilker Quality of Life and Pharmacoleconomics in Clinical Trials, 2nd ed, The Health Assessment Questionnaire 1995 -- Status and Review. Philadelphia: Lippincott-Raven Pub., 1996, p 227 - 237. Fries JF, Spitz P, Kraines G, Holman H. Measurement of Patient Outcome in Arthritis, Arthritis and Rheumatism, 1980, 23:137-145.	Weeks 4, 12 and 24;
Study Period 1- Proportion of Patients Achieving HAQ-DI© in Normal Range (≤ 0.5) at Weeks 4, 12 and 24;	Health assessment questionnaire disability index (HAQ-DI©) ranges from 0 (best) to 3 (worst)	Weeks 4, 12 and 24;
Study Period 1- Proportion of Patients Achieving HAQ-DI© Score Improvement >0.3 at Weeks 4, 12 and 24	Health assessment questionnaire (HAQ-DI©) disability index ranges from 0 (best) to 3 (worst)	Weeks 4, 12 and 24;
Study Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT©) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24 (Change From Baseline)	FACIT© fatigue scale is a 13- item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function, ranging from 0 (worst) to 52 (best).	Weeks 4, 12 and 24;
Study Period 1 - CRP (C-reactive Protein) Changes From Baseline in GP2017 and US-licensed Humira Treated at Weeks 4, 12 and 24	Outcome measure 13 presents changes in CRP measures in blood while Outome measure 7 presents changes in DAS28-CRP scores (calculated composite score to measure the disease activity)	Week 4, week 12, week 24
Study Period 1 -ESR (Erythrocyte Sedimentation Rate) Changes From Baseline in GP2017 and US-licensed Humira Treated at Weeks 4, 12 and 24	Outcome measure 13 presents changes in ESR measures in blood while outcome measure 7 presents changes in DAS28-ESR scores (calculated composite score to measure the disease activity)	Week 4, week 12, week 24
Study Period 1: Incidence and Severity of Injection Site Reactions in GP2017 and Humira	Incidence of injection site reactions in GP2017 and Humira	Treatment Period 1, 24 weeks
Study Period 1 - Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Formation Against Adalimumab in Patients Treated With GP2017 or Humira (Positive Patients)	Frequency of patients having anti-drug antibody (ADA) during 24 weeks	baseline, week 2, week 4, week 12, week 24
Study Period 2 - Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Formation Against Adalimumab in Patients Treated With GP2017 Who Continued GP2017 or Switched to GP2017 From Humira (Positive Patients)	Frequency of patients having anti-drug antibody (ADA) during 24 weeks	week 24, week 36, week 48
Study Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Week 48, in Patients Treated With GP2017 Who Continued GP2017 or Switched to GP2017 From Humira		week 48
Study Period 2 - Health Assessment Questionnaire-Disability Index (HAQ-DI©) Changes From Week 24 at Week 48 in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira	Health assessment questionnaire (HAQ-DI) disability index ranges from 0 (best) to 3 (worst)	Weeks 48
Study Period 2 :Proportion of Patients Treated Continuously With GP2017 and Patients Treated With GP2017 After Switch From Humira Achieving HAQ-DI© Score in Normal Range ≤0.5 at Week 48		week 48
Study Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT©) Fatigue Scale Changes From Week 24 at Week 48 in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira	FACIT©: from 0 (worst) to 52 (best), a score of less than 30 indicates severe fatigue	week 48
Study Period 2: Changes From Week 24 at Week 48 in DAS28-CRP and DAS28-ESR Scores in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira	DAS28-CRP is a disease activity score and defined in primary outcome measure. DAS28-ESR is the DAS28 erythrocyte sedimentation rate score. DAS28-CRP and DAS28-ESR: best is 0,; < 2.6 - remission,; ≥ 2.6 to ≤ 3.2 - low disease activity; > 3.2 to ≤ 5.1 - moderate disease activity; > 5.1 - high disease activity DAS28-ESR = 0.56 * sqrt(tender28) + 0.28* sqrt(swollen28) + 0.7 * ln(ESR) + 0.014 * GDA 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) • ESR is erythrocyte sedimentation rate (mm/h) • GDA is the global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm.Values range from 0 to 10. Higher values mean a higher disease activity.	week 48
Study Period 2: Incidence of Injection Site Reactions in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira	Incidence of injection site reactions	up to 48 weeks

Collaborators and Investigators

• Sponsor: Sandoz
• Collaborators: Hexal AG

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2016
• Primary Completion (Actual): January 31, 2017
• Study Completion (Actual): September 26, 2017

Study Registration Dates

• First Submitted: April 12, 2016
• First Submitted That Met QC Criteria: April 15, 2016
• First Posted (Estimate): April 20, 2016

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: November 30, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: GP17-302; 2015-003433-10 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided