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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Adalimumab - GP2017
Adalimumab - US licensed Humira
Sponsored by
Sandoz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Arm Type

Experimental

Active Comparator

Arm Label

GP2017

US Licensed Humira

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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- Proportion of Patients Achieving EULAR Criterion for Remission
Proportion of patients achieving European League against Rheumatism (EULAR) remission (defined as DAS28 CRP < 2.6 )
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.)
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) ;
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).
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- 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.
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.
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)
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)
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).
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)
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)
Study Period 1: Incidence and Severity of Injection Site Reactions in GP2017 and Humira
Incidence of injection site reactions in GP2017 and Humira
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
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
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
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)
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
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
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.
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

Full Information

First Posted
April 12, 2016
Last Updated
November 30, 2018
Sponsor
Sandoz
Collaborators
Hexal AG
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1. Study Identification

Unique Protocol Identification Number
NCT02744755
Brief Title
Clinical Trial to Compare Treatment With GP2017 and Humira® in Patients With Rheumatoid Arthritis
Acronym
ADMYRA
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 31, 2016 (Actual)
Primary Completion Date
January 31, 2017 (Actual)
Study Completion Date
September 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sandoz
Collaborators
Hexal AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
353 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GP2017
Arm Type
Experimental
Arm Description
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).
Arm Title
US Licensed Humira
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
Adalimumab - GP2017
Other Intervention Name(s)
GP2017
Intervention Description
Adalimumab - GP2017
Intervention Type
Biological
Intervention Name(s)
Adalimumab - US licensed Humira
Other Intervention Name(s)
Humira - Comparator
Intervention Description
Adalimumab - US licensed Humira
Primary Outcome Measure Information:
Title
Study Period 1: Change in DAS28-CRP Score From Baseline at Week 12 in Patients Treated With GP2017 and Patients Treated With Humira
Description
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
Time Frame
Study period 1: week 12
Secondary Outcome Measure Information:
Title
Study Period 1: Time-weighted Averaged Change From Baseline in DAS28-CRP Until Week 24 in Patients Treated With GP2017 and With Humira
Description
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
Time Frame
Study period 1: week 24
Title
Study Period 1- Proportion of Patients Achieving EULAR Criterion for Remission
Description
Proportion of patients achieving European League against Rheumatism (EULAR) remission (defined as DAS28 CRP < 2.6 )
Time Frame
week 4, week 12 and week 24
Title
Study Period 1- Proportion of Patients Achieving EULAR Criterion for Good Response
Description
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.)
Time Frame
week 4, week 12 and week 24
Title
Study Period 1- Proportion of Patients Achieving EULAR Criterion for Moderate Response
Description
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) ;
Time Frame
week 4, week 12 and week 24
Title
Study Period 1- Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria
Description
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).
Time Frame
week 4, week 12, week 24
Title
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
Description
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.
Time Frame
study period 1: week 2, 4, 24
Title
Study Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24
Description
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.
Time Frame
Week 4, week 12 and week 24
Title
Study Period 1 - Changes From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI©) at Weeks 4, 12 and 24;
Description
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.
Time Frame
Weeks 4, 12 and 24;
Title
Study Period 1- Proportion of Patients Achieving HAQ-DI© in Normal Range (≤ 0.5) at Weeks 4, 12 and 24;
Description
Health assessment questionnaire disability index (HAQ-DI©) ranges from 0 (best) to 3 (worst)
Time Frame
Weeks 4, 12 and 24;
Title
Study Period 1- Proportion of Patients Achieving HAQ-DI© Score Improvement >0.3 at Weeks 4, 12 and 24
Description
Health assessment questionnaire (HAQ-DI©) disability index ranges from 0 (best) to 3 (worst)
Time Frame
Weeks 4, 12 and 24;
Title
Study Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT©) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24 (Change From Baseline)
Description
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).
Time Frame
Weeks 4, 12 and 24;
Title
Study Period 1 - CRP (C-reactive Protein) Changes From Baseline in GP2017 and US-licensed Humira Treated at Weeks 4, 12 and 24
Description
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)
Time Frame
Week 4, week 12, week 24
Title
Study Period 1 -ESR (Erythrocyte Sedimentation Rate) Changes From Baseline in GP2017 and US-licensed Humira Treated at Weeks 4, 12 and 24
Description
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)
Time Frame
Week 4, week 12, week 24
Title
Study Period 1: Incidence and Severity of Injection Site Reactions in GP2017 and Humira
Description
Incidence of injection site reactions in GP2017 and Humira
Time Frame
Treatment Period 1, 24 weeks
Title
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)
Description
Frequency of patients having anti-drug antibody (ADA) during 24 weeks
Time Frame
baseline, week 2, week 4, week 12, week 24
Title
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)
Description
Frequency of patients having anti-drug antibody (ADA) during 24 weeks
Time Frame
week 24, week 36, week 48
Title
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
Time Frame
week 48
Title
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
Description
Health assessment questionnaire (HAQ-DI) disability index ranges from 0 (best) to 3 (worst)
Time Frame
Weeks 48
Title
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
Time Frame
week 48
Title
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
Description
FACIT©: from 0 (worst) to 52 (best), a score of less than 30 indicates severe fatigue
Time Frame
week 48
Title
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
Description
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.
Time Frame
week 48
Title
Study Period 2: Incidence of Injection Site Reactions in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira
Description
Incidence of injection site reactions
Time Frame
up to 48 weeks

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33651341
Citation
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.
Results Reference
derived
PubMed Identifier
33263165
Citation
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.
Results Reference
derived
PubMed Identifier
33119861
Citation
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.
Results Reference
derived

Learn more about this trial

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

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