Rheumatoid ArthritisPhase 3ADMYRANCT02744755
Clinical Trial to Compare Treatment With GP2017 and Humira® in Patients With Rheumatoid Arthritis
A Phase 3 study testing Adalimumab - GP2017 and Adalimumab - US licensed Humira in people with Rheumatoid Arthritis, run by Sandoz at 83 sites in 13 countries.
Trial summary
Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Adalimumab - GP2017 and Adalimumab - US licensed Humira
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- 83 sitesin 13 countries
- Study dates
- 31 Mar 2016to 26 Sep 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
83 sites in 13 countries.
83 sites in 13 countries
United States30 sites
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Austin Regional Clinic, P.A.
Austin, Texas, 78731
Tekton Research, Inc.
Austin, Texas, 78745
Arthritis & Rheumatic Disease Specialties
Aventura, Florida, 33180
RASF - Clinical Research Center
Boca Raton, Florida, 33486
Joao Nascimento (Private Practice)
Bridgeport, Connecticut, 06606
Medvin Clinical Research
Covina, California, 91723
Denver Arthritis Clinic
Denver, Colorado, 80230
Arthritis and Rheumatology Consultants
Edina, Minnesota, 55435
Center for Arthritis & Osteoporosis
Elizabethtown, Kentucky, 42701
Medication Management, LLC
Greensboro, North Carolina, 27410
MD Med Corp
Hemet, California, 92543
Talbert Medical Group
Huntington Beach, California, 92646
Montefiore Medical Center PRIME
Lake Success, New York, 10467
Physician Research Collaboration
Lincoln, Nebraska, 68516
Marietta Rheumatology Associates, PC
Marietta, Georgia, 30060
Ramesh C Gupta, MD
Memphis, Tennessee, 38119
Arizona Arthritis & Rheumatology
Mesa, Arizona, 85032
QPS MRA (Miami Research Associates)
Miami, Florida, 33143
Sentara Medical Group Clinical Research
Norfolk, Virginia, 23502
Low Country Rheumatology, PA
North Charleston, South Carolina, 29406
Omega Research Consultants Orlando
Orlando, Florida, 32804
Family Clinical Trials, LLC.
Pembroke Pines, Florida, 33026
Sun Valley Arthritis Center Ltd.
Peoria, Arizona, 85381
West Broward Rheumatology Associates, Inc.
Tamarac, Florida, 33321
McIlwain Medical Group, PA
Tampa, Florida, 33613
BayCare Medical Group, Inc
Tampa, Florida, 33614
Lovelace Scientific Resources, Inc.
Venice, Florida, 34292
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401
Poland8 sites
Szpital Uniwersytecki nr 2 im.dr J. Biziela Dept of Clinical Reumatology
Bydgoszcz, 85-168
Centrum Kliniczno - Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spółka Partnerska
Elblag, 82-300
Centrum Medyczne Pratia Gdynia ProFamilia Spolka Akcyjna, Oddzial w Gdyni
Gdynia, 81-338
Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
Lodz, 90-242
Ai Centrum Medyczne Sp. Z O.O. Sp.K.
Poznan, 61-113
RCMed
Sochaczew, 96-500
Slaskie Centrum Reumatologii,Rehabilitacji i Zapobiegania Niepelnosprawnosci im. Gen. Jerzego Zietka
Ustroń, 43-450
Niepubliczny Zakład Opieki Zdrowotnej "Biogenes" Sp. z o.o.
Wroclaw, 53-224
Hungary6 sites
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz
Békéscsaba, 5600
Sopron Medical Egeszsegugyi Szolgaltato Kft.
Budapest, 1039
Hevizgyogyfurdo es Szent Andras Reumakorhaz Reumatologia III
Hévíz, 8380
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz Reumatologiai Osztaly
Nyíregyháza, 4400
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, 6725
Vital Medical Center
Veszprém, 8200
Mexico6 sites
Investigacion y Biomedicina de Chihuahua, S.C.
Chihuahua City, 31000
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, 34000
Centro Investigacion en Artritis y Osteoporosis S.C.
Mexicali, Baja California Norte, 21200
RM Pharma Specialists SA de CV
México, 03100
Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.
San Luis Potosí City, San Luis Potos, 78213
Clinical Research Institute S.C.
Tlalnepantla, State of Mexico, 54055
Czechia5 sites
IMEDICA s.r.o.
Brno, 602 00
Revmacentrum MUDr. Mostera s.r.o.
Brno-Židenice, 615 00
Revmatologicka a interni ambulance
Kladno, 272 01
Revmatologicky Ustav
Prague, 12850
MEDICAL PLUS s.r.o.
Uherské Hradiště, 686 01
Malaysia5 sites
Hospital Selayang
Batu Caves, Selangor, 68100
Hospital Pulau Pinang
George Town, Pulau Pinang, 10990
Hospital Raja Permaisuri Bainun
Ipoh, Perak, 30990
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, 15586
Hospital Sibu
Sibu, Sarawak, 96000
Romania5 sites
Spitalul Clinic Judetean de Urgenta Brasov Sectia Reumatologie
Brasov, 500365
Spitalul Clinic Judetean de Urgenta Cluj Napoca Sectia Reumatologie
Cluj-Napoca, 400006
Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Galati Sectia Reumatologie
Galati, 800578
RK Medcenter SRL
Iași, 707027
Spitalul Municipal Ploiesti Sectia Reumatologie
Ploieşti, 100337
Russia5 sites
SBIH of Nizhniy Novgorod region " City Clinical Hospital # 5"
Nizhny Novgorod, 603005
SPb SBIH "Clinical Rheumatological Hospital # 25"
Saint Petersburg, 190068
Research Institute of Emergency Medical Care
Saint Petersburg, 192242
SHI Ulyanovsk Reg Clinical Hospital
Ulyanovsk, 432063
SBHI of Yaroslavl Region "Clinical Hospital #3"
Yaroslavl, 150007
Spain4 sites
Hospital de Cruces
Barakaldo, 48903
Hospital Universitario de Fuenlabrada
Fuenlabrada, 28942
Corporacio Sanitaria Parc Tauli
Sabadell, 08201
Hospital Infanta Luisa
Seville, 41010
Germany3 sites
Rheumatologische Schwerpunktpraxis Steglitz
Berlin, 12161
HRF Hamburger Rheuma Forschungszentrum
Hamburg, 20095
Praxis Dr. Walter
Rendsburg, Schleswig-Holstein, 24768
Italy2 sites
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
Milan, 20157
A.O.U. Senese Policlinico Santa Maria alle Scotte UOC Reumatologia
Siena, 53100
Serbia2 sites
Institute of Rheumatology
Belgrade, 11000
Special Hospital for Rheumatic Diseases
Novi Sad, 21112
United Kingdom2 sites
Princess Alexandra Hospital; Dept of Rheumatology; Williams Day Unit
Harlow, Essex, CM201QX
Royal Free Hospital
London, NW3 2QG
About this study
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
Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis
Read the 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).
- Conditions
- Rheumatoid Arthritis
- Being tested
- Adalimumab - GP2017, Adalimumab - US licensed Humira
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab - GP2017Biological
Also called GP2017
Adalimumab - GP2017
Adalimumab - US licensed HumiraBiological
Also called Humira - Comparator
Adalimumab - US licensed Humira
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Biological: Adalimumab - US licensed Humira |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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 )
Measured: 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.)
Measured: 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) ;
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study start31 Mar 2016
- Primary completion31 Jan 2017
- Study completion26 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hexal AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744755
- Sponsor's protocol ID
- GP17-302
- Other IDs
- 2015-003433-10, 2015
- Acronym
- ADMYRA
- Status last verified
- Nov 2018
- First submitted
- 12 Apr 2016
- Last updated
- 19 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 33651341Huizinga 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.
PubMed 33263165Wiland 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.
PubMed 33119861
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02744755
- Acronym / sponsor ID
- ADMYRA / GP17-302
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Collaborators
- Hexal AG
- Study start
- 31 Mar 2016 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 26 Sep 2017 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Posted 19 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GP2017 | Experimental | Biological: Adalimumab - GP2017Group 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). |
| US Licensed Humira | Active comparator | Biological: Adalimumab - US licensed HumiraGroup 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adalimumab - GP2017Also: GP2017Adalimumab - GP2017 | Biological | GP2017 |
| Adalimumab - US licensed HumiraAlso: Humira - ComparatorAdalimumab - US licensed Humira | Biological | US Licensed Humira |
Primary outcome
Study Period 1: Change in DAS28-CRP Score From Baseline at Week 12 in Patients Treated With GP2017 and Patients Treated With Humira
Time frame: Study period 1: week 12
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
22 secondary outcomes
Study Period 1: Time-weighted Averaged Change From Baseline in DAS28-CRP Until Week 24 in Patients Treated With GP2017 and With Humira
Time frame: Study period 1: week 24
Study Period 1- Proportion of Patients Achieving EULAR Criterion for Remission
Time frame: week 4, week 12 and week 24
Study Period 1- Proportion of Patients Achieving EULAR Criterion for Good Response
Time frame: week 4, week 12 and week 24
Study Period 1- Proportion of Patients Achieving EULAR Criterion for Moderate Response
Time frame: week 4, week 12 and week 24
Study Period 1- Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria
Time frame: 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
Time frame: study period 1: week 2, 4, 24
Study Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24
Time frame: 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;
Time frame: 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;
Time frame: Weeks 4, 12 and 24;
Study Period 1- Proportion of Patients Achieving HAQ-DI© Score Improvement >0.3 at Weeks 4, 12 and 24
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Week 4, week 12, week 24
Study Period 1: Incidence and Severity of Injection Site Reactions in GP2017 and Humira
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: up to 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33651341Blauvelt 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.
- Derived from this study: PubMed 33263165Huizinga 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.
- Derived from this study: PubMed 33119861Wiland 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
83 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adalimumab - GP2017 and Adalimumab - US licensed Humira in people with Rheumatoid Arthritis, run by Sandoz at 83 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 83 sites in United States, Poland, Hungary, Mexico, Czechia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Period 1: Change in DAS28-CRP Score From Baseline at Week 12 in Patients Treated With GP2017 and Patients Treated With Humira (time frame: Study period 1: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02744755, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.