Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With Rheumatoid Arthritis (EQUIRA)

A Randomized, Double-blind, Parallel-group Phase III Study to Demonstrate Equivalent Efficacy and to Compare Safety & Immunogenicity of GP2015 and Enbrel® (EU Authorized) in Patients With Moderate to Severe, Active Rheumatoid Arthritis

Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic drugs (DMARD) including methotrexate (MTX).

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: GP2015

Detailed Description

Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic drugs (DMARD) including methotrexate (MTX). In addition, data on the safety profiles of both products, including immunogenicity and local tolerability at the injection sites, will be collected and compared.

An additional study objective is to identify any potential risk of the transition from Enbrel to GP2015 in terms of general safety and immunogenicity in RA patients

• Study Type: Interventional
• Enrollment (Actual): 376
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Plovdiv, Bulgaria, 4000
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1431
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1505
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1784
    • Novartis Investigative Site
  • Varna, Bulgaria, 9010
    • Novartis Investigative Site
• Czechia
  • Praha 2, Czechia, 128 50
    • Novartis Investigative Site
  • Praha 4, Czechia, 140 59
    • Novartis Investigative Site
  • Praha 4, Czechia, 140 00
    • Novartis Investigative Site
  • Zlin, Czechia, 760 01
    • Novartis Investigative Site
  • Czech Republic
    • Pardubice, Czech Republic, Czechia, 53002
      • Novartis Investigative Site
    • Praha 11, Czech Republic, Czechia, 148 00
      • Novartis Investigative Site
• Estonia
  • Tallinn, Estonia, 13419
    • Novartis Investigative Site
  • Tallinn, Estonia, 10117
    • Novartis Investigative Site
  • Tartu, Estonia, 50107
    • Novartis Investigative Site
  • Tartu, Estonia, EE-50106
    • Novartis Investigative Site
• Germany
  • Berlin, Germany, 12161
    • Novartis Investigative Site
  • Magdeburg, Germany, 39112
    • Novartis Investigative Site
  • Muenchen, Germany, 80336
    • Novartis Investigative Site
• Hungary
  • Bekescsaba, Hungary, H-5600
    • Novartis Investigative Site
  • Budapest, Hungary, 1036
    • Novartis Investigative Site
  • Szentes, Hungary, 6600
    • Novartis Investigative Site
  • Szolnok, Hungary, H-5000
    • Novartis Investigative Site
• Italy
  • FI
    • Firenze, FI, Italy, 50139
      • Novartis Investigative Site
  • MI
    • Rozzano, MI, Italy, 20089
      • Novartis Investigative Site
• Latvia
  • Liepaja, Latvia, LV 3401
    • Novartis Investigative Site
  • Riga, Latvia, LV-1038
    • Novartis Investigative Site
  • Riga, Latvia, LV-1050
    • Novartis Investigative Site
• Lithuania
  • Panevezys, Lithuania, LT-35144
    • Novartis Investigative Site
  • Vilnius, Lithuania, LT 08661
    • Novartis Investigative Site
  • Klaipedos Apskritis
    • Klaipeda, Klaipedos Apskritis, Lithuania, 92288
      • Novartis Investigative Site
  • LTU
    • Kaunas, LTU, Lithuania, LT-50161
      • Novartis Investigative Site
• Mexico
  • Santiago De Queretaro, Mexico, 76178
    • Novartis Investigative Site
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44160
      • Novartis Investigative Site
  • San Luis Potosí
    • San Luis Potosi, San Luis Potosí, Mexico, 78240
      • Novartis Investigative Site
  • Yucatan
    • Merida, Yucatan, Mexico, 97070
      • Novartis Investigative Site
• Poland
  • Elblag, Poland, 82-300
    • Novartis Investigative Site
  • Nadarzyn, Poland, 05-830
    • Novartis Investigative Site
  • Warsaw, Poland, 01518
    • Novartis Investigative Site
  • Warszawa, Poland, 02 118
    • Novartis Investigative Site
  • Warszawa, Poland, 02 106
    • Novartis Investigative Site
  • Warszawa, Poland, 02 691
    • Novartis Investigative Site
  • Wroclaw, Poland, 53-224
    • Novartis Investigative Site
  • Lubelskie
    • Lublin, Lubelskie, Poland, 20-582
      • Novartis Investigative Site
  • Wielkopolskie
    • Poznan, Wielkopolskie, Poland, 61-397
      • Novartis Investigative Site
• Russian Federation
  • Ekaterinburg, Russian Federation, 620028
    • Novartis Investigative Site
  • Moscow, Russian Federation, 109240
    • Novartis Investigative Site
  • Petrozavodsk, Russian Federation, 185019
    • Novartis Investigative Site
  • Saratov, Russian Federation, 410028
    • Novartis Investigative Site
  • Smolensk, Russian Federation, 214025
    • Novartis Investigative Site
  • St Petersburg, Russian Federation, 190068
    • Novartis Investigative Site
  • Voronezh, Russian Federation, 394036
    • Novartis Investigative Site
  • Yaroslavl, Russian Federation, 150003
    • Novartis Investigative Site
• Serbia
  • Belgrade, Serbia, 11000
    • Novartis Investigative Site
• Slovakia
  • Bratislava, Slovakia, 84103
    • Novartis Investigative Site
  • Poprad, Slovakia, 058 01
    • Novartis Investigative Site
  • Rimavska Sobota, Slovakia, 979 01
    • Novartis Investigative Site
  • Zvolen, Slovakia, 960 01
    • Novartis Investigative Site
• Spain
  • Cordoba, Spain, 14004
    • Novartis Investigative Site
  • Andalucia
    • Malaga, Andalucia, Spain, 29010
      • Novartis Investigative Site
    • Sevilla, Andalucia, Spain, 41009
      • Novartis Investigative Site
  • Comunidad Valenciana
    • Valencia, Comunidad Valenciana, Spain, 46017
      • Novartis Investigative Site
  • Galicia
    • Santiago de Compostela, Galicia, Spain, 15706
      • Novartis Investigative Site
• United Kingdom
  • Edinburgh, United Kingdom, EH4 2XU
    • Novartis Investigative Site
  • London, United Kingdom, NW3 2QG
    • Novartis Investigative Site
  • London
    • Leytonstone, London, United Kingdom, E11 1NR
      • Novartis Investigative Site
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS7 4SA
      • Novartis Investigative Site
• United States
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Novartis Investigative Site
    • Phoenix, Arizona, United States, 85023
      • Novartis Investigative Site
  • California
    • El Cajon, California, United States, 92020
      • Novartis Investigative Site
    • Upland, California, United States, 91786
      • Novartis Investigative Site
    • Van Nuys, California, United States, 91405
      • Novartis Investigative Site
  • Connecticut
    • Trumbull, Connecticut, United States, 06611
      • Novartis Investigative Site
  • Florida
    • Clearwater, Florida, United States, 33765
      • Novartis Investigative Site
    • Gainesville, Florida, United States, 32607
      • Novartis Investigative Site
    • Miami, Florida, United States, 33135
      • Novartis Investigative Site
    • Miami, Florida, United States, 33169
      • Novartis Investigative Site
    • Orlando, Florida, United States, 32804
      • Novartis Investigative Site
    • Tampa, Florida, United States, 33603
      • Novartis Investigative Site
    • Zephyrhills, Florida, United States, 33542
      • Novartis Investigative Site
  • Kentucky
    • Lexington, Kentucky, United States, 40615
      • Novartis Investigative Site
  • Louisiana
    • Monroe, Louisiana, United States, 71203
      • Novartis Investigative Site
  • Maryland
    • Frederick, Maryland, United States, 21702
      • Novartis Investigative Site
  • Missouri
    • Saint Louis, Missouri, United States, 63128
      • Novartis Investigative Site
  • New York
    • Orchard Park, New York, United States, 14127
      • Novartis Investigative Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Novartis Investigative Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Novartis Investigative Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Novartis Investigative Site
    • Oklahoma City, Oklahoma, United States, 73103
      • Novartis Investigative Site
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Novartis Investigative Site
  • Texas
    • Austin, Texas, United States, 78731
      • Novartis Investigative Site
    • Carrollton, Texas, United States, 75007
      • Novartis Investigative Site
  • Washington
    • Spokane, Washington, United States, 99204
      • Novartis Investigative Site

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:

• Patients at least 18 years of age with RA diagnosis according to ACR 1987 or ACR/EULAR 20110 criteria >/= 6 months at the time of baseline visit
• Patient must have active disease defined as DAS28-CRP>/=3.2
• Patients must have CRP level above ULN >5mg/l) or erythrocyte sedimentation rate (ESR) >/=28mm/h
• Patients must have inadequate clinical response to MTX at a dose of 10-25 mg/wk after proper dose escalation according to local standards

Exclusion Criteria:

• Previous exposure to etanercept in the past
• Patients with functional status class IV according to the ACR 1991 revised criteria
• History of active tuberculosis (TB) or Presence of latent (inactive)TB detected by imaging and/or by the QuantiFERON-TB Gold test at screening

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 50mg GP2015; Group 1 will receive treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continue treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2).	Drug: GP2015; Enbrel comparator
Active Comparator: 50mg EU-authorized Enbrel; Group 2 will receive treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response will be switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2).	Drug: GP2015; Enbrel comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Change in DAS28-CRP Score From Baseline to Week 24 in Patients Treated With GP2015 and Patients Treated With Enbrel	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, 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 + 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	treatment period 1: up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Period 1: Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel	Frequency of participants with injection site reactions in GP2015 and Enbrel	Treatment Period 1, up to 24 weeks
Treatment Period 1 - Safety : Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients	Frequency of patients having anti-drug antibody (ADA) during 24 weeks (Treatment Period 1) using 1% false positive rate	baseline, week 2, week 4, week 12, week 24
Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24;	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	week 4, 12, 24
Treatment Period 1 - Changes From Baseline in DAS28-CRP and DAS-ESR Scores to Weeks 4, 12 and 24		baseline, Week 4, week 12, week 24
Treatment Period 1- Proportion of Patients Achieving EULAR Response	Proportion of patients achieving European League against Rheumatism (EULAR) good response (defined as DAS28 ≤ 3.2 and DAS28 improvement from Baseline > 1.2) and moderate response (defined as DAS28 ≤ 3.2 and DAS28 improvement > 0.6 and ≤ 1.2, or DAS28 > 3.2 and ≤ 5.1 and DAS28 improvement > 0.6 or DAS28 > 5.1 but DAS28 improvement > 1.2) ;	week 4, week 12 and week 24
Treatment Period 1- Proportion of Patients Achieving DAS28 < 2.6 at Weeks 4, 12 and 24	% patients in DAS28-ESR categories up to week 24	week 4, week 12 and week 24
Treatment 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 joints/swollen joints ≤ 1 and CRP (mg/dL) ≤ 1 and patient global assessment (1-10) ≤ 1) at Weeks 4, 12 and 24;	week 4, week 12, week 24
Treatment 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: 20% improvement in tender 68 joint-count; 20% improvement in swollen 68 joint-count; And 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 (HAQ 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
Treatment Period 1- ACR-N Scores at Weeks 4, 12 and 24;	ACR-N (American College of Rheumatology percentage of improvement): negative is worsening, positive (up to 100) is an improvement. ACR-N is a single number that characterizes the percentage of improvement from Baseline that a patient has experienced in analogy to ACR20 described above. ACR-N of X (such as 38) means that the patient had achieved an improvement of at least X% (such as 38%) in tender and swollen joints, and an improvement of at least X% (such as 38%) in 3 of the 5 other parameters mentioned above.	Weeks 4, 12 and 24;
Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI	Proportion of patients in each disease activity category as defined by the Simplified Disease Activity Index (SDAI): high disease activity, SDAI > 26, moderate disease activity, SDAI > 11 to ≤ 26, low disease activity, SDAI > 3.3 to ≤ 11, and remission, SDAI ≤ 3.3 at Weeks 4, 12 and 24; SDAI and CDAI are measures of disease activity in RA. The scores were calculated by numerical summation of the number of tender and swollen joints (using the 28-joint count), and the patient's and physician's global assessment of disease activity.	Weeks 4, 12 and 24;
Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI	Proportion of patients in each disease activity category as defined by the Clinical Disease Activity Index (CDAI): high disease activity, CDAI > 22, moderate disease activity, CDAI > 10 to ≤ 22, low disease activity, CDAI > 2.8 to ≤ 10, and remission, CDAI ≤ 2.8 at Weeks 4, 12 and 24; SDAI and CDAI are measures of disease activity in RA. The scores were calculated by numerical summation of the number of tender and swollen joints (using the 28-joint count), and the patient's and physician's global assessment of disease activity.	Weeks 4, 12 and 24;
Treatment Period 1- Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 4, 12 and 24;	Health assessment questionnaire (HAQ) disability index ranges from 0 (best) to 3 (worst)	Weeks 4, 12 and 24;
Treatment Period 1 - Health Assessment Questionnaire (HAQ) Index at Baseline, Weeks 4, 12 and 24;	Health assessment questionnaire (HAQ) disability index ranges from 0 (best) to 3 (worst)	Baseline, Weeks 4, 12 and 24;
Treatment Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24;	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). A score of less than 30 indicates severe fatigue.	Baseline, Weeks 4, 12 and 24;
Treatment Period 1 - CRP Levels at Baseline and Weeks 4, 12 and 24		Weeks 4, 12 and 24
Treatment Period 1 - ESR Levels at Baseline and Weeks 4, 12 and 24		Weeks 4, 12 and 24
Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48;	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	Baseline, week 4, week 12, week 24, week 36 and week 48.
Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48		week 4, week 12, week 24, week 36, week 48
Treatment Period 2: Proportion of Patients Achieving EULAR Reponse	Proportion of patients achieving EULAR good response (defined as DAS28 ≤ 3.2 and DAS28 improvement from Baseline > 1.2) and moderate response (defined as DAS28 ≤ 3.2 and DAS28 improvement > 0.6 and ≤ 1.2, or DAS28 > 3.2 and ≤ 5.1 and DAS28 improvement > 0.6 or DAS28 > 5.1 but DAS28 improvement > 1.2) at Weeks 36 and 48;	week 4, week 12, week 24, week 36 and week 48
Treatment Period 2 : Proportion of Patients Achieving DAS28 < 2.6 at Weeks 36 and 48;	percentage of participants in DAS28-ESR categories up to week 48	week 36 and week 48
Treatment Period 2 : Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria	Proportion of patients achieving EULAR/ACR Boolean remission criteria (defined as number of tender joints/swollen joints ≤ 1 and CRP (mg/dL) ≤ 1 and patient global assessment (1-10) ≤ 1) at Weeks 36 and 48;	week 4, week 12, week 24, week 36, week 48
Treatment Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Weeks 36 and 48;		week 36 and week 48
Treatment Period 2 : ACR-N Scores at Weeks 36 and 48;	ACR-N: negative is worsening, positive (up to 100) is an improvement	week 36 and week 48
Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI	Proportion of patients in each disease activity category as defined by the Simplified Disease Activity Index (SDAI): high disease activity, SDAI > 26, moderate disease activity, SDAI > 11 to ≤ 26, low disease activity, SDAI > 3.3 to ≤ 11, and remission, SDAI ≤ 3.3 at Weeks 36 and 48.	baseline, week 4, week 12, week 24, week 36. week 48
Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI	Proportion of patients in each disease activity category as defined by the Clinical Disease Activity Index (CDAI): high disease activity, CDAI > 22, moderate disease activity, CDAI > 10 to ≤ 22, low disease activity, CDAI > 2.8 to ≤ 10, and remission, CDAI ≤ 2.8 at Weeks 36 and 48;	baseline, week 4, week 12, week 24, week 36 and week 48
Treatment Period 2 :Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 36 and 48;		baseline, week 4, week 12, week 24, week 36, week 48
Treatment Period 2 :HAQ Index at Weeks 36 and 48;	HAQ: from 0 (best) to 3 (worst)	baseline, week 4, week 12, week 24, week 36, week 48
Treatment Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 36 and 48;	FACIT: from 0 (worst) to 52 (best), a score of less than 30 indicates severe fatigue	baseline, week 4, week 12, week 24, week 36, week 48
Treatment Period 2 : CRP Levels at Week 36 and 48		baseline, week 4, week 12, week 24, week 36, week 48
Treatment Period 2 : ESR Levels at Week 36 and 48		baseline, week 4, week 12, week 24, week 36, week 48
Safety - Overall Study : Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel	Frequency of participants with injection site reactions in GP2015 and Enbrel	up to 48 weeks
Safety : Overall Study: Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients	To assess the immunogenicity of continuous GP2015 treatment versus a treatment transition from Enbrel to GP2015 after 24 weeks of treatment by measuring the rate of ADA positive participants at Weeks 24, 30, 36 and 48. summary of ADA positive data up to week 48 using a 1% false positive cut point	baseline, week 4, week 12, week 24, week 36, week 48

Collaborators and Investigators

• Sponsor: Sandoz
• Investigators: Study Director: Arnd Schwebig, MD, Global Program Medical Director

Publications and helpful links

General Publications

• Jaworski J, Matucci-Cerinic M, Schulze-Koops H, Buch MH, Kucharz EJ, Allanore Y, Kavanaugh A, Young P, Babic G. Switch from reference etanercept to SDZ ETN, an etanercept biosimilar, does not impact efficacy, safety, and immunogenicity of etanercept in patients with moderate-to-severe rheumatoid arthritis: 48-week results from the phase III, randomized, double-blind EQUIRA study. Arthritis Res Ther. 2019 May 28;21(1):130. doi: 10.1186/s13075-019-1907-x.
• Matucci-Cerinic M, Allanore Y, Kavanaugh A, Buch MH, Schulze-Koops H, Kucharz EJ, Woehling H, Babic G, Poetzl J, Davis A, Schwebig A. Efficacy, safety and immunogenicity of GP2015, an etanercept biosimilar, compared with the reference etanercept in patients with moderate-to-severe rheumatoid arthritis: 24-week results from the comparative phase III, randomised, double-blind EQUIRA study. RMD Open. 2018 Nov 14;4(2):e000757. doi: 10.1136/rmdopen-2018-000757. eCollection 2018.

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2015
• Primary Completion (Actual): December 29, 2016
• Study Completion (Actual): June 12, 2017

Study Registration Dates

• First Submitted: December 16, 2015
• First Submitted That Met QC Criteria: December 18, 2015
• First Posted (Estimate): December 23, 2015

Study Record Updates

• Last Update Posted (Actual): September 19, 2018
• Last Update Submitted That Met QC Criteria: September 18, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; Etanercept; Biosimilars
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Dermatologic Agents; GP2015
• Other Study ID Numbers: GP15-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Via CSR