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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

GP2015

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Biosimilars, Rheumatoid Arthritis, Etanercept

Eligibility Criteria

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

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

50mg GP2015

50mg EU-authorized Enbrel

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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 - 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

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

Treatment Period 1 - Changes From Baseline in DAS28-CRP and DAS-ESR Scores to Weeks 4, 12 and 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) ;

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

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;

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.

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.

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.

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.

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)

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)

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.

Treatment Period 1 - CRP Levels at Baseline and Weeks 4, 12 and 24

Treatment Period 1 - ESR Levels at Baseline and 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

Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to 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;

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

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;

Treatment Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Weeks 36 and 48;

Treatment Period 2 : ACR-N Scores at Weeks 36 and 48;

ACR-N: negative is worsening, positive (up to 100) is an improvement

Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI

Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI

Treatment Period 2 :Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 36 and 48;

Treatment Period 2 :HAQ Index at Weeks 36 and 48;

HAQ: from 0 (best) to 3 (worst)

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

Treatment Period 2 : CRP Levels at Week 36 and 48

Treatment Period 2 : ESR Levels at Week 36 and 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

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

Full Information

NCT ID

NCT02638259

First Posted

December 16, 2015

Last Updated

September 18, 2018

Sponsor

Sandoz

1. Study Identification

Unique Protocol Identification Number

NCT02638259

Brief Title

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

Acronym

EQUIRA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

February 21, 2015 (Actual)

Primary Completion Date

December 29, 2016 (Actual)

Study Completion Date

June 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sandoz

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

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

Rheumatoid Arthritis

Keywords

Biosimilars, Rheumatoid Arthritis, Etanercept

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

376 (Actual)

8. Arms, Groups, and Interventions

Arm Title

50mg GP2015

Arm Type

Experimental

Arm Description

Arm Title

50mg EU-authorized Enbrel

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

GP2015

Intervention Description

Enbrel comparator

Primary Outcome Measure Information:

Title

Safety: Change in DAS28-CRP Score From Baseline to Week 24 in Patients Treated With GP2015 and Patients Treated With Enbrel

Description

Time Frame

treatment period 1: up to 24 weeks

Secondary Outcome Measure Information:

Title

Treatment Period 1: Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel

Description

Frequency of participants with injection site reactions in GP2015 and Enbrel

Time Frame

Treatment Period 1, up to 24 weeks

Title

Treatment Period 1 - Safety : Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients

Description

Frequency of patients having anti-drug antibody (ADA) during 24 weeks (Treatment Period 1) using 1% false positive rate

Time Frame

baseline, week 2, week 4, week 12, week 24

Title

Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24;

Description

Time Frame

week 4, 12, 24

Title

Treatment Period 1 - Changes From Baseline in DAS28-CRP and DAS-ESR Scores to Weeks 4, 12 and 24

Time Frame

baseline, Week 4, week 12, week 24

Title

Treatment Period 1- Proportion of Patients Achieving EULAR Response

Description

Time Frame

week 4, week 12 and week 24

Title

Treatment Period 1- Proportion of Patients Achieving DAS28 < 2.6 at Weeks 4, 12 and 24

Description

% patients in DAS28-ESR categories up to week 24

Time Frame

week 4, week 12 and week 24

Title

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

Description

Time Frame

week 4, week 12, week 24

Title

Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24;

Description

Time Frame

Week 4, week 12 and week 24

Title

Treatment Period 1- ACR-N Scores at Weeks 4, 12 and 24;

Description

Time Frame

Weeks 4, 12 and 24;

Title

Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI

Description

Time Frame

Weeks 4, 12 and 24;

Title

Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI

Description

Time Frame

Weeks 4, 12 and 24;

Title

Treatment Period 1- Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 4, 12 and 24;

Description

Health assessment questionnaire (HAQ) disability index ranges from 0 (best) to 3 (worst)

Time Frame

Weeks 4, 12 and 24;

Title

Treatment Period 1 - Health Assessment Questionnaire (HAQ) Index at Baseline, Weeks 4, 12 and 24;

Description

Health assessment questionnaire (HAQ) disability index ranges from 0 (best) to 3 (worst)

Time Frame

Baseline, Weeks 4, 12 and 24;

Title

Treatment Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24;

Description

Time Frame

Baseline, Weeks 4, 12 and 24;

Title

Treatment Period 1 - CRP Levels at Baseline and Weeks 4, 12 and 24

Time Frame

Weeks 4, 12 and 24

Title

Treatment Period 1 - ESR Levels at Baseline and Weeks 4, 12 and 24

Time Frame

Weeks 4, 12 and 24

Title

Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48;

Description

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

Time Frame

Baseline, week 4, week 12, week 24, week 36 and week 48.

Title

Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48

Time Frame

week 4, week 12, week 24, week 36, week 48

Title

Treatment Period 2: Proportion of Patients Achieving EULAR Reponse

Description

Time Frame

week 4, week 12, week 24, week 36 and week 48

Title

Treatment Period 2 : Proportion of Patients Achieving DAS28 < 2.6 at Weeks 36 and 48;

Description

percentage of participants in DAS28-ESR categories up to week 48

Time Frame

week 36 and week 48

Title

Treatment Period 2 : Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria

Description

Time Frame

week 4, week 12, week 24, week 36, week 48

Title

Treatment Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Weeks 36 and 48;

Time Frame

week 36 and week 48

Title

Treatment Period 2 : ACR-N Scores at Weeks 36 and 48;

Description

ACR-N: negative is worsening, positive (up to 100) is an improvement

Time Frame

week 36 and week 48

Title

Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI

Description

Time Frame

baseline, week 4, week 12, week 24, week 36. week 48

Title

Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI

Description

Time Frame

baseline, week 4, week 12, week 24, week 36 and week 48

Title

Treatment Period 2 :Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 36 and 48;

Time Frame

baseline, week 4, week 12, week 24, week 36, week 48

Title

Treatment Period 2 :HAQ Index at Weeks 36 and 48;

Description

HAQ: from 0 (best) to 3 (worst)

Time Frame

baseline, week 4, week 12, week 24, week 36, week 48

Title

Treatment Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 36 and 48;

Description

FACIT: from 0 (worst) to 52 (best), a score of less than 30 indicates severe fatigue

Time Frame

baseline, week 4, week 12, week 24, week 36, week 48

Title

Treatment Period 2 : CRP Levels at Week 36 and 48

Time Frame

baseline, week 4, week 12, week 24, week 36, week 48

Title

Treatment Period 2 : ESR Levels at Week 36 and 48

Time Frame

baseline, week 4, week 12, week 24, week 36, week 48

Title

Safety - Overall Study : Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel

Description

Frequency of participants with injection site reactions in GP2015 and Enbrel

Time Frame

up to 48 weeks

Title

Safety : Overall Study: Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients

Description

Time Frame

baseline, week 4, week 12, week 24, week 36, week 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arnd Schwebig, MD

Organizational Affiliation

Global Program Medical Director

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

Novartis Investigative Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85023

Country

United States

Facility Name

Novartis Investigative Site

City

El Cajon

State/Province

California

ZIP/Postal Code

92020

Country

United States

Facility Name

Novartis Investigative Site

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Novartis Investigative Site

City

Van Nuys

State/Province

California

ZIP/Postal Code

91405

Country

United States

Facility Name

Novartis Investigative Site

City

Trumbull

State/Province

Connecticut

ZIP/Postal Code

06611

Country

United States

Facility Name

Novartis Investigative Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Novartis Investigative Site

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33135

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33169

Country

United States

Facility Name

Novartis Investigative Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32804

Country

United States

Facility Name

Novartis Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33603

Country

United States

Facility Name

Novartis Investigative Site

City

Zephyrhills

State/Province

Florida

ZIP/Postal Code

33542

Country

United States

Facility Name

Novartis Investigative Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40615

Country

United States

Facility Name

Novartis Investigative Site

City

Monroe

State/Province

Louisiana

ZIP/Postal Code

71203

Country

United States

Facility Name

Novartis Investigative Site

City

Frederick

State/Province

Maryland

ZIP/Postal Code

21702

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63128

Country

United States

Facility Name

Novartis Investigative Site

City

Orchard Park

State/Province

New York

ZIP/Postal Code

14127

Country

United States

Facility Name

Novartis Investigative Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210

Country

United States

Facility Name

Novartis Investigative Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Novartis Investigative Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Novartis Investigative Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Novartis Investigative Site

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Facility Name

Novartis Investigative Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Novartis Investigative Site

City

Carrollton

State/Province

Texas

ZIP/Postal Code

75007

Country

United States

Facility Name

Novartis Investigative Site

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

Novartis Investigative Site

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1505

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1784

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Pardubice

State/Province

Czech Republic

ZIP/Postal Code

53002

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 11

State/Province

Czech Republic

ZIP/Postal Code

148 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 2

ZIP/Postal Code

128 50

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 4

ZIP/Postal Code

140 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 4

ZIP/Postal Code

140 59

Country

Czechia

Facility Name

Novartis Investigative Site

City

Zlin

ZIP/Postal Code

760 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

10117

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tartu

ZIP/Postal Code

50107

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tartu

ZIP/Postal Code

EE-50106

Country

Estonia

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12161

Country

Germany

Facility Name

Novartis Investigative Site

City

Magdeburg

ZIP/Postal Code

39112

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

80336

Country

Germany

Facility Name

Novartis Investigative Site

City

Bekescsaba

ZIP/Postal Code

H-5600

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szentes

ZIP/Postal Code

6600

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szolnok

ZIP/Postal Code

H-5000

Country

Hungary

Facility Name

Novartis Investigative Site

City

Firenze

State/Province

ZIP/Postal Code

50139

Country

Italy

Facility Name

Novartis Investigative Site

City

Rozzano

State/Province

ZIP/Postal Code

20089

Country

Italy

Facility Name

Novartis Investigative Site

City

Liepaja

ZIP/Postal Code

LV 3401

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV-1038

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV-1050

Country

Latvia

Facility Name

Novartis Investigative Site

City

Klaipeda

State/Province

Klaipedos Apskritis

ZIP/Postal Code

92288

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

LTU

ZIP/Postal Code

LT-50161

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Panevezys

ZIP/Postal Code

LT-35144

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

LT 08661

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44160

Country

Mexico

Facility Name

Novartis Investigative Site

City

San Luis Potosi

State/Province

San Luis Potosí

ZIP/Postal Code

78240

Country

Mexico

Facility Name

Novartis Investigative Site

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97070

Country

Mexico

Facility Name

Novartis Investigative Site

City

Santiago De Queretaro

ZIP/Postal Code

76178

Country

Mexico

Facility Name

Novartis Investigative Site

City

Lublin

State/Province

Lubelskie

ZIP/Postal Code

20-582

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

State/Province

Wielkopolskie

ZIP/Postal Code

61-397

Country

Poland

Facility Name

Novartis Investigative Site

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

Novartis Investigative Site

City

Nadarzyn

ZIP/Postal Code

05-830

Country

Poland

Facility Name

Novartis Investigative Site

City

Warsaw

ZIP/Postal Code

01518

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02 106

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02 118

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02 691

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

53-224

Country

Poland

Facility Name

Novartis Investigative Site

City

Ekaterinburg

ZIP/Postal Code

620028

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

109240

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Petrozavodsk

ZIP/Postal Code

185019

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saratov

ZIP/Postal Code

410028

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Smolensk

ZIP/Postal Code

214025

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

190068

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Voronezh

ZIP/Postal Code

394036

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

84103

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Poprad

ZIP/Postal Code

058 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Rimavska Sobota

ZIP/Postal Code

979 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Zvolen

ZIP/Postal Code

960 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Malaga

State/Province

Andalucia

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41009

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46017

Country

Spain

Facility Name

Novartis Investigative Site

City

Santiago de Compostela

State/Province

Galicia

ZIP/Postal Code

15706

Country

Spain

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Novartis Investigative Site

City

Leytonstone

State/Province

London

ZIP/Postal Code

E11 1NR

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Leeds

State/Province

West Yorkshire

ZIP/Postal Code

LS7 4SA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Edinburgh

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Via CSR

Citations:

PubMed Identifier

31138316

Citation

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.

Results Reference

derived

PubMed Identifier

30487998

Citation

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.

Results Reference

derived

Learn more about this trial

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

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

Rheumatoid Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial