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CompletedNCT02638259EQUIRAUpdated Sep 19, 2018Results posted

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

A Phase 3 interventional study of GP2015 in Rheumatoid Arthritis, sponsored by Sandoz. Completed at 92 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-19.

Sponsored by Sandoz · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Feb 2015, registered Dec 2015).
Phase
Phase 3
Study type
Interventional
Enrollment
376
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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).

Read the 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

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • Biosimilars
  • Rheumatoid Arthritis
  • Etanercept
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 376 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Sandoz is the lead sponsor of 136 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
376 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugGP2015

    Enbrel comparator

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: treatment period 1: up to 24 weeks

Secondary outcomes

  1. 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

    Time frame: Treatment Period 1, up to 24 weeks

  2. 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

    Time frame: baseline, week 2, week 4, week 12, week 24

  3. 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: 1. best is 0, 2. \< 2.6 - remission, 3. ≥ 2.6 to ≤ 3.2 - low disease activity 4. \> 3.2 to ≤ 5.1 - moderate disease activity 5. \> 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

    Time frame: week 4, 12, 24

  4. 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

  5. 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) ;

    Time frame: week 4, week 12 and week 24

  6. 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

    Time frame: week 4, week 12 and week 24

  7. 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;

    Time frame: week 4, week 12, week 24

  8. 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.

    Time frame: Week 4, week 12 and week 24

  9. 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.

    Time frame: Weeks 4, 12 and 24;

  10. 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.

    Time frame: Weeks 4, 12 and 24;

  11. 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.

    Time frame: Weeks 4, 12 and 24;

  12. 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)

    Time frame: Weeks 4, 12 and 24;

  13. 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)

    Time frame: Baseline, Weeks 4, 12 and 24;

  14. 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.

    Time frame: Baseline, Weeks 4, 12 and 24;

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

    Time frame: Weeks 4, 12 and 24

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

    Time frame: Weeks 4, 12 and 24

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

    DAS28-CRP and DAS28-ESR: 1. best is 0, 2. \< 2.6 - remission, 3. ≥ 2.6 to ≤ 3.2 - low disease activity 4. \> 3.2 to ≤ 5.1 - moderate disease activity 5. \> 5.1 - high disease activity

    Time frame: Baseline, week 4, week 12, week 24, week 36 and week 48.

  18. 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

  19. 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;

    Time frame: week 4, week 12, week 24, week 36 and week 48

  20. 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

    Time frame: week 36 and week 48

  21. 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;

    Time frame: week 4, week 12, week 24, week 36, week 48

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

    Time frame: week 36 and week 48

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

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

    Time frame: week 36 and week 48

  24. 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.

    Time frame: baseline, week 4, week 12, week 24, week 36. week 48

  25. 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;

    Time frame: baseline, week 4, week 12, week 24, week 36 and week 48

  26. 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

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

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

    Time frame: baseline, week 4, week 12, week 24, week 36, week 48

  28. 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

    Time frame: baseline, week 4, week 12, week 24, week 36, week 48

  29. Treatment Period 2 : CRP Levels at Week 36 and 48

    Time frame: baseline, week 4, week 12, week 24, week 36, week 48

  30. Treatment Period 2 : ESR Levels at Week 36 and 48

    Time frame: baseline, week 4, week 12, week 24, week 36, week 48

  31. 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

    Time frame: up to 48 weeks

  32. 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

    Time frame: baseline, week 4, week 12, week 24, week 36, week 48

07

Results

Posted Feb 23, 2018

Participant flow

Treatment Period 1
Participant flow — Treatment Period 1
Milestone50mg GP201550mg EU-authorized Enbrel
Started186190
Completed181172
Not completed518
Withdrew: Adverse event15
Withdrew: Death01
Withdrew: Lack of efficacy01
Withdrew: Protocol violation03
Withdrew: Withdrawal by subject46
Withdrew: Withdrawn per sponsor decision02
Treatment Period 2
Participant flow — Treatment Period 2
Milestone50mg GP201550mg EU-authorized Enbrel
Started175166
Completed169155
Not completed611
Withdrew: Adverse event54
Withdrew: Withdrawal by subject17

Outcome measures

PrimarySafety: 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

Time frame:
treatment period 1: up to 24 weeks
Reported as:
Least squares mean · scores on a scale
Safety: Change in DAS28-CRP Score From Baseline to Week 24 in Patients Treated With GP2015 and Patients Treated With Enbrel
scores on a scale50mg GP201550mg EU-authorized Enbrel
Safety: Change in DAS28-CRP Score From Baseline to Week 24 in Patients Treated With GP2015 and Patients Treated With Enbrel-2.80 ± 0.113-2.73 ± 0.117
Statistical analysis
  • 50mg GP2015 vs 50mg EU-authorized Enbrel · Mean difference (final values): -0.07 · 95% CI -0.26 to 0.12
SecondaryTreatment Period 1: Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel

Frequency of participants with injection site reactions in GP2015 and Enbrel

Time frame:
Treatment Period 1, up to 24 weeks
Reported as:
Count of participants · Participants
Treatment Period 1: Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel
Participants50mg GP201550mg EU-authorized Enbrel
All injection site reactions1335
Moderate injection site reactions15
Severe injection site reactions00
SecondaryTreatment 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

Time frame:
baseline, week 2, week 4, week 12, week 24
Reported as:
Count of participants · Participants
Treatment Period 1 - Safety : Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients
Participants50mg GP201550mg EU-authorized Enbrel
Baseline20
Week 225
Week 4342
Week 1205
Week 2400
SecondaryTreatment 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: 1. best is 0, 2. \< 2.6 - remission, 3. ≥ 2.6 to ≤ 3.2 - low disease activity 4. \> 3.2 to ≤ 5.1 - moderate disease activity 5. \> 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

Time frame:
week 4, 12, 24
Reported as:
Mean · score on a scale
Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24;
score on a scale50mg GP201550mg EU-authorized Enbrel
DAS28-CRP baseline5.42 ± 0.9215.53 ± 0.783
DAS28-CRP week 43.81 ± 1.0793.82 ± 1.077
DAS28-CRP week 123.15 ± 1.0453.31 ± 1.088
DAS28-CRP week 242.63 ± 0.9102.75 ± 0.928
DAS28-ESR baseline6.34 ± 0.8826.41 ± 0.768
DAS28-ESR week 44.62 ± 1.1834.56 ± 1.204
DAS28-ESR week 123.84 ± 1.2163.94 ± 1.284
DAS28-ESR week 243.24 ± 1.0603.32 ± 1.099
SecondaryTreatment 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
Reported as:
Mean · score on a scale
Treatment Period 1 - Changes From Baseline in DAS28-CRP and DAS-ESR Scores to Weeks 4, 12 and 24
score on a scale50mg GP201550mg EU-authorized Enbrel
DAS28-CRP change from baseline week 4-1.59 ± 1.032-1.70 ± 1.001
DAS28-CRP change from baseline week 12-2.23 ± 1.030-2.20 ± 1.071
DAS28-CRP change from baseline week 24-2.78 ± 1.058-2.78 ± 1.028
DAS28-ESR change from baseline week 4-1.72 ± 1.068-1.85 ± 1.078
DAS28-ESR change from baseline week 12-2.50 ± 1.145-2.47 ± 1.218
DAS28-ESR change from baseline week 24-3.10 ± 1.157-3.09 ± 1.119
SecondaryTreatment 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) ;

Time frame:
week 4, week 12 and week 24
Reported as:
Count of participants · Participants
Treatment Period 1- Proportion of Patients Achieving EULAR Response
Participants50mg GP201550mg EU-authorized Enbrel
Good response week 42621
Good response week 125447
Good response week 248874
Moderate response week 49599
Moderate response week 1210391
Moderate response week 247677
no response week 44634
no response week 121116
no response week 2444
SecondaryTreatment Period 1- Proportion of Patients Achieving DAS28 < 2.6 at Weeks 4, 12 and 24

% patients in DAS28-ESR categories up to week 24

Time frame:
week 4, week 12 and week 24
Reported as:
Count of participants · Participants
Treatment Period 1- Proportion of Patients Achieving DAS28 < 2.6 at Weeks 4, 12 and 24
Participants50mg GP201550mg EU-authorized Enbrel
Week 4 - remission (DAS28 <2.6)97
Week 12 - remission (DAS28 <2.6)2121
Week 24 - remission (DAS28 <2.6)4641
SecondaryTreatment 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;

Time frame:
week 4, week 12, week 24
Reported as:
Count of participants · Participants
Treatment Period 1- Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria
Participants50mg GP201550mg EU-authorized Enbrel
week 412
week 1298
week 242415
SecondaryTreatment 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.

Time frame:
Week 4, week 12 and week 24
Reported as:
Count of participants · Participants
Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24;
Participants50mg GP201550mg EU-authorized Enbrel
ACR20 response Week 48083
ACR20 response Week 12131116
ACR20 response Week 24147144
ACR50 response Week 42528
ACR50 response Week 125568
ACR50 response Week 24107110
ACR70 response Week 487
ACR70 response Week 122126
ACR70 response Week 245666
SecondaryTreatment 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.

Time frame:
Weeks 4, 12 and 24;
Reported as:
Mean · score on a scale
Treatment Period 1- ACR-N Scores at Weeks 4, 12 and 24;
score on a scale50mg GP201550mg EU-authorized Enbrel
week 419.9 ± 29.8922.6 ± 34.02
week 1238.3 ± 27.4638.7 ± 35.32
week 2455.4 ± 27.6159.4 ± 25.40
SecondaryTreatment 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.

Time frame:
Weeks 4, 12 and 24;
Reported as:
Count of participants · Participants
Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI
Participants50mg GP201550mg EU-authorized Enbrel
Baseline : Remission (SDAI<=3.3)00
Baseline: Low (3.3 < SDAI <= 11)00
Baseline : Moderate (11 < SDAI <= 262619
Baseline : High (SDAI > 26)142136
Week 4:Remission (SDAI<=3.3)54
Week 4:Low (3.3 < SDAI <= 11)3531
Week 4: Moderate (11 < SDAI <= 268482
Week 4:High (SDAI > 26)4136
Week 12:Remission (SDAI<=3.3)1513
Week 12:Low (3.3 < SDAI <= 11)6158
Week 12: Moderate (11 < SDAI <= 267568
Week 12:High (SDAI > 26)1411
Week 24: Remission (SDAI<=3.3)3831
Week 24: Low (3.3 < SDAI <= 11)8381
Week 24 : Moderate (11 < SDAI <= 264538
Week 24 :High (SDAI > 26)25
SecondaryTreatment 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.

Time frame:
Weeks 4, 12 and 24;
Reported as:
Count of participants · Participants
Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI
Participants50mg GP201550mg EU-authorized Enbrel
Baseline : Remission (CDAI<=2.8)00
Baseline: Low (2.8 < CDAI <= 10)00
Baseline : Moderate (10 < CDAI <= 22177
Baseline : High (CDAI > 22)151148
Week 4:Remission(CDAI<=2.8)43
Week 4: Low (2.8 < CDAI <= 10)3331
Week 4: Moderate (10 < CDAI <= 22)6771
Week 4:High High (CDAI > 22)6349
Week 12:Remission(CDAI<=2.8)1415
Week 12: Low (2.8 < CDAI <= 10)6353
Week 12: Moderate (10 < CDAI <= 22)7263
Week 12:High (CDAI > 22)1923
Week 24: Remission (CDAI<=2.8)3531
Week 24: Low (2.8 < CDAI <= 10)8178
Week 24 : (10 < CDAI <= 22)4639
Week 24 :High (CDAI > 22)67
SecondaryTreatment 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)

Time frame:
Weeks 4, 12 and 24;
Reported as:
Count of participants · Participants
Treatment Period 1- Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 4, 12 and 24;
Participants50mg GP201550mg EU-authorized Enbrel
Baseline115
Week 42230
Week 124046
Week 245462
SecondaryTreatment 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)

Time frame:
Baseline, Weeks 4, 12 and 24;
Reported as:
Mean · score on a scale
Treatment Period 1 - Health Assessment Questionnaire (HAQ) Index at Baseline, Weeks 4, 12 and 24;
score on a scale50mg GP201550mg EU-authorized Enbrel
Baseline1.44 ± 0.5471.47 ± 0.561
Week 41.19 ± 0.5581.14 ± 0.611
Week 121.02 ± 0.5600.97 ± 0.599
Week 240.88 ± 0.6010.80 ± 0.589
SecondaryTreatment 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.

Time frame:
Baseline, Weeks 4, 12 and 24;
Reported as:
Mean · score on a scale
Treatment Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24;
score on a scale50mg GP201550mg EU-authorized Enbrel
Baseline27.0 ± 9.6725.1 ± 10.33
Week 431.6 ± 8.8330.9 ± 10.01
Week 1234.4 ± 8.9333.9 ± 9.6
Week 2436.3 ± 8.9436.7 ± 9.24
SecondaryTreatment Period 1 - CRP Levels at Baseline and Weeks 4, 12 and 24
Time frame:
Weeks 4, 12 and 24
Reported as:
Mean · mg/dL
Treatment Period 1 - CRP Levels at Baseline and Weeks 4, 12 and 24
mg/dL50mg GP201550mg EU-authorized Enbrel
Baseline1.19 ± 2.1941.10 ± 1.526
Week 40.36 ± 0.7180.43 ± 0.693
Week 120.33 ± 0.7720.48 ± 0.850
Week 240.44 ± 0.9490.35 ± 0.466
SecondaryTreatment Period 1 - ESR Levels at Baseline and Weeks 4, 12 and 24
Time frame:
Weeks 4, 12 and 24
Reported as:
Mean · mm/h
Treatment Period 1 - ESR Levels at Baseline and Weeks 4, 12 and 24
mm/h50mg GP201550mg EU-authorized Enbrel
Baseline41.4 ± 16.8941.8 ± 17.94
Week 426.5 ± 16.5126.7 ± 17.27
Week 1223.2 ± 14.6723.8 ± 15.41
Week 2421.4 ± 15.4720.8 ± 14.05
SecondaryTreatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48;

DAS28-CRP and DAS28-ESR: 1. best is 0, 2. \< 2.6 - remission, 3. ≥ 2.6 to ≤ 3.2 - low disease activity 4. \> 3.2 to ≤ 5.1 - moderate disease activity 5. \> 5.1 - high disease activity

Time frame:
Baseline, week 4, week 12, week 24, week 36 and week 48.
Reported as:
Mean · score on a scale
Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48;
score on a scale50mg GP201550mg EU-authorized Enbrel
DAS28-CRP Baseline5.45 ± 0.9145.57 ± 0.794
DAS28-CRP Week 43.89 ± 1.0533.79 ± 1.101
DAS28-CRP Week 123.20 ± 1.0383.27 ± 1.127
DAS28-CRP Week 242.64 ± 0.8632.67 ± 0.892
DAS28-CRP Week 362.65 ± 1.0012.74 ± 1.017
DAS28-CRP Week 482.57 ± 1.0672.74 ± 1.062
DAS28-ESR Baseline6.39 ± 0.8726.43 ± 0.784
DAS28-ESR Week 44.70 ± 1.1754.49 ± 1.228
DAS28-ESR Week 123.90 ± 1.2363.85 ± 1.317
DAS28-ESR Week 243.23 ± 1.0223.19 ± 1.048
DAS28-ESR Week 363.25 ± 1.1603.28 ± 1.127
DAS28-ESR Week 483.20 ± 1.2013.30 ± 1.177
SecondaryTreatment 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
Reported as:
Mean · score on a scale
Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48
score on a scale50mg GP201550mg EU-authorized Enbrel
DAS28-CRP change from baseline, week 4-1.55 ± 1.014-1.76 ± 1.014
DAS28-CRP change from baseline, week 12-2.22 ± 1.031-2.27 ± 1.096
DAS28-CRP change from baseline, week 24-2.81 ± 1.007-2.90 ± 0.988
DAS28-CRP change from baseline, week 36-2.80 ± 1.087-2.82 ± 1.151
DAS28-CRP change from baseline, week 48-2.88 ± 1.198-2.83 ± 1.176
DAS28-ESR change from baseline, week 4-1.69 ± 1.048-1.92 ± 1.087
DAS28-ESR change from baseline, week 12-2.49 ± 1.152-2.57 ± 1.235
DAS28-ESR change from baseline, week 24-3.16 ± 1.106-3.23 ± 1.054
DAS28-ESR change from baseline, week 36-3.13 ± 1.232-3.14 ± 1.154
DAS28-ESR change from baseline, week 48-3.20 ± 1.297-3.14 ± 1.190
SecondaryTreatment 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;

Time frame:
week 4, week 12, week 24, week 36 and week 48
Reported as:
Count of participants · Participants
Treatment Period 2: Proportion of Patients Achieving EULAR Reponse
Participants50mg GP201550mg EU-authorized Enbrel
Good response week 42020
Good response week 124343
Good response week 247768
Good response week 368265
Good response week 488067
Moderate response week 48582
Moderate response week 129575
Moderate response week 247163
Moderate response week 366264
Moderate response week 486157
no response week 44228
no response week 121012
no response week 2400
no response week 3632
no response week 4865
SecondaryTreatment 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

Time frame:
week 36 and week 48
Reported as:
Count of participants · Participants
Treatment Period 2 : Proportion of Patients Achieving DAS28 < 2.6 at Weeks 36 and 48;
Participants50mg GP201550mg EU-authorized Enbrel
Week 36 Remission (DAS28 < 2.6)4538
Week 48 Remission (DAS28 < 2.6)4435
SecondaryTreatment 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;

Time frame:
week 4, week 12, week 24, week 36, week 48
Reported as:
Count of participants · Participants
Treatment Period 2 : Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria
Participants50mg GP201550mg EU-authorized Enbrel
Week 402
Week 1298
Week 242213
Week 362515
Week 482820
SecondaryTreatment Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Weeks 36 and 48;
Time frame:
week 36 and week 48
Reported as:
Count of participants · Participants
Treatment Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Weeks 36 and 48;
Participants50mg GP201550mg EU-authorized Enbrel
ACR20 response Week 36128114
ACR20 response Week 48131108
ACR50 response Week 369083
ACR50 response Week 489386
ACR70 response Week 364750
ACR70 response Week 485455
SecondaryTreatment Period 2 : ACR-N Scores at Weeks 36 and 48;

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

Time frame:
week 36 and week 48
Reported as:
Mean · score on a scale
Treatment Period 2 : ACR-N Scores at Weeks 36 and 48;
score on a scale50mg GP201550mg EU-authorized Enbrel
Week 419.7 ± 27.7224.9 ± 29.40
Week 1238.3 ± 27.8440.7 ± 34.80
Week 2456.3 ± 26.5860.9 ± 24.79
Week 3653.8 ± 28.2155.7 ± 28.37
Week 4856.9 ± 29.1856.4 ± 30.58
SecondaryTreatment 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.

Time frame:
baseline, week 4, week 12, week 24, week 36. week 48
Reported as:
Count of participants · Participants
Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI
Participants50mg GP201550mg EU-authorized Enbrel
Baseline : Remission (SDAI <= 3.3)00
Baseline : Low (3.3 < SDAI <= 11)00
Baseline : Moderate (11 < SDAI <= 26)2016
Baseline : High (SDAI > 26 )128115
Week 4 : Remission (SDAI <= 3.3)24
Week 4 : Low (3.3 < SDAI <= 11)2927
Week 4 : Moderate (11 < SDAI <= 267569
Week 4 : High (SDAI > 26 )3929
Week 12: Remission (SDAI <= 3.3)1412
Week 12 : Low (3.3 < SDAI <= 11)5051
Week 12 : Moderate (11 < SDAI <= 266953
Week 12 : High (SDAI > 26 )1311
Week 24: Remission (SDAI <= 3.3)3129
Week 24 : Low (3.3 < SDAI <= 11)7471
Week 24 : Moderate (11 < SDAI <= 264329
Week 24 : High (SDAI > 26 )02
Week 36: Remission (SDAI <= 3.3)3429
Week 36 : Low (3.3 < SDAI <= 116966
Week 36 : Moderate (11 < SDAI <= 264330
Week 36 : High (SDAI > 26 )15
Week 48: Remission (SDAI <= 3.3)3932
Week 48 : Low (3.3 < SDAI <= 117262
Week 48 : Moderate (11 < SDAI <= 263029
Week 48 : High (SDAI > 26 )68
SecondaryTreatment 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;

Time frame:
baseline, week 4, week 12, week 24, week 36 and week 48
Reported as:
Count of participants · Participants
Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI
Participants50mg GP201550mg EU-authorized Enbrel
Baseline : Remission (CDAI <=2.8)00
Baseline : Low (2.8 < CDAI <= 10)00
Baseline : Moderate (10 < CDAI <= 22)146
Baseline : High (CDAI > 22 )134125
Week 4 : Remission (CDAI <=2.8)23
Week 4 : Low (2.8 < CDAI <= 10)2728
Week 4 : Moderate (11 < SDAI <= 266060
Week 4 : High (CDAI > 22 )5839
Week 12: Remission (CDAI <=2.8)1214
Week 12 : Low (2.8 < CDAI <= 10)5247
Week 12 : Moderate (10 < CDAI <= 22)6750
Week 12 : High (CDAI > 22 )1719
Week 24: Remission (CDAI <=2.8)2929
Week 24 : Low (2.8 < CDAI <= 10)7168
Week 24 : Moderate (10 < CDAI <= 22)4530
Week 24 : High (CDAI > 22 )34
Week 36: Remission (CDAI <=2.8)3229
Week 36 : Low (2.8 < CDAI <= 10)6763
Week 36 : Moderate (10 < CDAI <= 22)4132
Week 36 : High (CDAI > 22 )77
Week 48: Remission (CDAI <=2.8)3729
Week 48 : Low (2.8 < CDAI <= 10)7163
Week 48 : Moderate (10 < CDAI <= 22)3231
Week 48 : High (CDAI > 22 )78
SecondaryTreatment 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
Reported as:
Count of participants · Participants
Treatment Period 2 :Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 36 and 48;
Participants50mg GP201550mg EU-authorized Enbrel
Baseline84
Week 41725
Week 123339
Week 244751
Week 364648
Week 485151
SecondaryTreatment Period 2 :HAQ Index at Weeks 36 and 48;

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

Time frame:
baseline, week 4, week 12, week 24, week 36, week 48
Reported as:
Mean · score on a scale
Treatment Period 2 :HAQ Index at Weeks 36 and 48;
score on a scale50mg GP201550mg EU-authorized Enbrel
Baseline1.47 ± 0.5471.50 ± 0.554
Week 41.22 ± 0.5541.14 ± 0.620
Week 121.04 ± 0.5600.97 ± 0.614
Week 240.88 ± 0.5940.83 ± 0.603
Week 360.89 ± 0.5840.85 ± 0.651
Week 480.85 ± 0.6090.84 ± 0.652
SecondaryTreatment 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

Time frame:
baseline, week 4, week 12, week 24, week 36, week 48
Reported as:
Mean · score on a scale
Treatment Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 36 and 48;
score on a scale50mg GP201550mg EU-authorized Enbrel
Baseline26.6 ± 9.7125.5 ± 10.78
Week 431.5 ± 8.7231.3 ± 10.07
Week 1234.4 ± 8.8934.1 ± 9.69
Week 2436.6 ± 8.7536.7 ± 9.05
Week 3636.9 ± 8.7936.4 ± 9.50
Week 4838.0 ± 8.7435.8 ± 9.97
SecondaryTreatment Period 2 : CRP Levels at Week 36 and 48
Time frame:
baseline, week 4, week 12, week 24, week 36, week 48
Reported as:
Mean · mg/dL
Treatment Period 2 : CRP Levels at Week 36 and 48
mg/dL50mg GP201550mg EU-authorized Enbrel
Baseline1.21 ± 2.2441.17 ± 1.589
Week 40.36 ± 0.7330.42 ± 0.625
Week 120.36 ± 0.8170.50 ± 0.910
Week 240.44 ± 0.9640.36 ± 0.487
Week 360.39 ± 0.7580.39 ± 0.655
Week 480.35 ± 0.6230.40 ± 0.878
SecondaryTreatment Period 2 : ESR Levels at Week 36 and 48
Time frame:
baseline, week 4, week 12, week 24, week 36, week 48
Reported as:
Mean · mm/h
Treatment Period 2 : ESR Levels at Week 36 and 48
mm/h50mg GP201550mg EU-authorized Enbrel
Baseline42.2 ± 16.9941.7 ± 17.99
Week 426.8 ± 16.3325.3 ± 16.11
Week 1223.8 ± 15.0723.0 ± 15.38
Week 2421.3 ± 15.6619.3 ± 12.66
Week 3622.1 ± 16.4120.3 ± 14.28
Week 4822.8 ± 16.6620.8 ± 14.62
SecondarySafety - Overall Study : Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel

Frequency of participants with injection site reactions in GP2015 and Enbrel

Time frame:
up to 48 weeks
Reported as:
Count of participants · Participants
Safety - Overall Study : Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel
Participants50mg GP201550mg EU-authorized Enbrel
participants with at least one ISR1337
participants with at least one moderate ISR17
participants with at least one severe ISR00
SecondarySafety : 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

Time frame:
baseline, week 4, week 12, week 24, week 36, week 48
Reported as:
Count of participants · Participants
Safety : Overall Study: Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients
Participants50mg GP201550mg EU-authorized Enbrel
Baseline20
Week 225
Week 4342
Week 1205
Week 2400
Week 3020
Week 3600
Week 4820

Adverse events

Collected over Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 1.5 years.. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment Period 1 TP1 SAF GP20150/186 (0%)1/186 (0.5%)52/186 (28%)
Treatment Period 1 TP1 SAF Enbrel1/190 (0.5%)5/190 (2.6%)64/190 (33.7%)
Treatment Period 2 TP2 SAF Continued GP20150/175 (0%)4/175 (2.3%)42/175 (24%)
Treatment Period 2 TP2 SAF Enbrel Switched to GP20150/166 (0%)4/166 (2.4%)37/166 (22.3%)
Entire Study SAF GP20150/186 (0%)5/186 (2.7%)79/186 (42.5%)
Entire Study SAF Enbrel/GP20151/190 (0.5%)9/190 (4.7%)81/190 (42.6%)
Most frequent serious events
Showing 10 of 15
Most frequent serious events
EventTreatment Period 1 TP1 SAF GP2015Treatment Period 1 TP1 SAF EnbrelTreatment Period 2 TP2 SAF Continued GP2015Treatment Period 2 TP2 SAF Enbrel Switched to GP2015Entire Study SAF GP2015Entire Study SAF Enbrel/GP2015
Cardiac failureCardiac disorders0/1860/1900/1751/1660/1861/190
Cholecystitis acuteHepatobiliary disorders0/1860/1900/1751/1660/1861/190
OsteomyelitisInfections and infestations0/1860/1900/1751/1660/1861/190
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1860/1900/1751/1660/1861/190
Colon adenomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1860/1900/1751/1660/1861/190
Salivary gland cystGastrointestinal disorders0/1860/1901/1750/1661/1860/190
PneumoniaInfections and infestations0/1860/1901/1750/1661/1860/190
Tibia fractureInjury, poisoning and procedural complications0/1860/1901/1750/1661/1860/190
Cystitis haemorrhagicRenal and urinary disorders0/1860/1901/1750/1661/1860/190
Spinal fractureInjury, poisoning and procedural complications1/1860/1900/1750/1661/1860/190
Most frequent other events
Showing 10 of 15
Most frequent other events
EventTreatment Period 1 TP1 SAF GP2015Treatment Period 1 TP1 SAF EnbrelTreatment Period 2 TP2 SAF Continued GP2015Treatment Period 2 TP2 SAF Enbrel Switched to GP2015Entire Study SAF GP2015Entire Study SAF Enbrel/GP2015
Injection site reactionGeneral disorders13/18635/1900/1756/16613/18637/190
NasopharyngitisInfections and infestations9/1864/19013/1759/16618/18612/190
Upper respiratory tract infectionInfections and infestations6/1867/1909/1759/16613/18615/190
Urinary tract infectionInfections and infestations8/1868/1907/1752/16613/1868/190
Alanine aminotransferase increasedInvestigations8/1864/1904/1756/16612/1868/190
Back painMusculoskeletal and connective tissue disorders5/1861/1903/1750/1668/1861/190
DiarrhoeaGastrointestinal disorders3/1864/1901/1752/1664/1866/190
BronchitisInfections and infestations2/1864/1902/1752/1664/1866/190
CystitisInfections and infestations2/1864/1902/1751/1664/1865/190
HeadacheNervous system disorders1/1861/1900/1754/1661/1865/190

Baseline characteristics

Baseline characteristics are presented for Full Analysis Set (FAS). The FAS is comprised of all randomized patients to whom study treatment has been assigned.

Age, Continuous
Age, Continuous(years)50mg GP201550mg EU-authorized EnbrelTotal
Mean55.2 ± 11.2253.1 ± 12.7054.1 ± 12.02
Sex: Female, Male
Sex: Female, Male(Participants)50mg GP201550mg EU-authorized EnbrelTotal
Female158150308
Male284068
Race (NIH/OMB)
Race (NIH/OMB)(Participants)50mg GP201550mg EU-authorized EnbrelTotal
American Indian or Alaska Native112
Asian033
Native Hawaiian or Other Pacific Islander000
Black or African American516
White180185365
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)50mg GP201550mg EU-authorized EnbrelTotal
Hungary71219
United States232649
Czechia161531
United Kingdom347
Spain5510
Russia121022
Latvia628
Poland444892
Italy101
Mexico459
Slovakia358
Bulgaria111122
Lithuania91221
Serbia121022
Germany459
Estonia262046
08

Study locations

92 sites
  • Novartis Investigative Site
    Peoria, Arizona 85381, United States
  • Novartis Investigative Site
    Phoenix, Arizona 85023, United States
  • Novartis Investigative Site
    El Cajon, California 92020, United States
  • Novartis Investigative Site
    Upland, California 91786, United States
  • Novartis Investigative Site
    Van Nuys, California 91405, United States
  • Novartis Investigative Site
    Trumbull, Connecticut 06611, United States
  • Novartis Investigative Site
    Clearwater, Florida 33765, United States
  • Novartis Investigative Site
    Gainesville, Florida 32607, United States
  • Novartis Investigative Site
    Miami, Florida 33135, United States
  • Novartis Investigative Site
    Miami, Florida 33169, United States
  • Novartis Investigative Site
    Orlando, Florida 32804, United States
  • Novartis Investigative Site
    Tampa, Florida 33603, United States
  • Novartis Investigative Site
    Zephyrhills, Florida 33542, United States
  • Novartis Investigative Site
    Lexington, Kentucky 40615, United States
  • Novartis Investigative Site
    Monroe, Louisiana 71203, United States
  • Novartis Investigative Site
    Frederick, Maryland 21702, United States
  • Novartis Investigative Site
    Saint Louis, Missouri 63128, United States
  • Novartis Investigative Site
    Orchard Park, New York 14127, United States
  • Novartis Investigative Site
    Charlotte, North Carolina 28210, United States
  • Novartis Investigative Site
    Cincinnati, Ohio 45219, United States
  • Novartis Investigative Site
    Oklahoma City, Oklahoma 73103, United States
  • Novartis Investigative Site
    Oklahoma City, Oklahoma 73112, United States
  • Novartis Investigative Site
    Rapid City, South Dakota 57701, United States
  • Novartis Investigative Site
    Austin, Texas 78731, United States
  • Novartis Investigative Site
    Carrollton, Texas 75007, United States
  • Novartis Investigative Site
    Spokane, Washington 99204, United States
  • Novartis Investigative Site
    Plovdiv, 4000, Bulgaria
  • Novartis Investigative Site
    Sofia, 1431, Bulgaria
  • Novartis Investigative Site
    Sofia, 1505, Bulgaria
  • Novartis Investigative Site
    Sofia, 1784, Bulgaria
  • Novartis Investigative Site
    Varna, 9010, Bulgaria
  • Novartis Investigative Site
    Pardubice, Czech Republic 53002, Czechia
  • Novartis Investigative Site
    Praha 11, Czech Republic 148 00, Czechia
  • Novartis Investigative Site
    Praha 2, 128 50, Czechia
  • Novartis Investigative Site
    Praha 4, 140 00, Czechia
  • Novartis Investigative Site
    Praha 4, 140 59, Czechia
  • Novartis Investigative Site
    Zlin, 760 01, Czechia
  • Novartis Investigative Site
    Tallinn, 10117, Estonia
  • Novartis Investigative Site
    Tallinn, 13419, Estonia
  • Novartis Investigative Site
    Tartu, 50107, Estonia
  • Novartis Investigative Site
    Tartu, EE-50106, Estonia
  • Novartis Investigative Site
    Berlin, 12161, Germany
  • Novartis Investigative Site
    Magdeburg, 39112, Germany
  • Novartis Investigative Site
    Muenchen, 80336, Germany
  • Novartis Investigative Site
    Bekescsaba, H-5600, Hungary
  • Novartis Investigative Site
    Budapest, 1036, Hungary
  • Novartis Investigative Site
    Szentes, 6600, Hungary
  • Novartis Investigative Site
    Szolnok, H-5000, Hungary
  • Novartis Investigative Site
    Firenze, FI 50139, Italy
  • Novartis Investigative Site
    Rozzano, MI 20089, Italy
  • Novartis Investigative Site
    Liepaja, LV 3401, Latvia
  • Novartis Investigative Site
    Riga, LV-1038, Latvia
  • Novartis Investigative Site
    Riga, LV-1050, Latvia
  • Novartis Investigative Site
    Klaipeda, Klaipedos Apskritis 92288, Lithuania
  • Novartis Investigative Site
    Kaunas, LTU LT-50161, Lithuania
  • Novartis Investigative Site
    Panevezys, LT-35144, Lithuania
  • Novartis Investigative Site
    Vilnius, LT 08661, Lithuania
  • Novartis Investigative Site
    Guadalajara, Jalisco 44160, Mexico
  • Novartis Investigative Site
    San Luis Potosi, San Luis Potosí 78240, Mexico
  • Novartis Investigative Site
    Merida, Yucatan 97070, Mexico
  • Novartis Investigative Site
    Santiago De Queretaro, 76178, Mexico
  • Novartis Investigative Site
    Lublin, Lubelskie 20-582, Poland
  • Novartis Investigative Site
    Poznan, Wielkopolskie 61-397, Poland
  • Novartis Investigative Site
    Elblag, 82-300, Poland
  • Novartis Investigative Site
    Nadarzyn, 05-830, Poland
  • Novartis Investigative Site
    Warsaw, 01518, Poland
  • Novartis Investigative Site
    Warszawa, 02 106, Poland
  • Novartis Investigative Site
    Warszawa, 02 118, Poland
  • Novartis Investigative Site
    Warszawa, 02 691, Poland
  • Novartis Investigative Site
    Wroclaw, 53-224, Poland
  • Novartis Investigative Site
    Ekaterinburg, 620028, Russian Federation
  • Novartis Investigative Site
    Moscow, 109240, Russian Federation
  • Novartis Investigative Site
    Petrozavodsk, 185019, Russian Federation
  • Novartis Investigative Site
    Saratov, 410028, Russian Federation
  • Novartis Investigative Site
    Smolensk, 214025, Russian Federation
  • Novartis Investigative Site
    St Petersburg, 190068, Russian Federation
  • Novartis Investigative Site
    Voronezh, 394036, Russian Federation
  • Novartis Investigative Site
    Yaroslavl, 150003, Russian Federation
  • Novartis Investigative Site
    Belgrade, 11000, Serbia
  • Novartis Investigative Site
    Bratislava, 84103, Slovakia
  • Novartis Investigative Site
    Poprad, 058 01, Slovakia
  • Novartis Investigative Site
    Rimavska Sobota, 979 01, Slovakia
  • Novartis Investigative Site
    Zvolen, 960 01, Slovakia
  • Novartis Investigative Site
    Malaga, Andalucia 29010, Spain
  • Novartis Investigative Site
    Sevilla, Andalucia 41009, Spain
  • Novartis Investigative Site
    Valencia, Comunidad Valenciana 46017, Spain
  • Novartis Investigative Site
    Santiago de Compostela, Galicia 15706, Spain
  • Novartis Investigative Site
    Cordoba, 14004, Spain
  • Novartis Investigative Site
    Leytonstone, London E11 1NR, United Kingdom
  • Novartis Investigative Site
    Leeds, West Yorkshire LS7 4SA, United Kingdom
  • Novartis Investigative Site
    Edinburgh, EH4 2XU, United Kingdom
  • Novartis Investigative Site
    London, NW3 2QG, United Kingdom
09

References and documents

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. PubMed 31138316 ↗
  • 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. PubMed 30487998 ↗

Individual participant data

Plan to share: Yes — Via CSR

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02638259
Lead sponsor
Sandoz
Responsible party
Sponsor
First posted
Dec 23, 2015
Start date
Feb 21, 2015
Primary completion
Dec 29, 2016
Completion
Jun 12, 2017
Results posted
Feb 23, 2018
Last update
Sep 19, 2018

Study contacts

Arnd Schwebig, MD
study director · Global Program Medical Director

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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