Rheumatoid Arthritis
Conditions
Keywords
Biosimilars, Rheumatoid Arthritis, Etanercept
Brief 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).
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
Interventions
DRUGGP2015
Enbrel comparator
Sponsors
Sandoz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Change in DAS28-CRP Score From Baseline to Week 24 in Patients Treated With GP2015 and Patients Treated With Enbrel | treatment period 1: up to 24 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Treatment Period 1: Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel | Treatment Period 1, up to 24 weeks | 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 | baseline, week 2, week 4, week 12, week 24 | 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; | week 4, 12, 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 |
| 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 | week 4, week 12 and week 24 | 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 | week 4, week 12 and week 24 | % patients in DAS28-ESR categories up to week 24 |
| Treatment Period 1- Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria | week 4, week 12, week 24 | 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; | Week 4, week 12 and week 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; | 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 | Weeks 4, 12 and 24; | 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 | Weeks 4, 12 and 24; | 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; | 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; | 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; | Baseline, 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 | 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; | Baseline, week 4, week 12, week 24, week 36 and 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 |
| 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 | week 4, week 12, week 24, week 36 and week 48 | 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; | week 36 and week 48 | percentage of participants in DAS28-ESR categories up to week 48 |
| Treatment Period 2 : Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria | week 4, week 12, week 24, week 36, week 48 | 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; | week 36 and week 48 | — |
| Treatment Period 2 : ACR-N Scores at Weeks 36 and 48; | week 36 and week 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 | baseline, week 4, week 12, week 24, week 36. week 48 | 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. |
| Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | baseline, week 4, week 12, week 24, week 36 and week 48 | 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; |
| 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; | baseline, week 4, week 12, week 24, week 36, week 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; | baseline, week 4, week 12, week 24, week 36, week 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 | 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 | up to 48 weeks | 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 | baseline, week 4, week 12, week 24, week 36, week 48 | 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 |
Countries
Bulgaria, Czechia, Estonia, Germany, Hungary, Italy, Latvia, Lithuania, Mexico, Poland, Russia, Serbia, Slovakia, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 50mg GP2015 Group 1 received 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 continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator | 186 |
| 50mg EU-authorized Enbrel Group 2 received 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 were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator | 190 |
| Total | 376 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Treatment Period 1 | Adverse Event | 1 | 5 |
| Treatment Period 1 | Death | 0 | 1 |
| Treatment Period 1 | Lack of Efficacy | 0 | 1 |
| Treatment Period 1 | Protocol Violation | 0 | 3 |
| Treatment Period 1 | Withdrawal by Subject | 4 | 6 |
| Treatment Period 1 | Withdrawn per sponsor decision | 0 | 2 |
| Treatment Period 2 | Adverse Event | 5 | 4 |
| Treatment Period 2 | Withdrawal by Subject | 1 | 7 |
Baseline characteristics
| Characteristic | 50mg GP2015 | Total | 50mg EU-authorized Enbrel |
|---|---|---|---|
| Age, Continuous | 55.2 years STANDARD_DEVIATION 11.22 | 54.1 years STANDARD_DEVIATION 12.02 | 53.1 years STANDARD_DEVIATION 12.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 6 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 180 Participants | 365 Participants | 185 Participants |
| Region of Enrollment Bulgaria | 11 Participants | 22 Participants | 11 Participants |
| Region of Enrollment Czechia | 16 Participants | 31 Participants | 15 Participants |
| Region of Enrollment Estonia | 26 Participants | 46 Participants | 20 Participants |
| Region of Enrollment Germany | 4 Participants | 9 Participants | 5 Participants |
| Region of Enrollment Hungary | 7 Participants | 19 Participants | 12 Participants |
| Region of Enrollment Italy | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment Latvia | 6 Participants | 8 Participants | 2 Participants |
| Region of Enrollment Lithuania | 9 Participants | 21 Participants | 12 Participants |
| Region of Enrollment Mexico | 4 Participants | 9 Participants | 5 Participants |
| Region of Enrollment Poland | 44 Participants | 92 Participants | 48 Participants |
| Region of Enrollment Russia | 12 Participants | 22 Participants | 10 Participants |
| Region of Enrollment Serbia | 12 Participants | 22 Participants | 10 Participants |
| Region of Enrollment Slovakia | 3 Participants | 8 Participants | 5 Participants |
| Region of Enrollment Spain | 5 Participants | 10 Participants | 5 Participants |
| Region of Enrollment United Kingdom | 3 Participants | 7 Participants | 4 Participants |
| Region of Enrollment United States | 23 Participants | 49 Participants | 26 Participants |
| Sex: Female, Male Female | 158 Participants | 308 Participants | 150 Participants |
| Sex: Female, Male Male | 28 Participants | 68 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 186 | 1 / 190 | 0 / 175 | 0 / 166 | 0 / 186 | 1 / 190 |
| other Total, other adverse events | 52 / 186 | 64 / 190 | 42 / 175 | 37 / 166 | 79 / 186 | 81 / 190 |
| serious Total, serious adverse events | 1 / 186 | 5 / 190 | 4 / 175 | 4 / 166 | 5 / 186 | 9 / 190 |
Outcome results
Primary
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
Population: Treatment Period 1 Per-Protocol set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 50mg GP2015 | Safety: Change in DAS28-CRP Score From Baseline to Week 24 in Patients Treated With GP2015 and Patients Treated With Enbrel | -2.80 scores on a scale | Standard Error 0.113 |
| 50mg EU-authorized Enbrel | Safety: Change in DAS28-CRP Score From Baseline to Week 24 in Patients Treated With GP2015 and Patients Treated With Enbrel | -2.73 scores on a scale | Standard Error 0.117 |
Comparison: Therapeutic equivalence in terms of change from baseline in DAS28-CRP at week 24 will be concluded if the 95% confidence interval for the LS mean difference between GP2015 and Enbrel is contained within the interval \[-0.6; 0.6\]. A mixed-model repeated measures analysis was performed for DAS28-CRP change from baseline including treatment, stratification factors, time, the interaction between time (visits) and treatment all as categorical variables, and baseline DAS28-CRP as a continuous variable.95% CI: [-0.26, 0.12]
Secondary
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
Population: Safety Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 50mg GP2015 | Safety - Overall Study : Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel | participants with at least one ISR | 13 Participants |
| 50mg GP2015 | Safety - Overall Study : Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel | participants with at least one moderate ISR | 1 Participants |
| 50mg GP2015 | Safety - Overall Study : Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel | participants with at least one severe ISR | 0 Participants |
| 50mg EU-authorized Enbrel | Safety - Overall Study : Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel | participants with at least one ISR | 37 Participants |
| 50mg EU-authorized Enbrel | Safety - Overall Study : Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel | participants with at least one moderate ISR | 7 Participants |
| 50mg EU-authorized Enbrel | Safety - Overall Study : Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel | participants with at least one severe ISR | 0 Participants |
Secondary
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
Population: Safety Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 50mg GP2015 | Safety : Overall Study: Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Week 4 | 3 Participants |
| 50mg GP2015 | Safety : Overall Study: Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Baseline | 2 Participants |
| 50mg GP2015 | Safety : Overall Study: Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Week 2 | 2 Participants |
| 50mg GP2015 | Safety : Overall Study: Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Week 12 | 0 Participants |
| 50mg GP2015 | Safety : Overall Study: Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Week 24 | 0 Participants |
| 50mg GP2015 | Safety : Overall Study: Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Week 30 | 2 Participants |
| 50mg GP2015 | Safety : Overall Study: Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Week 36 | 0 Participants |
| 50mg GP2015 | Safety : Overall Study: Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Week 48 | 2 Participants |
| 50mg EU-authorized Enbrel | Safety : Overall Study: Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Week 48 | 0 Participants |
| 50mg EU-authorized Enbrel | Safety : Overall Study: Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Week 24 | 0 Participants |
| 50mg EU-authorized Enbrel | Safety : Overall Study: Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Baseline | 0 Participants |
| 50mg EU-authorized Enbrel | Safety : Overall Study: Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Week 36 | 0 Participants |
| 50mg EU-authorized Enbrel | Safety : Overall Study: Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Week 2 | 5 Participants |
| 50mg EU-authorized Enbrel | Safety : Overall Study: Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Week 4 | 42 Participants |
| 50mg EU-authorized Enbrel | Safety : Overall Study: Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Week 30 | 0 Participants |
| 50mg EU-authorized Enbrel | Safety : Overall Study: Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Week 12 | 5 Participants |
Secondary
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;
Population: Treatment period 1 per protocol set. Patients with data available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 50mg GP2015 | Treatment Period 1- ACR-N Scores at Weeks 4, 12 and 24; | week 4 | 19.9 score on a scale | Standard Deviation 29.89 |
| 50mg GP2015 | Treatment Period 1- ACR-N Scores at Weeks 4, 12 and 24; | week 12 | 38.3 score on a scale | Standard Deviation 27.46 |
| 50mg GP2015 | Treatment Period 1- ACR-N Scores at Weeks 4, 12 and 24; | week 24 | 55.4 score on a scale | Standard Deviation 27.61 |
| 50mg EU-authorized Enbrel | Treatment Period 1- ACR-N Scores at Weeks 4, 12 and 24; | week 4 | 22.6 score on a scale | Standard Deviation 34.02 |
| 50mg EU-authorized Enbrel | Treatment Period 1- ACR-N Scores at Weeks 4, 12 and 24; | week 12 | 38.7 score on a scale | Standard Deviation 35.32 |
| 50mg EU-authorized Enbrel | Treatment Period 1- ACR-N Scores at Weeks 4, 12 and 24; | week 24 | 59.4 score on a scale | Standard Deviation 25.4 |
Secondary
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
Population: Treatment period 1 per protocol set. Patients with data available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 50mg GP2015 | Treatment Period 1 - Changes From Baseline in DAS28-CRP and DAS-ESR Scores to Weeks 4, 12 and 24 | DAS28-CRP change from baseline week 12 | -2.23 score on a scale | Standard Deviation 1.03 |
| 50mg GP2015 | Treatment Period 1 - Changes From Baseline in DAS28-CRP and DAS-ESR Scores to Weeks 4, 12 and 24 | DAS28-CRP change from baseline week 4 | -1.59 score on a scale | Standard Deviation 1.032 |
| 50mg GP2015 | Treatment Period 1 - Changes From Baseline in DAS28-CRP and DAS-ESR Scores to Weeks 4, 12 and 24 | DAS28-ESR change from baseline week 12 | -2.50 score on a scale | Standard Deviation 1.145 |
| 50mg GP2015 | Treatment Period 1 - Changes From Baseline in DAS28-CRP and DAS-ESR Scores to Weeks 4, 12 and 24 | DAS28-CRP change from baseline week 24 | -2.78 score on a scale | Standard Deviation 1.058 |
| 50mg GP2015 | Treatment Period 1 - Changes From Baseline in DAS28-CRP and DAS-ESR Scores to Weeks 4, 12 and 24 | DAS28-ESR change from baseline week 24 | -3.10 score on a scale | Standard Deviation 1.157 |
| 50mg GP2015 | Treatment Period 1 - Changes From Baseline in DAS28-CRP and DAS-ESR Scores to Weeks 4, 12 and 24 | DAS28-ESR change from baseline week 4 | -1.72 score on a scale | Standard Deviation 1.068 |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Changes From Baseline in DAS28-CRP and DAS-ESR Scores to Weeks 4, 12 and 24 | DAS28-ESR change from baseline week 24 | -3.09 score on a scale | Standard Deviation 1.119 |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Changes From Baseline in DAS28-CRP and DAS-ESR Scores to Weeks 4, 12 and 24 | DAS28-CRP change from baseline week 4 | -1.70 score on a scale | Standard Deviation 1.001 |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Changes From Baseline in DAS28-CRP and DAS-ESR Scores to Weeks 4, 12 and 24 | DAS28-CRP change from baseline week 12 | -2.20 score on a scale | Standard Deviation 1.071 |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Changes From Baseline in DAS28-CRP and DAS-ESR Scores to Weeks 4, 12 and 24 | DAS28-CRP change from baseline week 24 | -2.78 score on a scale | Standard Deviation 1.028 |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Changes From Baseline in DAS28-CRP and DAS-ESR Scores to Weeks 4, 12 and 24 | DAS28-ESR change from baseline week 4 | -1.85 score on a scale | Standard Deviation 1.078 |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Changes From Baseline in DAS28-CRP and DAS-ESR Scores to Weeks 4, 12 and 24 | DAS28-ESR change from baseline week 12 | -2.47 score on a scale | Standard Deviation 1.218 |
Secondary
Treatment Period 1 - CRP Levels at Baseline and Weeks 4, 12 and 24
Time frame: Weeks 4, 12 and 24
Population: Treatment period 1 per protocol set. Patients with data available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 50mg GP2015 | Treatment Period 1 - CRP Levels at Baseline and Weeks 4, 12 and 24 | Baseline | 1.19 mg/dL | Standard Deviation 2.194 |
| 50mg GP2015 | Treatment Period 1 - CRP Levels at Baseline and Weeks 4, 12 and 24 | Week 4 | 0.36 mg/dL | Standard Deviation 0.718 |
| 50mg GP2015 | Treatment Period 1 - CRP Levels at Baseline and Weeks 4, 12 and 24 | Week 12 | 0.33 mg/dL | Standard Deviation 0.772 |
| 50mg GP2015 | Treatment Period 1 - CRP Levels at Baseline and Weeks 4, 12 and 24 | Week 24 | 0.44 mg/dL | Standard Deviation 0.949 |
| 50mg EU-authorized Enbrel | Treatment Period 1 - CRP Levels at Baseline and Weeks 4, 12 and 24 | Week 24 | 0.35 mg/dL | Standard Deviation 0.466 |
| 50mg EU-authorized Enbrel | Treatment Period 1 - CRP Levels at Baseline and Weeks 4, 12 and 24 | Baseline | 1.10 mg/dL | Standard Deviation 1.526 |
| 50mg EU-authorized Enbrel | Treatment Period 1 - CRP Levels at Baseline and Weeks 4, 12 and 24 | Week 12 | 0.48 mg/dL | Standard Deviation 0.85 |
| 50mg EU-authorized Enbrel | Treatment Period 1 - CRP Levels at Baseline and Weeks 4, 12 and 24 | Week 4 | 0.43 mg/dL | Standard Deviation 0.693 |
Secondary
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
Population: Treatment period 1 per protocol set. Patients with data available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 50mg GP2015 | Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24; | DAS28-ESR baseline | 6.34 score on a scale | Standard Deviation 0.882 |
| 50mg GP2015 | Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24; | DAS28-CRP baseline | 5.42 score on a scale | Standard Deviation 0.921 |
| 50mg GP2015 | Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24; | DAS28-CRP week 4 | 3.81 score on a scale | Standard Deviation 1.079 |
| 50mg GP2015 | Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24; | DAS28-CRP week 12 | 3.15 score on a scale | Standard Deviation 1.045 |
| 50mg GP2015 | Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24; | DAS28-CRP week 24 | 2.63 score on a scale | Standard Deviation 0.91 |
| 50mg GP2015 | Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24; | DAS28-ESR week 4 | 4.62 score on a scale | Standard Deviation 1.183 |
| 50mg GP2015 | Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24; | DAS28-ESR week 12 | 3.84 score on a scale | Standard Deviation 1.216 |
| 50mg GP2015 | Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24; | DAS28-ESR week 24 | 3.24 score on a scale | Standard Deviation 1.06 |
| 50mg EU-authorized Enbrel | Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24; | DAS28-ESR week 24 | 3.32 score on a scale | Standard Deviation 1.099 |
| 50mg EU-authorized Enbrel | Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24; | DAS28-ESR week 4 | 4.56 score on a scale | Standard Deviation 1.204 |
| 50mg EU-authorized Enbrel | Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24; | DAS28-CRP baseline | 5.53 score on a scale | Standard Deviation 0.783 |
| 50mg EU-authorized Enbrel | Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24; | DAS28-CRP week 24 | 2.75 score on a scale | Standard Deviation 0.928 |
| 50mg EU-authorized Enbrel | Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24; | DAS28-CRP week 4 | 3.82 score on a scale | Standard Deviation 1.077 |
| 50mg EU-authorized Enbrel | Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24; | DAS28-ESR week 12 | 3.94 score on a scale | Standard Deviation 1.284 |
| 50mg EU-authorized Enbrel | Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24; | DAS28-CRP week 12 | 3.31 score on a scale | Standard Deviation 1.088 |
| 50mg EU-authorized Enbrel | Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24; | DAS28-ESR baseline | 6.41 score on a scale | Standard Deviation 0.768 |
Secondary
Treatment Period 1 - ESR Levels at Baseline and Weeks 4, 12 and 24
Time frame: Weeks 4, 12 and 24
Population: Treatment period 1 per protocol set. Patients with data available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 50mg GP2015 | Treatment Period 1 - ESR Levels at Baseline and Weeks 4, 12 and 24 | Baseline | 41.4 mm/h | Standard Deviation 16.89 |
| 50mg GP2015 | Treatment Period 1 - ESR Levels at Baseline and Weeks 4, 12 and 24 | Week 4 | 26.5 mm/h | Standard Deviation 16.51 |
| 50mg GP2015 | Treatment Period 1 - ESR Levels at Baseline and Weeks 4, 12 and 24 | Week 12 | 23.2 mm/h | Standard Deviation 14.67 |
| 50mg GP2015 | Treatment Period 1 - ESR Levels at Baseline and Weeks 4, 12 and 24 | Week 24 | 21.4 mm/h | Standard Deviation 15.47 |
| 50mg EU-authorized Enbrel | Treatment Period 1 - ESR Levels at Baseline and Weeks 4, 12 and 24 | Week 24 | 20.8 mm/h | Standard Deviation 14.05 |
| 50mg EU-authorized Enbrel | Treatment Period 1 - ESR Levels at Baseline and Weeks 4, 12 and 24 | Baseline | 41.8 mm/h | Standard Deviation 17.94 |
| 50mg EU-authorized Enbrel | Treatment Period 1 - ESR Levels at Baseline and Weeks 4, 12 and 24 | Week 12 | 23.8 mm/h | Standard Deviation 15.41 |
| 50mg EU-authorized Enbrel | Treatment Period 1 - ESR Levels at Baseline and Weeks 4, 12 and 24 | Week 4 | 26.7 mm/h | Standard Deviation 17.27 |
Secondary
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
Population: Safety Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 50mg GP2015 | Treatment Period 1: Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel | Severe injection site reactions | 0 Participants |
| 50mg GP2015 | Treatment Period 1: Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel | All injection site reactions | 13 Participants |
| 50mg GP2015 | Treatment Period 1: Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel | Moderate injection site reactions | 1 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1: Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel | Severe injection site reactions | 0 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1: Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel | All injection site reactions | 35 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1: Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel | Moderate injection site reactions | 5 Participants |
Secondary
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;
Population: Treatment period 1 per protocol set. Patients with data available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 50mg GP2015 | Treatment Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24; | Baseline | 27.0 score on a scale | Standard Deviation 9.67 |
| 50mg GP2015 | Treatment Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24; | Week 4 | 31.6 score on a scale | Standard Deviation 8.83 |
| 50mg GP2015 | Treatment Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24; | Week 12 | 34.4 score on a scale | Standard Deviation 8.93 |
| 50mg GP2015 | Treatment Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24; | Week 24 | 36.3 score on a scale | Standard Deviation 8.94 |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24; | Week 24 | 36.7 score on a scale | Standard Deviation 9.24 |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24; | Baseline | 25.1 score on a scale | Standard Deviation 10.33 |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24; | Week 12 | 33.9 score on a scale | Standard Deviation 9.6 |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24; | Week 4 | 30.9 score on a scale | Standard Deviation 10.01 |
Secondary
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;
Population: Treatment period 1 per protocol set. Patients with data available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 50mg GP2015 | Treatment Period 1 - Health Assessment Questionnaire (HAQ) Index at Baseline, Weeks 4, 12 and 24; | Baseline | 1.44 score on a scale | Standard Deviation 0.547 |
| 50mg GP2015 | Treatment Period 1 - Health Assessment Questionnaire (HAQ) Index at Baseline, Weeks 4, 12 and 24; | Week 4 | 1.19 score on a scale | Standard Deviation 0.558 |
| 50mg GP2015 | Treatment Period 1 - Health Assessment Questionnaire (HAQ) Index at Baseline, Weeks 4, 12 and 24; | Week 12 | 1.02 score on a scale | Standard Deviation 0.56 |
| 50mg GP2015 | Treatment Period 1 - Health Assessment Questionnaire (HAQ) Index at Baseline, Weeks 4, 12 and 24; | Week 24 | 0.88 score on a scale | Standard Deviation 0.601 |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Health Assessment Questionnaire (HAQ) Index at Baseline, Weeks 4, 12 and 24; | Week 24 | 0.80 score on a scale | Standard Deviation 0.589 |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Health Assessment Questionnaire (HAQ) Index at Baseline, Weeks 4, 12 and 24; | Baseline | 1.47 score on a scale | Standard Deviation 0.561 |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Health Assessment Questionnaire (HAQ) Index at Baseline, Weeks 4, 12 and 24; | Week 12 | 0.97 score on a scale | Standard Deviation 0.599 |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Health Assessment Questionnaire (HAQ) Index at Baseline, Weeks 4, 12 and 24; | Week 4 | 1.14 score on a scale | Standard Deviation 0.611 |
Secondary
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
Population: Treatment period 1 per protocol set. Patients with data available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24; | ACR20 response Week 12 | 131 Participants |
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24; | ACR50 response Week 24 | 107 Participants |
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24; | ACR50 response Week 4 | 25 Participants |
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24; | ACR70 response Week 4 | 8 Participants |
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24; | ACR20 response Week 24 | 147 Participants |
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24; | ACR70 response Week 12 | 21 Participants |
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24; | ACR50 response Week 12 | 55 Participants |
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24; | ACR70 response Week 24 | 56 Participants |
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24; | ACR20 response Week 4 | 80 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24; | ACR70 response Week 24 | 66 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24; | ACR20 response Week 4 | 83 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24; | ACR20 response Week 12 | 116 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24; | ACR20 response Week 24 | 144 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24; | ACR50 response Week 4 | 28 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24; | ACR50 response Week 12 | 68 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24; | ACR50 response Week 24 | 110 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24; | ACR70 response Week 4 | 7 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24; | ACR70 response Week 12 | 26 Participants |
Secondary
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
Population: Treatment period 1 per protocol set. Patients with data available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving DAS28 < 2.6 at Weeks 4, 12 and 24 | Week 4 - remission (DAS28 <2.6) | 9 Participants |
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving DAS28 < 2.6 at Weeks 4, 12 and 24 | Week 12 - remission (DAS28 <2.6) | 21 Participants |
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving DAS28 < 2.6 at Weeks 4, 12 and 24 | Week 24 - remission (DAS28 <2.6) | 46 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving DAS28 < 2.6 at Weeks 4, 12 and 24 | Week 4 - remission (DAS28 <2.6) | 7 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving DAS28 < 2.6 at Weeks 4, 12 and 24 | Week 12 - remission (DAS28 <2.6) | 21 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving DAS28 < 2.6 at Weeks 4, 12 and 24 | Week 24 - remission (DAS28 <2.6) | 41 Participants |
Secondary
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
Population: Treatment period 1 per protocol set. Patients with data available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria | week 24 | 24 Participants |
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria | week 4 | 1 Participants |
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria | week 12 | 9 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria | week 4 | 2 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria | week 12 | 8 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria | week 24 | 15 Participants |
Secondary
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
Population: Treatment period 1 per protocol set. Patients with data available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving EULAR Response | Good response week 12 | 54 Participants |
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving EULAR Response | Moderate response week 24 | 76 Participants |
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving EULAR Response | Moderate response week 4 | 95 Participants |
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving EULAR Response | no response week 4 | 46 Participants |
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving EULAR Response | Good response week 24 | 88 Participants |
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving EULAR Response | no response week 12 | 11 Participants |
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving EULAR Response | Moderate response week 12 | 103 Participants |
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving EULAR Response | no response week 24 | 4 Participants |
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving EULAR Response | Good response week 4 | 26 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving EULAR Response | no response week 24 | 4 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving EULAR Response | Good response week 4 | 21 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving EULAR Response | Good response week 12 | 47 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving EULAR Response | Good response week 24 | 74 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving EULAR Response | Moderate response week 4 | 99 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving EULAR Response | Moderate response week 12 | 91 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving EULAR Response | Moderate response week 24 | 77 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving EULAR Response | no response week 4 | 34 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving EULAR Response | no response week 12 | 16 Participants |
Secondary
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;
Population: Treatment period 1 per protocol set. Patients with data available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 4, 12 and 24; | Baseline | 11 Participants |
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 4, 12 and 24; | Week 4 | 22 Participants |
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 4, 12 and 24; | Week 12 | 40 Participants |
| 50mg GP2015 | Treatment Period 1- Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 4, 12 and 24; | Week 24 | 54 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 4, 12 and 24; | Week 24 | 62 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 4, 12 and 24; | Baseline | 5 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 4, 12 and 24; | Week 12 | 46 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1- Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 4, 12 and 24; | Week 4 | 30 Participants |
Secondary
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;
Population: Treatment period 1 per protocol set. Patients with data available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 24 :High (CDAI > 22) | 6 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Baseline : Remission (CDAI<=2.8) | 0 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Baseline: Low (2.8 < CDAI <= 10) | 0 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Baseline : Moderate (10 < CDAI <= 22 | 17 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Baseline : High (CDAI > 22) | 151 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 4:Remission(CDAI<=2.8) | 4 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 4: Low (2.8 < CDAI <= 10) | 33 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 4: Moderate (10 < CDAI <= 22) | 67 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 4:High High (CDAI > 22) | 63 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 12:Remission(CDAI<=2.8) | 14 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 12: Low (2.8 < CDAI <= 10) | 63 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 12: Moderate (10 < CDAI <= 22) | 72 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 12:High (CDAI > 22) | 19 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 24: Remission (CDAI<=2.8) | 35 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 24: Low (2.8 < CDAI <= 10) | 81 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 24 : (10 < CDAI <= 22) | 46 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 24 : (10 < CDAI <= 22) | 39 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 24 :High (CDAI > 22) | 7 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 4:High High (CDAI > 22) | 49 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Baseline : Remission (CDAI<=2.8) | 0 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 12:High (CDAI > 22) | 23 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Baseline: Low (2.8 < CDAI <= 10) | 0 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 12:Remission(CDAI<=2.8) | 15 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Baseline : Moderate (10 < CDAI <= 22 | 7 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 24: Low (2.8 < CDAI <= 10) | 78 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Baseline : High (CDAI > 22) | 148 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 12: Low (2.8 < CDAI <= 10) | 53 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 4:Remission(CDAI<=2.8) | 3 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 24: Remission (CDAI<=2.8) | 31 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 4: Low (2.8 < CDAI <= 10) | 31 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 12: Moderate (10 < CDAI <= 22) | 63 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 4: Moderate (10 < CDAI <= 22) | 71 Participants |
Secondary
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;
Population: Treatment period 1 per protocol set. Patients with data available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Baseline : Remission (SDAI<=3.3) | 0 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Baseline: Low (3.3 < SDAI <= 11) | 0 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Baseline : Moderate (11 < SDAI <= 26 | 26 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Baseline : High (SDAI > 26) | 142 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 4:Remission (SDAI<=3.3) | 5 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 4:Low (3.3 < SDAI <= 11) | 35 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 4: Moderate (11 < SDAI <= 26 | 84 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 4:High (SDAI > 26) | 41 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 12:Remission (SDAI<=3.3) | 15 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 12:Low (3.3 < SDAI <= 11) | 61 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 12: Moderate (11 < SDAI <= 26 | 75 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 12:High (SDAI > 26) | 14 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 24: Remission (SDAI<=3.3) | 38 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 24: Low (3.3 < SDAI <= 11) | 83 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 24 : Moderate (11 < SDAI <= 26 | 45 Participants |
| 50mg GP2015 | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 24 :High (SDAI > 26) | 2 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 24 :High (SDAI > 26) | 5 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Baseline : Remission (SDAI<=3.3) | 0 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 12:Remission (SDAI<=3.3) | 13 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Baseline: Low (3.3 < SDAI <= 11) | 0 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 24: Remission (SDAI<=3.3) | 31 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Baseline : Moderate (11 < SDAI <= 26 | 19 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 12:Low (3.3 < SDAI <= 11) | 58 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Baseline : High (SDAI > 26) | 136 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 24 : Moderate (11 < SDAI <= 26 | 38 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 4:Remission (SDAI<=3.3) | 4 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 12: Moderate (11 < SDAI <= 26 | 68 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 4:Low (3.3 < SDAI <= 11) | 31 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 24: Low (3.3 < SDAI <= 11) | 81 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 4: Moderate (11 < SDAI <= 26 | 82 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 12:High (SDAI > 26) | 11 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 4:High (SDAI > 26) | 36 Participants |
Secondary
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
Population: Safety Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 50mg GP2015 | Treatment Period 1 - Safety : Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Week 2 | 2 Participants |
| 50mg GP2015 | Treatment Period 1 - Safety : Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Week 12 | 0 Participants |
| 50mg GP2015 | Treatment Period 1 - Safety : Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Week 4 | 3 Participants |
| 50mg GP2015 | Treatment Period 1 - Safety : Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Week 24 | 0 Participants |
| 50mg GP2015 | Treatment Period 1 - Safety : Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Baseline | 2 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Safety : Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Week 24 | 0 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Safety : Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Baseline | 0 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Safety : Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Week 2 | 5 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Safety : Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Week 4 | 42 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 1 - Safety : Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients | Week 12 | 5 Participants |
Secondary
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
Population: Treatment period 2 per protocol set. Patients with data available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 50mg GP2015 | Treatment Period 2 : ACR-N Scores at Weeks 36 and 48; | Week 12 | 38.3 score on a scale | Standard Deviation 27.84 |
| 50mg GP2015 | Treatment Period 2 : ACR-N Scores at Weeks 36 and 48; | Week 36 | 53.8 score on a scale | Standard Deviation 28.21 |
| 50mg GP2015 | Treatment Period 2 : ACR-N Scores at Weeks 36 and 48; | Week 24 | 56.3 score on a scale | Standard Deviation 26.58 |
| 50mg GP2015 | Treatment Period 2 : ACR-N Scores at Weeks 36 and 48; | Week 48 | 56.9 score on a scale | Standard Deviation 29.18 |
| 50mg GP2015 | Treatment Period 2 : ACR-N Scores at Weeks 36 and 48; | Week 4 | 19.7 score on a scale | Standard Deviation 27.72 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : ACR-N Scores at Weeks 36 and 48; | Week 48 | 56.4 score on a scale | Standard Deviation 30.58 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : ACR-N Scores at Weeks 36 and 48; | Week 24 | 60.9 score on a scale | Standard Deviation 24.79 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : ACR-N Scores at Weeks 36 and 48; | Week 36 | 55.7 score on a scale | Standard Deviation 28.37 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : ACR-N Scores at Weeks 36 and 48; | Week 12 | 40.7 score on a scale | Standard Deviation 34.8 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : ACR-N Scores at Weeks 36 and 48; | Week 4 | 24.9 score on a scale | Standard Deviation 29.4 |
Secondary
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
Population: Treatment period 2 per protocol set. Patients with data available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 50mg GP2015 | Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48 | DAS28-CRP change from baseline, week 24 | -2.81 score on a scale | Standard Deviation 1.007 |
| 50mg GP2015 | Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48 | DAS28-ESR change from baseline, week 4 | -1.69 score on a scale | Standard Deviation 1.048 |
| 50mg GP2015 | Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48 | DAS28-CRP change from baseline, week 12 | -2.22 score on a scale | Standard Deviation 1.031 |
| 50mg GP2015 | Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48 | DAS28-ESR change from baseline, week 12 | -2.49 score on a scale | Standard Deviation 1.152 |
| 50mg GP2015 | Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48 | DAS28-CRP change from baseline, week 36 | -2.80 score on a scale | Standard Deviation 1.087 |
| 50mg GP2015 | Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48 | DAS28-ESR change from baseline, week 24 | -3.16 score on a scale | Standard Deviation 1.106 |
| 50mg GP2015 | Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48 | DAS28-CRP change from baseline, week 4 | -1.55 score on a scale | Standard Deviation 1.014 |
| 50mg GP2015 | Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48 | DAS28-ESR change from baseline, week 36 | -3.13 score on a scale | Standard Deviation 1.232 |
| 50mg GP2015 | Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48 | DAS28-ESR change from baseline, week 48 | -3.20 score on a scale | Standard Deviation 1.297 |
| 50mg GP2015 | Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48 | DAS28-CRP change from baseline, week 48 | -2.88 score on a scale | Standard Deviation 1.198 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48 | DAS28-ESR change from baseline, week 48 | -3.14 score on a scale | Standard Deviation 1.19 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48 | DAS28-CRP change from baseline, week 4 | -1.76 score on a scale | Standard Deviation 1.014 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48 | DAS28-CRP change from baseline, week 12 | -2.27 score on a scale | Standard Deviation 1.096 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48 | DAS28-CRP change from baseline, week 24 | -2.90 score on a scale | Standard Deviation 0.988 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48 | DAS28-CRP change from baseline, week 36 | -2.82 score on a scale | Standard Deviation 1.151 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48 | DAS28-CRP change from baseline, week 48 | -2.83 score on a scale | Standard Deviation 1.176 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48 | DAS28-ESR change from baseline, week 4 | -1.92 score on a scale | Standard Deviation 1.087 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48 | DAS28-ESR change from baseline, week 12 | -2.57 score on a scale | Standard Deviation 1.235 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48 | DAS28-ESR change from baseline, week 24 | -3.23 score on a scale | Standard Deviation 1.054 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48 | DAS28-ESR change from baseline, week 36 | -3.14 score on a scale | Standard Deviation 1.154 |
Secondary
Treatment Period 2 : CRP Levels at Week 36 and 48
Time frame: baseline, week 4, week 12, week 24, week 36, week 48
Population: Treatment period 2 per protocol set. Patients with data available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 50mg GP2015 | Treatment Period 2 : CRP Levels at Week 36 and 48 | Baseline | 1.21 mg/dL | Standard Deviation 2.244 |
| 50mg GP2015 | Treatment Period 2 : CRP Levels at Week 36 and 48 | Week 4 | 0.36 mg/dL | Standard Deviation 0.733 |
| 50mg GP2015 | Treatment Period 2 : CRP Levels at Week 36 and 48 | Week 12 | 0.36 mg/dL | Standard Deviation 0.817 |
| 50mg GP2015 | Treatment Period 2 : CRP Levels at Week 36 and 48 | Week 24 | 0.44 mg/dL | Standard Deviation 0.964 |
| 50mg GP2015 | Treatment Period 2 : CRP Levels at Week 36 and 48 | Week 36 | 0.39 mg/dL | Standard Deviation 0.758 |
| 50mg GP2015 | Treatment Period 2 : CRP Levels at Week 36 and 48 | Week 48 | 0.35 mg/dL | Standard Deviation 0.623 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : CRP Levels at Week 36 and 48 | Week 36 | 0.39 mg/dL | Standard Deviation 0.655 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : CRP Levels at Week 36 and 48 | Baseline | 1.17 mg/dL | Standard Deviation 1.589 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : CRP Levels at Week 36 and 48 | Week 24 | 0.36 mg/dL | Standard Deviation 0.487 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : CRP Levels at Week 36 and 48 | Week 4 | 0.42 mg/dL | Standard Deviation 0.625 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : CRP Levels at Week 36 and 48 | Week 48 | 0.40 mg/dL | Standard Deviation 0.878 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : CRP Levels at Week 36 and 48 | Week 12 | 0.50 mg/dL | Standard Deviation 0.91 |
Secondary
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.
Population: Treatment period 2 per protocol set. Patients with data available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 50mg GP2015 | Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; | DAS28-CRP Baseline | 5.45 score on a scale | Standard Deviation 0.914 |
| 50mg GP2015 | Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; | DAS28-CRP Week 4 | 3.89 score on a scale | Standard Deviation 1.053 |
| 50mg GP2015 | Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; | DAS28-CRP Week 12 | 3.20 score on a scale | Standard Deviation 1.038 |
| 50mg GP2015 | Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; | DAS28-CRP Week 24 | 2.64 score on a scale | Standard Deviation 0.863 |
| 50mg GP2015 | Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; | DAS28-CRP Week 36 | 2.65 score on a scale | Standard Deviation 1.001 |
| 50mg GP2015 | Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; | DAS28-CRP Week 48 | 2.57 score on a scale | Standard Deviation 1.067 |
| 50mg GP2015 | Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; | DAS28-ESR Baseline | 6.39 score on a scale | Standard Deviation 0.872 |
| 50mg GP2015 | Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; | DAS28-ESR Week 4 | 4.70 score on a scale | Standard Deviation 1.175 |
| 50mg GP2015 | Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; | DAS28-ESR Week 12 | 3.90 score on a scale | Standard Deviation 1.236 |
| 50mg GP2015 | Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; | DAS28-ESR Week 24 | 3.23 score on a scale | Standard Deviation 1.022 |
| 50mg GP2015 | Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; | DAS28-ESR Week 36 | 3.25 score on a scale | Standard Deviation 1.16 |
| 50mg GP2015 | Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; | DAS28-ESR Week 48 | 3.20 score on a scale | Standard Deviation 1.201 |
| 50mg EU-authorized Enbrel | Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; | DAS28-ESR Week 36 | 3.28 score on a scale | Standard Deviation 1.127 |
| 50mg EU-authorized Enbrel | Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; | DAS28-CRP Baseline | 5.57 score on a scale | Standard Deviation 0.794 |
| 50mg EU-authorized Enbrel | Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; | DAS28-ESR Baseline | 6.43 score on a scale | Standard Deviation 0.784 |
| 50mg EU-authorized Enbrel | Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; | DAS28-CRP Week 4 | 3.79 score on a scale | Standard Deviation 1.101 |
| 50mg EU-authorized Enbrel | Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; | DAS28-ESR Week 24 | 3.19 score on a scale | Standard Deviation 1.048 |
| 50mg EU-authorized Enbrel | Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; | DAS28-CRP Week 12 | 3.27 score on a scale | Standard Deviation 1.127 |
| 50mg EU-authorized Enbrel | Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; | DAS28-ESR Week 4 | 4.49 score on a scale | Standard Deviation 1.228 |
| 50mg EU-authorized Enbrel | Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; | DAS28-CRP Week 24 | 2.67 score on a scale | Standard Deviation 0.892 |
| 50mg EU-authorized Enbrel | Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; | DAS28-ESR Week 48 | 3.30 score on a scale | Standard Deviation 1.177 |
| 50mg EU-authorized Enbrel | Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; | DAS28-CRP Week 36 | 2.74 score on a scale | Standard Deviation 1.017 |
| 50mg EU-authorized Enbrel | Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; | DAS28-ESR Week 12 | 3.85 score on a scale | Standard Deviation 1.317 |
| 50mg EU-authorized Enbrel | Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; | DAS28-CRP Week 48 | 2.74 score on a scale | Standard Deviation 1.062 |
Secondary
Treatment Period 2 : ESR Levels at Week 36 and 48
Time frame: baseline, week 4, week 12, week 24, week 36, week 48
Population: Treatment period 2 per protocol set. Patients with data available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 50mg GP2015 | Treatment Period 2 : ESR Levels at Week 36 and 48 | Week 24 | 21.3 mm/h | Standard Deviation 15.66 |
| 50mg GP2015 | Treatment Period 2 : ESR Levels at Week 36 and 48 | Week 4 | 26.8 mm/h | Standard Deviation 16.33 |
| 50mg GP2015 | Treatment Period 2 : ESR Levels at Week 36 and 48 | Week 36 | 22.1 mm/h | Standard Deviation 16.41 |
| 50mg GP2015 | Treatment Period 2 : ESR Levels at Week 36 and 48 | Week 12 | 23.8 mm/h | Standard Deviation 15.07 |
| 50mg GP2015 | Treatment Period 2 : ESR Levels at Week 36 and 48 | Week 48 | 22.8 mm/h | Standard Deviation 16.66 |
| 50mg GP2015 | Treatment Period 2 : ESR Levels at Week 36 and 48 | Baseline | 42.2 mm/h | Standard Deviation 16.99 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : ESR Levels at Week 36 and 48 | Week 48 | 20.8 mm/h | Standard Deviation 14.62 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : ESR Levels at Week 36 and 48 | Week 4 | 25.3 mm/h | Standard Deviation 16.11 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : ESR Levels at Week 36 and 48 | Week 12 | 23.0 mm/h | Standard Deviation 15.38 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : ESR Levels at Week 36 and 48 | Week 24 | 19.3 mm/h | Standard Deviation 12.66 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : ESR Levels at Week 36 and 48 | Week 36 | 20.3 mm/h | Standard Deviation 14.28 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : ESR Levels at Week 36 and 48 | Baseline | 41.7 mm/h | Standard Deviation 17.99 |
Secondary
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
Population: Treatment period 2 per protocol set. Patients with data available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 50mg GP2015 | Treatment Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 36 and 48; | Baseline | 26.6 score on a scale | Standard Deviation 9.71 |
| 50mg GP2015 | Treatment Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 36 and 48; | Week 4 | 31.5 score on a scale | Standard Deviation 8.72 |
| 50mg GP2015 | Treatment Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 36 and 48; | Week 12 | 34.4 score on a scale | Standard Deviation 8.89 |
| 50mg GP2015 | Treatment Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 36 and 48; | Week 24 | 36.6 score on a scale | Standard Deviation 8.75 |
| 50mg GP2015 | Treatment Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 36 and 48; | Week 36 | 36.9 score on a scale | Standard Deviation 8.79 |
| 50mg GP2015 | Treatment Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 36 and 48; | Week 48 | 38.0 score on a scale | Standard Deviation 8.74 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 36 and 48; | Week 36 | 36.4 score on a scale | Standard Deviation 9.5 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 36 and 48; | Baseline | 25.5 score on a scale | Standard Deviation 10.78 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 36 and 48; | Week 24 | 36.7 score on a scale | Standard Deviation 9.05 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 36 and 48; | Week 4 | 31.3 score on a scale | Standard Deviation 10.07 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 36 and 48; | Week 48 | 35.8 score on a scale | Standard Deviation 9.97 |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 36 and 48; | Week 12 | 34.1 score on a scale | Standard Deviation 9.69 |
Secondary
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
Population: Treatment period 2 per protocol set. Patients with data available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 50mg GP2015 | Treatment Period 2 :HAQ Index at Weeks 36 and 48; | Baseline | 1.47 score on a scale | Standard Deviation 0.547 |
| 50mg GP2015 | Treatment Period 2 :HAQ Index at Weeks 36 and 48; | Week 4 | 1.22 score on a scale | Standard Deviation 0.554 |
| 50mg GP2015 | Treatment Period 2 :HAQ Index at Weeks 36 and 48; | Week 12 | 1.04 score on a scale | Standard Deviation 0.56 |
| 50mg GP2015 | Treatment Period 2 :HAQ Index at Weeks 36 and 48; | Week 24 | 0.88 score on a scale | Standard Deviation 0.594 |
| 50mg GP2015 | Treatment Period 2 :HAQ Index at Weeks 36 and 48; | Week 36 | 0.89 score on a scale | Standard Deviation 0.584 |
| 50mg GP2015 | Treatment Period 2 :HAQ Index at Weeks 36 and 48; | Week 48 | 0.85 score on a scale | Standard Deviation 0.609 |
| 50mg EU-authorized Enbrel | Treatment Period 2 :HAQ Index at Weeks 36 and 48; | Week 36 | 0.85 score on a scale | Standard Deviation 0.651 |
| 50mg EU-authorized Enbrel | Treatment Period 2 :HAQ Index at Weeks 36 and 48; | Baseline | 1.50 score on a scale | Standard Deviation 0.554 |
| 50mg EU-authorized Enbrel | Treatment Period 2 :HAQ Index at Weeks 36 and 48; | Week 24 | 0.83 score on a scale | Standard Deviation 0.603 |
| 50mg EU-authorized Enbrel | Treatment Period 2 :HAQ Index at Weeks 36 and 48; | Week 4 | 1.14 score on a scale | Standard Deviation 0.62 |
| 50mg EU-authorized Enbrel | Treatment Period 2 :HAQ Index at Weeks 36 and 48; | Week 48 | 0.84 score on a scale | Standard Deviation 0.652 |
| 50mg EU-authorized Enbrel | Treatment Period 2 :HAQ Index at Weeks 36 and 48; | Week 12 | 0.97 score on a scale | Standard Deviation 0.614 |
Secondary
Treatment Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Weeks 36 and 48;
Time frame: week 36 and week 48
Population: Treatment period 2 per protocol set. Patients with data available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Weeks 36 and 48; | ACR20 response Week 36 | 128 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Weeks 36 and 48; | ACR20 response Week 48 | 131 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Weeks 36 and 48; | ACR50 response Week 36 | 90 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Weeks 36 and 48; | ACR50 response Week 48 | 93 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Weeks 36 and 48; | ACR70 response Week 36 | 47 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Weeks 36 and 48; | ACR70 response Week 48 | 54 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Weeks 36 and 48; | ACR70 response Week 36 | 50 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Weeks 36 and 48; | ACR20 response Week 36 | 114 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Weeks 36 and 48; | ACR50 response Week 48 | 86 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Weeks 36 and 48; | ACR20 response Week 48 | 108 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Weeks 36 and 48; | ACR70 response Week 48 | 55 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Weeks 36 and 48; | ACR50 response Week 36 | 83 Participants |
Secondary
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
Population: Treatment period 2 per protocol set. Patients with data available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients Achieving DAS28 < 2.6 at Weeks 36 and 48; | Week 36 Remission (DAS28 < 2.6) | 45 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients Achieving DAS28 < 2.6 at Weeks 36 and 48; | Week 48 Remission (DAS28 < 2.6) | 44 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients Achieving DAS28 < 2.6 at Weeks 36 and 48; | Week 36 Remission (DAS28 < 2.6) | 38 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients Achieving DAS28 < 2.6 at Weeks 36 and 48; | Week 48 Remission (DAS28 < 2.6) | 35 Participants |
Secondary
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
Population: Treatment period 2 per protocol set. Patients with data available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria | Week 12 | 9 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria | Week 36 | 25 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria | Week 24 | 22 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria | Week 48 | 28 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria | Week 4 | 0 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria | Week 48 | 20 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria | Week 4 | 2 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria | Week 12 | 8 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria | Week 24 | 13 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria | Week 36 | 15 Participants |
Secondary
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
Population: Treatment period 2 per protocol set. Patients with data available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 50mg GP2015 | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | no response week 36 | 3 Participants |
| 50mg GP2015 | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | Good response week 4 | 20 Participants |
| 50mg GP2015 | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | Good response week 12 | 43 Participants |
| 50mg GP2015 | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | Good response week 24 | 77 Participants |
| 50mg GP2015 | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | Good response week 36 | 82 Participants |
| 50mg GP2015 | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | Good response week 48 | 80 Participants |
| 50mg GP2015 | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | Moderate response week 4 | 85 Participants |
| 50mg GP2015 | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | Moderate response week 12 | 95 Participants |
| 50mg GP2015 | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | Moderate response week 24 | 71 Participants |
| 50mg GP2015 | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | Moderate response week 36 | 62 Participants |
| 50mg GP2015 | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | Moderate response week 48 | 61 Participants |
| 50mg GP2015 | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | no response week 4 | 42 Participants |
| 50mg GP2015 | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | no response week 12 | 10 Participants |
| 50mg GP2015 | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | no response week 24 | 0 Participants |
| 50mg GP2015 | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | no response week 48 | 6 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | no response week 36 | 2 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | Moderate response week 24 | 63 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | Good response week 4 | 20 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | no response week 12 | 12 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | Good response week 12 | 43 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | Moderate response week 36 | 64 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | Good response week 24 | 68 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | no response week 48 | 5 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | Good response week 36 | 65 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | Moderate response week 48 | 57 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | Good response week 48 | 67 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | no response week 24 | 0 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | Moderate response week 4 | 82 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | no response week 4 | 28 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2: Proportion of Patients Achieving EULAR Reponse | Moderate response week 12 | 75 Participants |
Secondary
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
Population: Treatment period 2 per protocol set. Patients with data available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 50mg GP2015 | Treatment Period 2 :Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 36 and 48; | Baseline | 8 Participants |
| 50mg GP2015 | Treatment Period 2 :Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 36 and 48; | Week 4 | 17 Participants |
| 50mg GP2015 | Treatment Period 2 :Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 36 and 48; | Week 12 | 33 Participants |
| 50mg GP2015 | Treatment Period 2 :Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 36 and 48; | Week 24 | 47 Participants |
| 50mg GP2015 | Treatment Period 2 :Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 36 and 48; | Week 36 | 46 Participants |
| 50mg GP2015 | Treatment Period 2 :Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 36 and 48; | Week 48 | 51 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 :Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 36 and 48; | Week 36 | 48 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 :Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 36 and 48; | Baseline | 4 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 :Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 36 and 48; | Week 24 | 51 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 :Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 36 and 48; | Week 4 | 25 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 :Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 36 and 48; | Week 48 | 51 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 :Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 36 and 48; | Week 12 | 39 Participants |
Secondary
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
Population: Treatment period 2 per protocol set. Patients with data available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 4 : Moderate (11 < SDAI <= 26 | 60 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Baseline : Low (2.8 < CDAI <= 10) | 0 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Baseline : Moderate (10 < CDAI <= 22) | 14 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Baseline : High (CDAI > 22 ) | 134 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 4 : Remission (CDAI <=2.8) | 2 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 4 : Low (2.8 < CDAI <= 10) | 27 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Baseline : Remission (CDAI <=2.8) | 0 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 4 : High (CDAI > 22 ) | 58 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 12: Remission (CDAI <=2.8) | 12 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 12 : Low (2.8 < CDAI <= 10) | 52 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 12 : Moderate (10 < CDAI <= 22) | 67 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 12 : High (CDAI > 22 ) | 17 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 24: Remission (CDAI <=2.8) | 29 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 24 : Low (2.8 < CDAI <= 10) | 71 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 24 : Moderate (10 < CDAI <= 22) | 45 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 24 : High (CDAI > 22 ) | 3 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 36: Remission (CDAI <=2.8) | 32 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 36 : Low (2.8 < CDAI <= 10) | 67 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 36 : Moderate (10 < CDAI <= 22) | 41 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 36 : High (CDAI > 22 ) | 7 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 48: Remission (CDAI <=2.8) | 37 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 48 : Low (2.8 < CDAI <= 10) | 71 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 48 : Moderate (10 < CDAI <= 22) | 32 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 48 : High (CDAI > 22 ) | 7 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 48 : Moderate (10 < CDAI <= 22) | 31 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Baseline : Remission (CDAI <=2.8) | 0 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 24: Remission (CDAI <=2.8) | 29 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Baseline : Low (2.8 < CDAI <= 10) | 0 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 36 : Moderate (10 < CDAI <= 22) | 32 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Baseline : Moderate (10 < CDAI <= 22) | 6 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 24 : Low (2.8 < CDAI <= 10) | 68 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Baseline : High (CDAI > 22 ) | 125 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 48 : Low (2.8 < CDAI <= 10) | 63 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 4 : Remission (CDAI <=2.8) | 3 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 24 : Moderate (10 < CDAI <= 22) | 30 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 4 : Low (2.8 < CDAI <= 10) | 28 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 36 : High (CDAI > 22 ) | 7 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 4 : Moderate (11 < SDAI <= 26 | 60 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 24 : High (CDAI > 22 ) | 4 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 4 : High (CDAI > 22 ) | 39 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 48 : High (CDAI > 22 ) | 8 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 12: Remission (CDAI <=2.8) | 14 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 36: Remission (CDAI <=2.8) | 29 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 12 : Low (2.8 < CDAI <= 10) | 47 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 48: Remission (CDAI <=2.8) | 29 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 12 : Moderate (10 < CDAI <= 22) | 50 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 36 : Low (2.8 < CDAI <= 10) | 63 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI | Week 12 : High (CDAI > 22 ) | 19 Participants |
Secondary
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
Population: Treatment period 2 per protocol set. Patients with data available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 4 : Moderate (11 < SDAI <= 26 | 75 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Baseline : Low (3.3 < SDAI <= 11) | 0 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Baseline : Moderate (11 < SDAI <= 26) | 20 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Baseline : High (SDAI > 26 ) | 128 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 4 : Remission (SDAI <= 3.3) | 2 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 4 : Low (3.3 < SDAI <= 11) | 29 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Baseline : Remission (SDAI <= 3.3) | 0 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 4 : High (SDAI > 26 ) | 39 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 12: Remission (SDAI <= 3.3) | 14 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 12 : Low (3.3 < SDAI <= 11) | 50 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 12 : Moderate (11 < SDAI <= 26 | 69 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 12 : High (SDAI > 26 ) | 13 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 24: Remission (SDAI <= 3.3) | 31 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 24 : Low (3.3 < SDAI <= 11) | 74 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 24 : Moderate (11 < SDAI <= 26 | 43 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 24 : High (SDAI > 26 ) | 0 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 36: Remission (SDAI <= 3.3) | 34 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 36 : Low (3.3 < SDAI <= 11 | 69 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 36 : Moderate (11 < SDAI <= 26 | 43 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 36 : High (SDAI > 26 ) | 1 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 48: Remission (SDAI <= 3.3) | 39 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 48 : Low (3.3 < SDAI <= 11 | 72 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 48 : Moderate (11 < SDAI <= 26 | 30 Participants |
| 50mg GP2015 | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 48 : High (SDAI > 26 ) | 6 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 48 : Moderate (11 < SDAI <= 26 | 29 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Baseline : Remission (SDAI <= 3.3) | 0 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 24: Remission (SDAI <= 3.3) | 29 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Baseline : Low (3.3 < SDAI <= 11) | 0 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 36 : Moderate (11 < SDAI <= 26 | 30 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Baseline : Moderate (11 < SDAI <= 26) | 16 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 24 : Low (3.3 < SDAI <= 11) | 71 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Baseline : High (SDAI > 26 ) | 115 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 48 : Low (3.3 < SDAI <= 11 | 62 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 4 : Remission (SDAI <= 3.3) | 4 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 24 : Moderate (11 < SDAI <= 26 | 29 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 4 : Low (3.3 < SDAI <= 11) | 27 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 36 : High (SDAI > 26 ) | 5 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 4 : Moderate (11 < SDAI <= 26 | 69 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 24 : High (SDAI > 26 ) | 2 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 4 : High (SDAI > 26 ) | 29 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 48 : High (SDAI > 26 ) | 8 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 12: Remission (SDAI <= 3.3) | 12 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 36: Remission (SDAI <= 3.3) | 29 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 12 : Low (3.3 < SDAI <= 11) | 51 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 48: Remission (SDAI <= 3.3) | 32 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 12 : Moderate (11 < SDAI <= 26 | 53 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 36 : Low (3.3 < SDAI <= 11 | 66 Participants |
| 50mg EU-authorized Enbrel | Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI | Week 12 : High (SDAI > 26 ) | 11 Participants |