| 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 | Treatment Period 1 Per-Protocol set | Posted | | Least Squares Mean | Standard Error | scores on a scale | | treatment period 1: up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-2.80± 0.113
- OG001-2.73± 0.117
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| 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. | | | | | Mean Difference (Final Values) | -0.07 | Standard Error of the Mean | 0.097 | 2-Sided | 95 | -0.26 | 0.12 | | | | | Equivalence |
|
| 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 | | Posted | | Count of Participants | | Participants | | Treatment Period 1, up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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 | | Posted | | Count of Participants | | Participants | | baseline, week 2, week 4, week 12, week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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:
- best is 0,
- < 2.6 - remission,
- ≥ 2.6 to ≤ 3.2 - low disease activity
- > 3.2 to ≤ 5.1 - moderate disease activity
- > 5.1 - high disease activity
DAS28-ESR = 0.56 * sqrt(tender28) + 0.28* sqrt(swollen28) + 0.7 * ln(ESR) + 0.014 * GDA where • tender28 and swollen28 are the number of tender and swollen joints as assessed using 28-joint count • CRP is C-reactive protein (mg/l) • ESR is erythrocyte sedimentation rate (mm/h) • GDA is the global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm | Treatment period 1 per protocol set. Patients with data available | Posted | | Mean | Standard Deviation | score on a scale | | week 4, 12, 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Treatment Period 1 - Changes From Baseline in DAS28-CRP and DAS-ESR Scores to Weeks 4, 12 and 24 | | Treatment period 1 per protocol set. Patients with data available | Posted | | Mean | Standard Deviation | score on a scale | | baseline, Week 4, week 12, week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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) ; | Treatment period 1 per protocol set. Patients with data available | Posted | | Count of Participants | | Participants | | week 4, week 12 and week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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 | Treatment period 1 per protocol set. Patients with data available | Posted | | Count of Participants | | Participants | | week 4, week 12 and week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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; | Treatment period 1 per protocol set. Patients with data available | Posted | | Count of Participants | | Participants | | week 4, week 12, week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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.
| Treatment period 1 per protocol set. Patients with data available | Posted | | Count of Participants | | Participants | | Week 4, week 12 and week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | Treatment period 1 per protocol set. Patients with data available | Posted | | Mean | Standard Deviation | score on a scale | | Weeks 4, 12 and 24; | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | Treatment period 1 per protocol set. Patients with data available | Posted | | Count of Participants | | Participants | | Weeks 4, 12 and 24; | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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. | Treatment period 1 per protocol set. Patients with data available | Posted | | Count of Participants | | Participants | | Weeks 4, 12 and 24; | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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) | Treatment period 1 per protocol set. Patients with data available | Posted | | Count of Participants | | Participants | | Weeks 4, 12 and 24; | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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) | Treatment period 1 per protocol set. Patients with data available | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Weeks 4, 12 and 24; | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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. | Treatment period 1 per protocol set. Patients with data available | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Weeks 4, 12 and 24; | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | Treatment Period 1 - CRP Levels at Baseline and Weeks 4, 12 and 24 | | Treatment period 1 per protocol set. Patients with data available | Posted | | Mean | Standard Deviation | mg/dL | | Weeks 4, 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | Treatment Period 1 - ESR Levels at Baseline and Weeks 4, 12 and 24 | | Treatment period 1 per protocol set. Patients with data available | Posted | | Mean | Standard Deviation | mm/h | | Weeks 4, 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; | DAS28-CRP and DAS28-ESR:
- best is 0,
- < 2.6 - remission,
- ≥ 2.6 to ≤ 3.2 - low disease activity
- > 3.2 to ≤ 5.1 - moderate disease activity
- > 5.1 - high disease activity
| Treatment period 2 per protocol set. Patients with data available | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, week 4, week 12, week 24, week 36 and week 48. | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48 | | Treatment period 2 per protocol set. Patients with data available | Posted | | Mean | Standard Deviation | score on a scale | | week 4, week 12, week 24, week 36, week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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; | Treatment period 2 per protocol set. Patients with data available | Posted | | Count of Participants | | Participants | | week 4, week 12, week 24, week 36 and week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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 | Treatment period 2 per protocol set. Patients with data available | Posted | | Count of Participants | | Participants | | week 36 and week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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; | Treatment period 2 per protocol set. Patients with data available | Posted | | Count of Participants | | Participants | | week 4, week 12, week 24, week 36, week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | Treatment Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Weeks 36 and 48; | | Treatment period 2 per protocol set. Patients with data available | Posted | | Count of Participants | | Participants | | week 36 and week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | Treatment Period 2 : ACR-N Scores at Weeks 36 and 48; | ACR-N: negative is worsening, positive (up to 100) is an improvement | Treatment period 2 per protocol set. Patients with data available | Posted | | Mean | Standard Deviation | score on a scale | | week 36 and week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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. | Treatment period 2 per protocol set. Patients with data available | Posted | | Count of Participants | | Participants | | baseline, week 4, week 12, week 24, week 36. week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| 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; | Treatment period 2 per protocol set. Patients with data available | Posted | | Count of Participants | | Participants | | baseline, week 4, week 12, week 24, week 36 and week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Treatment Period 2 :Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 36 and 48; | | Treatment period 2 per protocol set. Patients with data available | Posted | | Count of Participants | | Participants | | baseline, week 4, week 12, week 24, week 36, week 48 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Treatment Period 2 :HAQ Index at Weeks 36 and 48; | HAQ: from 0 (best) to 3 (worst) | Treatment period 2 per protocol set. Patients with data available | Posted | | Mean | Standard Deviation | score on a scale | | baseline, week 4, week 12, week 24, week 36, week 48 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| 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 | Treatment period 2 per protocol set. Patients with data available | Posted | | Mean | Standard Deviation | score on a scale | | baseline, week 4, week 12, week 24, week 36, week 48 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Treatment Period 2 : CRP Levels at Week 36 and 48 | | Treatment period 2 per protocol set. Patients with data available | Posted | | Mean | Standard Deviation | mg/dL | | baseline, week 4, week 12, week 24, week 36, week 48 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Treatment Period 2 : ESR Levels at Week 36 and 48 | | Treatment period 2 per protocol set. Patients with data available | Posted | | Mean | Standard Deviation | mm/h | | baseline, week 4, week 12, week 24, week 36, week 48 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| 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 | | Posted | | Count of Participants | | Participants | | up to 48 weeks | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| 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 | | Posted | | Count of Participants | | Participants | | baseline, week 4, week 12, week 24, week 36, week 48 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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