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| Name | Class |
|---|---|
| Hexal AG | INDUSTRY |
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The purpose of this study is to demonstrate equivalent efficacy of GP2015 and Enbrel® in patients with moderate to severe chronic plaque-type psoriasis with respect to PASI 75 response rate at Week 12.
The purpose of this confirmatory safety and efficacy study (GP15-302) was to demonstrate equivalence in efficacy and similarity in safety and immunogenicity of GP2015 and Enbrel (EU-authorized) in patients with moderate to severe chronic plaque-type psoriasis and to evaluate the effects of repeated switching between GP2015 and Enbrel on efficacy, overall safety, and immunogenicity. Since only EU-authorized Enbrel was utilized in this study, the use of the term "Enbrel" throughout this report describes EU-authorized Enbrel only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GP2015 Etanercept | Experimental | Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter |
|
| Enbrel ® Etanercept | Active Comparator | Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GP2015 Etanercept | Drug | Sandoz has developed GP2015 Etanercept (Sandoz's code for the drug product containing the active ingredient etanercept) to be biosimilar to Enbrel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PASI 75 Response Rate at Week 12 - GP2015 Etanercept vs. Enbrel ® Etanercept | The 95% CI for the Psoriasis Area and Severity Index (PASI) 75 response rate differences at Week12 between GP2015 Etanercept and Enbrel ® Etanercept. PASI 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretic maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in PASI Score up to Week 12 | The key secondary efficacy endpoint was the % change from baseline in PASI score up to Week 12. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretic maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity. Two approaches (longitudinal approach applying a Mixed Model Repeated Measures and Averaged Treatment Effect approach applying an ANCOVA model) were employed in order to calculate 2-sided 95% confidence intervals (CI) for the difference between the treatment groups. |
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Inclusion Criteria:
Men or women at least 18 years of age at time of screening
Chronic plaque-type psoriasis diagnosed for at least 6 months before baseline
Moderate to severe psoriasis as defined at baseline by:
Chronic plaque-type psoriasis patients who have previously received phototherapy or systemic psoriasis therapy at least once or who are candidates for such therapies in the opinion of the investigator.
Exclusion Criteria:
Other In-/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Sascha Gerdes, MD | Klinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Schleswig Holstein, Kiel, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sandoz Investigational Site | Pleven | Bulgaria | ||||
| Sandoz Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40279006 | Derived | Thaci D, Gerdes S, Schulze-Koops H, Allanore Y, Kavanaugh A, Both C, Gattu S, Hachaichi S, Matucci-Cerinic M. Patient-Reported Outcome Measures in Patients with Rheumatoid Arthritis, Psoriasis, or Psoriatic Arthritis Treated with GP2015, an Etanercept Biosimilar: Results from Two Phase III Studies (EGALITY and EQUIRA). Drugs R D. 2025 Jun;25(2):107-115. doi: 10.1007/s40268-025-00507-8. Epub 2025 Apr 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | GP2015 Etanercept | Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter GP2015 Etanercept |
| FG001 | Enbrel ® Etanercept |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
|
Not provided
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Not provided
|
| Enbrel | Drug | Enbrel is used as reference product to GP2015. |
|
|
| 12 weeks |
| PASI 50, 75 and 90 Response Rates | Percentage of patients achieving Psoriasis Area and Severity Index (PASI) 50, PASI 75, and PASI 90 responses at Week 12. PASI 50 response: patients who achieved ≥ 50% improvement (reduction) in PASI score compared to baseline were defined as PASI 50 responders .PASI 90 response: patients who achieved ≥ 90% improvement (reduction) in PASI score compared to baseline were defined as PASI 90 responders . | Week12 |
| Injection Site Reactions | Percentage of patients with injection site reactions up to Week 52 | Week52 |
| Immunogenicity: Measurement of Rate of ADA Formations Against GP2015 Etanercept and Enbrel ® Etanercept | Immunogenicity was analyzed by the percentage of patients with positive anti-drug antibodies (ADA) to either GP2015 Etanercept or Enbrel ® up to Week 52. | Week 52 |
| Plovdiv |
| Bulgaria |
| Sandoz Investigational Site 1 | Sofia | Bulgaria |
| Sandoz Investigational Site 2 | Sofia | Bulgaria |
| Sandoz Investigational Site 3 | Sofia | Bulgaria |
| Sandoz Investigational Site | Olomouc | Czechia |
| Sandoz Investigational Site | Prague | Czechia |
| Sandoz Investigational Site | Ústí nad Labem | Czechia |
| Sandoz Investigational Site 1 | Tallinn | Estonia |
| Sandoz Investigational Site 2 | Tallinn | Estonia |
| Sandoz Investigational Site 3 | Tallinn | Estonia |
| Sandoz Investigational Site 1 | Tartu | Estonia |
| Sandoz Investigational Site 2 | Tartu | Estonia |
| Sandoz Investigational Site 1 | Berlin | Germany |
| Sandoz Investigational Site 2 | Berlin | Germany |
| Sandoz Investigational Site 1 | Dresden | Germany |
| Sandoz Investigational Site 2 | Dresden | Germany |
| Sandoz Investigational Site | Kiel | Germany |
| Sandoz Investigational Site | Lübeck | Germany |
| Sandoz Investigational Site | Munich | Germany |
| Sandoz Investigational Site | Budapest | Hungary |
| Sandoz Investigational Site | Debrecen | Hungary |
| Sandoz Investigational Site | Gyula | Hungary |
| Sandoz Investigational Site | Szolnok | Hungary |
| Sandoz Investigational Site | Gdansk | Poland |
| Sandoz Investigational Site | Gdynia | Poland |
| Sandoz Investigational Site | Katowice | Poland |
| Sandoz Investigational Site 1 | Krakow | Poland |
| Sandoz Investigational Site 2 | Krakow | Poland |
| Sandoz Investigational Site 1 | Lodz | Poland |
| Sandoz Investigational Site 2 | Lodz | Poland |
| Sandoz Investigational Site 3 | Lodz | Poland |
| Sandoz Investigational Site 4 | Lodz | Poland |
| Sandoz Investigational Site | Poznan | Poland |
| Sandoz Investigational Site | Rzeszów | Poland |
| Sandoz Investigational Site | Warsaw | Poland |
| Sandoz Investigational Site | Wroclaw | Poland |
| Sandoz Investigational Site | Zgierz | Poland |
| Sandoz Investigational Site | Brasov | Romania |
| Sandoz Investigational Site 1 | Bucharest | Romania |
| Sandoz Investigational Site 2 | Bucharest | Romania |
| Sandoz Investigational Site 3 | Bucharest | Romania |
| Sandoz Investigational Site | Cluj-Napoca | Romania |
| Sandoz Investigational Site 1 | Iași | Romania |
| Sandoz Investigational Site 2 | Iași | Romania |
| Sandoz Investigational Site | Târgu Mureş | Romania |
| Sandoz Investigational Site | Timișoara | Romania |
| Sandoz Investigational Site | Saint Petersburg | Russia |
| Sandoz Investigational Site | Smolensk | Russia |
| Sandoz Investigational Site | Banská Bystrica | Slovakia |
| Sandoz Investigational Site | Bojnice | Slovakia |
| Sandoz Investigational Site 1 | Bratislava | Slovakia |
| Sandoz Investigational Site 2 | Bratislava | Slovakia |
| Sandoz Investigational Site | Kosice-Saka | Slovakia |
| Sandoz Investigational Site | Košice | Slovakia |
| Sandoz Investigational Site | Nitra | Slovakia |
| Sandoz Investigational Site | Svidník | Slovakia |
| Sandoz Investigational Site | Bloemfontein | South Africa |
| Sandoz Investigational Site | Krugersdorp | South Africa |
| Sandoz Investigational Site 1 | Pretoria | South Africa |
| Sandoz Investigational Site | Worcester | South Africa |
| Sandoz Investigational Site | Dnipropetrovsk | Ukraine |
| Sandoz Investigational Site | Donetsk | Ukraine |
| Sandoz Investigational Site | Kharkiv | Ukraine |
| Sandoz Investigational Site | Kyiv | Ukraine |
| Sandoz Investigational Site | Luhansk | Ukraine |
| Sandoz Investigational Site | Rivne | Ukraine |
| Sandoz Investigational Site | Simferopol | Ukraine |
| Sandoz investigational Site | Zaporizhzhia | Ukraine |
| Sandoz Investigational Site | Dundee | United Kingdom |
| Sandoz Investigational Site | Leeds | United Kingdom |
| Sandoz Investigational Site | London | United Kingdom |
| Sandoz Investigational Site | Newcastle upon Tyne | United Kingdom |
| Sandoz Investigational Site | Salford | United Kingdom |
Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter Enbrel ® Etanercept |
| FG002 | GP2015 Etanercept Continued | GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 13 until Week 30 (Treatment Period 2). GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2 |
| FG003 | Enbrel ® Etanercept Continued | Enbrel ® 50 mg subcutaneous (s.c.) injection of study drug from week 13 until Week 30 (Treatment Period 2) Enbrel ® 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2. |
| FG004 | GP2015 Etanercept Switched | GP2015/Enbrel ® 50 mg subcutaneous (s.c.) injection of study drug until Week 30. Three periods of 6 weeks alternating between Enbrel/GP2015/Enbrel (Treatment Period 2). Enbrel ® 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2. |
| FG005 | Enbrel ® Etanercept Switched | Enbrel ®/GP2015 50 mg subcutaneous (s.c.) injection of study drug until Week 30. Three periods of 6 weeks alternating between GP2015/Enbrel/GP2015 (Treatment Period 2). GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Treatment Period 2 |
|
|
| Extension Period |
|
|
All patients randomized in GP15-302 study
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| ID | Title | Description |
|---|---|---|
| BG000 | GP2015 Etanercept | Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter GP2015 Etanercept |
| BG001 | Enbrel ® Etanercept | Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter Enbrel ® Etanercept |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PASI 75 Response Rate at Week 12 - GP2015 Etanercept vs. Enbrel ® Etanercept | The 95% CI for the Psoriasis Area and Severity Index (PASI) 75 response rate differences at Week12 between GP2015 Etanercept and Enbrel ® Etanercept. PASI 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretic maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity. | The analysis of the primary outcome measure was based on the per-protocol set (PPS) consisting of patients who completed study until 12 weeks without any major protocol deviation. | Posted | Number | % of patients achieving PASI75 response | Week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in PASI Score up to Week 12 | The key secondary efficacy endpoint was the % change from baseline in PASI score up to Week 12. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretic maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity. Two approaches (longitudinal approach applying a Mixed Model Repeated Measures and Averaged Treatment Effect approach applying an ANCOVA model) were employed in order to calculate 2-sided 95% confidence intervals (CI) for the difference between the treatment groups. | The analysis was based on the per-protocol set (PPS) consisting of patients who completed study until 12 weeks without any major protocol deviation. | Posted | Least Squares Mean | Standard Error | percentage difference | 12 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PASI 50, 75 and 90 Response Rates | Percentage of patients achieving Psoriasis Area and Severity Index (PASI) 50, PASI 75, and PASI 90 responses at Week 12. PASI 50 response: patients who achieved ≥ 50% improvement (reduction) in PASI score compared to baseline were defined as PASI 50 responders .PASI 90 response: patients who achieved ≥ 90% improvement (reduction) in PASI score compared to baseline were defined as PASI 90 responders . | The analysis of this secondary outcome measure was based on the per-protocol set (PPS) consisting of patients who completed study until 12 weeks without any major protocol deviation. | Posted | Number | percentage of patients | Week12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Injection Site Reactions | Percentage of patients with injection site reactions up to Week 52 | The analysis was performed on safety set including all patients who took at least 1 dose of study treatment | Posted | Number | percentage of patients with ISRs | Week52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Immunogenicity: Measurement of Rate of ADA Formations Against GP2015 Etanercept and Enbrel ® Etanercept | Immunogenicity was analyzed by the percentage of patients with positive anti-drug antibodies (ADA) to either GP2015 Etanercept or Enbrel ® up to Week 52. | The analysis was performed on immunogenicity set consisting of patients who provided data for ADA assessment of etanercept at baseline visit. | Posted | Number | percentage patients with positive ADA | Week 52 |
|
Adverse events are reported until the end of the study (week 52).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GP2015 Etanercept Continued | GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks. GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2). GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2. | 7 | 164 | 97 | 164 | ||
| EG001 | Enbrel ® Etanercept Switched | Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks. Enbrel ® Etanercept /GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between GP2015/Enbrel/GP2015 (Treatment Period 2). GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2. | 6 | 96 | 57 | 96 | ||
| EG002 | GP2015 Etanercept Switched | GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks. GP2015 Etanercept /Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between Enbrel/GP2015/Enbrel (Treatment Period 2). Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2. | 6 | 100 | 60 | 100 | ||
| EG003 | Enbrel ® Etanercept Continued | Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks. Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2). Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2. | 7 | 171 | 94 | 171 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Squamous cell carcinoma of the cervix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Milk allergy | Immune system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | Fatal event |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pulmonary sarcoidosis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Mesenteric vascular insufficiency | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Acid-base balance disorder mixed | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Eczema infected | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertenson | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Schiatica | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Eye haemorrhage | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hepatitis alcoholic | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dermatitis psoriasiform | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pruritus generalized | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
None reported
At least sixty days prior to submitting/presenting manuscript or other materials relating to the study a copy should be provided to Sandoz and Sandoz has sixty days to review and comment. Sandoz has the right to require amendments to any such proposed presentation or publication on reasonable grounds. Sandoz may require any proposed publication or presentation to be delayed for up to four months to enable a patent application to be prepared and filed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Guido Wuerth - Global Program Medical Director | Sandoz | +4980244762925 | guido.wuerth@sandoz.com |
| ID | Term |
|---|---|
| C000628566 | GP2015 |
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
Not provided
Not provided
| Physician Decision |
|
| Site Termination |
|
| Lack of Efficacy |
|
| Adverse Event |
|
| Termination of Site |
|
| Withdrawal by Subject |
|
| Pregnancy |
|
| Adverse Event |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| >=65 years |
|
| Male |
|
| Russian Federation |
|
| Romania |
|
| Hungary |
|
| Ukraine |
|
| Poland |
|
| South Africa |
|
| United Kingdom |
|
| Slovakia |
|
| Bulgaria |
|
| Germany |
|
| Estonia |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Participants |
|
|
GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks. GP2015 Etanercept /Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between Enbrel/GP2015/Enbrel (Treatment Period 2). Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2. |
| OG003 | Enbrel ® Etanercept Continued | Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks. Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2). Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2. |
|
|
| OG002 | GP2015 Etanercept Switched | GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks. GP2015 Etanercept /Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between Enbrel/GP2015/Enbrel (Treatment Period 2). Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2. |
| OG003 | Enbrel ® Etanercept Continued | Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks. Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2). Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2. |
|
|