GP2017 (adalimumab biosimilar) ( DrugBank: Adalimumab )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 271 | 強直性脊椎炎 | 14 |
271. 強直性脊椎炎
臨床試験数 : 574 / 薬物数 : 359 - (DrugBank : 68) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 146
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2017-000679-10-GR (EUCTR) | 05/03/2019 | 19/12/2018 | A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS | A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS | Ankylosing spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Trade Name: Hyrimoz Product Name: adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 837 | Phase 3 | United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan | ||
| 2 | JPRN-JapicCTI-184106 | 07/11/2018 | 11/09/2018 | Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar) (SURPASS) | A Randomized, Partially-blinded Study of Secukinumab to Demonstrate Reduction of Radiographic Progression Versus GP2017 (Adalimumab Biosimilar) at 104 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis | Ankylosing Spondylitis | Intervention name : Secukinumab INN of the intervention : Secukinumab Dosage And administration of the intervention : Secukinumab 150mg or 300mg will be administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100 Control intervention name : GP2017 (adalimumab biosimilar) INN of the control intervention : Adalimumab Dosage And administration of the control intervention : GP2017 (adalimumab biosimilar) 40 mg will be administered at Baseline followed by dosing every 2 weeks until Week 102 | Novartis Pharma K.K. | NULL | complete | 18 | BOTH | 15 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa | |
| 3 | EUCTR2017-000679-10-SK (EUCTR) | 24/10/2018 | 02/10/2017 | Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar) | A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS | Ankylosing spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Trade Name: Hyrimoz Product Name: adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 837 | Phase 3 | United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan | ||
| 4 | EUCTR2017-000679-10-PT (EUCTR) | 16/07/2018 | 15/01/2018 | Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar) | A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS | Ankylosing spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Trade Name: Hyrimoz Product Name: adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 837 | Phase 3 | Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan | ||
| 5 | EUCTR2017-000679-10-PL (EUCTR) | 19/06/2018 | 28/03/2018 | Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar) | A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS | Ankylosing spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Trade Name: Hyrimoz Product Name: adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 837 | Phase 3 | United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan | ||
| 6 | EUCTR2017-000679-10-NL (EUCTR) | 07/06/2018 | 18/12/2017 | A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS | A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS | Ankylosing spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Trade Name: Hyrimoz Product Name: adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 837 | Phase 3 | United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan | ||
| 7 | EUCTR2017-000679-10-FR (EUCTR) | 22/01/2018 | 22/09/2017 | A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS | A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS | Ankylosing spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Product Name: adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 837 | Phase 3 | United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Israel;Chile;Russian Federation;Colombia;France;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany | ||
| 8 | EUCTR2017-000679-10-CZ (EUCTR) | 10/01/2018 | 25/09/2017 | Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar) | A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS | Ankylosing spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Trade Name: Hyrimoz Product Name: adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 837 | Phase 3 | Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Israel;Chile;Russian Federation;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan | ||
| 9 | EUCTR2017-000679-10-FI (EUCTR) | 18/12/2017 | 05/10/2017 | A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS | A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS | Ankylosing spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Trade Name: Hyrimoz Product Name: adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 837 | Phase 3 | United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan | ||
| 10 | EUCTR2017-000679-10-DE (EUCTR) | 18/12/2017 | 24/08/2017 | A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS | A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS | Ankylosing spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Trade Name: Hyrimoz Product Name: adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 837 | Phase 3 | United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan | ||
| 11 | NCT03259074 (ClinicalTrials.gov) | November 30, 2017 | 21/8/2017 | Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar) | A Randomized, Partially-blinded Study of Secukinumab to Demonstrate Reduction of Radiographic Progression Versus GP2017 (Adalimumab Biosimilar) at 104 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis | Ankylosing Spondylitis | Biological: Secukinumab;Biological: GP2017 (adalimumab biosimilar) | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 861 | Phase 3 | United States;Argentina;Australia;Belgium;Canada;Chile;Colombia;Czechia;Denmark;Finland;France;Germany;Greece;Israel;Japan;Korea, Republic of;Mexico;Netherlands;Peru;Philippines;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Taiwan;Turkey;United Kingdom;Monaco |
| 12 | EUCTR2017-000679-10-ES (EUCTR) | 23/11/2017 | 18/09/2017 | Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar) | A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS | Ankylosing spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Product Name: adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 837 | Phase 3 | Portugal;United States;Philippines;Taiwan;Slovakia;Spain;Russian Federation;Chile;Israel;Colombia;France;Australia;Denmark;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany | ||
| 13 | EUCTR2017-000679-10-DK (EUCTR) | 23/11/2017 | 25/10/2017 | A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS | A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS | Ankylosing spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Trade Name: Hyrimoz Product Name: adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 837 | Phase 3 | United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan | ||
| 14 | EUCTR2017-000679-10-GB (EUCTR) | 16/11/2017 | 08/08/2017 | Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar) | A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS | Ankylosing spondylitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: secukinumab Other descriptive name: SECUKINUMAB Product Name: adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 837 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Chile;Israel;Colombia;France;Australia;Denmark;Peru;Netherlands;Korea, Republic of;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan |