Secukinumab (DrugBank: Secukinumab)
7 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 13 | 多発性硬化症／視神経脊髄炎 | 12 |
| 37 | 膿疱性乾癬（汎発型） | 12 |
| 41 | 巨細胞性動脈炎 | 2 |
| 46 | 悪性関節リウマチ | 43 |
| 160 | 先天性魚鱗癬 | 1 |
| 269 | 化膿性無菌性関節炎・壊疽性膿皮症・アクネ症候群 | 3 |
| 271 | 強直性脊椎炎 | 72 |
| 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 | EUCTR2012-004019-29-PL (EUCTR) | 07/10/2013 | 02/09/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | United States;Portugal;Finland;Spain;Turkey;Russian Federation;Colombia;Switzerland;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 2 | EUCTR2012-004019-29-DE (EUCTR) | 19/09/2013 | 06/05/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: Secukinumab | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 3 | EUCTR2012-004019-29-PT (EUCTR) | 02/08/2013 | 03/06/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 4 | EUCTR2012-004019-29-CZ (EUCTR) | 18/07/2013 | 13/05/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 5 | EUCTR2012-004019-29-IT (EUCTR) | 10/07/2013 | 11/01/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebocontrolled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 470 | Phase 2 | United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;Canada;Argentina;Poland;Germany;Japan;Sweden | ||
| 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 |
| 6 | EUCTR2012-004019-29-SE (EUCTR) | 19/06/2013 | 12/04/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 7 | EUCTR2012-004019-29-FI (EUCTR) | 19/06/2013 | 16/05/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 8 | JPRN-JapicCTI-132178 | 01/6/2013 | A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis | A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis | Intervention name : AIN457 INN of the intervention : secukinumab Dosage And administration of the intervention : AIN457 will be administered intravenously. Patients will be randomized to AIN457 Low/Middle/High dose. Control intervention name : Placebo Dosage And administration of the control intervention : Matching placebo will be administered intravenously. | Novartis Pharma K.K. | NULL | 18 | 55 | BOTH | 380 | Phase 2 | NULL | ||
| 9 | NCT01874340 (ClinicalTrials.gov) | June 2013 | 28/5/2013 | Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis | A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Placebo;Drug: AIN457 | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 55 Years | All | 28 | Phase 2 | Belgium;Czech Republic;France;Italy;Japan;Poland;Russian Federation;Spain;Sweden;Turkey;Canada;Finland;Germany;Romania;Switzerland;United States |
| 10 | EUCTR2012-004019-29-ES (EUCTR) | 24/05/2013 | 24/06/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Other descriptive name: SECUKINUMAB | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 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 |
| 11 | EUCTR2012-004019-29-BE (EUCTR) | 29/04/2013 | 23/10/2012 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan;Sweden | ||
| 12 | EUCTR2011-001629-25-CZ (EUCTR) | 10/01/2012 | 11/10/2011 | A clinical extension study to evaluate the safety, tolerability and efficacy of AIN457 in multiple sclerosis patients with relapses | An open label extension study to evaluate the safety, tolerability and efficacy of AIN457 in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: rhumAb to IL-17A igG1-k-class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 40 | Czech Republic;Ukraine;Russian Federation |
| 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 | JPRN-JapicCTI-184065 | 22/8/2018 | 15/08/2018 | I6T-MC-AMAJ | A Multicenter Randomized Double-Blind Placebo-Controlled Study Comparing the Efficacy and Safety of Mirikizumab to Secukinumab and Placebo in Patients with Moderate-to-Severe Plaque Psoriasis OASIS-2 | Psoriasis valgaris, Generalized pustular psoriasis, Erythrodermic psoriasis | Intervention name : LY3074828 INN of the intervention : mirikizumab Dosage And administration of the intervention : Administered subcutaneous injection Control intervention name : Secukinumab INN of the control intervention : secukinumab Dosage And administration of the control intervention : Administered subcutaneous injection Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Administered subcutaneous injection | Eli Lilly Japan K.K. | NULL | complete | 20 | BOTH | 120 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Oceania | |
| 2 | EUCTR2013-003086-34-PL (EUCTR) | 18/04/2014 | 10/03/2014 | Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular Psoriasis | A 52-week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks | moderate to severe chronic palmoplantar pustular psoriasis MedDRA version: 17.1;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 17.1;Level: LLT;Classification code 10037158;Term: Psoriasis palm & soles;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | France;Belgium;Spain;Poland;Austria;Russian Federation;Germany;Italy;United Kingdom;Sweden | ||
| 3 | EUCTR2013-003086-34-IT (EUCTR) | 04/03/2014 | 12/12/2013 | Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular Psoriasis | A 52-week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis | moderate to severe chronic palmoplantar pustular psoriasis MedDRA version: 14.1;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 14.1;Level: LLT;Classification code 10037158;Term: Psoriasis palm & soles;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Other descriptive name: SECUKINUMAB | NOVARTIS FARMA S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | France;Belgium;Spain;Poland;Austria;Russian Federation;Germany;United Kingdom;Italy;Sweden | ||
| 4 | EUCTR2013-003086-34-BE (EUCTR) | 10/02/2014 | 09/12/2013 | Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular Psoriasis | A 52-week, multicenter, randomized, double-blind, placebo-controlledstudy of subcutaneous secukinumab to demonstrate efficacy as assessedby palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at16 weeks of treatment, compared to placebo, and to assess long-termsafety, tolerability, and efficacy in subjects with moderate to severechronic palmoplantar pustular psoriasis - amended with an optionalextension treatment period of up to a total of 148 weeks | moderate to severe chronic palmoplantar pustular psoriasis MedDRA version: 20.0;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Level: LLT;Classification code 10037158;Term: Psoriasis palm & soles;System Organ Class: 100000018190;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Secukinumab 150 mg/1 mL Solution for injection Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | France;Poland;Spain;Belgium;Austria;Russian Federation;Germany;Italy;United Kingdom;Sweden | ||
| 5 | EUCTR2013-003086-34-DE (EUCTR) | 27/12/2013 | 05/12/2013 | Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular Psoriasis | A 52-week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks | moderate to severe chronic palmoplantar pustular psoriasis MedDRA version: 19.0;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 19.0;Level: LLT;Classification code 10037158;Term: Psoriasis palm & soles;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Secukinumab Product Code: AIN457, 150mg INN or Proposed INN: SECUKINUMAB Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | France;Poland;Belgium;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Sweden | ||
| 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 |
| 6 | NCT02008890 (ClinicalTrials.gov) | December 26, 2013 | 8/12/2013 | Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab | A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab to Demonstrate Efficacy as Assessed by Palmoplantar Pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 Weeks of Treatment, Compared to Placebo, and to Assess Long-term Safety, Tolerability, and Efficacy in Subjects With Moderate to Severe Chronic Palmoplantar Pustular Psoriasis - Amended With an Optional Extension Treatment Period of up to a Total of 148 Weeks | Palmoplantar Pustular Psoriasis | Biological: Secukinumab 300mg;Biological: Secukinumab 150mg;Biological: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 237 | Phase 3 | Austria;Belgium;France;Germany;Italy;Poland;Russian Federation;Spain;Sweden;United Kingdom |
| 7 | EUCTR2013-003086-34-AT (EUCTR) | 17/12/2013 | 28/11/2013 | Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular Psoriasis | A 52-week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks | moderate to severe chronic palmoplantar pustular psoriasis MedDRA version: 18.0;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 18.0;Level: LLT;Classification code 10037158;Term: Psoriasis palm & soles;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | France;Poland;Belgium;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Sweden | ||
| 8 | EUCTR2013-003086-34-GB (EUCTR) | 12/12/2013 | 28/11/2013 | Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular Psoriasis | A 52-week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks. | moderate to severe chronic palmoplantar pustular psoriasis MedDRA version: 17.1;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 17.1;Level: LLT;Classification code 10037158;Term: Psoriasis palm & soles;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | France;Poland;Belgium;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Sweden | |||
| 9 | EUCTR2013-003086-34-ES (EUCTR) | 09/12/2013 | 05/12/2013 | Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular Psoriasis. | A 52-week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis. | Moderate to severe chronic palmoplantar pustular psoriasis. MedDRA version: 14.1;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 14.1;Level: LLT;Classification code 10037158;Term: Psoriasis palm & soles;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | France;Belgium;Poland;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Sweden | ||
| 10 | EUCTR2013-003086-34-SE (EUCTR) | 04/12/2013 | 22/11/2013 | Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular Psoriasis | A 52-week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis | Moderate to severe chronic palmoplantar pustular psoriasis MedDRA version: 16.1;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 16.1;Level: LLT;Classification code 10037158;Term: Psoriasis palm & soles;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | France;Spain;Belgium;Poland;Austria;Russian Federation;Germany;United Kingdom;Italy;Sweden | ||
| 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 |
| 11 | NCT01952015 (ClinicalTrials.gov) | August 21, 2013 | 24/9/2013 | Study to Assess the Efficacy, Safety and Tolerability of Secukinumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP) | A Multi-center, Open Label Study of Subcutaneous Secukinumab in Prefilled Syringes as Mono- or Co-therapy to Assess the Efficacy, Safety and Tolerability in Japanese Subjects With Generalized Pustular Psoriasis | Psoriasis | Biological: Secukinumab | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 12 | Phase 3 | Japan |
| 12 | JPRN-JapicCTI-132305 | 01/8/2013 | 18/10/2013 | Study to assess the efficacy, safety and tolerability of secukinumab in Japanese subjects with GPP | A multi-center, open label study of subcutaneous secukinumab in prefilled syringes as mono- or co-therapy to assess the efficacy, safety and tolerability up to 52 weeks in Japanese subjects with generalized pustular psoriasis | Generalized Pustular Psoriasis (GPP) | Intervention name : AIN457 INN of the intervention : Secukinumab Dosage And administration of the intervention : Secukinumab 150 mg, provided in a 1 mL prefilled syringe (one syringe for 150 mg dose, two syringes for the 300 mg dose) Control intervention name : null | Novartis Pharma K.K. | NULL | 18 | BOTH | Phase 3 | NULL |
| 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 | NCT03765788 (ClinicalTrials.gov) | January 30, 2019 | 3/12/2018 | A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell Arteritis | A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab (AIN457) in Patients With Giant Cell Arteritis (TitAIN) | Giant Cell Arteritis | Biological: Secukinumab 300 mg, s.c.;Drug: Prednisolone;Drug: Placebo to match Secukinumab, s.c. | Novartis Pharmaceuticals | NULL | Active, not recruiting | 50 Years | N/A | All | 52 | Phase 2 | Germany |
| 2 | EUCTR2018-002610-12-DE (EUCTR) | 06/12/2018 | 23/08/2018 | Study in patients with giant cell arteritis to assess efficacy of secukinumab compared to placebo | A randomized, parallel-group, double-blind, placebo-controlled, multicenter phase 2 trial to investigate the safety and efficacy of secukinumab (AIN457) in patients with giant cell arteritis (TitAIN) - TitAIN | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Novartis Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | Germany |
| 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 | EUCTR2013-000944-25-HU (EUCTR) | 19/09/2013 | 16/07/2013 | Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with rheumatoid arthritis | A three year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in subjects with active rheumatoid arthritis - REASSURE-1 Extension | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 454 | Panama;United States;Thailand;Guatemala;Colombia;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Japan | |||
| 2 | JPRN-JapicCTI-132209 | 01/9/2013 | Safety and Efficacy of Extended Treatment With Secukinumab in Anti-TNF Inadequate Responders in RA (REASSURE-E) | A Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Intervention name : AIN457 INN of the intervention : Secukinumab Dosage And administration of the intervention : Subjects will receive 150 mg secukinumab s.c. Control intervention name : null | Novartis Pharma K.K. | NULL | 18 | BOTH | 454 | Phase 3 | NULL | |||
| 3 | NCT01901900 (ClinicalTrials.gov) | September 2013 | 10/7/2013 | Safety and Efficacy of Extended Treatment With Secukinumab in Anti-TNF Inadequate Responders in RA. | A Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Secukinumab (AIN457) | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 196 | Phase 3 | United States;Argentina;Canada;Guatemala;Hungary;India;Italy;Japan;Mexico;Thailand;Colombia;Panama;Puerto Rico |
| 4 | EUCTR2013-000944-25-IT (EUCTR) | 02/08/2013 | 06/06/2013 | Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with rheumatoid arthritis | A three year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in subjects with active rheumatoid arthritis - REASSURE-1 Extension | Rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Farma S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 454 | Panama;United States;Thailand;Guatemala;Colombia;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Japan | |||
| 5 | EUCTR2011-006058-94-DE (EUCTR) | 04/03/2013 | 27/08/2012 | Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents | A Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - REASSURE 2 | Rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 234 | Phase 3 | United States;Portugal;Panama;Ecuador;Greece;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Japan;Korea, Republic of | ||
| 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 |
| 6 | EUCTR2012-002760-27-BG (EUCTR) | 21/01/2013 | 09/11/2012 | Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 345 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany | |||
| 7 | EUCTR2011-006058-94-PT (EUCTR) | 11/12/2012 | 23/10/2012 | Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents | A Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - REASSURE 2 | Rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 234 | Phase 3 | Panama;Portugal;United States;Ecuador;Greece;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Japan;Korea, Republic of | ||
| 8 | EUCTR2011-006058-94-GR (EUCTR) | 04/12/2012 | 23/10/2012 | Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents | A Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 234 | Phase 3 | Panama;Portugal;United States;Greece;Ecuador;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Korea, Republic of | ||
| 9 | EUCTR2012-002760-27-ES (EUCTR) | 14/11/2012 | 23/01/2013 | Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Farmaceutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 345 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany | |||
| 10 | EUCTR2012-002760-27-SK (EUCTR) | 12/11/2012 | 11/10/2012 | Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 345 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany | |||
| 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 |
| 11 | EUCTR2012-002760-27-IT (EUCTR) | 08/11/2012 | 30/10/2012 | A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis. | A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 15.0;Level: LLT;Classification code 10037738;Term: R arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 345 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Bulgaria;Germany | |||
| 12 | EUCTR2012-002760-27-DE (EUCTR) | 06/11/2012 | 25/09/2012 | Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 345 | Romania;Bulgaria;Germany;United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil | |||
| 13 | EUCTR2012-002760-27-HU (EUCTR) | 09/10/2012 | 03/09/2012 | Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 345 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Romania;Bulgaria;Germany | |||
| 14 | JPRN-JapicCTI-132091 | 01/10/2012 | A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFalpha Agents | A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFalpha Agents | Rheumatoid Arthritis | Intervention name : AIN457 INN of the intervention : secukinumab Dosage And administration of the intervention : subcutaneously 75mg, 150mg Control intervention name : null | Novartis Pharma K.K. | NULL | 18 | BOTH | 234 | Phase 3 | NULL | |||
| 15 | NCT01770379 (ClinicalTrials.gov) | October 2012 | 16/10/2012 | Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFa Agents. | A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFa Agents | Rheumatoid Arthritis | Biological: Secukinumab (AIN457);Biological: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 242 | Phase 3 | United States;Argentina;Brazil;Colombia;Czech Republic;Dominican Republic;Germany;Greece;Guatemala;India;Italy;Japan;Korea, Republic of;Panama;Portugal;South Africa;Ecuador;Puerto Rico |
| 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 |
| 16 | EUCTR2012-002760-27-CZ (EUCTR) | 27/09/2012 | 13/08/2012 | Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 345 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany | |||
| 17 | EUCTR2011-006058-94-CZ (EUCTR) | 26/09/2012 | 19/07/2012 | Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents | A Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - REASSURE 2 | Rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 234 | Phase 3 | Portugal;Panama;United States;Ecuador;Greece;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Japan;Korea, Republic of | ||
| 18 | EUCTR2011-006058-94-IT (EUCTR) | 04/09/2012 | 13/09/2012 | Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents | A Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents | Rheumatoid arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457F INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457F INN or Proposed INN: SECUKINUMAB | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 234 | Phase 3 | Portugal;Panama;United States;Greece;Ecuador;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Korea, Republic of | ||
| 19 | NCT01640938 (ClinicalTrials.gov) | September 2012 | 12/7/2012 | Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis | A Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Secukinumab (AIN457) | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 259 | Phase 3 | United States;Brazil;Bulgaria;Canada;Colombia;Czech Republic;France;Germany;Hungary;Italy;Mexico;Russian Federation;Slovakia;Spain;Romania |
| 20 | EUCTR2011-001220-38-DE (EUCTR) | 30/11/2011 | 21/07/2011 | A study identifying blood serum markers that predict response to a 12 week treatment with secukinumab in patients with Rheumatoid Arthritis | A multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of secukinumab (AIN457) in rheumatoid arthritis patients followed by an open label extension | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | United States;Belgium;Russian Federation;Germany;United Kingdom | |||
| 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 |
| 21 | EUCTR2011-000275-13-BE (EUCTR) | 29/11/2011 | 20/10/2011 | Safety and efficacy of secukinumab compared to placebo in patients with active rheumatoid arthritis who did not respond to anti-TNFa drugs | A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 630 | Panama;United States;Thailand;Guatemala;Turkey;Colombia;Italy;United Kingdom;India;Hungary;Mexico;Canada;Argentina;Belgium;Peru;Japan | |||
| 22 | EUCTR2011-000102-21-BG (EUCTR) | 09/11/2011 | 01/09/2011 | Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents | A randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - NURTURE-1 | Rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Trade Name: Orencia Product Name: Abatacept INN or Proposed INN: ABATACEPT | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 548 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany | |||
| 23 | EUCTR2010-024516-34-BG (EUCTR) | 09/11/2011 | 07/09/2011 | Compare the efficacy and assess the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis despite treatment with methotrexate | A randomized, double-blind, placebo-controlled regimen finding study of efficacy, safety and tolerability of secukinumab at 12 weeks administered with an i.v. or s.c. loading regimen compared to placebo in patients with active Rheumatoid Arthritis despite treatment with methotrexate | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 215 | United States;Hungary;Slovakia;Canada;Bulgaria;Italy | |||
| 24 | EUCTR2011-000102-21-DE (EUCTR) | 20/10/2011 | 09/08/2011 | Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents | A randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - NARTURE-1 | Rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Trade Name: Orencia Product Name: Abatacept INN or Proposed INN: ABATACEPT | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 548 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany | |||
| 25 | NCT01359943 (ClinicalTrials.gov) | October 2011 | 19/5/2011 | Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking Methotrexate | A Randomized, Double-blind, Placebo-controlled Study of Efficacy, Safety and Tolerability of Secukinumab at 12 Weeks Administered With an Intravenous (i.v.) or Subcutaneous (s.c.) Loading Regimen Compared to Placebo in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate | Rheumatoid Arthritis | Biological: secukinumab (AIN457);Drug: placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 221 | Phase 2 | United States;Bulgaria;Canada;Hungary;Italy;Poland;Puerto Rico;Slovakia |
| 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 |
| 26 | EUCTR2010-024516-34-SK (EUCTR) | 29/09/2011 | 13/04/2012 | Compare the efficacy and assess the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis despite treatment with methotrexate | A randomized, double-blind, placebo-controlled regimen finding study of efficacy, safety and tolerability of secukinumab at 12 weeks administered with an i.v. or s.c. loading regimen compared to placebo in patients with active Rheumatoid Arthritis despite treatment with methotrexate | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 215 | United States;Hungary;Slovakia;Canada;Bulgaria;Italy | |||
| 27 | EUCTR2011-000102-21-SK (EUCTR) | 22/09/2011 | 28/06/2011 | Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents | A randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents | Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Trade Name: Orencia Product Name: Abatacept INN or Proposed INN: ABATACEPT | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 548 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Bulgaria;Germany | |||
| 28 | EUCTR2011-001220-38-BE (EUCTR) | 19/09/2011 | 30/08/2011 | A study identifying blood serum markers that predict response to a 12 week treatment with secukinumab in patients with Rheumatoid Arthritis | A multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of secukinumab (AIN457) in rheumatoid arthritis patients followed by an open label extension | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | United States;Belgium;Russian Federation;Germany;United Kingdom | ||
| 29 | NCT01350804 (ClinicalTrials.gov) | September 2011 | 9/5/2011 | Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor a (Anti-TNFa) Agents (CAIN457F2309 and CAIN457F2309E1) | A Randomized, Double-blind, Placebo- and Active-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 1 Year in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFa Agents (CAIN457F2309) and A Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2309E1) | Rheumatoid Arthritis | Biological: AIN457;Biological: Placebo;Biological: Abatacept | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 551 | Phase 3 | United States;Brazil;Bulgaria;Canada;Colombia;Czech Republic;France;Germany;Hungary;Italy;Mexico;Romania;Russian Federation;Slovakia;Spain |
| 30 | EUCTR2010-024516-34-HU (EUCTR) | 31/08/2011 | 29/06/2011 | Compare the efficacy and assess the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis despite treatment with methotrexate | A randomized, double-blind, placebo-controlled regimen finding study of efficacy, safety and tolerability of secukinumab at 12 weeks administered with an i.v. or s.c. loading regimen compared to placebo in patients with active Rheumatoid Arthritis despite treatment with methotrexate | Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 215 | United States;Hungary;Canada;Bulgaria;Italy | |||
| 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 |
| 31 | NCT01377012 (ClinicalTrials.gov) | August 30, 2011 | 17/6/2011 | Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFa Agents | A Randomized, Double-blind, Placebo-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 2 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFa Agents (CAIN457F2302) and a Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2302E1) | Rheumatoid Arthritis | Biological: Secukinumab (AIN457);Biological: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 637 | Phase 3 | United States;Argentina;Belgium;Canada;Colombia;Guatemala;Hungary;India;Italy;Japan;Mexico;Panama;Puerto Rico;Thailand;Turkey;United Kingdom;Peru;Romania |
| 32 | EUCTR2011-000102-21-CZ (EUCTR) | 19/08/2011 | 27/05/2011 | Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents | A randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - NURTURE-1 | Rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Trade Name: Orencia Product Name: Abatacept INN or Proposed INN: ABATACEPT | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 548 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany | |||
| 33 | EUCTR2011-000102-21-ES (EUCTR) | 17/08/2011 | 04/07/2011 | Seguridad y Eficacia de secukinumab comparado con placebo y abatacept in pacientes con artritis reumatoide activa que no respodieron a agentes anti- TNFalfa | Estudio aleatorizado, doble ciego, controlado con placebo y con control activo de secukinumab para demostrar la eficacia en 24 semanas y evaluar la seguridad, tolerabilidad y eficacia a largo plazo durante 1 año en pacientes con artritis reumatoide activa que tienen una respuesta inadecuada a anti-TNFalfa | ARTRITIS REUMATOIDE MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: secukinumab Other descriptive name: NO APLICA Trade Name: ORENCIA 250 mg polvo para concentrado para sol. para perfusión INN or Proposed INN: ABATACEPT Other descriptive name: ABATACEPT | Novartis Farmacéutica S.A. | NULL | Not Recruiting | Female: yes Male: yes | 548 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Bulgaria;Germany | |||
| 34 | NCT01426789 (ClinicalTrials.gov) | August 2011 | 12/8/2011 | A Biomarker Study of Secukinumab in Rheumatoid Arthritis (RA) Patients | A Multicenter, 12 Week, Randomized, Double-blind, Placebo-controlled Biomarker Study of Secukinumab (AIN457) in Rheumatoid Arthritis Patients Followed by an Open Label Extension | Rheumatoid Arthritis | Drug: Placebo;Drug: Secukinumab | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 100 | Phase 2 | United States;Belgium;Germany;Russian Federation;United Kingdom |
| 35 | EUCTR2011-000275-13-HU (EUCTR) | 29/07/2011 | 10/06/2011 | Safety and efficacy of secukinumab compared to placebo in patients with active rheumatoid arthritis who did not respond to anti-TNFa drugs | A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 630 | Panama;United States;Thailand;Guatemala;Turkey;Colombia;Italy;United Kingdom;India;Hungary;Mexico;Canada;Argentina;Belgium;Peru;Japan | |||
| 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 |
| 36 | EUCTR2010-024516-34-IT (EUCTR) | 25/07/2011 | 29/12/2011 | Compare the efficacy and assess the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis despite treatment with methotrexate | A randomized, double-blind, placebo-controlled study of efficacy, safety and tolerability of secukinumab at 12 weeks administered with an i.v. or s.c. loading regimen compared to placebo in patients with active rheumatoid arthritis despite treatment with methotrexate | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457F Other descriptive name: Secukinumab | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 215 | United States;Hungary;Canada;Bulgaria;Italy | |||
| 37 | EUCTR2011-000275-13-GB (EUCTR) | 20/07/2011 | 18/07/2011 | Safety and efficacy of secukinumab compared to placebo in patients with active rheumatoid arthritis who did not respond to anti-TNFa drugs | A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents | Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 630 | Panama;United States;Thailand;Guatemala;Turkey;Colombia;Italy;United Kingdom;India;Hungary;Mexico;Canada;Argentina;Belgium;Peru;Japan | |||
| 38 | EUCTR2011-000102-21-HU (EUCTR) | 14/07/2011 | 08/06/2011 | Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents | A randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - NURTURE-1 | Rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Trade Name: Orencia Product Name: Abatacept INN or Proposed INN: ABATACEPT | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 548 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Romania;Bulgaria;Germany | |||
| 39 | EUCTR2011-001220-38-GB (EUCTR) | 12/07/2011 | 17/05/2011 | A study identifying blood serum markers that predict response to a 12 week treatment with secukinumab in patients with Rheumatoid Arthritis | A multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of secukinumab (AIN457) in rheumatoid arthritis patients followed by an open label extension | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | United States;Belgium;Russian Federation;Germany;United Kingdom | ||
| 40 | EUCTR2011-000275-13-IT (EUCTR) | 28/06/2011 | 23/02/2012 | Safety and efficacy of secukinumab compared to placebo in patients with active rheumatoid arthritis who did not respond to anti-TNFa drugs. | A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents. | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 630 | Panama;United States;Thailand;Guatemala;Turkey;Colombia;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Peru;Japan | |||
| 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 |
| 41 | EUCTR2011-000102-21-IT (EUCTR) | 28/06/2011 | 09/01/2012 | Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti- TNFa agents | A randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457F INN or Proposed INN: Secukinumab Trade Name: ORENCIA*IV 2FL 250MG+2SIR INN or Proposed INN: ABATACEPT | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 548 | United States;Slovakia;Spain;Russian Federation;Colombia;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Bulgaria;Germany | |||
| 42 | NCT00928512 (ClinicalTrials.gov) | July 2009 | 25/6/2009 | Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX) | A 16-week Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Secukinumab (AIN457) Followed by an Extension Phase up to a Total of 60 Weeks in Patients With Active Rheumatoid Arthritis Despite Stable Treatment With Methotrexate | Rheumatoid Arthritis | Drug: Secukinmab;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 237 | Phase 2 | United States;Belgium;Czech Republic;Germany;Hungary;Japan;Korea, Republic of;Poland;Russian Federation;Slovakia;Taiwan;Puerto Rico |
| 43 | JPRN-JapicCTI-111601 | 05/09/2011 | A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNF-alpha agents | A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNF-alpha agents | Rheumatoid Arthritis | Intervention name : Secukinumab INN of the intervention : Secukinumab Dosage And administration of the intervention : s.c. i.v. | Novartis Pharma K.K. | NULL | 18 | BOTH | Phase 3 | NULL |
| 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 | NCT03041038 (ClinicalTrials.gov) | December 2016 | 17/1/2017 | The Efficacy and Safety of Secukinumab in Patients With Ichthyoses | A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Open-Label Maintenance Dosing Period to Evaluate the Efficacy and Safety of Secukinumab in Patients With Ichthyoses | Ichthyosis;Autosomal Recessive Congenital Ichthyosis;Lamellar Ichthyosis;Congenital Ichthyosiform Erythroderma;Epidermolytic Ichthyosis;Netherton Syndrome | Drug: Secukinumab;Drug: Placebo | Northwestern University | Icahn School of Medicine at Mount Sinai | Completed | 18 Years | N/A | All | 21 | Phase 2 | United States |
| 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 | NCT04274166 (ClinicalTrials.gov) | January 2021 | 12/2/2020 | Secukinumab for the Inflammatory Phase of Pyoderma Gangrenosum | The Efficacy and Safety of Secukinumab for the Inflammatory Phase of Pyoderma Gangrenosum | Pyoderma Gangrenosum | Drug: secukinumab 150 mg (2 injections per dose | Wake Forest University Health Sciences | Novartis | Not yet recruiting | 18 Years | 75 Years | All | 6 | Phase 2 | United States |
| 2 | NCT02733094 (ClinicalTrials.gov) | April 2016 | 28/3/2016 | Single-arm Study to Assess a Potential Effect of Anti-IL-17 (Secukinumab) in the Treatment of Pyoderma Gangrenosum | Single-arm Study to Assess a Potential Effect of Anti-IL-17 (Secukinumab) in the Treatment of Pyoderma Gangrenosum | Pyoderma Gangrenosum | Drug: Secukinumab | Technische Universität München | Novartis | Active, not recruiting | 18 Years | 75 Years | All | 8 | Phase 1;Phase 2 | Germany |
| 3 | EUCTR2015-000762-65-DE (EUCTR) | 09/07/2015 | 25/06/2015 | Single-arm study to assess a potential effect of anti-IL-17 (Secukinumab) in the treatment of pyoderma gangrenosu | Single-arm study to assess a potential effect of anti-IL-17 (Secukinumab) in the treatment of pyoderma gangrenosum | Pyoderma gangrenosum is an autoinflammatory disease, characterized by relapsing, painful ulcers of the skin. Treatment of PG is difficult. Patients suffer from long hospitalization, pain and reduced life quality. New therapeutic strategies are needed. Immunohistological staining show a high amount of IL-17 in PG. IL-17+ immune cells were located in proximity to cellular damage, indicating an involvement in the pathogenesis. Targeting IL-17 with neutralizing IL-17 antibodies seems promising. MedDRA version: 20.0;Level: PT;Classification code 10037635;Term: Pyoderma gangrenosum;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Cosentyx® Product Name: Cosentyx Product Code: EU/1/14/980/002; EU/1/14/980/003 | Technische Universität München, School of Medicine, represented by Dean | NULL | Not Recruiting | Female: yes Male: yes | 7 | Phase 2;Phase 3 | Germany |
| 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 | EUCTR2019-001177-90-SE (EUCTR) | 30/06/2020 | 17/12/2019 | Study to demonstrate the efficacy, safety and tolerability of an intravenous(i.v.) regimen of secukinumab compared to placebo in subjects with activeaxSpA | A randomized, double-blind, placebo-controlled, parallel group, phase IIImulticenter study of intravenous secukinumab to compare efficacy at 16weeks with placebo and to assess safety and tolerability up to 52 weeks insubjects with active Ankylosing Spondylitis or non-radiographic axialSpondyloArthritis | Axial Spondyloarthritis MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3 | United States;Philippines;Greece;Thailand;Guatemala;Turkey;Russian Federation;Colombia;Italy;India;Egypt;Czech Republic;Poland;Belgium;Brazil;Malaysia;Bulgaria;Sweden;Korea, Republic of | ||
| 2 | EUCTR2019-001177-90-BG (EUCTR) | 07/04/2020 | 12/02/2020 | Study to demonstrate the efficacy, safety and tolerability of an intravenous(i.v.) regimen of secukinumab compared to placebo in subjects with activeaxSpA | A randomized, double-blind, placebo-controlled, parallel group, phase IIImulticenter study of intravenous secukinumab to compare efficacy at 16weeks with placebo and to assess safety and tolerability up to 52 weeks insubjects with active Ankylosing Spondylitis or non-radiographic axialSpondyloArthritis | Axial Spondyloarthritis MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3 | United States;Philippines;Greece;Thailand;Guatemala;Turkey;Russian Federation;Colombia;Italy;India;Egypt;Czech Republic;Poland;Belgium;Brazil;Malaysia;Bulgaria;Sweden;Korea, Republic of | ||
| 3 | EUCTR2019-001177-90-GR (EUCTR) | 23/01/2020 | 13/11/2019 | Study to demonstrate the efficacy, safety and tolerability of an intravenous (i.v.) regimen of secukinumab compared to placebo in subjects with active axSpA | A randomized, double-blind, placebo-controlled, parallel group, phase III multicenter study of intravenous secukinumab to compare efficacy at 16 weeks with placebo and to assess safety and tolerability up to 52 weeks in subjects with active Ankylosing Spondylitis or non-radiographic axial SpondyloArthritis | Axial Spondyloarthritis MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3 | United States;Philippines;Greece;Thailand;Guatemala;Turkey;Russian Federation;Colombia;Italy;India;Egypt;Czech Republic;Poland;Malaysia;Belgium;Brazil;Bulgaria;Korea, Republic of;Sweden | |||
| 4 | NCT04156620 (ClinicalTrials.gov) | December 11, 2019 | 8/10/2019 | Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA | A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Multicenter Study of Intravenous Secukinumab to Compare Efficacy at 16 Weeks With Placebo and to Assess Safety and Tolerability up to 52 Weeks in Subjects With Active Ankylosing Spondylitis or Non-radiographic Axial SpondyloArthritis | Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis | Drug: Secukinumab;Drug: Placebo | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 500 | Phase 3 | United States;Belgium;Brazil;Bulgaria;Colombia;Czechia;Greece;Guatemala;India;Italy;Korea, Republic of;Malaysia;Philippines;Poland;Russian Federation;Sweden;Thailand;Turkey |
| 5 | EUCTR2017-000679-10-GR (EUCTR) | 05/03/2019 | 19/12/2018 | 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;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 | ||
| 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 |
| 6 | NCT03639740 (ClinicalTrials.gov) | January 15, 2019 | 17/8/2018 | Treat-to-target With Secukinumab in Axial Spondyloarthritis | TReat-to-tArget (T2T) With seCukinumab in Axial Spondyloarthritis. IdEntification of MRI and Biochemical Biomarkers for Disease Activity, Treatment Response and Structural Damage Progression (the TRACE Study) | Axial Spondyloarthritis;Ankylosing Spondylitis | Drug: Secukinumab 150 milligram [Cosentyx] | Professor Mikkel Østergaard | Novartis Healthcare A/S | Recruiting | 18 Years | 70 Years | All | 88 | Phase 4 | Denmark |
| 7 | 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 | |
| 8 | 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 | Authorised-recruitment may be ongoing or finished | 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-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 | United States;Portugal;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 | ||
| 10 | 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] | 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;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 | |||
| 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 |
| 11 | EUCTR2017-000679-10-NL (EUCTR) | 07/06/2018 | 18/12/2017 | 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 | 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 | ||
| 12 | NCT03350815 (ClinicalTrials.gov) | March 13, 2018 | 31/10/2017 | Study Estimating the Clinical Difference Between 300 mg and 150 mg of Secukinumab Following Dose Escalation to 300 mg in Patients With Ankylosing Spondylitis | A Randomized, Double-blind, Parallel-group, Multicenter Study of Secukinumab to Compare 300 mg and 150 mg at Week 52 in Patients With Ankylosing Spondylitis Who Are Randomized to Dose Escalation After Not Achieving Inactive Disease During an Initial 16 Weeks of Open-label Treatment With Secukinumab 150 mg (ASLeap) | Ankylosing Spondylitis | Drug: 150 mg open-label secukinumab;Drug: 150 mg double-blinded secukinumab;Drug: 300 mg double-blinded secukinumab | Novartis Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 313 | Phase 4 | United States |
| 13 | EUCTR2017-000679-10-FR (EUCTR) | 22/01/2018 | 22/09/2017 | 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] | 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;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 | |||
| 14 | EUCTR2017-004037-93-DK (EUCTR) | 17/01/2018 | 07/11/2017 | TReat-to-tArget (T2T) with seCukinumab in axial spondyloarthritis. IdEntification of MRI and biochemical biomarkers for disease activity, treatment response and structural damage progression (the TRACE study) | TReat-to-tArget (T2T) with seCukinumab in axial spondyloarthritis. IdEntification of MRI and biochemical biomarkers for disease activity, treatment response and structural damage progression (the TRACE study) | Axial spondyloarthritis and ankylosing spondylitis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 88 | Phase 4 | Denmark | |||
| 15 | 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] | 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;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 | |||
| 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 |
| 16 | EUCTR2017-000679-10-DE (EUCTR) | 18/12/2017 | 24/08/2017 | 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 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 | United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Israel;Chile;Russian Federation;Colombia;France;Denmark;Australia;Peru;Netherlands;Korea, Republic of;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan | ||
| 17 | EUCTR2017-000679-10-FI (EUCTR) | 18/12/2017 | 05/10/2017 | 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] | 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;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 | |||
| 18 | EUCTR2017-000679-10-DK (EUCTR) | 23/11/2017 | 25/10/2017 | 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] | 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;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 | |||
| 19 | 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 | ||
| 20 | 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] | 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;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 | |||
| 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 |
| 21 | NCT03259074 (ClinicalTrials.gov) | July 4, 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 | Active, not recruiting | 18 Years | N/A | All | 860 | 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 |
| 22 | NCT02896127 (ClinicalTrials.gov) | October 18, 2016 | 4/5/2016 | Study of Efficacy and Safety of Secukinumab in Patients With Ankylosing Spondylitis | A Randomized, Double-blind, Placebo-controlled, Phase III Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes, to Compare Efficacy at 16 Weeks With Placebo and to Assess Safety and Tolerability up to 52 Weeks in Subjects With Active Ankylosing Spondylitis | Ankylosing Spondyloarthritis | Drug: Secukinumab;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 458 | Phase 3 | China;Czechia;Korea, Republic of;United Kingdom;Czech Republic |
| 23 | EUCTR2015-005021-39-CZ (EUCTR) | 15/09/2016 | 14/07/2016 | Study of efficacy and safety of secukinumab in patients with Ankylosing Spondylitis. | A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab in prefilled syringes, to compare efficacy at 16 weeks with placebo and to assess safety and tolerability up to 52 weeks in subjects with active Ankylosing Spondylitis. - MEASURE 5 | Ankylosing Spondyloarthritis 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] | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 454 | Phase 3 | Czech Republic;Korea, Democratic People's Republic of;China;United Kingdom | |||
| 24 | EUCTR2015-005021-39-GB (EUCTR) | 04/08/2016 | 12/07/2016 | Study of efficacy and safety of secukinumab in patients with Ankylosing Spondylitis. | A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab in prefilled syringes, to compare efficacy at 16 weeks with placebo and to assess safety and tolerability up to 52 weeks in subjects with active Ankylosing Spondylitis. - MEASURE 5 | Ankylosing Spondyloarthritis 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] | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 454 | Phase 3 | Czech Republic;Korea, Democratic People's Republic of;China;United Kingdom | |||
| 25 | NCT02763046 (ClinicalTrials.gov) | May 31, 2016 | 3/5/2016 | Study to Examine the Clinical Efficacy and the Nonsteroidal Anti-inflammatory Drug (NSAID)-Sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing Spondylitis | A Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab (AIN457) to Examine the Clinical Efficacy and the NSAID-sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing Spondylitis (ASTRUM) | Ankylosing Spondylitis | Drug: Secukinumab (AIN457) 150 mg s.c.;Drug: Placebo - Secukinumab (AIN457) 150 mg s.c. | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 211 | Phase 4 | Germany |
| 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 |
| 26 | NCT02750592 (ClinicalTrials.gov) | March 22, 2016 | 4/4/2016 | Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis | An Open-label, Phase III, Study of Subcutaneous Secukinumab to Assess Efficacy, Safety and Tolerability at up to 52 Weeks in Japanese Patients With Active Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Secukinumab 150 mg provided in 1.0 mL pre-filled syringes (PFSs) for sc injection. | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 30 | Phase 3 | Japan |
| 27 | EUCTR2015-004575-74-DE (EUCTR) | 16/03/2016 | 18/02/2016 | Clinical study to examine the clinical efficacy and the NSAID-sparing effect of Secukinumab in patients with ankylosing spondylitis | A randomized, double-blind, placebo-controlled multicenter study of Secukinumab (AIN457) to examine the clinical efficacy and the NSAID-sparing effect of Secukinumab over 16 weeks in patients with ankylosing spondylitis (ASTRUM) - ASTRUM | 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] | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 4 | Germany | |||
| 28 | JPRN-JapicCTI-163241 | 01/3/2016 | An Open-label, Phase III, Study of Subcutaneous Secukinumab to Assess Efficacy, Safety and Tolerability at up to 52 Weeks in Japanese Patients With Active Ankylosing Spondylitis | An Open-label, Phase III, Study of Subcutaneous Secukinumab to Assess Efficacy, Safety and Tolerability at up to 52 Weeks in Japanese Patients With Active Ankylosing Spondylitis | Ankylosing Spondylitis | Intervention name : AIN457 Dosage And administration of the intervention : secukinumab 150mg : Baseline, 1, 2, 3, 4 week. After 4 week, administered every 4 weeks. Control intervention name : null | Novartis Pharma K.K. | NULL | 18 | BOTH | 30 | Phase 3 | NULL | |||
| 29 | EUCTR2013-005575-41-GB (EUCTR) | 28/07/2015 | 27/02/2015 | 16-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitis | A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 | Ankylosing Spondylitis MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 3 | United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;United Kingdom;Switzerland;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany | |||
| 30 | EUCTR2013-005575-41-BG (EUCTR) | 28/05/2015 | 18/03/2015 | 16-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitis | A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 | 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 Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany | ||
| 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 |
| 31 | NCT02159053 (ClinicalTrials.gov) | May 18, 2015 | 28/2/2014 | 16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis | A Randomized, Double-blind, Placebo-controlled, Phase III Multicenter Study of Subcutaneous Secukinumab (150 mg) With and Without a Subcutaneous Loading Regimen to Assess Efficacy, Safety, and Tolerability up to 2 Years in Patients With Active Ankylosing Spondylitis | Spondylitis, Ankylosing | Biological: Secukinumab;Biological: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 350 | Phase 3 | United States;Australia;Austria;Bulgaria;Canada;Czechia;Denmark;Finland;Germany;Greece;Italy;Netherlands;Norway;Poland;Russian Federation;Slovakia;Spain;Switzerland;United Kingdom;Czech Republic;Mexico |
| 32 | EUCTR2013-005575-41-ES (EUCTR) | 11/05/2015 | 03/03/2015 | 16-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitis | A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 | Ankylosing Spondylitis MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 3 | Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany;United States;Slovakia;Greece;Finland | ||
| 33 | EUCTR2013-005575-41-PL (EUCTR) | 04/05/2015 | 19/03/2015 | 16-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitis | A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 | 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 Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany | ||
| 34 | EUCTR2013-005575-41-NO (EUCTR) | 29/04/2015 | 23/02/2015 | 16-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitis | A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 | Ankylosing Spondylitis MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 3 | United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Netherlands;Germany;Norway | ||
| 35 | EUCTR2013-005575-41-DE (EUCTR) | 27/04/2015 | 03/02/2015 | 16-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitis | A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 | Ankylosing Spondylitis MedDRA version: 18.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 3 | United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany | ||
| 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 |
| 36 | EUCTR2013-005575-41-SK (EUCTR) | 16/04/2015 | 13/03/2015 | 16-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitis | A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 | Ankylosing Spondylitis MedDRA version: 18.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 3 | United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany | ||
| 37 | EUCTR2013-005575-41-DK (EUCTR) | 13/04/2015 | 25/02/2015 | 16-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitis | A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 | Ankylosing Spondylitis MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 3 | United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany | ||
| 38 | EUCTR2013-005575-41-NL (EUCTR) | 13/04/2015 | 10/02/2015 | 16-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitis | A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 | Ankylosing Spondylitis MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 3 | United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Germany;Netherlands | ||
| 39 | EUCTR2013-005575-41-FI (EUCTR) | 08/04/2015 | 20/02/2015 | 16-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitis | A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 | Ankylosing Spondylitis MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 3 | United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany | ||
| 40 | EUCTR2013-005575-41-GR (EUCTR) | 02/04/2015 | 29/04/2015 | 16-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitis | A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 | Ankylosing Spondylitis MedDRA version: 18.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 3 | United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany | ||
| 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 |
| 41 | EUCTR2013-005575-41-CZ (EUCTR) | 31/03/2015 | 30/01/2015 | 16-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitis | A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 | 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 Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany | ||
| 42 | EUCTR2013-005575-41-AT (EUCTR) | 23/03/2015 | 05/02/2015 | 16-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitis | A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 | 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 Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany | ||
| 43 | EUCTR2013-005575-41-IT (EUCTR) | 05/03/2015 | 11/03/2016 | 16-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitis | A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 | Ankylosing Spondylitis MedDRA version: 18.1;Level: LLT;Classification code 10002555;Term: Ankles swollen;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | NOVARTIS FARMA S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 3 | Slovakia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Germany;Netherlands;Norway | ||
| 44 | EUCTR2013-001090-24-NO (EUCTR) | 29/04/2014 | 07/03/2014 | 16-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patients | A randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis | Ankylosing spondylitis MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 222 | Phase 3 | United States;Portugal;Czech Republic;Mexico;Greece;Spain;Belgium;Russian Federation;Germany;Norway;United Kingdom;Sweden | |||
| 45 | EUCTR2013-001090-24-GB (EUCTR) | 26/03/2014 | 31/12/2013 | 16-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patients | A randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis | Ankylosing spondylitis MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 222 | Phase 3 | Portugal;United States;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom;Sweden | |||
| 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 |
| 46 | EUCTR2013-001090-24-GR (EUCTR) | 25/02/2014 | 09/12/2013 | 16-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patients | A randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis | Ankylosing spondylitis MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 222 | Phase 3 | United States;Portugal;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom | ||
| 47 | EUCTR2013-001090-24-BE (EUCTR) | 13/02/2014 | 14/01/2014 | 16-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patients | A randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis | Ankylosing spondylitis MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 222 | Phase 3 | United Kingdom;Sweden;United States;Portugal;Czech Republic;Mexico;Greece;Spain;Belgium;Russian Federation;Norway;Germany | ||
| 48 | EUCTR2013-001089-40-BE (EUCTR) | 23/01/2014 | 02/12/2013 | 3-year follow-up study of secukinumab treatment in patients with active Ankylosing Spondylitis | An extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients with active Ankylosing Spondylitis | Ankylosing spondylitis MedDRA version: 18.1;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 Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab 150 mg/1 ml Solution for injection Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab 75 mg/0.5 ml Solution for injection | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands | ||
| 49 | EUCTR2013-001090-24-PT (EUCTR) | 23/01/2014 | 14/11/2013 | 16-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patients | A randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis | Ankylosing spondylitis MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 222 | Phase 3 | United States;Portugal;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom;Sweden | |||
| 50 | NCT02008916 (ClinicalTrials.gov) | January 14, 2014 | 8/12/2013 | 16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients | A Randomized, Double-blind, Placebo-controlled Phase III Study of Secukinumab to Demonstrate the Efficacy at 16 Weeks and to Assess the Long-term Safety, Tolerability and Efficacy up to 3 Years in Subjects With Active Ankylosing Spondylitis | Spondylitis, Ankylosing | Drug: Secukinumab;Drug: Placebo secukinumab | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 226 | Phase 3 | United States;Belgium;Czechia;Germany;Greece;Mexico;Portugal;Russian Federation;Spain;United Kingdom;Czech Republic;Norway;Sweden |
| 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 |
| 51 | EUCTR2013-001090-24-DE (EUCTR) | 08/01/2014 | 24/10/2013 | 16-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patients | A randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis | Ankylosing spondylitis MedDRA version: 18.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 222 | Phase 3 | Portugal;United States;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom | ||
| 52 | EUCTR2013-001089-40-BG (EUCTR) | 07/01/2014 | 21/11/2013 | 3-year follow-up study of secukinumab treatment in patients with active Ankylosing Spondylitis | An extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients with active Ankylosing Spondylitis | 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 Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 274 | Phase 3 | United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands | ||
| 53 | EUCTR2013-001090-24-CZ (EUCTR) | 30/12/2013 | 08/11/2013 | 16-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patients | A randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis | 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 Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 222 | Phase 3 | Portugal;United States;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom | ||
| 54 | EUCTR2013-001090-24-ES (EUCTR) | 26/12/2013 | 12/11/2013 | 16-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patients | A randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis | Ankylosing spondylitis MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 222 | Phase 3 | United States;Portugal;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom;Sweden | ||
| 55 | EUCTR2013-001089-40-DE (EUCTR) | 20/11/2013 | 07/08/2013 | 3-year follow-up study of secukinumab treatment in patients with active Ankylosing Spondylitis | An extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients with active Ankylosing Spondylitis | 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 Product Name: Secukinumab Product Code: AIN457, 150 mg INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457, 75 mg INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 274 | Phase 3 | United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands | ||
| 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 |
| 56 | NCT01863732 (ClinicalTrials.gov) | November 6, 2013 | 23/5/2013 | Extension in AS: Sustainability of Benefits, Safety and Tolerability | An Extension Study to Evaluate the Sustainability of Clinical Benefits, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis | Spondylitis, Ankylosing | Biological: Secukinumab;Other: Placebo (Pbo) | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 274 | Phase 3 | United States;Belgium;Bulgaria;Canada;France;Germany;Italy;Mexico;Netherlands;Peru;Russian Federation;Taiwan;Turkey;United Kingdom |
| 57 | EUCTR2013-001089-40-NL (EUCTR) | 24/10/2013 | 26/09/2013 | 3-year follow-up study of secukinumab treatment in patients with active Ankylosing Spondylitis | An extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients with active Ankylosing Spondylitis | Ankylosing spondylitis MedDRA version: 19.0;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 Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Netherlands;Germany | ||
| 58 | EUCTR2013-001089-40-GB (EUCTR) | 03/10/2013 | 16/07/2013 | 3-year follow-up study of secukinumab treatment in patients with active Ankylosing Spondylitis | An extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients with active Ankylosing Spondylitis | Ankylosing spondylitis MedDRA version: 19.0;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 Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands | ||
| 59 | EUCTR2013-001089-40-IT (EUCTR) | 27/08/2013 | 02/07/2013 | 3-year follow-up study of secukinumab treatment in patients with active Ankylosing Spondylitis | An extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients with active Ankylosing Spondylitis | Ankylosing spondylitis MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Farma SpA | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Taiwan;Turkey;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Belgium;Peru;Bulgaria;Netherlands;Germany | ||
| 60 | EUCTR2012-000046-35-DE (EUCTR) | 20/12/2012 | 19/09/2012 | Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS) | A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis - MEASURE 2 | Ankylosing spondylitis MedDRA version: 19.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 219 | Phase 3 | United States;Finland;Spain;Austria;Russian Federation;Switzerland;United Kingdom;Italy;Czech Republic;Canada;Singapore;Germany;Netherlands | ||
| 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 |
| 61 | EUCTR2012-000046-35-ES (EUCTR) | 13/11/2012 | 26/09/2012 | Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS) | A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis | Ankylosing spondylitis MedDRA version: 15.0;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 222 | Phase 3 | United States;Finland;Spain;Austria;Russian Federation;Switzerland;United Kingdom;Italy;Czech Republic;Canada;Singapore;Germany;Netherlands | ||
| 62 | EUCTR2012-000046-35-NL (EUCTR) | 30/10/2012 | 16/08/2012 | Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS) | A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis - MEASURE 2 | Ankylosing spondylitis MedDRA version: 19.0;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 219 | Phase 3 | Italy;Czech Republic;Canada;Singapore;Netherlands;Germany;United States;Finland;Spain;Austria;Russian Federation;Switzerland;United Kingdom | ||
| 63 | NCT01649375 (ClinicalTrials.gov) | October 18, 2012 | 20/7/2012 | 16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis | A Randomized, Double-blind, Placebo-controlled Phase III Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Efficacy at 16 Weeks and to Assess Long-term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Ankylosing Spondylitis | Anklyosing Spondylitis | Drug: Secukinumab (75 mg);Drug: Placebo;Drug: Secukinumab (150 mg) | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 219 | Phase 3 | United States;Austria;Canada;Czechia;Finland;Germany;Italy;Netherlands;Russian Federation;Singapore;Spain;Switzerland;United Kingdom;Czech Republic |
| 64 | EUCTR2012-000046-35-FI (EUCTR) | 10/10/2012 | 28/08/2012 | Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS) | A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis - MEASURE 2 | Ankylosing spondylitis MedDRA version: 19.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 219 | Phase 3 | United States;Finland;Spain;Austria;Russian Federation;Switzerland;United Kingdom;Italy;Czech Republic;Canada;Singapore;Germany;Netherlands | ||
| 65 | EUCTR2012-000046-35-GB (EUCTR) | 17/09/2012 | 20/07/2012 | Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS) | A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis - MEASURE 2 | Ankylosing spondylitis MedDRA version: 19.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 219 | Phase 3 | Spain;United States;Finland;Austria;Russian Federation;United Kingdom;Italy;Switzerland;Czech Republic;Canada;Singapore;Germany;Netherlands | ||
| 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 |
| 66 | EUCTR2012-000046-35-IT (EUCTR) | 31/07/2012 | 02/08/2012 | Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS) | A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis | Ankylosing spondylitis MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457F INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457F INN or Proposed INN: SECUKINUMAB | NOVARTIS FARMA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 222 | Phase 3 | United States;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Singapore;Netherlands;Germany | ||
| 67 | EUCTR2010-024529-18-BE (EUCTR) | 16/12/2011 | 20/10/2011 | 2-year study of secukinumab treatment in patients with active Ankylosing Spondylitis | A randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis - MEASURE-1 | Ankylosing spondylitis MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | United States;Taiwan;Turkey;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Belgium;Peru;Bulgaria;Netherlands;Germany | |||
| 68 | EUCTR2010-024529-18-DE (EUCTR) | 28/11/2011 | 01/08/2011 | 2-year study of secukinumab treatment in patients with active Ankylosing Spondylitis | A randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis - MEASURE-1 | Ankylosing spondylitis MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | United States;Taiwan;Turkey;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands | |||
| 69 | EUCTR2010-024529-18-BG (EUCTR) | 14/11/2011 | 09/11/2011 | 2-year study of secukinumab treatment in patients with active Ankylosing Spondylitis | A randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis - MEASURE-1 | Ankylosing spondylitis MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands | |||
| 70 | NCT01358175 (ClinicalTrials.gov) | October 2011 | 19/5/2011 | 16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis | A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the 16 Week Efficacy and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Secukinumab (75 mg);Drug: Secukinumab (150 mg);Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 371 | Phase 3 | United States;Belgium;Bulgaria;Canada;France;Germany;Italy;Mexico;Netherlands;Peru;Russian Federation;Taiwan;Turkey;United Kingdom |
| 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 |
| 71 | EUCTR2010-024529-18-GB (EUCTR) | 02/08/2011 | 18/07/2011 | 2-year study of secukinumab treatment in patients with active Ankylosing Spondylitis | A randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis - MEASURE 1 | Ankylosing spondylitis MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Netherlands;Germany | |||
| 72 | EUCTR2010-024529-18-IT (EUCTR) | 25/07/2011 | 29/12/2011 | 2-year study of secukinumab treatment in patients with active Ankylosing Spondylitis | A randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis | Ankylosing spondylitis MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 350 | Taiwan;Mexico;Canada;Belgium;Turkey;Peru;Bulgaria;Russian Federation;Germany;United Kingdom;Italy |