41. 巨細胞性動脈炎 Giant cell arteritis Clinical trials / Disease details
臨床試験数 : 131 / 薬物数 : 139 - (DrugBank : 36) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 125
| 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 | NCT05623592 (ClinicalTrials.gov) | November 23, 2022 | 8/11/2022 | Methotrexate as Remission Maintenance Therapy After Remission-Induction With Tocilizumab and Glucocorticoids in Giant Cell Arteritis | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy of Methotrexate as Remission Maintenance Therapy After Remission-Induction Therapy With Tocilizumab and Glucocorticoids in Subjects With Giant Cell Arteritis | Giant Cell Arteritis | Drug: Methotrexate;Drug: Sodium chloride | University of Bonn | NULL | Recruiting | 18 Years | N/A | All | 40 | Phase 2 | Germany |
| 2 | NCT05380453 (ClinicalTrials.gov) | September 21, 2022 | 22/2/2022 | Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical Remission | A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Trial to Investigate the Efficacy and Safety of Subcutaneously Administered Secukinumab in Patients With New-onset of Giant Cell Arteritis (GCA) Who Are in Clinical Remission and Eligible for Treatment With Glucocorticoid-monotherapy | Giant Cell Arteritis | Biological: Secukinumab 300 mg, s.c.;Drug: Placebo to match Secukinumab, s.c. | Novartis Pharmaceuticals | NULL | Recruiting | 50 Years | N/A | All | 146 | Phase 3 | Germany |
| 3 | EUCTR2021-002528-18-DK (EUCTR) | 22/02/2022 | 30/07/2021 | RESCUE - Effect of supplemental hydrocortisone during stress in prednisolone-induced adrenal insufficiency. | RESCUE - Effect of supplemental hydrocortisone during stress in prednisolone-induced adrenal insufficiency; A multicentre, randomised, double blinded, placebo-controlled clinical trial on health-related quality of life in patients with polymyalgia rheumatica/giant cell arteritis receiving ongoing low-dose prednisolone treatment. - RESCUE | Glucocorticoid-induced adrenal insufficiency MedDRA version: 20.0;Level: LLT;Classification code 10001369;Term: Adrenal insufficiency NOS;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Hydrokortison orion Product Name: hydrokortison Product Code: H02AB09 INN or Proposed INN: hydrocortisone Other descriptive name: HYDROCORTISONE | Copenhagen University Hospital Rigshospitalet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 325 | Phase 4 | Denmark | ||
| 4 | EUCTR2020-004809-31-SE (EUCTR) | 11/01/2022 | 21/10/2021 | Study of efficacy and safety of secukinumab 300 mg and 150 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled, multicenter Phase III trial to investigate the efficacy and safety of secukinumab 300 mg and 150 mg administered subcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cell arteritis (GCA) | giant cell arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx 300 mg solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB Trade Name: PredniSONE Tablets, USP, 1 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets, USP 2.5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets, USP 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets, USP 10 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 348 | Phase 3 | United States;Portugal;Estonia;Spain;Russian Federation;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 5 | EUCTR2020-004809-31-DK (EUCTR) | 18/11/2021 | 01/08/2021 | Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (GCA) | giant cell arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx 300 mg solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB Trade Name: PredniSONE Tablets USP, 1 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 10 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Portugal;Estonia;Spain;Russian Federation;Italy;Switzerland;France;Australia;Denmark;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 6 | EUCTR2020-004809-31-NO (EUCTR) | 16/11/2021 | 28/06/2021 | Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (GCA) | giant cell arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx 300 mg solution for injection in pre-filled syringe Product Name: Cosentyx Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 10 mg Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Portugal;Estonia;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 7 | EUCTR2020-004809-31-BG (EUCTR) | 08/11/2021 | 26/08/2021 | Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (GCA) | giant cell arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx 300mg solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB Trade Name: PredniSONE Tablets USP, 1mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 20mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Portugal;Estonia;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 8 | EUCTR2020-004809-31-DE (EUCTR) | 19/10/2021 | 12/07/2021 | Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (GCA) | giant cell arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx 300 mg solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB Trade Name: PredniSONE Tablets USP, 1 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 10 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Portugal;Estonia;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 9 | EUCTR2020-004809-31-PT (EUCTR) | 13/10/2021 | 07/07/2021 | Study of efficacy and safety of secukinumab 300 mg and 150 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate the efficacy and safety of secukinumab 300 mg and 150 mg administered subcutaneously versus placebo, in combination with a glucocorticoid taper regimen, in patients with giant cell arteritis (GCA) | giant cell arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx 300 mg solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB Trade Name: PredniSONE Tablets USP, 1 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 10 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 348 | Phase 3 | Russian Federation;United States;Czechia;Portugal;Sweden;Netherlands;Brazil;Guatemala;Poland;France;Bulgaria;Argentina;Hungary;United Kingdom;Switzerland;Spain;New Zealand;Canada;Turkey;Belgium;Norway;Finland;Denmark;South Africa;Italy;Australia;Germany;Estonia | ||
| 10 | NCT04930094 (ClinicalTrials.gov) | October 6, 2021 | 15/6/2021 | Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA) | A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase III Trial to Investigate the Efficacy and Safety of Secukinumab 300 mg and 150 mg Administered Subcutaneously Versus Placebo, in Combination With a Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA) | Giant Cell Arteritis (GCA) | Biological: Secukinumab 300 mg;Other: Placebo;Biological: Secukinumab 150 mg | Novartis Pharmaceuticals | NULL | Recruiting | 50 Years | N/A | All | 349 | Phase 3 | United States;Argentina;Australia;Belgium;Bulgaria;Canada;Czechia;Denmark;Estonia;Finland;France;Germany;Guatemala;Hungary;Italy;Poland;Portugal;Russian Federation;South Africa;Spain;Switzerland;Turkey;United Kingdom |
| 11 | EUCTR2020-004809-31-FI (EUCTR) | 05/10/2021 | 16/07/2021 | Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (GCA) | giant cell arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx 300 mg solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB Trade Name: PredniSONE Tablets USP, 1 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 10 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Portugal;Estonia;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 12 | EUCTR2020-004809-31-FR (EUCTR) | 24/09/2021 | 22/06/2021 | Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (GCA) | giant cell arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx Product Name: Cosentyx Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Trade Name: Prednisone Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednisone Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednisone Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednisone Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Portugal;Estonia;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Belgium;Brazil;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 13 | EUCTR2020-004809-31-IT (EUCTR) | 16/09/2021 | 22/10/2021 | Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled, multicenter Phase III trial to investigate the efficacy and safety of secukinumab 300 mg administered subcutaneously versus placebo, in combination with a glucocorticoid taper regimen, in patients with giant cell arteritis (GCA) - - | Giant cell arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Prednisone Product Name: Prednisone Product Code: [-] INN or Proposed INN: PREDNISONE Trade Name: Prednisone Product Name: Prednisone Product Code: [-] INN or Proposed INN: PREDNISONE Trade Name: Prednisone Product Name: Prednisone Product Code: [-] INN or Proposed INN: PREDNISONE Trade Name: Prednisone Product Name: Prednisone Product Code: [-] INN or Proposed INN: PREDNISONE Trade Name: Cosentyx Product Name: Cosentyx Product Code: [AIN457] INN or Proposed INN: SECUKINUMAB | NOVARTIS PHARMA AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Portugal;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Belgium;Brazil;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 14 | NCT05168475 (ClinicalTrials.gov) | July 14, 2021 | 9/12/2021 | Biologics in Refractory Vasculitis | Biologics in Refractory Vasculitis (BIOVAS): A Pragmatic, Randomised, Double-blind, Placebo-controlled, Modified-crossover Trial of Biologic Therapy for Refractory Primary Non-ANCA Associated Vasculitis in Adults and Children | Giant Cell Arteritis;Takayasu Arteritis;Cogan Syndrome;Relapsing Polychondritis;Cryoglobulinemic Vasculitis;IgA Vasculitis;Polyarteritis Nodosa;Cutaneous Polyarteritis Nodosa;Primary Angiitis of Central Nervous System | Biological: Rituximab;Biological: Infliximab;Biological: Tocilizumab | Cambridge University Hospitals NHS Foundation Trust | NULL | Recruiting | 5 Years | N/A | All | 140 | Phase 2 | United Kingdom |
| 15 | NCT04885829 (ClinicalTrials.gov) | May 31, 2021 | 3/5/2021 | Comparative Study of 3 Tocilizumab Products in Normal Healthy Volunteeers | A Single Dose, Double-Blind, Two-Period, Crossover, Comparative Pharmacokinetic Study of Three Tocilizumab Products Administered by the Subcutaneous Route to Normal Healthy Volunteers | Rheumatoid Arthritis;Giant Cell Arteritis | Drug: Tocilizumab Prefilled Syringe | Syneos Health | Dr. Reddy's Laboratories Limited | Active, not recruiting | 18 Years | 50 Years | All | 300 | Phase 1 | Australia;India;New Zealand |
| 16 | NCT04888221 (ClinicalTrials.gov) | May 2021 | 25/3/2021 | Efficacy of Tocilizumab in Association to Steroids in Giant Cell Arteritis With Cerebro-vascular Involvement | Efficacy of Tocilizumab in Association to Steroids in Giant Cell Arteritis With Cerebro-vascular Involvement (ToGiAC) | Giant Cell Arteritis;Neurovascular Disorder | Drug: Tocilizumab;Drug: Placebo | Assistance Publique - Hôpitaux de Paris | Roche Chugai;Roche Pharma AG | Not yet recruiting | 60 Years | N/A | All | 66 | Phase 3 | France |
| 17 | NCT04474847 (ClinicalTrials.gov) | March 15, 2021 | 13/7/2020 | Abatacept for the Treatment of Giant Cell Arteritis | A Randomized Double-Blind, Placebo Controlled Trial of Abatacept (CTLA4-Ig) in Giant Cell Arteritis (ABAGART) | Giant Cell Arteritis | Drug: Abatacept;Drug: Placebo | University of Pennsylvania | NULL | Active, not recruiting | 50 Years | N/A | All | 78 | Phase 3 | United States;Canada |
| 18 | EUCTR2020-001019-26-NL (EUCTR) | 26/02/2021 | 14/07/2020 | Imaging of inflamed arteries in giant cell arteritis with a PET/CT scan. | [18F]fluor-PEG-folate PET/CT imaging in Giant Cell Arteritis. | giant cell arteritis;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: [18F]PEG-Folate INN or Proposed INN: Fluorine-18 Other descriptive name: FLUORINE-18 | University Medical Center Groningen, Department of Rheumatology and Clinical Immunology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Phase 2 | Netherlands | ||
| 19 | EUCTR2020-000622-26-DE (EUCTR) | 22/01/2021 | 17/09/2020 | A Proof-of-Concept Study of Guselkumab in the Treatment of Subjects with New-Onset or Relapsing Giant Cell Arteritis | A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Participants with New-Onset or Relapsing Giant Cell Arteritis - THEIA | Giant Cell Arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;France;Canada;Spain;Poland;Belgium;Israel;Germany;Italy | ||
| 20 | EUCTR2020-000622-26-IT (EUCTR) | 18/12/2020 | 24/05/2021 | A Proof-of-Concept Study of Guselkumab in the Treatment of Subjects with New-Onset or Relapsing Giant Cell Arteritis | A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Participants with New-Onset or Relapsing Giant Cell Arteritis - THEIA | Giant Cell Arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Virus Diseases [C02] | Product Name: Guselkumab Product Code: [CNTO1959] INN or Proposed INN: GUSELKUMAB Other descriptive name: * D.3.6.2.1 - valore :Every 4 weeks dosing of 400 mg Product Name: Guselkumab Product Code: [CNTO1959] INN or Proposed INN: GUSELKUMAB Other descriptive name: * D.3.6.2.1 - valore : Every 4 weeks dosing of 200 mg | JANSSEN CILAG INTERNATIONAL NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | France;United States;Canada;Spain;Poland;Belgium;Germany;Italy | ||
| 21 | NCT04633447 (ClinicalTrials.gov) | December 10, 2020 | 6/11/2020 | A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis | A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis | Giant Cell Arteritis | Drug: Guselkumab;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 50 Years | N/A | All | 51 | Phase 2 | United States;Belgium;Canada;France;Germany;Israel;Italy;Poland;Spain |
| 22 | NCT04012905 (ClinicalTrials.gov) | November 5, 2020 | 5/7/2019 | Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids Tapering | A Randomized, Controled, Open Label Trial: Comparison Between Two Standardized Corticosteroids Tapering, Respectively Short (North American) and Long (European), in Giant Cell Arteritis | Giant Cell Arteritis | Drug: Corticosteroids for Systemic Use | University Hospital, Caen | University Hospital, Lille;Amiens University Hospital;University Hospital, Rouen;University Hospital, Limoges;Central Hospital Saint Quentin;Central Hospital, Valenciennes;Central Hospital, Lisieux | Not yet recruiting | 50 Years | N/A | All | 150 | Phase 3 | NULL |
| 23 | EUCTR2019-003964-30-GB (EUCTR) | 22/10/2020 | 31/07/2020 | Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory vasculitis in adults and children. | Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory primary non-ANCA associated vasculitis in adults and children - Biologics in refractory vasculitis (BIOVAS) | Non-ANCA associated vasculitides: 1.Giant cell arteritis (GCA)2.Takayasu’s arteritis (TA)3.Polyarteritis nodosa (PAN) or cutaneous polyarteritis unrelated to hepatitis B (CPAN)4.Relapsing polychondritis (RP)5.IgA vasculitis (IgAV)6.Cogan’s syndrome7.Non-infective cryoglobulinaemia8.Primary angiitis of central nervous system (PACNS) MedDRA version: 21.1;Level: PT;Classification code 10047115;Term: Vasculitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Infliximab Product Code: N/A INN or Proposed INN: Infliximab Trade Name: Rituximab Product Name: Rituximab INN or Proposed INN: Rituximab Trade Name: Tocilizumab Product Name: Tocilizumab Product Code: N/A INN or Proposed INN: Tocilizumab | Cambridge University Hospitals NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 2 | United Kingdom | ||
| 24 | NCT04239196 (ClinicalTrials.gov) | July 1, 2020 | 19/11/2019 | Efficacy of Tocilizumab for the Treatment of Acute AION Related to GCA | Open Label Phase II Randomized Non-comparative Study of SC Tocilizumab Associated With IV Pulse Steroid Versus IV Pulse Steroid Alone for the Treatment of Acute Anterior Ischemic Optic Neuropathy Associated With Giant Cell Arteritis | Giant Cell Arteritis;Optic Ischaemic Neuropathy | Drug: tocilizumab and IV steroids combination;Other: IV steroids combination alone | Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts | Roche Chugai | Not yet recruiting | 50 Years | N/A | All | 58 | Phase 2 | France |
| 25 | NCT05394909 (ClinicalTrials.gov) | February 7, 2020 | 20/5/2022 | Ultra-short Glucocorticosteroids and Tocilizumab Therapy in GCA Patients | Treatment Of Giant Cell Arteritis Patients With Ultra-short Glucocorticosteroids And tociliZumab: Role of Imaging in a Observational Study | GCA;TOCILIZUMAB;Glucocorticoids;PET | Drug: Tocilizumab 162Mg/0.9Ml Autoinjector | Azienda Unità Sanitaria Locale Reggio Emilia | NULL | Active, not recruiting | N/A | N/A | All | 20 | Italy | |
| 26 | NCT03892785 (ClinicalTrials.gov) | January 27, 2020 | 26/3/2019 | MEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis: a Multicenter, Randomized, Controlled Trial | MEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis: a Multicenter, Randomized, Controlled Trial | Giant Cell Arteritis | Drug: Prednisone treatment;Drug: Tocilizumab treatment;Drug: Methotrexate treatment;Other: Questionnaires;Biological: Blood samples | Centre Hospitalier Universitaire Dijon | NULL | Recruiting | 50 Years | N/A | All | 230 | Phase 3 | France |
| 27 | EUCTR2017-003978-13-RO (EUCTR) | 06/11/2019 | 07/03/2022 | A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis | Giant Cell Arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Pr | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Greece;Spain;Austria;Russian Federation;Italy;France;Hungary;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 28 | EUCTR2017-002988-18-FI (EUCTR) | 02/10/2019 | 12/09/2019 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | Portugal;Serbia;United States;Estonia;Spain;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;Slovenia;Finland;Austria;United Kingdom;Hungary;Canada;Argentina;Belgium;Croatia;Germany;Norway;Sweden | ||
| 29 | EUCTR2017-003978-13-DK (EUCTR) | 17/09/2019 | 25/02/2019 | A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA | Giant Cell Arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Pr | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | Canada;United States;Portugal;Greece;Spain;Austria;Russian Federation;Italy;France;Hungary;Belgium;Romania;Denmark;Australia;Netherlands;Germany;Japan;New Zealand | ||
| 30 | EUCTR2017-003978-13-FR (EUCTR) | 22/08/2019 | 19/04/2019 | A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolone 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 31 | NCT03923738 (ClinicalTrials.gov) | August 5, 2019 | 19/4/2019 | A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab (TCZ) Administered to Participants With Giant Cell Arteritis (GCA). | A Phase Ib, Open-Label, Dose-Ranging Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Administered by Intravenous Infusion to Patients With Giant Cell Arteritis | Giant Cell Arteritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 50 Years | N/A | All | 23 | Phase 1 | Switzerland |
| 32 | EUCTR2017-003978-13-GR (EUCTR) | 26/07/2019 | 18/03/2019 | A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: SELECT GCA | Giant Cell Arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Pr | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Greece;Spain;Austria;Russian Federation;Italy;France;Hungary;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 33 | EUCTR2017-003978-13-PT (EUCTR) | 08/07/2019 | 14/03/2019 | A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA | Giant Cell Arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Pr | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | Portugal;United States;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 34 | EUCTR2017-003978-13-IT (EUCTR) | 02/07/2019 | 07/10/2020 | A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis - na | Giant Cell Arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone Product Code: [na] INN or Proposed INN: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone Product Code: [na] INN or Proposed INN: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone Product Code: [na] INN or Proposed INN: PREDNISOLONE Trade Name: Prednisolon 20 mg JENAPHARM Product Name: Prednisolone Product Code: [na] INN or Proposed INN: PREDNISOLONE Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: Upadacitinib Trade Name: Prednisolon 10 mg JENAPHARM Product Name: Prednisolone Product Code: [na] INN or Proposed INN: PREDNISOLONE | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Greece;Spain;Austria;Russian Federation;Italy;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 35 | NCT03656627 (ClinicalTrials.gov) | June 27, 2019 | 31/8/2018 | Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease | Safety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease | Autoimmune Diseases;Non-small Cell Lung Cancer;Rheumatoid Arthritis;Psoriasis;Giant Cell Arteritis;Polymyalgia Rheumatica;Systemic Lupus Erythematosus;Crohn Disease;Multiple Sclerosis;Ulcerative Colitis | Drug: Nivolumab | Alliance Foundation Trials, LLC. | Bristol-Myers Squibb | Terminated | 18 Years | N/A | All | 7 | Phase 1 | United States |
| 36 | EUCTR2017-003978-13-NL (EUCTR) | 26/06/2019 | 26/06/2019 | A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA | Giant Cell Arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Pr | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 37 | EUCTR2017-003978-13-ES (EUCTR) | 22/05/2019 | 27/05/2019 | A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 38 | EUCTR2017-003978-13-AT (EUCTR) | 15/05/2019 | 05/03/2019 | A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA | Giant Cell Arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Pr | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 39 | EUCTR2017-003978-13-BE (EUCTR) | 15/05/2019 | 01/05/2019 | A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA | Giant Cell Arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Pr | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Greece;Spain;Austria;Russian Federation;Italy;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 40 | EUCTR2017-003978-13-DE (EUCTR) | 14/05/2019 | 05/03/2019 | A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA | Giant Cell Arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Pr | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Greece;Spain;Austria;Russian Federation;Italy;France;Hungary;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 41 | EUCTR2017-003978-13-HU (EUCTR) | 08/05/2019 | 25/03/2019 | A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA | Giant Cell Arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 1 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Prednisolon 5 mg JENAPHARM Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Pr | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Greece;Spain;Austria;Russian Federation;Italy;France;Hungary;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 42 | EUCTR2017-002988-18-HR (EUCTR) | 15/04/2019 | 17/05/2019 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 43 | EUCTR2018-001003-36-HR (EUCTR) | 10/04/2019 | 17/05/2019 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 44 | EUCTR2017-002988-18-SI (EUCTR) | 22/03/2019 | 19/12/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Israel;Chile;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 45 | EUCTR2018-002826-22-FR (EUCTR) | 07/03/2019 | 21/11/2018 | MEthotrexate versus TOcilizumab for treatment of GIant cell Arteritis: a multicenter, randomized, controlled trial - METOGIA | MEthotrexate versus TOcilizumab for treatment of GIant cell Arteritis: a multicenter, randomized, controlled trial - METOGIA | MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: METOJECT Trade Name: RoActemra | CHU Dijon Bourgogne | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: no | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 46 | EUCTR2017-002988-18-GB (EUCTR) | 04/03/2019 | 20/06/2019 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg | Sanofi-Aventis Recherche & Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 508 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Estonia;Slovenia;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;Switzerland;France;Hungary;Canada;Argentina;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 47 | NCT03841734 (ClinicalTrials.gov) | March 2019 | 5/2/2019 | Study of the Benefit of Early Treatment With an Endothelin Inhibitor (Bosentan) in Patients With Sudden Blindness Due to Giant Cell Arteritis: CECIBO | Study of the Benefit of Early Treatment With an Endothelin Inhibitor (Bosentan) in Patients With Sudden Blindness Due to Giant Cell Arteritis: CECIBO | Arteritis, Giant Cell;Blindness and Low Vision | Drug: treatment | Centre Hospitalier Universitaire de Nice | NULL | Not yet recruiting | 50 Years | N/A | All | 8 | Phase 3 | France |
| 48 | EUCTR2018-001003-36-DE (EUCTR) | 27/02/2019 | 21/06/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 49 | EUCTR2017-002988-18-PT (EUCTR) | 25/02/2019 | 05/11/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Israel;Chile;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 50 | EUCTR2017-002988-18-AT (EUCTR) | 19/02/2019 | 28/09/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 51 | EUCTR2018-004072-35-FR (EUCTR) | 13/02/2019 | 06/11/2018 | Study of the value of early treatment in patients with sudden blindness | Study of the value of early treatment with an endothelin inhibitor (Bosentan) in patients with sudden blindness secondary to giant cell arteritis - CECIBO | giant cell arteritis MedDRA version: 20.0;Level: PT;Classification code 10003232;Term: Arteritis coronary;System Organ Class: 10007541 - Cardiac disorders ;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Trade Name: BOSENTAN MYLAN Product Name: BOSENTAN MYLAN | CHU de Nice | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 8 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 52 | NCT03482479 (ClinicalTrials.gov) | February 4, 2019 | 22/3/2018 | Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis | Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis | Eosinophilic Granulomatosis With Polyangiitis (EGPA);Churg-Strauss Syndrome (CSS);Giant Cell Arteritis;Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Polyarteritis Nodosa;Takayasu Arteritis | Drug: Naltrexone Hydrochloride;Other: Placebo Comparator | University of Pennsylvania | NULL | Recruiting | 18 Years | N/A | All | 36 | Phase 2 | United States |
| 53 | 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 | Drug: Secukinumab 300 mg, s.c.;Drug: Prednisolone;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 50 Years | N/A | All | 52 | Phase 2 | Germany |
| 54 | NCT03725202 (ClinicalTrials.gov) | January 24, 2019 | 27/10/2018 | A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Giant Cell Arteritis: SELECT-GCA | Giant Cell Arteritis (GCA) | Drug: Upadacitinib;Drug: Corticosteroid (CS);Other: Placebo | AbbVie | NULL | Recruiting | 50 Years | N/A | All | 420 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Japan;Netherlands;New Zealand;Norway;Portugal;Romania;Russian Federation;Spain;Sweden;Switzerland;United Kingdom |
| 55 | EUCTR2017-002988-18-FR (EUCTR) | 14/01/2019 | 09/10/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 56 | NCT03711448 (ClinicalTrials.gov) | January 7, 2019 | 15/10/2018 | Ustekinumab for the Treatment of Relapse of Refractory Giant Cell Arteritis | Ustekinumab for the Treatment of Relapse of Refractory Giant Cell Arteritis | Patients Relapsing Refractory Giant Cell Arteritis | Drug: prednisone treatment;Drug: prednisone and ustekinumab treatment;Other: questionnaires;Biological: Blood samples | Centre Hospitalier Universitaire Dijon | NULL | Recruiting | 50 Years | N/A | All | 38 | Phase 2 | France |
| 57 | EUCTR2017-002988-18-DK (EUCTR) | 04/01/2019 | 29/09/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 58 | EUCTR2018-000344-25-FR (EUCTR) | 18/12/2018 | 10/08/2018 | Essai, randomisé, contrôlé, ouvert, de deux schémas standardisés de décroissance, respectivement rapide (nord-américain) et lent (européen), de cortisone dans l’artérite à cellules géantes. | Essai, randomisé, contrôlé, ouvert, de deux schémas standardisés de décroissance, respectivement rapide (nord-américain) et lent (européen), de cortisone dans l’artérite à cellules géantes. - CORTODOSE | Patients atteints d’artérite à cellules géantes MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: CORTANCYL Product Name: CORTANCYL | CHU CAEN | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 59 | EUCTR2017-002988-18-NL (EUCTR) | 10/12/2018 | 01/11/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Israel;Chile;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 60 | EUCTR2017-002988-18-BE (EUCTR) | 07/12/2018 | 06/03/2019 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 61 | 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: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Cosentyx Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Other descriptive name: SECUKINUMAB | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Germany | ||
| 62 | EUCTR2018-001003-36-GB (EUCTR) | 06/12/2018 | 20/06/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: Prednisone Tablets, USP Product Code: N/A INN or Proposed INN: n/a Other descriptive name: PREDNISONE | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 2 | United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 63 | NCT03745586 (ClinicalTrials.gov) | December 1, 2018 | 6/11/2018 | Giant Cell Arteritis Treatment With Ultra-short Glucocorticoids and Tocilizumab | Giant Cell Arteritis Treatment With Ultra-short Glucocorticoids and Tocilizumab | Giant Cell Arteritis | Drug: Tocilizumab;Drug: Glucocorticoids | University Hospital Inselspital, Berne | NULL | Completed | 50 Years | N/A | All | 18 | Phase 1/Phase 2 | Switzerland;Italy |
| 64 | EUCTR2018-001003-36-IT (EUCTR) | 30/11/2018 | 11/10/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovenia;Spain;Ireland;Italy;United Kingdom;Poland;Belgium;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 65 | NCT03726749 (ClinicalTrials.gov) | November 28, 2018 | 30/10/2018 | Tocilizumab Plus a Short Prednisone Taper for GCA | Tocilizumab Plus a Short Prednisone Taper for Giant Cell Arteritis (GCA) | Giant Cell Arteritis | Drug: Tocilizumab;Drug: Prednisone | Massachusetts General Hospital | Roche-Genentech | Recruiting | 50 Years | N/A | All | 30 | Phase 4 | United States |
| 66 | EUCTR2018-001003-36-BE (EUCTR) | 28/11/2018 | 16/08/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Poland;Belgium;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 67 | EUCTR2017-002988-18-DE (EUCTR) | 26/11/2018 | 26/09/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 68 | NCT03600805 (ClinicalTrials.gov) | November 20, 2018 | 17/7/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Giant Cell Arteritis | Giant Cell Arteritis | Drug: Sarilumab SAR153191;Drug: Sarilumab matching placebo;Drug: Prednisone;Drug: Prednisone matching placebo | Sanofi | Regeneron Pharmaceuticals | Terminated | 50 Years | N/A | All | 83 | Phase 3 | United States;Argentina;Australia;Belgium;Canada;Croatia;Denmark;Estonia;France;Germany;Hungary;Israel;Italy;Netherlands;Portugal;Russian Federation;Slovenia;Spain;Sweden;Switzerland;United Kingdom;Austria;Finland |
| 69 | EUCTR2017-002988-18-HU (EUCTR) | 19/11/2018 | 04/10/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 70 | EUCTR2018-001003-36-NL (EUCTR) | 13/11/2018 | 29/06/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Serbia;United States;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Netherlands;Germany;New Zealand | ||
| 71 | EUCTR2017-002988-18-IT (EUCTR) | 08/11/2018 | 12/02/2021 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate theefficacy and safety of sarilumab in patients with giant cell arteritis - n.a. | Giant Cell Arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® Product Name: NA Product Code: [NA] INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® Product Name: na Product Code: [na] INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg Product Name: NA Product Code: [NA] INN or Proposed INN: PREDNISONE Trade Name: Cortancyl ® 1 mg Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Trade Name: Cortancyl ® 20 mg Product Name: NA Product Code: [NA] INN or Proposed INN: PREDNISONE Trade Name: Cortancyl ® 5 mg Product Name: NA Product Code: [NA] INN or Proposed INN: PREDNISONE | SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | Portugal;United States;Estonia;Slovenia;Finland;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 72 | EUCTR2017-002988-18-ES (EUCTR) | 19/10/2018 | 25/10/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | Portugal;United States;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Israel;Chile;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 73 | EUCTR2017-002988-18-EE (EUCTR) | 18/10/2018 | 15/10/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 74 | EUCTR2017-002988-18-SE (EUCTR) | 18/10/2018 | 11/10/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Israel;Chile;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 75 | EUCTR2018-001003-36-SI (EUCTR) | 03/10/2018 | 30/08/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 76 | NCT03827018 (ClinicalTrials.gov) | September 20, 2018 | 25/1/2019 | KPL-301 for Subjects With Giant Cell Arteritis | A Phase 2, Randomized, Double-blind Placebo-controlled Study to Test the Efficacy and Safety of KPL-301 in Giant Cell Arteritis | Giant Cell Arteritis | Combination Product: mavrilimumab;Combination Product: placebo;Drug: prednisone | Kiniksa Pharmaceuticals, Ltd. | NULL | Completed | 50 Years | 85 Years | All | 70 | Phase 2 | United States;Australia;Belgium;Croatia;Estonia;Germany;Ireland;Italy;Netherlands;New Zealand;Poland;Serbia;Slovenia;Spain;United Kingdom |
| 77 | EUCTR2018-001003-36-ES (EUCTR) | 08/08/2018 | 28/06/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 78 | EUCTR2018-001003-36-EE (EUCTR) | 09/07/2018 | 11/06/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 79 | NCT03313102 (ClinicalTrials.gov) | November 16, 2017 | 13/10/2017 | Study of T Lymphocytes in Patients With Horton Disease | Study of T Lymphocytes in the Mucosa in Giant-cell Arteritis (GCA) - Giant Cell Arteritis and Mucosal Associated Invariant T Cells | Horton Disease | Biological: blood samples | Centre Hospitalier Universitaire Dijon | NULL | Recruiting | 51 Years | N/A | All | 60 | N/A | France |
| 80 | NCT03202368 (ClinicalTrials.gov) | October 25, 2017 | 27/6/2017 | An Extension Study to Evaluate Long-Term Safety of Subcutaneous (SC) Tocilizumab in Participants With Giant Cell Arteritis (GCA) | An Extension Study to Evaluate Long Term Safety of Subcutaneous Tocilizumab in Patients With Giant Cell Arteritis Who Have Completed WA28119 Core Study in France, and Subsequently Having Flare or Persisting Disease Activity. | Giant Cell Arteritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 50 Years | N/A | All | 3 | Phase 3 | France |
| 81 | NCT03192969 (ClinicalTrials.gov) | July 15, 2017 | 14/6/2017 | A Study to Evaluate Efficacy and Safety of Subcutaneous Abatacept With Steroid Treatment Compared to Steroid Treatment Alone in Adults With Giant Cell Arteritis (GCA) | A Phase III Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Combination With Glucocorticoid Treatment Compared to Glucocorticoid Monotherapy in Adults With Giant Cell Arteritis | Giant Cell Arteritis | Drug: Abatacept;Other: Placebo;Drug: Glucocorticoid Treatment | Bristol-Myers Squibb | NULL | Withdrawn | 50 Years | N/A | All | 0 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Denmark;Estonia;France;Germany;Greece;Ireland;Italy;Netherlands;Poland;Romania;Serbia;Spain;Sweden;Switzerland;United Kingdom |
| 82 | EUCTR2016-002716-41-FR (EUCTR) | 24/05/2017 | 04/04/2017 | A STUDY TO EVALUATE LONG TERM SAFETY OF TOCILIZUMAB IN PATIENTS WITH GIANT CELL ARTERITIS WHO HAVE COMPLETED WA28119 CORE STUDY IN FRANCE | AN EXTENSION STUDY TO EVALUATE LONG TERM SAFETY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH GIANT CELL ARTERITIS WHO HAVE COMPLETED WA28119 CORE STUDY IN FRANCE, AND SUBSEQUENTLY HAVING FLARE OR PERSISTING DISEASE ACTIVITY | Giant cell arteritis (GCA) MedDRA version: 19.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra 162 mg solution for injection in pre-filled syringe INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | ROCHE SAS | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 3 | France | ||
| 83 | NCT02902731 (ClinicalTrials.gov) | May 11, 2017 | 5/7/2016 | Giant Cell Arteritis and Anakinra Trial | Randomized, Controlled, Double-blind Study of Anakinra Against Placebo in Addition to Steroids in Giant Cell Arteritis | Giant Cell Arteritis | Drug: PLACEBO;Drug: ANAKINRA | University Hospital, Caen | Hôpital Claude-Huriez;Amiens University Hospital;University Hospital, Rouen;University Hospital, Limoges;Central Hospital Saint Quentin;Valenciennes Hospital, Valenciennes, FRANCE | Recruiting | 51 Years | N/A | All | 70 | Phase 3 | France |
| 84 | NCT03026504 (ClinicalTrials.gov) | March 9, 2017 | 17/1/2017 | Baricitinib in Relapsing Giant Cell Arteritis | Baricitinib in Relapsing Giant Cell Arteritis (GCA): A Phase II, Single-institution, Open-label Pilot Study | Arteritis, Giant Cell | Drug: Baricitinib | Matthew J Koster | Eli Lilly and Company | Completed | 50 Years | N/A | All | 15 | Phase 2 | United States |
| 85 | NCT02955147 (ClinicalTrials.gov) | December 1, 2016 | 31/10/2016 | Ustekinumab for the Treatment of Giant Cell Arteritis | Open Label Study to Test the Safety and Efficacy of Ustekinumab in Patients With Giant Cell Arteritis | Giant Cell Arteritis;Temporal Arteritis;Horton's Disease | Drug: Ustekinumab;Drug: Prednisone | Massachusetts General Hospital | NULL | Terminated | 50 Years | N/A | All | 13 | Phase 1/Phase 2 | United States |
| 86 | EUCTR2015-001758-14-IT (EUCTR) | 08/06/2016 | 20/01/2021 | A study to assess the efficacy and safety of Sirukumab in the treatment ofpatients with Giant Cell Arteritis, using multiple sites, and an untreatedpatient group | A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - NA | Giant Cell Arteritis (GCA) MedDRA version: 20.0;Level: SOC;Classification code 10047065;Term: Vascular disorders;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Trade Name: Capsule di prednisone INN or Proposed INN: PREDNISONE Trade Name: Prednisone Capsule INN or Proposed INN: PREDNISONE Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone capsule INN or Proposed INN: PREDNISONE Other descriptive name: Prednisone | GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | New Zealand;Sweden;United States;Spain;United Kingdom;Italy;France;Hungary;Belgium;Poland;Australia;Bulgaria;Germany;Netherlands | ||
| 87 | EUCTR2015-005804-27-FR (EUCTR) | 04/06/2016 | 29/01/2016 | GiAnT (Giant cell arteritis and Anakinra Trial) | Essai randomisé, contrôlé, en double aveugle, de l'anakinra contre placebo, en adjonction à la corticothérapie dans l'artérite à cellules géantes. - GiAnT | Patients atteints d’artérite à cellules géantes (ou maladie de Horton) MedDRA version: 18.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Trade Name: KINERET | CHU CAEN | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | France | ||
| 88 | EUCTR2015-001758-14-HU (EUCTR) | 15/04/2016 | 19/01/2016 | A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient group | A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable | Giant Cell Arteritis (GCA) MedDRA version: 20.0;Level: HLGT;Classification code 10047116;Term: Vascular inflammations;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Encorton Product Name: Encorton INN or Proposed INN: prednisone Other descriptive name: PREDNISONE | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden | ||
| 89 | EUCTR2015-001758-14-NL (EUCTR) | 04/02/2016 | 26/08/2015 | A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient group | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable | Giant Cell Arteritis (GCA) MedDRA version: 19.1;Level: SOC;Classification code 10047065;Term: Vascular disorders;System Organ Class: 10047065 - Vascular disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 204 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden | ||
| 90 | EUCTR2015-001758-14-BG (EUCTR) | 08/01/2016 | 21/10/2015 | A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient group | A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable | Giant Cell Arteritis (GCA) MedDRA version: 19.0;Level: HLGT;Classification code 10047116;Term: Vascular inflammations;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden | ||
| 91 | EUCTR2015-001758-14-DE (EUCTR) | 18/12/2015 | 15/07/2015 | A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient group | A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable | Giant Cell Arteritis (GCA) MedDRA version: 19.1;Level: HLGT;Classification code 10047116;Term: Vascular inflammations;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Hungary;Belgium;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand | ||
| 92 | EUCTR2015-001758-14-BE (EUCTR) | 14/12/2015 | 05/02/2016 | A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient group | A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable | Giant Cell Arteritis (GCA);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden | ||
| 93 | NCT02531633 (ClinicalTrials.gov) | October 16, 2015 | 6/7/2015 | Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients With Giant Cell Arteritis | Giant Cell Arteritis | Drug: Sirukumab;Drug: Placebo to match sirukumab;Drug: Prednisone;Drug: Placebo to match prednisone | GlaxoSmithKline | NULL | Terminated | 50 Years | N/A | All | 161 | Phase 3 | United States;Australia;Belgium;Bulgaria;France;Germany;Hungary;Italy;Netherlands;New Zealand;Poland;Spain;United Kingdom |
| 94 | NCT02857192 (ClinicalTrials.gov) | October 5, 2015 | 29/6/2016 | Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Horton's Disease | Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Giant Cell Arteritis (Horton's Disease) | Horton's Disease | Biological: Blood samples | Centre Hospitalier Universitaire Dijon | NULL | Completed | 51 Years | N/A | All | 41 | N/A | France |
| 95 | EUCTR2015-001758-14-ES (EUCTR) | 30/09/2015 | 31/07/2015 | A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient group | A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable | Giant Cell Arteritis (GCA);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden | ||
| 96 | EUCTR2013-002778-38-EE (EUCTR) | 12/02/2015 | 13/01/2015 | A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | Giant cell arteritis MedDRA version: 17.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier (IRIS) | NULL | Not Recruiting | Female: yes Male: yes | 50 | Estonia;Finland;Spain;Ireland;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Norway | |||
| 97 | EUCTR2013-002778-38-FI (EUCTR) | 04/02/2015 | 14/10/2014 | A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | Giant cell arteritis MedDRA version: 18.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: Gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier (IRIS) | NULL | Not Recruiting | Female: yes Male: yes | 50 | Estonia;Finland;Spain;Ireland;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Poland;Denmark;Norway | |||
| 98 | EUCTR2013-002778-38-BE (EUCTR) | 21/01/2015 | 09/12/2014 | A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | Giant cell arteritis MedDRA version: 18.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier (IRIS) | NULL | Not Recruiting | Female: yes Male: yes | 50 | Estonia;Finland;Spain;Ireland;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Norway | |||
| 99 | EUCTR2013-002778-38-IE (EUCTR) | 19/01/2015 | 09/01/2015 | A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | Giant cell arteritis MedDRA version: 18.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier (IRIS) | NULL | Not Recruiting | Female: yes Male: yes | 50 | Estonia;Finland;Spain;Ireland;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway | |||
| 100 | NCT03244709 (ClinicalTrials.gov) | January 1, 2015 | 1/8/2017 | Tocilizumab Dose-tapering and Interruption in Patients With Giant Cell Arteritis Achieving the Clinical Remission. | Tocilizumab Dose-tapering and Interruption in Patients With Giant Cell Arteritis Achieving the Clinical Remission: a Prospective, Pilot Study. | Giant Cell Arteritis | Drug: Tocilizumab | Hospital of Prato | NULL | Recruiting | 18 Years | 90 Years | All | 15 | Phase 4 | Italy |
| 101 | EUCTR2013-002778-38-AT (EUCTR) | 18/12/2014 | 10/12/2014 | A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | Giant cell arteritis MedDRA version: 18.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier (IRIS) | NULL | Not Recruiting | Female: yes Male: yes | 50 | Estonia;Finland;Spain;Ireland;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Norway | |||
| 102 | EUCTR2013-002778-38-DK (EUCTR) | 18/12/2014 | 09/12/2014 | A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | Giant cell arteritis MedDRA version: 17.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier (IRIS) | NULL | Not Recruiting | Female: yes Male: yes | 50 | Estonia;Finland;Spain;Ireland;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Norway | |||
| 103 | NCT03285945 (ClinicalTrials.gov) | October 2014 | 12/10/2016 | FDG Uptake in Large-Vessel Giant Cell Arteritis After Short-term, High-Dose Steroid Treatment | Fluorine-18-fluorodeoxyglucose Uptake in Large-Vessel Giant Cell Arteritis After Short-term, High-Dose Steroid Treatment - A Diagnostic Window of Opportunity? | Giant Cell Arteritis | Drug: PET3;Drug: PET10 | University of Aarhus | NULL | Completed | 50 Years | N/A | All | 24 | N/A | Denmark |
| 104 | EUCTR2013-002778-38-GB (EUCTR) | 29/07/2014 | 29/10/2013 | A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | Giant cell arteritis MedDRA version: 18.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier (IRIS) | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Estonia;Finland;Spain;Ireland;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway | ||
| 105 | EUCTR2013-002778-38-CZ (EUCTR) | 12/02/2014 | 06/01/2014 | A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | Giant cell arteritis MedDRA version: 17.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier (IRIS) | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Estonia;Finland;Spain;Ireland;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Norway | ||
| 106 | EUCTR2013-002778-38-ES (EUCTR) | 14/01/2014 | 18/10/2013 | A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | Giant cell arteritis MedDRA version: 16.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Laboratorios Servier SL | Institut de Recherches Internationales Servier ( IRIS ) | Not Recruiting | Female: yes Male: yes | 50 | Estonia;Czech Republic;Canada;Finland;Belgium;Spain;Ireland;Austria;Denmark;Australia;Russian Federation;United Kingdom | |||
| 107 | EUCTR2013-002778-38-IT (EUCTR) | 11/11/2013 | 02/10/2013 | A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis | Giant cell arteritis MedDRA version: 14.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier (IRIS) | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Estonia;Finland;Spain;Ireland;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Belgium;Australia;Denmark | ||
| 108 | NCT01910038 (ClinicalTrials.gov) | November 8, 2013 | 17/7/2013 | Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study. | Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study. | Giant Cell Arteritis | Drug: corticoids+ tocilizumab 8mg/Kg/4 weeks | Centre Hospitalier Universitaire Dijon | NULL | Completed | 50 Years | N/A | All | 20 | Phase 2 | France |
| 109 | EUCTR2011-006022-25-NL (EUCTR) | 09/10/2013 | 24/05/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 17.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: TOCILIZUMAB SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB SC Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Norway;Sweden | ||
| 110 | EUCTR2011-006022-25-BE (EUCTR) | 30/09/2013 | 17/06/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000013753;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 111 | EUCTR2011-006022-25-PL (EUCTR) | 09/09/2013 | 16/07/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 19.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB SC Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 112 | NCT01791153 (ClinicalTrials.gov) | July 22, 2013 | 12/2/2013 | An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA) | A Phase III, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects With Giant Cell Arteritis | Giant Cell Arteritis | Drug: Tocilizumab;Drug: Prednisone;Drug: Tocilizumab Placebo;Drug: Prednisone Placebo;Drug: Corticosteroids;Drug: Methotrexate | Hoffmann-La Roche | NULL | Completed | 50 Years | N/A | All | 251 | Phase 3 | United States;Belgium;Canada;Denmark;France;Germany;Italy;Netherlands;Norway;Poland;Portugal;Spain;Sweden;United Kingdom;Austria |
| 113 | EUCTR2011-006022-25-ES (EUCTR) | 24/06/2013 | 10/06/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 16.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Portugal;Spain;Austria;Italy;United Kingdom;France;Canada;Belgium;Poland;Denmark;Netherlands;Norway;Germany;Sweden | ||
| 114 | EUCTR2011-006022-25-DK (EUCTR) | 14/06/2013 | 14/05/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000013753;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB SC Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden;United States;Spain;Portugal | ||
| 115 | EUCTR2011-006022-25-PT (EUCTR) | 07/06/2013 | 22/05/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 14.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Netherlands;Norway;Germany;Sweden | ||
| 116 | EUCTR2011-006022-25-DE (EUCTR) | 06/06/2013 | 13/05/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000013753;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 117 | EUCTR2011-006022-25-GB (EUCTR) | 23/05/2013 | 15/05/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 19.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 118 | EUCTR2011-006022-25-SE (EUCTR) | 16/05/2013 | 07/05/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB SC Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 119 | EUCTR2011-006022-25-AT (EUCTR) | 14/05/2013 | 10/05/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 17.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 120 | EUCTR2011-006022-25-IT (EUCTR) | 05/05/2013 | 07/03/2013 | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 14.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Portugal;Spain;Austria;Italy;United Kingdom;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 121 | JPRN-UMIN000008812 | 2012/10/01 | 01/10/2012 | Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR) | Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR) - Treatment of LVV and PMR by tocilizumab mono-therapy | Rheumatoid arthritis | tocilizumab monotherapy | Department of Rheumatology & Clinical ImmunologySaitama Medical Center, Saitama Medical Universitity | NULL | Complete: follow-up complete | 16years-old | 80years-old | Male and Female | 40 | Not selected | Japan |
| 122 | EUCTR2011-005090-22-GB (EUCTR) | 28/02/2012 | 17/01/2012 | A study of the effectiveness and safety of delayed release prednisone in patients with newly diagnosed Giant Cell Arteritis | A study of efficacy and safety of delayed release prednisone in newly diagnosed cases of Giant Cell Arteritis - Efficacy and safety of delayed release prednisone in GCA | Giant Cell Arteritis MedDRA version: 14.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Trade Name: Lodotra Product Name: Lodotra (delayed release prednisolone) INN or Proposed INN: Prednisolone Other descriptive name: 17,21-Dihydroxypregna-1,4-diene-3,11,20-trione | Southend Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | United Kingdom | ||||
| 123 | NCT01450137 (ClinicalTrials.gov) | September 2011 | 3/10/2011 | Tocilizumab for Patients With Giant Cell Arteritis | A Phase II, Randomized, Double-blind, Placebo Controlled Study of Tocilizumab in Patients With Giant Cell Arteritis | Giant Cell Arteritis | Drug: Tocilizumab + Glucocorticoids (GCs);Drug: Placebo + Glucocorticoids (GCs) | University Hospital Inselspital, Berne | University of Bern;Roche Pharma AG | Completed | 50 Years | N/A | All | 30 | Phase 2 | Switzerland |
| 124 | NCT01400464 (ClinicalTrials.gov) | July 2009 | 21/7/2011 | Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis | Study the Link Between Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis | Giant Cell Arteritis | Drug: Prednisone therapy and pharmacokinetic | University Hospital, Caen | NULL | Active, not recruiting | 50 Years | N/A | Both | 150 | Phase 4 | France |
| 125 | NCT00556439 (ClinicalTrials.gov) | December 2008 | 9/11/2007 | Abatacept for Treating Adults With Giant Cell Arteritis and Takayasu's Arteritis | Concurrent Pilot Studies in Giant Cell Arteritis and Takayasu's Arteritis to Examine the Safety, Efficacy, and Immunologic Effects of Abatacept (CTLA4-Ig) in Large Vessel Vasculitis | Takayasu's Arteritis;Giant Cell Arteritis | Drug: Abatacept;Drug: Placebo | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | The Cleveland Clinic;Office of Rare Diseases (ORD);Rare Diseases Clinical Research Network | Completed | 15 Years | N/A | All | 97 | Phase 2 | United States;Canada |
| 126 | NCT00305539 (ClinicalTrials.gov) | May 2006 | 21/3/2006 | HECTHOR: Humira to Spare Steroids in Giant Cell Arteritis | HECTHOR: A Pilot Multicenter Double-blind Randomised Study of 3 Months Treatment With Humira Added to Steroids in Giant Cell Arteritis | Giant Cell Arteritis | Drug: adalimumab;Drug: placebo | Assistance Publique - Hôpitaux de Paris | Abbott | Completed | 50 Years | N/A | Both | 69 | Phase 3 | France |
| 127 | NCT00076726 (ClinicalTrials.gov) | November 2003 | 2/2/2004 | A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Giant Cell Arteritis | A Randomized, Double-Masked, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Infliximab in Subjects With Giant Cell Arteritis | Giant Cell Arteritis | Drug: Infliximab | Centocor, Inc. | The Cleveland Clinic | Terminated | 50 Years | N/A | Both | 44 | Phase 2 | United States;Belgium;Italy;Spain;United Kingdom |
| 128 | NCT00430807 (ClinicalTrials.gov) | January 2002 | 31/1/2007 | Hydroxychloroquine in Giant Cell Arteritis | Multicentric Double Blind Versus Placebo Randomised Study Evaluating the Corticosteroid Sparing Effect of Hydrocyschloroquine in Non Complicated Giant Cell Arteritis. | Giant Cell Arteritis | Drug: hydroxychloroquine/placebo | University Hospital, Toulouse | NULL | Completed | 18 Years | 85 Years | Both | 75 | Phase 3 | France |
| 129 | NCT00138983 (ClinicalTrials.gov) | May 2000 | 29/8/2005 | Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol. | Prevention of Glucocorticoid-Induced Osteoporosis in Patients With Rheumatic Diseases. The STOP-Study: a Randomized Placebo Controlled Trial With Alendronate Versus Alfacalcidol. | Rheumatoid Arthritis;Polymyalgia Rheumatica;Giant Cell Arteritis;Polymyositis;Wegener’s Granulomatosis | Drug: Alendronate versus alfacalcidol (1-alpha OH vitamin D) | UMC Utrecht | Dutch Health Care Insurance Board | Completed | 18 Years | 90 Years | Both | 200 | Phase 3 | Netherlands |
| 130 | NCT00006055 (ClinicalTrials.gov) | March 2000 | 5/7/2000 | Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases | Purpura, Schoenlein-Henoch;Graft Versus Host Disease;Anemia, Hemolytic, Autoimmune;Rheumatoid Arthritis;Churg-Strauss Syndrome;Hypersensitivity Vasculitis;Wegener's Granulomatosis;Systemic Lupus Erythematosus;Giant Cell Arteritis;Pure Red Cell Aplasia;Juvenile Rheumatoid Arthritis;Polyarteritis Nodosa;Autoimmune Thrombocytopenic Purpura;Takayasu Arteritis | Drug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell Transplantation | Fairview University Medical Center | NULL | Active, not recruiting | 1 Year | 55 Years | Both | 10 | N/A | United States | |
| 131 | NCT00004686 (ClinicalTrials.gov) | February 1994 | 24/2/2000 | Phase II Randomized Study of Glucocorticoids With or Without Methotrexate for Treatment of Giant Cell Arteritis | Giant Cell Arteritis | Drug: methotrexate;Drug: prednisone | The Cleveland Clinic | NULL | Completed | 50 Years | N/A | Both | 300 | Phase 2 | NULL |