DDrare: Database of Drug Development for Rare Diseases

Searched query = "Scleroderma", "Systemic sclerosis", "SSc", "dcSSc", "lcSSc"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 0,5 mg Prevenar i.m.; 0,5 mg seasonal influenza vaccine i.m.; 0.9% sodium chloride; 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID; 1-22460; 10% Nitroglycerine in Propylene Glycol, USP; 3-[4-(1H-imidazol-1-ylmethyl)phenyl]-5-(2-methylpropyl)thiophene-2-[(N-butyloxylcarbamate)-sulphonamide] sodium salt; ABR-215757; ACHIM as solute (10^9 intestinal microbes/ml); ACT-064992; ACT-293987; ADEMPAS - 1 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE; ADEMPAS - 1,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE; ADEMPAS - 2 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE; ADEMPAS - 2,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE; ADSVF application in the right hand; AIMSPRO; AL; AM-01; ANTI-HUMAN T-LYMPHOCYTE IMMUNOGLOBULIN FROM RABBITS; ASASANTIN Retard; ASC; AUC of MPA measure; AVID200; Abatacept; Abituzumab; Abituzumab 1500 mg; Abituzumab 500 mg; Acetaminophen; Acetate; Acetylcysteine; Acetylsalicylic acid; Acotiamide; Adempas; Administration of rituximab and methylprednisolone; Air; Ajulemic acid; Albumin; Alemtuzumab; Alginic acid; Allogeneic Mesenchymal Stem Cells (AlloMSC); Alpha-2C AR antagonist; Alprostadil; Ambrisentan; Amlodipine; Amlodipine Gel; Anaerobically Cultivated Human Intestinal Microbiota; Anaerobically Cultivated medium; Anti-CT51 antigen mAb; Anti-Thymocyte Globulin; Anti-Thymocyte Globulin, Rabbit; Anti-integrin alphaV mAb; Anti-pandemic H1N1 influenza vaccine; Anti-thymocyte globulin; Asasantin Retard ®; Aspirin; Atorvastatin; Autologous ASC; Autologous Stem Cells; Autologous stemcell transplantation with CD (cluster of differentiation) 34 selected stem cells; Aviptadil; BAY63-2521; BERMEKIMAB; BH4; BIBF 1120; BMS-986020; BOSENTAN MONOHYDRATE; BOTOX® solution; Beam; Belimumab; Belumosudil (KD025); Bermekimab; Biopsy; Blood coagulation factor XIII; Blood sample; Blood samples; Blood sampling; Bortezomib; Bosentan; Bosentan (Tracleer); Bosentan 125 mg; Bosentan 62.5 mg; Bosentan group; Bosentan monohydrate; Botox; Botulinum Toxin Type B; Botulinum toxin A; Botulinum toxin type B (2500 units / vial); Botulinum toxin(Botox); Bovine type I collagen; Brentuximab; Brentuximab Vedotin; Brentuximab vedotin; Brodalumab; Bupivacaine; Buspirone; Busulfan; Butanoic acid; C-82 Topical Gel, 1%; C21; C225; CAM2043; CAPILLAREMA; CC; CC-4047; CD; CD34 selected autologous hematopoietic cells; CD34+SC; CILOSTAZOL; CYCLOPHOSPHAMIDE; Calcipotriene; Calcium; Calcium Channel Blockers; Campath; Carbon; Carbon dioxide; Cetuximab; Chloride; Cialis; Cilostazol; Clobetasol; Cuprimine (penicillamine); Currently available therapy in the community; Cutaneous iontophoresis of treprostinil; Cyclophosphamide; Cyclophosphamide Injection 1g; DI-17E6; DIGNA P144 CREAM; DIGNA P144 cream; Dabigatran; Dabigatran etexilate; Dasatinib; Depot leuprolide acetate 3.75 mg; Dersimelagon; Device: Air filled balloon catheter; Device: Fractional carbon dioxide laser; Device: Manual toothbrush; Device: Manual toothbrush and water flosser (Philips Sonicare AirFloss); Device: Measurment with Aspirational Medical Device; Device: Measurment with Cutometer MPA 580; Device: Serial night time position splint; Device: Solid state catheter; Device: Sonic toothbrush; Device: Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss); Device: Ultraviolet A1 phototherapy (UVA1); Device: the ozone generator device (Human Pro medic, German); Diagnostic Test: CMRI; Diagnostic Test: Imaging; Diagnostic Test: P-MPA concentration; Diagnostic Test: Pulmonary function test; Diltiazem; Diltiazem Gel 2%; Dimethyl Fumarate (DMF); Dimethyl fumarate; Diphenhydramine; Dipyridamole; Divalproex sodium; Domperidone; Double-Blind Rituximab; Drug treatment; Dupilumab; Dupilumab 300Mg Solution for Injection; EDTA; EMA/CHMP/212874/2015; EMD 525797; ENDOPROST; ENDOPROST - 0.05 MG/0.5 ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FIALA; ENDOPROST 0,05MG/0,5ML 1F; ENDOPROST 50*INFUS 1F 0,050MG/; EX VIVO CULTURED HUMAN MESENCHYMAL STEM CELLS; Endoprost; Endothelin receptor blocker; Erbitux; Esbriet; Ethanol; FILGRASTIM; FT011; Factor XIII; Fasudil; Fibrogammin® 1250; Fibrogammin®P, coagulation factor XIII concentrate (Human); Filgrastim; Fludarabine; Fludarabine phosphate; Fresolimumab; From August 2020 'no additional treatment'; G-CSF; G451990; GLIVEC; GLPG1690; GM-CSF; GS-248; GSK2330811; GSK2330811 Solution for Injection, 100mg/ml; Genetic: FCX-013; Glivec; Glivec 100 mg Filmtabletten; Glycyrrhizin; Gran; HIDONAC*EV 1FL 5G 25ML; HUMAN NORMAL IMMUNOGLOBULIN; Hematopoietic stem cell transplantation; High-dose intravenous immunoglobulin (Venoglobulin-IH); Hizentra; Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody; Human normal immunoglobulin; Human normal immunoglobulin for intravenous (IV) administration; Human normal immunoglobulin for intravenous administration; Human normal immunoglobulin for subcutaneous administration; Hyaluronidase; Hyaluronidase injected intradermally; Hyperimmune caprine serum; Hyperoxia; ILOPROST SALE DI TROMETAMOLO; ILOPROST TROMETAMOL; IMATINIB MESILATO; INCB039110; INJECTION OF ALLOGENEIC MESENCHYMAL STEM CELLS; INTERLEUKIN 2; ITACITINIB; IV Cyclophosphamide; IVA337; IVIg; Ifetroban; IgPro10; IgPro20; Iguratimod; Ilomedin; Iloprost; Iloprost Injection, for intravenous use; Iloprost low dose; Iloprost therapy up to 2 ng/kg x min; Iloprost trometamol; Imatinib; Imatinib Mesylate; Imatinib mesylate; Imiquimod; Imiquimod 5% cream; Imnovid; Imnovid 1 mg hard capsules; Indocyanine Green; Indocyanine green; Indole; Influenza vaccine; Injection of autologous stromal vascular fraction; Interleukin 2; Intravenous immunoglobulin; Iontophoresis of treprostinil; Itacitinib; JBT-101; KHK4827; LANIFIBRANOR; LENABASUM; Lactobacillus; Lanifibranor; Lenabasum; Lenabasum 20 mg; Lenabasum 20 mg Powder in Capsule; Lenabasum 5 mg; Lenabasum 5 mg Powder in Capsule; Leuprolide; Lidocaine; Lidocaine 2% without vessel constrictor; Lipitor; Liposomal bupivacaine; MABp1 (Bermekimab); MEDI-546; MEDI-551; MESNA; METHYLPREDNISOLONE; METHYLPREDNISOLONE SODIUM SUCCINATE; METOCLOPRAMIDE; METOCLOPRAMIDE ACCORD - 10 MG COMPRESSE 28 COMPRESSE IN BLISTER PVC/PVDC/AL; MHSCT; MMF; MPA; MQX-503; MSC; MT-7117; MabThera; Mabthera; Macitentan; Macitentan 10 mg; Macitentan 10mg; Macitentan 3 mg; Macitentan 3mg; Medrone; Mesenchymal Stem Cells from Wharton ´s jellyintravenous infusion of Mesenchymal Stem Cells from Wharton ´s jelly; Mesenchymal Stromal Cells; Mesenchymal stem cells; Mesenchymal stromal cells; Mesna; Methotrexate; Methylprednisolon; Methylprednisolone; Methylprednisolone acetate; Metoclopramide; Metronidazole; Mg; Microgynon; Mizoribine; Mycophenolate; Mycophenolate Mofetil; Mycophenolate Mofetil (MMF); Mycophenolate mofetil; Mycophenolic Acid; Mycophenolic acid; N-acetylcysteine (NAC); NAC; ND; NINTEDANIB; NON PROPIETRY, THEREFORE N/A; Neovasculgen; Neupogen; Nilotinib; Nilotinib (Tasigna); Nintedanib; Nitroglycerin; Nitroglycerin Ointment 2%; Nitroglycerine; Nitroglycerine gel; Nitroprusside; Nivolumab; Non applicabile; Null; ORENCIA; ORM-12471; ORM-12471 30mg; ORM-12741; Ofev; Omeprazole; Omeprazole 20mg; Onabotulinumtoxin A; Ophthalmic Emulsion; Opsumit 10 Mg Tablet; Oral Ifetroban; Oral bovine type I collagen; Oral treprostinil; Orencia; Other vasodilator; Other: Biopsy; Other: Bronchoalveolar samples; Other: Laboratory Biomarker Analysis; Other: Physalis angulata ethanol extract; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Rosemary essential oil; Other: Vasculopathy assessment; Other: flow cytometry; Other: laboratory biomarker analysis; Other: sodium chloride; Ozone; P144; P144 Cytokine Inhibitor; P144 Cytokines Inhibitors; P144 DIGNA CREAM; P144 cream; P144. Cytokines Inhibitors; PFD; PIRFENIDONE; PLETAL; PR1; PRUCALOPRIDE SUCCINATE; Paquinimod; Part B Open-Label Extension; Patients will be randomized to receive EHP-101; Penicillamine; Peripheral Blood Stem Cells; Phosphate; Phosphodiesterase Inhibitors; Physiological saline; Pirfenidone; Pirfenidone (PFD); Placebo; Platelet Gel; Plerixafor; Pletal; Polydeoxyribonucleotides; Pomalidomida; Pomalidomide; Pomalidomide (CC-4047); Prednisolon; Prednisolona; Prednisolone; Prednisolone 5 mg; Prednisolone 5mg Gastro-resistant Tablets; Prednisolone and taper; Prednisoloni; Prednisolonum; Prednisone; Prednizolon; Prednizolonas; Privigen; Procedure: 2 ml of whole blood sample will be collected on EDTA tube; Procedure: Adipose tissue harvest; Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Procedure: Autologous Hematopoietic Stem Cell Transplantation; Procedure: Leukapheresis; Procedure: Leukopheresis; Procedure: Order of two elements of surgical procedure; Procedure: Peripheral Blood Stem Cell Transplantation; Procedure: Reduced Intensity Allogeneic Transplant; Procedure: Self bone marrow transplant; Procedure: Total Body Irradiation; Procedure: Total-Body Irradiation; Procedure: biopsy; Procedure: bone marrow transplantation; Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation; Procedure: quality-of-life assessment; Procedure: reduced intensity allogeneic hematopoietic stem cell transplantation; Procedure: stem cell transplantation; Propylene glycol; Prostanoids; Prucalopride; QAX576; RATG; RESOLOR*28CPR RIV 2MG; RIOCIGUAT; RO487-7533/F10-04; Rabbit; Rabeprazole; Radiation: Cone Beam Computed Tomography (CBCT); Radiation: Intensity-Modulated Radiation Therapy; Radiation: Total Body Irradiation; Radiation: total-body irradiation; Rapamycin; RbATG; Recombinant humanized anti-human monoclonal antibody directed against the IL-6R; Relaxin; Resolor; Resunab, ajulemic acid, anabasum; Rilonacept; Ringer lactate; Riocigu; Riociguat; Riociguat (Adempas, BAY63-2521); Riociguat coated tablet 0.5 mg; Riociguat coated tablet 1.0 mg; Riociguat coated tablet 1.5 mg; Riociguat coated tablet 2.0 mg; Riociguat coated tablet 2.5 m; Riociguat coated tablet 2.5 mg; Rituximab; Ro 47-0203; Ro 487-7533/F10-04; Ro47-0203 / ACT-050088; RoActemra; RoActemra 162 mg; Rosemary; Rosuvastatin; SAR100842; SAR156597; SAR156597 (ACT14604); SAR231893; SELEXIPAG; SINVACOR*28CPR RIV 20MG; SODIUM NITROPRUSSIDE; SODIUM THIOSULFATE PENTAHYDRATE; STI571; STS; Saccharomyces; Saccharomyces Boulardii Oral Tablet; Selexipag; Sildenafil; Sildenafil 20mg; Sildenafil 20mg and Bosentan 62.5mg; Sildenafil citrate; Sildenafil therapy; Simvastatin; Sinvacor; Sirolimus; Sodium Thiosulfate 10%; Sodium chloride; Sodium fluoride; Sodium fluoride 18F; Sodium thiosulfate; Sodium thiosulfate 10%; Solu-Medrol; Solu-Medrone; Solu-medrol; Solu-medrone; Soluble Ve cadherin; Standard of care; Sterile saline solution; Steroids; Stromal Vascular fraction; Study of the gene expression profile; TEPEZZA; TERGURIDE HYDROGENMALEATE; TOCILIZUMAB; TRACLEER*125MG 56CPR RIV.; TRACLEER*56CPR RIV 125MG; TREPROSTINIL SODIUM; Tacrolimus; Tadalafil; Tadalafil and ambrisentan upfront combination therapy; Tepezza; Terguride; Thalidomide; Thiotepa; Thymoglobulin; Thymoglobuline; Tocilizumab; Tocilizumab SC 162 mg/0.9 ml prefilled syringe with safety device (PFS); Tocilizumab [RoActemra/Actemra]; Tofacitinib; Topical AmphiMatrix; Topical AmphiMatrix with nitroglycerin (MQX-503); Topical calcipotriene 0.005% ointment; Topical organogel with nitroglycerin; Tracleer; Transdihydrolisuride; Treprostinil; Treprostinil Sodium; Treprostinil diethanolamine; Trimebutine; Trometamol; UCMSC; UT-15 SR; UT-15C SR; UT-15C-SR; Urine sample; VIB7734; VIP; Vaseline; Veledimex; Vessel; Vivomixx probiotics; Volibris; Water; Yellow Fever Vaccine; Yellow Fever vaccine (17D); ZD4054; Zibotentan; Ziritaxestat

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	EUCTR2004-000632-82-GB (EUCTR)	16/09/2004	11/02/2005	Long term bosentan open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers - RAPIDS-2 Open label extension	Long term bosentan open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers - RAPIDS-2 Open label extension	SSc is a multi-system disorder of unknown etiology characterized by fibrosis and vascular obliteration in the skin and visceral organs. The pathogenesis of SSc involves immunologic mechanisms vascular damage and excessive accumulation of fibrosis in the skin and internal organs. As vascular damage progresses the microvascular bed in the skin and other sites is impaired, producing a state of chronic ischemia. SSc is commonly divided into the diffuse and limited form of the disease	Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	Italy;United Kingdom

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agemin

Inclusion_
agemax

Inclusion_
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EUCTR2004-000632-82-GB
(EUCTR)

16/09/2004

11/02/2005

Long term bosentan open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers - RAPIDS-2 Open label extension

SSc is a multi-system disorder of unknown etiology characterized by fibrosis and vascular obliteration in the skin and visceral organs. The pathogenesis of SSc involves immunologic mechanisms vascular damage and excessive accumulation of fibrosis in the skin and internal organs. As vascular damage progresses the microvascular bed in the skin and other sites is impaired, producing a state of chronic ischemia. SSc is commonly divided into the diffuse and limited form of the disease

Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

Italy;United Kingdom