DDrare: Database of Drug Development for Rare Diseases

Searched query = "Dermatomyositis", "Polymyositis"
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 = 0.9% w/v isotonic sodium chloride solution; 10% nifedipine cream; 3 MPDN pulse + PDN; 3 MPDN pulse + PDN + CSA; 3 MPDN pulse + PDN + MTX; 35mg; 44/154/85-C; 44/196/81-C; 5% sildenafil cream; 56/104/75-C; 5mg; ABATACEPT; ALFACALCIDOL; Abatacept; Abatacept Active Treatment; Abatacept Delayed-Onset Treatment; Abatacept subcutaneous; Acthar; Acthar Gel; Adrenocorticotropic Hormone Gel; Adrenocorticotropic hormone; Ajulemic acid; Alendronate; Alendronate versus alfacalcidol (1-alpha OH vitamin D); Alfacalcidol; Alfacalcidol 2 micrograms/ml; Anakinra; Anti-pandemic H1N1 influenza vaccine; Apremilast; Apremilast 30mg; BAF312; BAF312 0,5 mg tablet; BAF312 0.25 mg; BAF312 0.25 mg tablet; BAF312 0.25mg tablet; BAF312 0.5 mg; BAF312 0.50 mg; BAF312 1 mg; BAF312 1 mg tablet; BAF312 1mg; BAF312 1mg tablet; BAF312 2 mg; BAF312 2 mg tablet; BAF312 2mg; BAF312 4mg tablet; BAF312 5 mg tablet; BAF312 hemifumarate; BAF312X; BARICITINIB; Baricitinib; Basiliximab; Calcineurin Inhibitors; Carbon; Carbon dioxide; Cervarix; Cervarix suspensie voor injectie; Chloride; Ciclosporin; Creapure; Creatine; CsA; CyA; Cyclophosphamide; Cyclophosphamide Injection 1g; Cyclosporin; Cyclosporine; Cyclosporine A; Denosumab; Device: Fractionated Carbon Dioxide (FCO2) Laser; Drops; EMEA/H/C/000701; Etanercept; GB-0998; Gamma Globulin; Gevokizumab; Glucose; Glucose Tablet; Gold; Grapefruit; H.P. Acthar Gel; H5G1.1-mAb; HBVAXPRO; HBvaxpro; HUMAN NORMAL IMMUNOGLOBULIN; Hbvaxpro; Hizentra; Human Normal Immunoglobulin; Human immunoglobulin G; Human normal immunoglobulin; Human normal immunoglobulin (IVIg); Human normal immunoglogulin (IVIg); IFN-K; IFN-Kinoid; IFN-Kinoid Drug Substance; IFNa-Kinoid; IGVENA*FL 200ML 10G+SET; IMMUNOGLOBULIN G; IMO-8400; IMO-8400 Dose Group 1; IMO-8400 Dose Group 2; IVIg; Ig VENA; Ig VENA (10g/200mL); Ig Vena; IgPro20; Immunoglobulin (Hizentra); Immunosuppressive Agents; Impact; Infliximab; Influvac; Isotone Kochsalz-Lösung 0,9 % Braun Infusionslösung; JBT-101; KZR-616; KZR-616 maleate; L0133; LY3009104; Lenabasum; Lenabasum 20 mg; Lenabasum 5 mg; Lipid-lowering agents (Artovastatin); MEDI-545; MEDI7734; METHOTREXATE; MMF; MTX; MabThera; Mabthera; Methimazole; Methotrexat; Methotrexat Lachema 2,5mg; Methotrexat Lachema 2,5mg tbl.; Methotrexat Lachema 5 inj. sol; Methotrexate; Methotrexate Lachema 5inj. sol; Methotrexate Wyeth 2,5mg; Methotrexate Wyeth 2,5mg tbl.; Methylprednisolone; Methylprednisolone sodium succinate; Methylprednisoloni natrii succinas; Metoject 10 mg/ml; Metotrexat; Metotrexate; Nifedipine; Nivolumab; ORENCIA; Octagam 10%; Octanorm; Octanorm 16.5%; One Alpha; One Alpha Drops; One-Alpha drops; One-alpha; Orencia; Orencia (trade name); Other: ISA 51; PF-06823859 high; PF-06823859 low; PREDNISON 5, 20 Léciva por. tablet nob; Pirfenidone; Placebo; Placebo IV; Placebo SC; Pneumovax 23; Prednisolon; Prednisolon Pfizer; Prednisolone; Prednison 5, 20 Léciva por. tablet nob.; Prednisone; RISEDRONATE SODIUM; Resunab, ajulemic acid, anabasum; Risedronate; Risedronate Sodium; Rituximab; S78989; SODIUM CHLORIDE; SODIUM THIOSULFATE PENTAHYDRATE; STS; Sildenafil; Siponimid; Siponimod; Siponimod 0.25 mg tablet; Siponimod 0.5 mg tablet; Siponimod 1 mg tablet; Siponimod 2 mg Tablet; Sodium Thiosulfate; Sodium Thiosulfate 10%; Sodium chloride; Sodium thiosulfate; Sodium thiosulfate 10%; Solu-Medrol; Solu-medrol; Solu-medrol inj. PSO LQF 40mg; Solu-medrol inj. PSO lqf 40mg; Steroids; Tacrolimus; Tocilizumab; Tofacitinib; Tofacitinib 5 MG [Xeljanz]; Treatment defined only by active substance; Ustekinumab; Ustekinumab 6 mg/kg; Ustekinumab 90 mg; VIB7734; Vitamin D; XOMA 052; Yellow Fever Vaccine; Yellow Fever vaccine (17D)

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	JPRN-UMIN000018376	2015/07/22	22/07/2015	Efficacy and safety of rituximab for patients with severe rheumatic disease	Efficacy and safety of rituximab for patients with severe rheumatic disease - Efficacy and safety of rituximab for patients with severe rheumatic disease	Childhood-onset severe rheumatic disease(systemic lupus erhythematosus, dermatomyositis, poly myositis, systemic sclerosis , mixed connective tissue disease, Sjogren's syndrome, anti-phospholipid syndrome)	1) Induction Therapy rituximab 375mg/m2 (max500mg) 1-4 times/1-2 weeks 2) Maintenance Therapy rituximab 375mg/m2 (max500mg) 1 times/6-12 months	Yokohama City University Hospital Department of Pediatrics	NULL	Complete: follow-up complete	2years-old	Not applicable	Male and Female	20	Not selected	Japan
2	EUCTR2012-003633-42-GB (EUCTR)	18/10/2013	22/08/2013	A trial of rituximab compared to usual best care in patients with interstitial (inflammatory or scarring conditions) lung disease due to systemic autoimmune (connective tissue) diseases	A randomized, double blind controlled trial comparing rituximab against intravenous cyclophosphamide in connective tissue disease associated interstitial lung disease - Rituximab versus cyclophosphamide in connective tissue disease-ILD	A diagnosis of connective tissue disease associated interstitial lung disease, based on internationally accepted criteria, in one of the following categories: o Systemic sclerosis o Idiopathic interstitial myopathy (including polymyositis/dermatomyositis) o Mixed connective tissue disease MedDRA version: 14.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 14.1;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10027754;Term: Mixed connective tissue disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Classification code 10039710;Term: Scleroderma;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: MabThera Product Name: Rituximab INN or Proposed INN: Rituximab Trade Name: Cyclophosphamide Injection 1g Product Name: Cyclophosphamide Injection 1g INN or Proposed INN: Cyclophosphamide	Royal Brompton and Harefield NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			United Kingdom
3	EUCTR2006-000078-65-GB (EUCTR)	08/12/2008	07/12/2010	Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) - Rituximab in myositis	Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) - Rituximab in myositis	Adult polymyositis or adult dermatomyositis or juvenile dermatomyositis MedDRA version: 8.1;Level: LLT;Classification code 10036102;Term: Polymyositis	Trade Name: Mabthera Product Name: Mabthera	Karolinska University Hospital	NULL	Not Recruiting			Female: yes Male: yes	202	Phase 2	Czech Republic;United Kingdom;Sweden
4	EUCTR2006-000078-65-CZ (EUCTR)	12/11/2007	18/10/2007	Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM)and Adult Polmyositis (PM) - Rituximab in myositis (RIM)	Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM)and Adult Polmyositis (PM) - Rituximab in myositis (RIM)	Adult polymyositis or adult dermatomyositis or juvenile dermatomyositis. MedDRA version: 9.1;Level: LLT;Classification code 10036102;Term: Polymyositis	Trade Name: Mabthera Product Code: Mabthera	Karolinska University Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	202		United Kingdom;Czech Republic;Sweden
5	EUCTR2006-000078-65-SE (EUCTR)	17/01/2007	02/11/2006	Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) - Rituximab in myositis	Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) - Rituximab in myositis	Adult polymyositis or adult dermatomyositis or juvenile dermatomyositis MedDRA version: 8.1;Level: LLT;Classification code 10036102;Term: Polymyositis	Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: Rituximab	Karolinska University Hospital	NULL	Not Recruiting			Female: yes Male: yes	202		United Kingdom;Czech Republic;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	NCT00106184 (ClinicalTrials.gov)	March 2006	21/3/2005	Rituximab for the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM)	Rituximab Therapy in Refractory Adult and Juvenile Idiopathic Inflammatory Myopathy (IIM)	Myositis;Dermatomyositis;Polymyositis;Juvenile Dermatomyositis	Drug: Rituximab;Drug: Placebo	University of Pittsburgh	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Genentech, Inc.;Biogen	Completed	5 Years	N/A	All	200	Phase 2	United States;Canada;Czech Republic;Sweden;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

JPRN-UMIN000018376

2015/07/22

22/07/2015

Efficacy and safety of rituximab for patients with severe rheumatic disease

Efficacy and safety of rituximab for patients with severe rheumatic disease - Efficacy and safety of rituximab for patients with severe rheumatic disease

Childhood-onset severe rheumatic disease(systemic lupus erhythematosus, dermatomyositis, poly myositis, systemic sclerosis , mixed connective tissue disease, Sjogren's syndrome, anti-phospholipid syndrome)

1) Induction Therapy
rituximab 375mg/m2 (max500mg)
1-4 times/1-2 weeks

2) Maintenance Therapy
rituximab 375mg/m2 (max500mg)
1 times/6-12 months

Yokohama City University Hospital Department of Pediatrics

NULL

Complete: follow-up complete

2years-old

Not applicable

Male and Female

Not selected

Japan

EUCTR2012-003633-42-GB
(EUCTR)

18/10/2013

22/08/2013

A trial of rituximab compared to usual best care in patients with interstitial (inflammatory or scarring conditions) lung disease due to systemic autoimmune (connective tissue) diseases

A randomized, double blind controlled trial comparing rituximab against intravenous cyclophosphamide in connective tissue disease associated interstitial lung disease - Rituximab versus cyclophosphamide in connective tissue disease-ILD

A diagnosis of connective tissue disease associated interstitial lung disease, based on internationally accepted criteria, in one of the following categories: o Systemic sclerosis o Idiopathic interstitial myopathy (including polymyositis/dermatomyositis) o Mixed connective tissue disease
MedDRA version: 14.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 14.1;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Classification code 10027754;Term: Mixed connective tissue disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1;Classification code 10039710;Term: Scleroderma;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Trade Name: MabThera
Product Name: Rituximab
INN or Proposed INN: Rituximab
Trade Name: Cyclophosphamide Injection 1g
Product Name: Cyclophosphamide Injection 1g
INN or Proposed INN: Cyclophosphamide

Royal Brompton and Harefield NHS Foundation Trust

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom

EUCTR2006-000078-65-GB
(EUCTR)

08/12/2008

07/12/2010

Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) - Rituximab in myositis

Adult polymyositis or adult dermatomyositis or juvenile dermatomyositis
MedDRA version: 8.1;Level: LLT;Classification code 10036102;Term: Polymyositis

Trade Name: Mabthera
Product Name: Mabthera

Karolinska University Hospital

NULL

Not Recruiting

Female: yes
Male: yes

202

Phase 2

Czech Republic;United Kingdom;Sweden

EUCTR2006-000078-65-CZ
(EUCTR)

12/11/2007

18/10/2007

Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM)and Adult Polmyositis (PM) - Rituximab in myositis (RIM)

Adult polymyositis or adult dermatomyositis or juvenile dermatomyositis.
MedDRA version: 9.1;Level: LLT;Classification code 10036102;Term: Polymyositis

Trade Name: Mabthera
Product Code: Mabthera

Karolinska University Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

202

United Kingdom;Czech Republic;Sweden

EUCTR2006-000078-65-SE
(EUCTR)

17/01/2007

02/11/2006

Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) - Rituximab in myositis

Adult polymyositis or adult dermatomyositis or juvenile dermatomyositis
MedDRA version: 8.1;Level: LLT;Classification code 10036102;Term: Polymyositis

Trade Name: Mabthera
Product Name: Mabthera
INN or Proposed INN: Rituximab

Karolinska University Hospital

NULL

Not Recruiting

Female: yes
Male: yes

202

United Kingdom;Czech Republic;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT00106184
(ClinicalTrials.gov)

March 2006

21/3/2005

Rituximab for the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM)

Rituximab Therapy in Refractory Adult and Juvenile Idiopathic Inflammatory Myopathy (IIM)

Myositis;Dermatomyositis;Polymyositis;Juvenile Dermatomyositis

Drug: Rituximab;Drug: Placebo

University of Pittsburgh

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Genentech, Inc.;Biogen

Completed

5 Years

N/A

All

200

Phase 2

United States;Canada;Czech Republic;Sweden;United Kingdom