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_ gender	Target_ size	Phase	Countries
1	EUCTR2016-002269-77-FR (EUCTR)	02/09/2017	11/02/2019	A Phase 3 trial to evaluate the effectiveness and safety of Abatacept SC alongside standard treatment in comparison to standard treatment alone in improving disease activity in adults with active idiopathic inflammatory myopathy, a group of chronic autoimmune inflammatory diseases that affect skeletal muscle.	A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC with Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults with Active Idiopathic Inflammatory Myopathy (IIM)	Idiopathic Inflammatory Myopathy (IIM; eg, Dermatomyositis [DM], Polymyositis [PM], autoimmune necrotizing myopathy) MedDRA version: 20.0;Level: LLT;Classification code 10042753;Term: Symptomatic inflammatory myopathy;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Orencia INN or Proposed INN: ABATACEPT	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	150	Phase 3	United States;France;Hungary;Czech Republic;Mexico;Brazil;Australia;Germany;Japan;Italy;Sweden;Korea, Republic of
2	EUCTR2016-002269-77-CZ (EUCTR)	20/07/2017	18/05/2017	A Phase 3 trial to evaluate the effectiveness and safety of Abatacept SC alongside standard treatment in comparison to standard treatment alone in improving disease activity in adults with active idiopathic inflammatory myopathy, a group of chronic autoimmune inflammatory diseases that affect skeletal muscle.	A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC with Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults with Active Idiopathic Inflammatory Myopathy (IIM)	Idiopathic Inflammatory Myopathy (IIM; eg, Dermatomyositis [DM], Polymyositis [PM], autoimmune necrotizing myopathy) MedDRA version: 20.0;Level: LLT;Classification code 10042753;Term: Symptomatic inflammatory myopathy;System Organ Class: 100000018885;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Orencia INN or Proposed INN: ABATACEPT	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	150	Phase 3	France;United States;Hungary;Czech Republic;Mexico;Brazil;Australia;Germany;Japan;Italy;Korea, Republic of;Sweden
3	EUCTR2009-015957-20-GB (EUCTR)	29/05/2012	20/04/2012	A clinical trial to investigate treatment with the drug abatacept in patients with polymyositis and dermatomyositis.	Abatacept Treatment in Polymyositis and Dermatomyositis - Artemis UK	Polymyositis and dermatomyositis MedDRA version: 14.1;Level: PT;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Orencia Product Name: Orencia Product Code: EMEA/H/C/000701 INN or Proposed INN: Abatacept Other descriptive name: Orencia (trade name)	Karolinska University Hospital	NULL	Not Recruiting	Female: yes Male: yes	20		United Kingdom;Sweden
4	EUCTR2009-015957-20-CZ (EUCTR)	27/01/2011	17/09/2010	Abatacept treatment in polymyositis and dermatomyositis - ARTEMIS	Abatacept treatment in polymyositis and dermatomyositis - ARTEMIS	polymyositis and dermatomyositis MedDRA version: 12.1;Level: LLT;Classification code 10036102;Term: Polymyositis MedDRA version: 12.1;Classification code 10012503;Term: Dermatomyositis	Trade Name: ORENCIA INN or Proposed INN: ABATACEPT	Karolinska University Hospital	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	20	Phase 2	Czech Republic;United Kingdom;Sweden
5	EUCTR2009-015957-20-SE (EUCTR)	16/02/2010	07/01/2010	Abatacept treatment in polymyositis and dermatomyositis - ARTEMIS	Abatacept treatment in polymyositis and dermatomyositis - ARTEMIS	polymyositis and dermatomyositis MedDRA version: 12.1;Level: LLT;Classification code 10036102;Term: Polymyositis MedDRA version: 12.1;Classification code 10012503;Term: Dermatomyositis	Trade Name: ORENCIA INN or Proposed INN: ABATACEPT	Karolinska University Hospital	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	20		United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2016-002269-77-FR
(EUCTR)

02/09/2017

11/02/2019

A Phase 3 trial to evaluate the effectiveness and safety of Abatacept SC alongside standard treatment in comparison to standard treatment alone in improving disease activity in adults with active idiopathic inflammatory myopathy, a group of chronic autoimmune inflammatory diseases that affect skeletal muscle.

A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC with Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults with Active Idiopathic Inflammatory Myopathy (IIM)

Idiopathic Inflammatory Myopathy (IIM; eg, Dermatomyositis [DM], Polymyositis [PM], autoimmune necrotizing myopathy)
MedDRA version: 20.0;Level: LLT;Classification code 10042753;Term: Symptomatic inflammatory myopathy;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Orencia
INN or Proposed INN: ABATACEPT

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 3

United States;France;Hungary;Czech Republic;Mexico;Brazil;Australia;Germany;Japan;Italy;Sweden;Korea, Republic of

EUCTR2016-002269-77-CZ
(EUCTR)

20/07/2017

18/05/2017

Idiopathic Inflammatory Myopathy (IIM; eg, Dermatomyositis [DM], Polymyositis [PM], autoimmune necrotizing myopathy)
MedDRA version: 20.0;Level: LLT;Classification code 10042753;Term: Symptomatic inflammatory myopathy;System Organ Class: 100000018885;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Orencia
INN or Proposed INN: ABATACEPT

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 3

France;United States;Hungary;Czech Republic;Mexico;Brazil;Australia;Germany;Japan;Italy;Korea, Republic of;Sweden

EUCTR2009-015957-20-GB
(EUCTR)

29/05/2012

20/04/2012

A clinical trial to investigate treatment with the drug abatacept in patients with polymyositis and dermatomyositis.

Abatacept Treatment in Polymyositis and Dermatomyositis - Artemis UK

Polymyositis and dermatomyositis
MedDRA version: 14.1;Level: PT;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Orencia
Product Name: Orencia
Product Code: EMEA/H/C/000701
INN or Proposed INN: Abatacept
Other descriptive name: Orencia (trade name)

Karolinska University Hospital

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom;Sweden

EUCTR2009-015957-20-CZ
(EUCTR)

27/01/2011

17/09/2010

Abatacept treatment in polymyositis and dermatomyositis - ARTEMIS

polymyositis and dermatomyositis
MedDRA version: 12.1;Level: LLT;Classification code 10036102;Term: Polymyositis
MedDRA version: 12.1;Classification code 10012503;Term: Dermatomyositis

Trade Name: ORENCIA
INN or Proposed INN: ABATACEPT

Karolinska University Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Czech Republic;United Kingdom;Sweden

EUCTR2009-015957-20-SE
(EUCTR)

16/02/2010

07/01/2010

Abatacept treatment in polymyositis and dermatomyositis - ARTEMIS

polymyositis and dermatomyositis
MedDRA version: 12.1;Level: LLT;Classification code 10036102;Term: Polymyositis
MedDRA version: 12.1;Classification code 10012503;Term: Dermatomyositis

Trade Name: ORENCIA
INN or Proposed INN: ABATACEPT

Karolinska University Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom;Sweden