DDrare: Database of Drug Development for Rare Diseases

271. 強直性脊椎炎
［臨床試験数：531，薬物数：343（DrugBank：66），標的遺伝子数：41，標的パスウェイ数：141］

Searched query = "Ankylosing spondylitis", "Spondylarthritis ankylopoietica"
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 = (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid; 0881; 150 mg double-blinded secukinumab; 150 mg open-label secukinumab; 300 mg double-blinded secukinumab; 331731-18-1; 40 mg MSB11022; 42942019; 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin; 5057732; 99mTc-rhAnnexin V-128; ABATACEPT; ABT-494; ADALIMUMAB; AIN457; AIN457, 150 mg; AIN457, 75 mg; AIN457A; AIN457F; ARCOXIA; ARCOXIA 90 mg comprimidos recubiertos con película; ARRY-371797; ARRY-371797, p38 inhibitor; AS; ATORVASTATIN; Abatacept; Acetaminophen; Aclasta; Adalimumab; Adalimumab (D2E7); Adalimumab (Humira); Adalimumab 40 mg sc every other week; Adalimumab, Etanercept, Golimumab or infliximab; Alendronate; Anti TNF alpha agent; Anti TNF alpha therapy; Anti-(human tumor necrosis factor) immunoglobulin G (human-mouse monoclonal cA2 heavy chain); Anti-Human Interleukin-23 Monoclonal Antibody; Anti-TNF; Anti-TNF biologics; Anti-TNF therapy (etanercept or adalimumab); Anti-Tumor Necrosis Factor; Apremilast; Apremilast tablet 20 mg; Apremilast tablet 30 mg BID; Arcoxia; Atorvastatin; BAT1406; BCD-055; BCD-085; BDMARD treatment; BI 655066; BI 655066 90 mg/ml; BI 730357; BIMEKIZUMAB; BMS-188667; BMS-986251; Bawei Shenqi Pill; Behavioral: AbbVie Care 2.0; Behavioral: Cannabis questionnaire; Behavioral: General healthy eating; Behavioral: Low Starch Diet (LSD); Bimekizumab; Biologic DMARD; Biosimilar; Blood collection; Blood samples; CA2; CANNABIDIOL; CC; CC-10004; CDP870; CERTOLIZUMAB PEGOL; CIMZIA certolizumab pegol 200 mg/ml solution for injection; CNTO 148; COSENTYX; CP; CP-690,550; CP-690,550-10; CT-P13; CTLA4Ig; Cannabidiol; Cannabidiol tablet 10 mg; Cannabis; Celebrex; Celecoxib; Celecoxib 200 milligrams; Celecoxib 400 milligrams; Celecoxib, Celebrex®; Certolizumab; Certolizumab Pegol; Certolizumab pegol; Certolizumab pegol (CZP); Certolizumab pegol / CIMZIA; Chlor; Chloride; Cimzia; Cimzia 200 mg solution for injection; Cimzia®; Cosentyx; DMARDs; DRONABINOL; Device: Technetium labelled glucosamine; Diclofenac; Diclofenac 50 milligrams; Diclofenac SR; Diclophenac; Dronabinol; Dronabinol capsule 2.5. mg; Drug treatment; E-Device; ENBREL; ENIA11; ETANERCEPT; ETORICOXIB; Enbrel; Enbrel (Etanercept); Enbrel (etanercept); Enbrel plus Celebrex; Enbrel®; Entecavir; Etanercept; Etanercept (50mg per week); Etanercept (50mg per week, for 2 weeks); Etanercept (50mg per week, for 4 weeks); Etanercept (Enbrel); Etanercept (Full-Dose); Etanercept (Half-Dose); Etoricoxib; FILGOTINIB; Fengshigutong Capsule; Fengshigutong Capsule plus Imrecoxib; Filgotinib; Focetria (Monovalent MF59-Adjuvanted vaccine); GLPG0634; GOLIMUMAB; GP2017; GP2017 (adalimumab biosimilar); Glucosamine; Gold; Golimumab; Golimumab (CNTO 148); Golimumab Injection; Golimumab Liquid in Vial; Golimumab Pre-Filled Syringe; Herpes Zoster Vaccine; Human Anti-TNF IgG1 Monoclonal Antibody; Human Anti-TNFalfa; Human anti-TNFa monoclonal antibody; Human umbilical cord-derived MSCs; Humira; Humira 40 mg/0.8 ml solution for injection; Humira®; Hydroxychloroquine; Hyrimoz; IBI303; INFLIXIMAB; INTERLEUKIN 2; IXEKIZUMAB; Ibuprofen; Iguratimod; Ilumetri; Imrecoxib; Indomethacin; Infliximab; Infliximab (BCD-055); Infliximab (Remicade); Infliximab and MTX; Interleukin 2; Intravenous infusion of MSCs; Ixekizumab; Jaktinib Hydrochloride Tablets; KIN-1901; Kunxian capsule; L04AA24; L04AB01; L04AB04; L04AB05; LSD; LY2439821; Leflunomide; Loxoprofen; Loxoprofen sodium hydrogel patch; Loxoprofen sodium tablet; Lyophilized etanercept powder(Yisaipu); METHOTREXATE; MK-0663; MK-3222; MSC; MTX; MabThera; MabThera 500; Meloxicam; Meloxicam suppository; Meloxicam tablet; Methotrexate; Methylprednisolone; Misoprostol; Monoclonal Antibody (MAb); Méthotrexate; Méthotrexate Bellon Comprimé; N.A.; NAPROXEN; NSAIDs; NSAIDs and sulfasalazine; Nanocurcumin; Naprosyn; Naprosysn; Naproxen; Naproxen 500 mg tablets (PN 200 minus omeprazole); Non-anti-TNF biologics; None; NsNSAIDs; Null; Observational study; Olsalazine; Omeprazole; Oral; Orencia; Originator; Originator (legacy) drug; Other COX-2 inhibitor; Other Cox-2 inhibitors; Other Non-selective NSAIDs; Other: 0.9ml sodium chloride; Other: No anti-inflammatory treatment; Other: general population; PN 200 tablets (500 mg naproxen and 20 mg omeprazole); Pamidronate; Parecoxib; Part I - etoricoxib 60 mg; Part I - etoricoxib 90 mg; Part I- naproxen 1000 mg; Part II- etoricoxib 60 mg; Part II- etoricoxib 90 mg; Part II- naproxen 1000 mg; Placebo; Prednisolone; Prefilled liquid etanercept(Yisaipu); Procedure: Blood sampling from infant; Procedure: Blood sampling from mother; Procedure: Blood sampling from umbilical cord; Procedure: Breast milk sampling; Propanoic acid; REMICADE; REMICADE 100 mg polvo para concentrado para solución para perfusión; REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO; ROACTEMRA 20 mg/ml, concentrado para solución para perfusión; RTNV148B IgG; Rebamipide; Recombinant TNF-a receptor: IgG Fc fusion protein; Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class; Remicade; Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning; Remicade®; Remsima; Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning; RhuTNFR:Fc; Risankizumab; Rituximab; Rituximab/ Mabthera; Ro 487-533/F01; Ro 487-5733/F01; Ro 487-7533/F01; Ro45-2294; RoActemra; RoActemra®; Rosuvastatin; SAR153191; SB4; SB4 (etanercept biosimilar); SB5; SECUKINUMAB; SHR0302; SSZ; SUNPG1622 I dose; Salazopyrin; Salazopyrin EN; Salazopyrin EN-Tabs; Salazopyrin En-Tabs; Salicylazosulfapyridine; Sarilumab; Secukinumab; Secukinumab (150 mg); Secukinumab (75 mg); Secukinumab (AIN457) 150 mg s.c.; Secukinumab 150 mg provided in 1.0 mL pre-filled syringes (PFSs) for sc injection.; Secukinumab 150 mg/1 ml Solution for injection; Secukinumab 150 milligram [Cosentyx]; Secukinumab 75 mg/0.5 ml Solution for injection; Simponi; Simponi®; Sodium chloride; Standard of Care; Stelara; Sulfasalazine; Sulfasalazine, SSZ; Sulphasalazine; Sulphasalazine (SSZ); Sulphasalazine 500 mg En-Tabs; Systemic non-biological treatments; TA-650 (Infliximab); THA; TNF alpha; TNF blockers (infliximab, adalimumab, etanercept); TNF-a antagonists, non-TNFs, DMARD non-biologics; TNF-alpha antagonists; TNF-inhibition; TNFR:Fc; TNR-001; TNR-001, TNFR:FC; TOCILIZUMAB; TOFACITINIB CITRATE; Taltz; Taltz (80 mg solution for injection in pre-filled syringe); Tapering or discontinuation of etanercept; Thalidomide; Thalidomide 100mg; Thalidomide 150mg; Tildrakizumab; Tildrakizumab 100 mg (one 1-mL injection of 100 mg/mL; Tildrakizumab 100 mg/ml; Tildrakizumab 200 mg (two 1-mL injections of 100 mg/mL); Tocilizumab; Tofacitinib; Tofacitinib 10 mg; Tofacitinib 2 mg; Tofacitinib 5 mg; Total Glucosides Paeony Capsules; Tramadol; Tramadol /acetaminophen; Tripterygium; Tripterygium Wilfordii; UCB4940; UPADACITINIB; Ultracet; Upadacitinib; Ustekinumab; Vessel; Voltaren resinat; Xeljanz; Yisaipu®; [18F]Fluoride

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	EUCTR2014-004887-39-PL (EUCTR)	08/08/2015	07/07/2015	A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis	An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis	Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC). MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: SB5 INN or Proposed INN: ADALIMUMAB Product Code: SB5 INN or Proposed INN: ADALIMUMAB	Samsung Bioepis Co., Ltd	NULL	Not Recruiting	Female: yes Male: yes			Poland
2	EUCTR2013-005013-13-PL (EUCTR)	25/06/2014	31/03/2014	A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira ® Product Name: Humira ® INN or Proposed INN: ADALIMUMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting	Female: yes Male: yes	490		Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of
3	EUCTR2013-005013-13-BG (EUCTR)	28/04/2014	23/04/2014	A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira ® Product Name: Humira ® INN or Proposed INN: ADALIMUMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting	Female: yes Male: yes	490	Phase 3	Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
4	EUCTR2013-005013-13-LT (EUCTR)	08/04/2014	13/02/2014	A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira ® Product Name: Humira ® INN or Proposed INN: ADALIMUMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting	Female: yes Male: yes	490		Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
5	EUCTR2013-005013-13-CZ (EUCTR)	03/04/2014	13/02/2014	A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira ® Product Name: Humira ® INN or Proposed INN: ADALIMUMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting	Female: yes Male: yes	490		Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina

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

EUCTR2014-004887-39-PL
(EUCTR)

08/08/2015

07/07/2015

A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis

An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis

Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC).
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: SB5
INN or Proposed INN: ADALIMUMAB
Product Code: SB5
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Poland

EUCTR2013-005013-13-PL
(EUCTR)

25/06/2014

31/03/2014

A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira ®
Product Name: Humira ®
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

490

Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of

EUCTR2013-005013-13-BG
(EUCTR)

28/04/2014

23/04/2014

A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira ®
Product Name: Humira ®
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

490

Phase 3

Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina

EUCTR2013-005013-13-LT
(EUCTR)

08/04/2014

13/02/2014

A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira ®
Product Name: Humira ®
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

490

Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina

EUCTR2013-005013-13-CZ
(EUCTR)

03/04/2014

13/02/2014

A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira ®
Product Name: Humira ®
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

490

Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina