DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
271	強直性脊椎炎	2

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	NCT03733925 (ClinicalTrials.gov)	January 7, 2019	5/11/2018	A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis	A Phase-IV, Multicenter, Noncomparative, Open-Label Study Evaluating the Safety and Efficacy of Golimumab (a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously) in the Treatment of Indian Patients With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis	Spondylitis, Ankylosing;Arthritis, Psoriatic	Drug: Golimumab	Johnson & Johnson Private Limited	NULL	Recruiting	18 Years	N/A	All	100	Phase 4	India
2	EUCTR2014-000241-74-DE (EUCTR)	30/12/2014	01/10/2014	A Study of Golimumab in Participants with Active Ankylosing Spondylitis	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Ankylosing Spondylitis - GO - ALIVE	Ankylosing spondylitis (AS) MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: golimumab INN or Proposed INN: GOLIMUMAB Other descriptive name: Human anti-TNFa monoclonal antibody	Janssen Biologics, BV	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	United States;Mexico;Canada;Poland;Brazil;Ukraine;Romania;Australia;Russian Federation;Germany;Korea, Republic of

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

NCT03733925
(ClinicalTrials.gov)

January 7, 2019

5/11/2018

A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis

A Phase-IV, Multicenter, Noncomparative, Open-Label Study Evaluating the Safety and Efficacy of Golimumab (a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously) in the Treatment of Indian Patients With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis

Spondylitis, Ankylosing;Arthritis, Psoriatic

Drug: Golimumab

Johnson & Johnson Private Limited

NULL

Recruiting

18 Years

N/A

All

100

Phase 4

India

EUCTR2014-000241-74-DE
(EUCTR)

30/12/2014

01/10/2014

A Study of Golimumab in Participants with Active Ankylosing Spondylitis

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Ankylosing Spondylitis - GO - ALIVE

Ankylosing spondylitis (AS)
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: golimumab
INN or Proposed INN: GOLIMUMAB
Other descriptive name: Human anti-TNFa monoclonal antibody

Janssen Biologics, BV

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 3

United States;Mexico;Canada;Poland;Brazil;Ukraine;Romania;Australia;Russian Federation;Germany;Korea, Republic of