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
46	悪性関節リウマチ	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	NCT01651936 (ClinicalTrials.gov)	August 2012	25/7/2012	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Participants With Rheumatoid Arthritis (MK-8457-010)	A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects With Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy	Rheumatoid Arthritis	Drug: MK-8457 100 mg;Drug: Methotrexate;Drug: Dose-match placebo	Merck Sharp & Dohme Corp.	NULL	Terminated	18 Years	N/A	All	56	Phase 2	Australia;Colombia;Denmark;France;Greece;Hungary;Italy;Korea, Republic of;New Zealand;Poland;South Africa;Spain;United Kingdom;United States
2	NCT01569152 (ClinicalTrials.gov)	May 22, 2012	30/3/2012	Safety and Efficacy of MK-8457 and Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Despite MTX Therapy (P08683, MK-8457-008)	A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Dose-Ranging Clinical Trial With a Proof-of-Concept Lead Cohort to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy	Rheumatoid Arthritis (RA)	Drug: MK-8457 100 mg;Drug: Dose-Matched Placebo;Drug: Methotrexate	Merck Sharp & Dohme Corp.	NULL	Terminated	18 Years	N/A	All	82	Phase 2	Canada;Chile;Denmark;Germany;Hungary;Japan;Korea, Republic of;Lithuania;Moldova, Republic of;Peru;Poland;South Africa;Taiwan;United Kingdom;United States

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

NCT01651936
(ClinicalTrials.gov)

August 2012

25/7/2012

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Participants With Rheumatoid Arthritis (MK-8457-010)

A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects With Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy

Rheumatoid Arthritis

Drug: MK-8457 100 mg;Drug: Methotrexate;Drug: Dose-match placebo

Merck Sharp & Dohme Corp.

NULL

Terminated

18 Years

N/A

All

Phase 2

Australia;Colombia;Denmark;France;Greece;Hungary;Italy;Korea, Republic of;New Zealand;Poland;South Africa;Spain;United Kingdom;United States

NCT01569152
(ClinicalTrials.gov)

May 22, 2012

30/3/2012

Safety and Efficacy of MK-8457 and Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Despite MTX Therapy (P08683, MK-8457-008)

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Dose-Ranging Clinical Trial With a Proof-of-Concept Lead Cohort to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Rheumatoid Arthritis (RA)

Drug: MK-8457 100 mg;Drug: Dose-Matched Placebo;Drug: Methotrexate

Merck Sharp & Dohme Corp.

NULL

Terminated

18 Years

N/A

All

Phase 2

Canada;Chile;Denmark;Germany;Hungary;Japan;Korea, Republic of;Lithuania;Moldova, Republic of;Peru;Poland;South Africa;Taiwan;United Kingdom;United States