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	1

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	NCT02760407 (ClinicalTrials.gov)	May 24, 2016	29/4/2016	Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo and Adalimumab, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active Disease	A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy	Rheumatoid Arthritis	Drug: Olokizumab 64mg q4w;Drug: Olokizumab 64mg q2w;Drug: Adalimumab 40mg q2w;Drug: Placebo q2w	R-Pharm	Quintiles, Inc.;OCT Clinical Trials	Active, not recruiting	18 Years	N/A	All	1575	Phase 3	United States;Argentina;Brazil;Bulgaria;Colombia;Czechia;Estonia;Germany;Hungary;Korea, Republic of;Latvia;Lithuania;Mexico;Poland;Romania;Russian Federation;Taiwan;United Kingdom;China;Czech Republic

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

NCT02760407
(ClinicalTrials.gov)

May 24, 2016

29/4/2016

Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo and Adalimumab, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active Disease

A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy

Rheumatoid Arthritis

Drug: Olokizumab 64mg q4w;Drug: Olokizumab 64mg q2w;Drug: Adalimumab 40mg q2w;Drug: Placebo q2w

R-Pharm

Quintiles, Inc.;OCT Clinical Trials

Active, not recruiting

18 Years

N/A

All

1575

Phase 3

United States;Argentina;Brazil;Bulgaria;Colombia;Czechia;Estonia;Germany;Hungary;Korea, Republic of;Latvia;Lithuania;Mexico;Poland;Romania;Russian Federation;Taiwan;United Kingdom;China;Czech Republic