Abatacept Post-marketing Clinical Study in Japan | NCT01758198

Official Title

A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate vs. Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Status Module

Name	Class
Ono Pharmaceutical Co., Ltd.	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1: Abatacept + Methotrexate (MTX)	Experimental	Abatacept 10 mg/kg solution intravenous (IV) infusion, once monthly for 12 months Methotrexate ≥6 mg/week for 12 months	Biological: Abatacept Drug: Methotrexate
Group 2: Placebo matching with Abatacept + Methotrexate	Placebo Comparator	Placebo matching with Abatacept 0 mg/kg solution, intravenous (IV) infusion once monthly for 12 months Methotrexate ≥6 mg/week for 12 months	Drug: Placebo matching with Abatacept Drug: Methotrexate

Name	Type	Description	Arm Group Labels	Other Names
Abatacept	Biological		Group 1: Abatacept + Methotrexate (MTX)	BMS-188667 (Orencia)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
American College of Rheumatology (ACR) 20% response rate		4 months (week 16)
Change from baseline in Total Sharp Score (TSS) using the Modified van der Heijde Sharp (vdH-S) method to 6 months (Week 24)		Baseline (Day 1), 6 months (Week 24)

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in Disease Activity Score-28 (DAS28)-CRP to 4 months (Week16)		Baseline (Day 1), 4 months (Week 16)
Non-progressors rate for the structural damage	The non-progressors rate is defined as the proportion of subjects meeting the change from baseline in the TSS at 6 months less than or equal to the smallest detectable difference (SDD) and/or the smallest detectable change (SDC)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Kamogawa	Chiba	296-8602	Japan
Local Institution

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Ancestor Terms

ID	Term
D018796	Immunoconjugates
D000906	Antibodies
D007136	Immunoglobulins
D012712	Serum Globulins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D005916	Globulins
D000630	Aminopterin
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases