臨床研究等提出・公開システム

Date of registration	Aug. 16, 2021
Last modified on	Sept. 21, 2023
Trial ID	jRCT2041210052

Scientific Title	[M20-466] A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs)
Public Title	[M20-466] Moderate to Severe Rheumatoid Arthritis: A Phase 2b, Dose-Ranging, Safety and Efficacy Study of ABBV-154

Contact for Scientific Queries	Name	Yamazaki Hayato
	Affiliation	AbbVie G.K.
	Address	3-1-21 Shibaura, Minato-ku, Tokyo
	Telephone	+81-120-587-874
	E-mail	AbbVie_JPN_info_clingov@abbvie.com
Contact for Public Queries	Name	Patients and HCP Contact for
	Affiliation	AbbVie. G.K.
	Address	3-1-21 Shibaura, Minato-ku, Tokyo
	Telephone	+81-120-587-874
	E-mail	AbbVie_JPN_info_clingov@abbvie.com

Recruitment status	Suspended

Anticipated date of first enrollment		Aug. 16, 2021
Actual date of first enrollment		Sept. 10, 2021
Target sample size		425
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	--Clinical diagnosis of rheumatoid arthritis(RA) with fulfillment of the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria for RA. --Participant has 6 swollen joints (based on 66 joint count) and 6 tender joints (based on 68 joint count) at baseline. --Participant must have had an inadequate response to at least one prior biologic and/or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) treatment for RA. --Participants must be on stable dose of methotrexate (MTX).
	Exclusion Criteria	--Participant discontinued prior adalimumab therapy due to intolerability or toxicity.
	Age Minimum	18age old over
	Age Maximum	75age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Rheumatiod Arthritis
Intervention(s)		Experimental: Dose A of ABBV-154 Participants in this group will receive dose A of ABBV-154 subcutaneously (SC) every other week (eow) for 12 weeks in the placebo-controlled period and 66 weeks in the long term extension (LTE) period. Experimental: Dose B of ABBV-154 Participants in this group will receive dose B of ABBV-154 SC eow for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period. Experimental: Dose C of ABBV-154 EOW Participants in this group will receive dose C of ABBV-154 SC eow for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period. Experimental: Dose C of ABBV-154 E4W Participants in this group will receive dose C of ABBV-154 SC every 4 weeks (e4w) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period. Experimental: Placebo Participants in this group will receive placebo SC eow for 12 weeks in the placebo-controlled period and will be re-randomized in 1:1 ratio to receive ABBV-154 dose B or C respectively SC eow for 66 weeks in the LTE period.
Primary Outcome(s)		Percentage of Participants Achieving American College of Rheumatology 50 % (ACR50) Response [ Time Frame: At 12 weeks ]

Primary Sponsor	AbbVie G.K.

Name of Certified Review Board	IRB of Chubu Rosai Hospital
Address	1-10-6 Komei, Minato Ward, Nagoya City, Aichi
Telephone	+81-52-652-5511
Approval Status	Approval
Date of approval	July. 20, 2021

Secondary ID(s)	NCT04888585
Issuing Authority	Clinical Trial.gov

Countries of Recruitment（Except Japan）	Australia/Austria/Canada/Czech/France/Germany/Greece/Hungary/Isreal/Italy/Holland/New Zealand/Poland/Russia/Slovakia/South Korea/Spain/Taiwan/Turkey/Ukraine/England/United States

History of Changes

No	Publication date
3	Sept. 21, 2023	(this page)	Changes
2	Dec. 25, 2022	Detail	Changes
1	Aug. 16, 2021	Detail

List of change history