NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031210315

Registered date:15/09/2021

A Study to Evaluate the Change in Disease State and Adverse Events in Adult Participants with Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, Receiving Subcutaneous Injections of ABBV-154

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedPolymyalgia Rheumatica
Date of first enrollment15/09/2021
Target sample size200
Countries of recruitmentAustralia,Austria,Canada,France,Germany,Hungary,Italy,Netherlands,New Zealand,Poland,South Korea,Spain,United Kingdom,United States,Japan
Study typeInterventional
Intervention(s)Participants will receive ABBV-154 (dose A, B or C) or placebo subcutaneously (SC) every other week (eow) for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.

Outcome(s)

Primary OutcomeTime to Flare
Secondary Outcome- Cumulative glucocorticoid dose by 24 weeks - Achievement of flare-free state up to Week 24 - Change from Baseline in glucocorticoid dose at Week 24

Key inclusion & exclusion criteria

Age minimum>= 50age old
Age maximum<= 80age old
GenderBoth
Include criteria- Clinical diagnosis of Polymyalgia Rheumatica (PMR) and fulfillment of the 2012 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) provisional classification criteria for PMR. - Must have had at least 2 episodes of unequivocal PMR flare. - Must be on a stable dose of prednisone. - Must be willing to follow the protocol-defined glucocorticoid tapering regimen.
Exclude criteria- Have been treated with a prior TNF antagonist. - Current use of immunomodulators other than prednisone.

Related Information

Contact

Public contact
Name Contact for Patients and HCP
Address 3-1-21 Shibaura, Minato-ku, Tokyo Tokyo Japan 108-0023
Telephone +81-120-587-874
E-mail AbbVie_JPN_info_clingov@abbvie.com
Affiliation AbbVie. G.K.
Scientific contact
Name Hayato Yamazaki
Address 3-1-21 Shibaura, Minato-ku, Tokyo Tokyo Japan 108-0023
Telephone +81-120-587-874
E-mail AbbVie_JPN_info_clingov@abbvie.com
Affiliation AbbVie G.K.