ASP1707
DrugOral
NCT Number: NCT02884635
The objective of this study is to evaluate the efficacy, pharmacokinetics, pharmacodynamics and safety of ASP1707 in combination with MTX in postmenopausal female patients with RA.
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Notify MeFemale
Interventional
Phase 2
Site JP00004, Numakunai, Iwate, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Non-steroidal anti-inflammatory drugs, oral morphine or equivalent opioid analgesics, acetaminophen, or oral corticosteroids.
Exclusion criteria
Oral
Oral
Methotrexate will be orally administered at stable dose from at least 28 days prior to screening through the screening and treatment periods until the end of the follow-up period.
Time frame: Week 12
ACR20: American College of Rheumatology 20
Time frame: Up to Week 8
Time frame: Up to Week 12
Time frame: Up to Week 12
Time frame: Baseline and Up to Week 12
DAS28-CRP: Disease Activity Score28 - C-reactive protein
Time frame: Baseline and Up to Week 12
DAS28-ESR: Disease Activity Score28 - Erythrocyte sedimentation rate
Time frame: Baseline and Up to Week 12
Time frame: Baseline and Up to Week 12
Time frame: Up to Week 12
Time frame: Up to Week 12
Time frame: Baseline and Up to Week 12
Time frame: Baseline and Up to Week 12
Time frame: Up to Week 12
EULAR: European league Against Rheumatism
Time frame: Up to Week 12
Time frame: Up to Week 12
Time frame: Up to Week 12
SDAI: Simplified Disease Activity Index
Time frame: Baseline and Up to Week 12
Time frame: Baseline and Up to Week 12
HAQ-DI: Health Assessment Questionnaire - Disability Index
Time frame: Up to Week 13
Time frame: Up to Week 13
Time frame: Up to Week 13
Time frame: Up to Week 13
Time frame: Up to Week 13
Time frame: Up to Week 13
Time frame: Up to Week 13
Time frame: Up to Week 13
Time frame: Up to Week 13
Time frame: Up to Week 12
Time frame: Up to Week 12
Time frame: Up to Week 13
Time frame: Up to Week 13
TNF: Tumor Necrosis Factor
Time frame: Up to Week 13
MMP3: Matrix metalloproteinase 3
Time frame: Up to Week 13
IL-6: Interleukin-6
Astellas Pharma Inc
Industry
Phase IIa Study of ASP1707 A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Phase 2a Study of ASP1707 in Postmenopausal Female Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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