A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01554696
• Date of registration: 13/03/2012
• Prospective Registration: Yes
• Primary sponsor: Astellas Pharma Inc
• Public title: A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate
• Scientific title: A Phase 2b, Randomized, Double-blind, Parallel-group, Placebo Controlled, Dose-finding, Multi-center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis in Patients Who Have Had an Inadequate Response to Methotrexate
• Date of first enrolment: July 6, 2012
• Target sample size: 379
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01554696
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Belgium, Bulgaria, Colombia, Czech Republic, Czechia, Hungary, Mexico, Poland, United States

Contacts

• Name: Senior Medical Director Director
• Affiliation: Astellas Pharma Global Development

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subject has rheumatoid arthritis (RA) diagnosed according to the 1987 revised ACR
criteria for at least 6 months prior to Screening

- Subject has been treated with oral methotrexate (MTX) for a minimum of 90 days and at
a stable dose for 28 days prior to the first dose of study drug

- =6 tender/painful joints; =6 swollen joints

- Subject meets the ACR 1991 Revised Criteria for Global Functional Status in RA Class
I, II or III at Screening and Baseline

- Subject's other medication taken for treatment of RA must be stable for at least 28
days prior to start of the study

- Male and female subjects must be willing to comply with contraception requirements as
well as restrictions regarding egg and sperm donation

- Female subject must not be breastfeeding at Screening or during the study period, and
for 60 days after the final study drug administration

- Subject agrees not to participate in another interventional study while on treatment

Exclusion Criteria:

- Positive Mycobacterium tuberculosis (TB) test within 90 days of Screening

- Abnormal chest x-ray indicative of an acute or chronic infectious process or
malignancy

- Receipt of live or live attenuated virus vaccination within 30 days prior to the first
dose of study drug

- Known history of positive test for hepatitis B surface antigen (HBsAg) or hepatitis C
antibody or history of a positive test for human immunodeficiency virus (HIV)
infection

- History of any other autoimmune rheumatic disease, other than Sjogren's syndrome

- Previous history of clinically significant infections or illness (requiring
hospitalization or requiring parenteral therapy) within 90 days of the Baseline visit,
or a history of any illness that would preclude participation in the study

- History of any malignancy, except for successfully treated basal or squamous cell
carcinoma of the skin or in-situ carcinoma of the cervix

- Does not meet specified washout criteria for the following RA medications: gold,
azathioprine, minocycline, penicillamine, etanercept, certolizumab, adalimumab,
golimumab, infliximab, cyclophosphamide, and leflunomide

- Subject has previously used a non anti-TNF biologic disease-modifying antirheumatic
drug (DMARD) (e.g., anakinra, abatacept, rituximab, tocilizumab)

- Previous intolerance to Janus kinase (JAK) inhibitors

- Receipt of intra-articular or parenteral corticosteroid within 28 days prior to the
first dose of study drug or is currently taking > 30 mg oral morphine (or narcotic
equivalent) per day

- Absolute lymphocyte count (ALC) < 750/mm3

- Receipt of plasma exchange therapy within 60 days prior to the start of study drug

- Receipt of any investigational agent within 30 days or 5 half-lives, whichever is
longer, prior to first dose of study drug

- Receipt of medications that are CYP3A substrates with narrow therapeutic range within
14 days prior to first dose of study drug

- History of heart failure, defined as New York Heart Association (NYHA) grade 3 or
greater

- History of long QT syndrome or prolonged QT interval

- Any ongoing severe, progressive, or uncontrolled renal, hepatic, hematological,
gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological, or
infectious disease, or any ongoing illness which would make the subject unsuitable for
the study. This includes stomatitis, gastrointestinal ulcers, or any other condition
that would preclude continued treatment with methotrexate

- Subject has any condition possibly affecting oral absorption (e.g., gastrectomy, other
malabsorption syndromes, or clinically significant diabetic gastroenteropathy)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: Placebo

Drug: methotrexate

Drug: peficitinib

Primary Outcome(s)

Percentage of subjects achieving American College of Rheumatology Criteria 20 (ACR 20) response [Time Frame: Week 12]

Trough plasma concentration of ASP015K and metabolite(s) [Time Frame: up to Week 12]

Secondary Outcome(s)

Percentage of subjects achieving ACR 50 response [Time Frame: Week 12]

Percentage of subjects achieving ACR 70 response [Time Frame: Week 12]

Change from baseline in Disease Activity Score using 28 joint count and C Reactive Protein (DAS28-CRP) [Time Frame: Baseline and Week 12]

Secondary ID(s)

2011-006018-15

015K-CL-RA21

Source(s) of Monetary Support

Please refer to primary and secondary sponsors