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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01554696
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of ASP015K in moderate to severe rheumatoid arthritis subjects who are methotrexate-inadequate responders (MTX-IR).

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: peficitinib Drug: Placebo Drug: methotrexate Phase 2

Detailed Description:
Subjects in each treatment group will continue to take their concomitant oral weekly dose of methotrexate (MTX) in addition to daily ASP015K or matching placebo, taken orally with food, daily for 12 weeks after randomization.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 379 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : July 6, 2012
Actual Primary Completion Date : February 11, 2014
Actual Study Completion Date : February 11, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ASP015K lowest dose
ASP015K lowest dose daily in addition to concomitant weekly oral methotrexate
Drug: peficitinib
oral
Other Name: ASP015K

Drug: methotrexate
oral

Experimental: ASP015K low dose
ASP015K low dose daily in addition to concomitant weekly oral methotrexate
Drug: peficitinib
oral
Other Name: ASP015K

Drug: methotrexate
oral

Experimental: ASP015K medium dose
ASP015K medium dose daily in addition to concomitant weekly oral methotrexate
Drug: peficitinib
oral
Other Name: ASP015K

Drug: methotrexate
oral

Experimental: ASP015K high dose
ASP015K high dose daily in addition to concomitant weekly oral methotrexate
Drug: peficitinib
oral
Other Name: ASP015K

Drug: methotrexate
oral

Placebo Comparator: Placebo
Placebo daily in addition to concomitant weekly oral methotrexate
Drug: Placebo
oral

Drug: methotrexate
oral




Primary Outcome Measures :
  1. Percentage of subjects achieving American College of Rheumatology Criteria 20 (ACR 20) response [ Time Frame: Week 12 ]
  2. Trough plasma concentration of ASP015K and metabolite(s) [ Time Frame: up to Week 12 ]

Secondary Outcome Measures :
  1. Percentage of subjects achieving ACR 50 response [ Time Frame: Week 12 ]
  2. Percentage of subjects achieving ACR 70 response [ Time Frame: Week 12 ]
  3. Change from baseline in Disease Activity Score using 28 joint count and C Reactive Protein (DAS28-CRP) [ Time Frame: Baseline and Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01554696


Locations
Show Show 49 study locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Senior Medical Director Director Astellas Pharma Global Development

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01554696    
Other Study ID Numbers: 015K-CL-RA21
2011-006018-15 ( EudraCT Number )
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
URL: https://www.clinicalstudydatarequest.com/
Keywords provided by Astellas Pharma Inc:
ASP015K
Rheumatoid Arthritis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Niacinamide
Methotrexate
Peficitinib
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Vitamin B Complex
Vitamins
Micronutrients
Nutrients