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Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis (MOVE-RA)

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ClinicalTrials.gov Identifier: NCT02919475
Recruitment Status : Completed
First Posted : September 29, 2016
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Akros Pharma Inc.

Brief Summary:
This study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of JTE-051 administered for 12 weeks in subjects with active rheumatoid arthritis who are receiving background non-biologic disease-modifying anti-rheumatic drug therapy.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: JTE-051 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, PlacebO-controlled, Parallel-group Study to EValuate the Efficacy and Safety of JTE-051 Administered for 12 Weeks to Subjects With Active Rheumatoid Arthritis (MOVE-RA)
Actual Study Start Date : September 14, 2016
Actual Primary Completion Date : June 25, 2018
Actual Study Completion Date : June 25, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: JTE-051 Dose 1
One dose of study drug by mouth daily for 12 weeks
Drug: JTE-051
Active drug tablets containing JTE-051

Experimental: JTE-051 Dose 2
One dose of study drug by mouth daily for 12 weeks
Drug: JTE-051
Active drug tablets containing JTE-051

Experimental: JTE-051 Dose 3
One dose of study drug by mouth daily for 12 weeks
Drug: JTE-051
Active drug tablets containing JTE-051

Experimental: JTE-051 Dose 4
One dose of study drug by mouth daily for 12 weeks
Drug: JTE-051
Active drug tablets containing JTE-051

Experimental: Placebo
One dose of study drug by mouth daily for 12 weeks
Drug: Placebo
Placebo tablets identical in appearance to the active drug tablets




Primary Outcome Measures :
  1. Percentage of subjects achieving ACR20 response rate at 12 weeks [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  1. Percentage of subjects achieving ACR20/50/70 response rate [ Time Frame: Weeks 2, 4, 8, 12 and 16 ]
  2. Change from baseline in Simplified Disease Activity Index (SDAI) [ Time Frame: Weeks 2, 4, 8, 12 and 16 ]
  3. Change from baseline in Clinical Disease Activity Index (CDAI) [ Time Frame: Weeks 2, 4, 8, 12 and 16 ]
  4. Change from baseline in Disease Activity Score (DAS) based on hs-CRP (DAS28-CRP) [ Time Frame: Weeks 2, 4, 8, 12 and 16 ]
  5. Change from baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: Weeks 2, 4, 8, 12 and 16 ]
  6. Number of adverse events [ Time Frame: 16 Weeks ]
  7. Trough concentrations (Ctrough) of JTE-051 in plasma [ Time Frame: Weeks 2, 4, 8 and 12 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of RA prior to the Screening Visit.
  • Active disease despite ongoing therapy with up to two non-biologic disease-modifying anti-rheumatic drugs, including methotrexate at both the Screening and Baseline Visits.
  • Screening hs-CRP ≥1.2 x upper limit of normal (ULN).

Exclusion Criteria:

  • Prior/current exposure to biologic and/or kinase inhibitor therapy.
  • Known history or presence of polyneuropathy of any cause and no presence of clinically active compression neuropathy, radiculopathy or plexopathy at the Screening Visit.
  • Positive test results for human immunodeficiency (HIV) virus, hepatitis B virus or hepatitis C (HCV) virus at the Screening Visit.
  • Positive drug of abuse and alcohol test results.
  • History of a clinically-significant infection that required oral antimicrobial or antiviral therapy within 8 weeks prior to Day 1.

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): NCT02919475


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Sponsors and Collaborators
Akros Pharma Inc.
Investigators
Study Chair: Yoshiro Masuda Akros Pharma Inc.

Responsible Party: Akros Pharma Inc.
ClinicalTrials.gov Identifier: NCT02919475     History of Changes
Other Study ID Numbers: AE051-G-13-003
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018

Keywords provided by Akros Pharma Inc.:
JTE-051
Active Rheumatoid Arthritis
Efficacy
Safety
Tolerability
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases