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Trial record 1 of 1 for:    MT-5547-J01
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Efficacy and Safety of MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain

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ClinicalTrials.gov Identifier: NCT03245008
Recruitment Status : Recruiting
First Posted : August 10, 2017
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Brief Summary:
The objective of this study is to verify the superiority of 16 weeks of MT-5547 treatment to placebo, as evidenced by the WOMAC pain score (the efficacy outcome measure), in patients with osteoarthritis of the knee or hip. Additional objectives of the study are to investigate the efficacy, safety, and pharmacokinetics of MT-5547 in long-term use.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee / Osteoarthritis, Hip Drug: MT-5547 Drug: MT-5547-matching placebo Phase 2 Phase 3

Detailed Description:
The blind will be maintained, including for the study sponsor, until the key code is opened after the data have been fixed for all subjects in Week 24. In addition, in order to eliminate any bias that could affect the study assessments, to the extent possible, the blind will be maintained with respect to the study site and the subject even after the opening of the study sponsor key code.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 563 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2/3 (Placebo-Controlled, Double-Blind, Comparative) Study on MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain
Actual Study Start Date : September 8, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: MT-5547 dosing regimen 1
MT-5547 Subcutaneous (SC) dosing regimen 1. Naproxen-matching placebo oral after Week 16.
Drug: MT-5547
Solution for injection in pre-filled syringe
Other Name: Fasinumab

Experimental: MT-5547 dosing regimen 2
MT-5547 SC dosing regimen 2. Naproxen-matching placebo oral after Week 16.
Drug: MT-5547
Solution for injection in pre-filled syringe
Other Name: Fasinumab

Drug: MT-5547-matching placebo
Solution for injection in pre-filled syringe

Placebo Comparator: MT-5547-matching placebo
MT-5547-matching placebo SC dosing. Naproxen oral after Week 16.
Drug: MT-5547-matching placebo
Solution for injection in pre-filled syringe




Primary Outcome Measures :
  1. WOMAC pain score (change from baseline at Week 16) [ Time Frame: Baseline to Week 16 ]

Secondary Outcome Measures :
  1. Patient Global Assessment (PGA) (change from baseline at each assessment time point) [ Time Frame: Baseline to Week 68 ]
  2. WOMAC pain score (change from baseline at each assessment time point) [ Time Frame: Baseline to Week 68 ]
  3. WOMAC physical function score (change from baseline at each assessment time point) [ Time Frame: Baseline to Week 68 ]
  4. WOMAC stiffness score (change from baseline at each assessment time point) [ Time Frame: Baseline to Week 68 ]
  5. WOMAC total score (change from baseline at each assessment time point) [ Time Frame: Baseline to Week 68 ]
  6. Adverse events and adverse drug reactions [ Time Frame: Baseline to Week 68 ]
  7. Assessments if a Joint Replacement Procedure Is Scheduled [ Time Frame: Baseline to Week 68 ]


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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Additional screening criteria check may apply for qualification:

  • Male and female Japanese patients, 40 years to 85 years at the time written informed consent is obtained.
  • Patients who have been diagnosed with osteoarthritis (OA) of the knee or hip based on the American College of Rheumatology (ACR) criteria.
  • Patients with an evaluated joint (knee or hip) with a K-L (Kellgren-Lawrence) score of ≥2 based on the X-ray test performed.
  • Moderate to severe pain in the evaluated joint, defined as a WOMAC pain score of ≥4 (mean of the 5 items), on the WOMAC assessments.
  • Patients who satisfy both 1) and 2) below.

    1. Inadequate OA pain relief from at least 1 oral NSAID.
    2. Intolerance to or inadequate OA pain relief from at least 1 opioid (including combination drugs), or unwillingness to take opioid therapy.
  • Patients who agree to not change their current lifestyle (daily living activities and exercise) throughout the study.
  • Patients who are able to complete post-operative follow-up for any joint replacement surgery that is performed during the study.
  • Body mass index at screening ≤39.
  • Patient who are able to understand and answer endpoint questions used in the study.

Exclusion Criteria:

Additional screening criteria check may apply for qualification:

  • Presence of symptoms of carpal tunnel syndrome within 6 months before screening.
  • Patients who cannot undergo MRI.
  • Trauma to the index joint within 3 months prior to screening.
  • Presence or history of inflammatory joint diseases other than OA, Paget's disease of the spine, pelvis or femur, multiple sclerosis, fibromyalgia, vertebral tumors or infections, or renal osteodystrophy.
  • Presence or history, confirmed by imaging, of arthropathy, neuropathic joint arthropathy, hip dislocation, knee dislocation, extensive subchondral cyst, marked bone destruction or bone loss, or pathologic fractures.
  • Autonomic neuropathy diagnosed in the assessment of autonomic nerve symptoms performed at screening, or baseline.
  • Presence or history of orthostatic hypotension at the orthostatic hypotension assessments performed at screening, prerandomization, or baseline.
  • Presence or history of autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy such as reflex sympathetic dystrophy at screening.
  • Presence or history of chronic familial dysautonomia.
  • Intolerance to naproxen.
  • Systemic (excluding topical, intranasal, ophthalmic, and inhaled formulations) corticosteroids within 4 weeks prior to screening.
  • Intra-articular corticosteroids in the evaluated joint within 12 weeks prior to screening, or in any other joint within 4 weeks prior to screening.
  • Received an intra-articular injection of hyaluronic acid in any joint within the period specified for each medicine prior to screening.
  • Resting heart rate of <50 bpm or >100 bpm at screening, or baseline.
  • Presence or history of 2nd or 3rd degree heart block, 1st degree heart block with abnormal QRS, or bifascicular block by ECG assessment at screening.
  • Non-compliance with the Numerical rating scale (NRS) recording (average pain on walking in the evaluated joint over 1 day) during the pre-treatment observation period.
  • Women who are pregnant, breast-feeding, or may be pregnant.
  • Use of an anti-Nerve growth factor (anti-NGF) antibody in the past, or apparent hypersensitivity or intolerance to anti-NGF antibodies.

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): NCT03245008


Contacts
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Contact: Clinical Trials Information Desk, to prevent miscommunication, please email: cti-inq-ml@ml.mt-pharma.co.jp

Locations
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Japan
Investigational Site Recruiting
Aichi, Japan
Investigational Site Recruiting
Aomori, Japan
Investigational Site Recruiting
Chiba, Japan
Investigational Site Recruiting
Ehime, Japan
Investigational Site Recruiting
Fukui, Japan
Investigational Site Recruiting
Fukuoka, Japan
Investigational Site Recruiting
Fukushima, Japan
Investigational Site Recruiting
Gunma, Japan
Investigational Site Recruiting
Hiroshima, Japan
Investigational Site Recruiting
Hokkaido, Japan
Investigational Site Recruiting
Hyogo, Japan
Investigational Site Recruiting
Ibaraki, Japan
Investigational Site Recruiting
Kagoshima, Japan
Investigational Site Recruiting
Kanagawa, Japan
Investigational Site Recruiting
Kumamoto, Japan
Investigational Site Recruiting
Kyoto, Japan
Investigational Site Recruiting
Mie, Japan
Investigational Site Recruiting
Miyagi, Japan
Investigational Site Recruiting
Miyazaki, Japan
Investigational Site Recruiting
Oita, Japan
Investigational Site Recruiting
Osaka, Japan
Investigational Site Recruiting
Saitama, Japan
Investigational Site Recruiting
Shiga, Japan
Investigational Site Recruiting
Shizuoka, Japan
Investigational Site Recruiting
Tokyo, Japan
Investigational Site Recruiting
Yamagata, Japan
Investigational Site Recruiting
Yamaguchi, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
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Study Director: General Manager Mitsubishi Tanabe Pharma Corporation

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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT03245008     History of Changes
Other Study ID Numbers: MT-5547-J01
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases