Trials Sponsors Conditions Drugs Pricing

Conditions

Osteoarthritis, Knee / Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (1)

WOMAC Pain Score (Change From Baseline at Week 16)
The WOMAC is a scale that is used to assess the activities of daily living in osteoarthritis, the WOMAC pain subscale score was defined as the average of 5 items (during walking, using stairs, in bed, sitting or lying, and standing). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no pain) to 10 (worst pain imaginable), where higher scores indicated worse pain.
Baseline to Week 16

Secondary Outcomes (8)

WOMAC Physical Function Score (Change From Baseline at Week 16)
Baseline to Week 16
WOMAC Pain Score (Change From Baseline at Each Assessment Time Point)
Baseline to Week 68
WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point)
Baseline to Week 68
WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point)
Baseline to Week 68
WOMAC Total Score (Change From Baseline at Each Assessment Time Point)
Baseline to Week 68
+3 more secondary outcomes

Study Arms (3)

MT-5547 dosing regimen 1

EXPERIMENTAL

MT-5547 Subcutaneous (SC) dosing regimen 1. Naproxen-matching placebo oral after Week 16.

Drug: MT-5547

MT-5547 dosing regimen 2

EXPERIMENTAL

MT-5547 SC dosing regimen 2. Naproxen-matching placebo oral after Week 16.

Drug: MT-5547Drug: MT-5547-matching placebo

MT-5547-matching placebo

PLACEBO COMPARATOR

MT-5547-matching placebo SC dosing. Naproxen oral after Week 16.

Interventions

MT-5547Drug

Solution for injection in pre-filled syringe

Also known as: Fasinumab

MT-5547 dosing regimen 1MT-5547 dosing regimen 2

MT-5547-matching placeboDrug

Solution for injection in pre-filled syringe

Eligibility Criteria

Age40 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Tanabe Pharma Corporation
Industrylead

Study Sites (27)

Investigational Site

Aichi, Japan

Investigational Site

Aomori, Japan

Investigational Site

Chiba, Japan

Investigational Site

Ehime, Japan

Investigational Site

Fukui, Japan

Investigational Site

Fukuoka, Japan

Investigational Site

Fukushima, Japan

Investigational Site

MeSH Terms

Conditions

Osteoarthritis

Interventions

fasinumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title: Clinical Trials, Information Desk
Organization: Tanabe Pharma Corporation

Study Officials

General Manager
Tanabe Pharma Corporation
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

626 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 7, 2017

First Posted

August 10, 2017

Study Start

September 8, 2017

Actual (reported)

Efficacy and Safety of MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (3)

MT-5547 dosing regimen 1

MT-5547 dosing regimen 2

MT-5547-matching placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (27)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (3)

MT-5547 dosing regimen 1

MT-5547 dosing regimen 2

MT-5547-matching placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (27)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations