Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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24 July 2017 |
Main ID: |
EUCTR2014-003224-40-SE |
Date of registration:
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16/06/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study of Safety, Efficacy of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3007
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Scientific title:
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Randomized, 16-Week, Multi-Phase, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Fulranumab as Adjunctive Therapy in Subjects with Signs and Symptoms of Osteoarthritis of the Hip or Knee |
Date of first enrolment:
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04/08/2015 |
Target sample size:
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900 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003224-40 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: Adjunctive Therapy
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 3
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Canada
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Czech Republic
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France
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Germany
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Hungary
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Italy
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Korea, Republic of
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Mexico
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Poland
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Romania
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Russian Federation
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Spain
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Sweden
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Registry Group-JB BVent
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Address:
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Archimedesweg 29
2333CMW
LeidenW
Netherlands |
Telephone:
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+31071 52421 66W |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen Research and Development |
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Name:
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Clinical Registry Group-JB BVent
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Address:
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Archimedesweg 29
2333CMW
LeidenW
Netherlands |
Telephone:
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+31071 52421 66W |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen Research and Development |
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Key inclusion & exclusion criteria
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Inclusion criteria: -Clinical diagnosis of osteoarthritis (OA) of hip or knee based on criteria defined by the American College of Rheumatology and radiographic evidence of OA (Kellgren-Lawrence class =2) of the study joint -Scheduled joint replacement or planning to undergo a joint replacement surgery for the study joint -Unsatisfactory response (inadequate efficacy or poor tolerability) on standard of care that includes 3 of any of the following classes of analgesic medications (acetaminophen/paracetamol, NSAIDs, or opioid) -Moderate to severe pain and functional impairment based on the NRS, WOMAC pain and physical function subscales, and PGA -During treatment and within 24 weeks after the last injection of study drug: if female of childbearing potential, is not pregnant, breast-feeding, or planning to become pregnant, or if male, will not father a child Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 600 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria: -Increased risk of osteonecrosis (ON) or rapidly progressive osteoarthritis (RPOA) -Unstable or progressive neurologic disorders
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Osteoarthritis of the Hip or Knee MedDRA version: 18.0
Level: LLT
Classification code 10023476
Term: Knee osteoarthritis
System Organ Class: 100000004859
MedDRA version: 18.0
Level: LLT
Classification code 10020108
Term: Hips osteoarthritis
System Organ Class: 100000004859
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Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
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Intervention(s)
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Product Name: Fulranumab Product Code: JNJ-42160443 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Fulranumab CAS Number: 902141-80-4 Current Sponsor code: JNJ-42160443 Other descriptive name: FULRANUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 4- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use
Product Name: Fulranumab Product Code: JNJ-42160443 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Fulranumab CAS Number: 902141-80-4 Current Sponsor code: JNJ-42160443 Other descriptive name: FULRANUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 12- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Secondary Objective: Secondary Objectives To evaluate the effect of fulranumab on: Efficacy as measured by the subject for pain, function, stiffness, health status and well-being Additional analgesic medication use Pharmacokinetics and immunogenicity of fulranumab
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Primary end point(s): The number of participants with Adverse Events as a measure of safety and tolerability
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Timepoint(s) of evaluation of this end point: Up to Week 52
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Main Objective: The primary objective is to demonstrate the safety and tolerability of fulranumab subcutaneous (SC) injections compared with SC placebo, in subjects with standard of care and who have signs and symptoms of osteoarthritis of the hip or knee.
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: End of week 16
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Secondary end point(s): - Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) pain subscale score
- Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) physical function subscale score
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Secondary ID(s)
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42160443PAI3007
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2014-003224-40-DE
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Source(s) of Monetary Support
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Janssen Research & Development, LLC
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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