Study of Safety, Efficacy of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3007

• Register: EUCTR
• Last refreshed on: 17 July 2017
• Main ID: EUCTR2014-003224-40-CZ
• Date of registration: 19/03/2015
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International N.V.
• Public title: Study of Safety, Efficacy of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3007
• Scientific title: 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: 06/05/2015
• Target sample size: 643
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003224-40
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Canada, Czech Republic, France, Germany, Hungary, Italy, Korea, Republic of, Mexico, Poland, Romania, Russian Federation, Spain, Sweden, United Kingdom, United States

Contacts

• Name: Clinical Registry Group-JB BVent
• Affiliation: Janssen Research and Development

• Name: Clinical Registry Group-JB BVent
• Affiliation: Janssen Research and Development

Key inclusion & exclusion criteria

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 local standard of care that includes 3 medications from at least 2 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

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Osteoarthritis of the Hip or Knee
MedDRA version: 18.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859
MedDRA version: 18.1 Level: LLT Classification code 10020108 Term: Hips osteoarthritis System Organ Class: 100000004859

Intervention(s)

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

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Up to Week 52

Primary end point(s): The number of participants with Adverse Events as a measure of safety and tolerability

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

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.

Secondary Outcome(s)

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

Timepoint(s) of evaluation of this end point: End of week 16

Secondary ID(s)

2014-003224-40-DE

42160443PAI3007

Source(s) of Monetary Support

Janssen Research & Development, LLC