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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02336685




Registration number
NCT02336685
Ethics application status
Date submitted
8/01/2015
Date registered
13/01/2015
Date last updated
2/10/2017

Titles & IDs
Public title
Study of Efficacy, Safety of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3001
Scientific title
Randomized, 16-Week, Multi-Phase, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fulranumab as Adjunctive Therapy in Subjects With Signs and Symptoms of Osteoarthritis of the Hip or Knee
Secondary ID [1] 0 0
42160443PAI3001
Secondary ID [2] 0 0
CR100068
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Pain 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Fulranumab 1 mg
Treatment: Drugs - Fulranumab 3 mg
Treatment: Drugs - Opioid

Placebo Comparator: Placebo - Participants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks) of placebo during the double-blind treatment phase in addition to opioids as standard of care.

Experimental: Fulranumab 1 mg - Participants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks) of fulranumab 1 mg during the double-blind treatment phase in addition to opioids as standard of care.

Experimental: Fulranumab 3 mg - Participants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks) of fulranumab 3 mg during the double-blind treatment phase in addition to opioids as standard of care.


Treatment: Drugs: Placebo
Placebo will be administered once every 4 weeks for 16 weeks by subcutaneous (SC) injection (injection under the skin) into the thigh or abdomen.

Treatment: Drugs: Fulranumab 1 mg
Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.

Treatment: Drugs: Fulranumab 3 mg
Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.

Treatment: Drugs: Opioid
Opioids will be administered as standard of care for osteoarthritis (OA) pain therapy during the double-blind treatment phase as per investigator discretion.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) pain subscale score - The WOMAC 3.1 is a multi-dimensional, osteoarthritis (OA) specific self-administered questionnaire using 24 questions with a 48-hour recall that are grouped into 3 subscales (pain, stiffness, and physical function) associated with hip or knee OA. Pain, stiffness, and physical function is rated on a scale of 0-10 (0 = less severe up to 10 = more severe).
Timepoint [1] 0 0
Baseline, Week 16
Primary outcome [2] 0 0
Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) physical function subscale score - See WOMAC 3.1 described above.
Timepoint [2] 0 0
Baseline, Week 16
Primary outcome [3] 0 0
Change from baseline to the end of Week 16 in Patient Global Assessment (PGA) score - The PGA is part of a comprehensive assessment of the impact of treatment for osteoarthritis that also includes pain and physical function. The PGA included in the present study indicates the perception of osteoarthritis in the study joint at the current time. Ratings are provided on an 11-point numerical rating scale from 0 ("Very Good") to 10 ("Very Bad").
Timepoint [3] 0 0
Baseline, Week 16
Secondary outcome [1] 0 0
Change from baseline to the end of Week 16 in Patient Global Assessment (PGA) score - See PGA described above.
Timepoint [1] 0 0
Baseline, Week 16
Secondary outcome [2] 0 0
Change from baseline to the end of Week 16 in WOMAC Stiffness subscale score - See WOMAC 3.1 described above.
Timepoint [2] 0 0
Baseline, Week 16
Secondary outcome [3] 0 0
Change from baseline to the end of Week 16 in daily numerical rating scale (NRS) score - The numerical rating scale (NRS) uses an 11-point scale to assess OA pain ranging from 0 to 10 with high scores representing greater symptom severity (0=no pain and 10=pain as bad as you can imagine).
Timepoint [3] 0 0
Baseline, Week 16
Secondary outcome [4] 0 0
Change from baseline to the end of Week 16 in Medical Outcomes Study (MOS) Sleep subscale scores - The MOS Sleep Scale (acute version) contains 12 items that address aspects of sleep. Six subscale scores may be calculated including: daytime somnolence, sleep disturbances, snoring, shortness of breath or headache upon awaking, adequacy of sleep and amount of sleep plus a summary index of sleep disturbances. A higher score indicates worse sleep in most domains, but the amount of sleep and adequacy of sleep are scored in the opposite direction. The primary subscale of interest in this study is daytime somnolence.
Timepoint [4] 0 0
Baseline, Week 16
Secondary outcome [5] 0 0
Change from baseline to the end of Week 16 in Short-Form-36 (SF-36) subscale scores - The SF-36 is a self-administered, generic, 36-item questionnaire designed to cover 8 domains of functional health status and well-being, physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Scoring yields 8 subscales based on the 8 domains covered in the questionnaire. These scales are scored from 0 to 100 with higher scores indicating better health.
Timepoint [5] 0 0
Baseline, Week 16
Secondary outcome [6] 0 0
Change from baseline to the end of Week 16 in EuroQol, 5 dimensions, 5 levels (EQ-5D-5L) scale score - The EQ-5D is a self-administered, standardized measure of health status designed to provide a generic measure of health for clinical and economic appraisal that includes the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D 5 level (5L) version will be used in this study. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and unable or extreme problems. A unique health state is defined by combining 1 level from each of the 5 dimensions.
Timepoint [6] 0 0
Baseline, Week 16
Secondary outcome [7] 0 0
Change from baseline to the end of Week 16 in the percentage of participants who are responders based on WOMAC pain and physical function subscale scores and PGA scale scores - Responders are defined as participants with percent improvement equal to and above the threshold values for WOMAC pain and physical function subscale scores and PGA scale scores, reported separately.
Timepoint [7] 0 0
Baseline, Week 16
Secondary outcome [8] 0 0
Change from baseline to the end of Week 16 in the percentage of participants who are responders based on OMERACT-OARSI, MCII, and PASS scale scores - Responders are defined as participants with percent improvement equal to and above the threshold values for Outcome Measures in Rheumatology initiative/Osteoarthritis Research Society International (OMERACT-OARSI), Minimal Clinically Important Improvement (MCII), and the Patient Acceptable Symptom State (PASS) scale scores.
Timepoint [8] 0 0
Baseline, Week 16
Secondary outcome [9] 0 0
Change from baseline to the end of Week 16 in the percentage of participants who use rescue medication and other osteoarthritis (OA) analgesia - Use of rescue medication (acetaminophen/paracetamol) and other OA pain medication will be recorded weekly during the study.
Timepoint [9] 0 0
Baseline, Week 16

Eligibility
Key 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

- An unsatisfactory response (inadequate efficacy or poor tolerability) that includes
all 3 classes of analgesic medications (acetaminophen/paracetamol, NSAIDs, and
opioids) and receiving an opioid at study entry; For participants in the USA and
Canada: An unsatisfactory response (inadequate efficacy or poor tolerability) that
includes all 3 classes of analgesic medications (acetaminophen/paracetamol, NSAIDs,
and opioids other than codeine or codeine combination products) and receiving an
opioid (other than codeine or codeine combination products) at study entry

- 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
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Increased risk of osteonecrosis (ON) or rapidly progressive osteoarthritis (RPOA)

- Unstable or progressive neurologic disorders

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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United States of America
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Alabama
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California
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Colorado
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United States of America
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Connecticut
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Delaware
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United States of America
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Florida
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United States of America
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Georgia
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Illinois
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Kansas
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Louisiana
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Maryland
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Massachusetts
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Nevada
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New Mexico
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New York
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Oklahoma
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Pennsylvania
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Tennessee
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Texas
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Utah
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United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Hungary
State/province [23] 0 0
Baja
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Hungary
State/province [24] 0 0
Szeged
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New Zealand
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Canterbury
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New Zealand
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Newtown
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New Zealand
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Takapuna
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New Zealand
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Tauranga
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Poland
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Bialystok
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Poland
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Gdansk
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Poland
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Myslenice
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United Kingdom
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Blackpool
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United Kingdom
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Cannock
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United Kingdom
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Greater Manchester
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United Kingdom
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Mancheter
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United Kingdom
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Matrix Park Buckshow Willage
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United Kingdom
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Stourton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of
fulranumab as adjunctive therapy compared with placebo in participants with chronic moderate
to severe pain and functional impairment from knee or hip osteoarthritis that is not
adequately controlled by current pain therapy.
Trial website
https://clinicaltrials.gov/show/NCT02336685
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications