Trial from ClinicalTrials.gov

For full trial details, please see the original record at



Trial ID
NCT02301234
Ethics application status
Date submitted
21/11/2014
Date registered
21/11/2014
Date last updated
6/09/2017

Titles & IDs
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
Secondary ID [1] 0 0
42160443PAI3007
Secondary ID [2] 0 0
CR106249
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 - Celecoxib 100 mg
Treatment: drugs - Celecoxib 100 mg Matching Placebo

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, participants may take adjunctive therapy with celecoxib 100 mg orally (by mouth) twice daily for up to 16 weeks.

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, participants may take adjunctive therapy with celecoxib placebo orally twice daily for up to 16 weeks.

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, participants may take adjunctive therapy with celecoxib placebo orally twice daily for up to 16 weeks.


Treatment: drugs: Placebo
Placebo will be administered once every 4 weeks with or without adjunctive therapy 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 with or without adjunctive therapy 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 with or without adjunctive therapy for up to 16 weeks by SC injection into the thigh or abdomen.

Treatment: drugs: Celecoxib 100 mg
Double-blind capsules taken twice daily for up to 16 weeks.

Treatment: drugs: Celecoxib 100 mg Matching Placebo
Double-blind capsules taken twice daily for up to 16 weeks.

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

Outcomes
Primary outcome [1] 0 0
The number of participants with Adverse Events as a measure of safety and tolerability
Timepoint [1] 0 0
Up to Week 52
Secondary 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
Secondary 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

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

- 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). For participants
in the USA and Canada only: 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)

- 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
Current
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Hobart
Recruitment hospital [3] 0 0
- Kippa Ring
Recruitment hospital [4] 0 0
- Kogarah
Recruitment hospital [5] 0 0
- Maroochydore
Recruitment hospital [6] 0 0
- Melbourne
Recruitment hospital [7] 0 0
- Sherwood
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Hobart
Recruitment postcode(s) [3] 0 0
- Kippa Ring
Recruitment postcode(s) [4] 0 0
- Kogarah
Recruitment postcode(s) [5] 0 0
- Maroochydore
Recruitment postcode(s) [6] 0 0
- Melbourne
Recruitment postcode(s) [7] 0 0
- Sherwood
Recruitment outside Australia
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United States of America
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Arizona
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Colorado
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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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United States of America
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Illinois
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United States of America
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Kansas
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United States of America
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Maryland
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United States of America
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Michigan
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United States of America
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Missouri
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United States of America
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New York
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United States of America
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Oklahoma
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United States of America
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Tennessee
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United States of America
State/province [15] 0 0
Texas
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United States of America
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Virginia
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Canada
State/province [17] 0 0
British Columbia
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Canada
State/province [20] 0 0
West Vancouver
Country [21] 0 0
Czechia
State/province [21] 0 0
Praha
Country [22] 0 0
Germany
State/province [22] 0 0
Leipzig
Country [23] 0 0
Hungary
State/province [23] 0 0
Szekszard
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Anyang
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Korea, Republic of
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Jeju
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Korea, Republic of
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Seoul
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Poland
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Elblag
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Poland
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Katowice
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Poland
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Krakow
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Poland
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Torun
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Poland
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Warszawa
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Poland
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Warszaw
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Poland
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Wroclaw
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Spain
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A Coruña
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Spain
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Santiago De Compostela
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Sweden
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Lund
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Sweden
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Malmo
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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
State/province [40] 0 0
Mancheter
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United Kingdom
State/province [41] 0 0
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 signs and
symptoms of osteoarthritis of the hip or knee that are not adequately controlled by current
pain therapy.
Trial website
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
Contact person responsible for updating information