Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02301234




Registration number
NCT02301234
Ethics application status
Date submitted
21/11/2014
Date registered
25/11/2014
Date last updated
14/09/2017

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
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
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
Sex
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
25/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/09/2016
Sample size
Target
Accrual to date
Final
111
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
Oklahoma
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
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
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Jeju
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Seoul
Country [27] 0 0
Poland
State/province [27] 0 0
Elblag
Country [28] 0 0
Poland
State/province [28] 0 0
Katowice
Country [29] 0 0
Poland
State/province [29] 0 0
Krakow
Country [30] 0 0
Poland
State/province [30] 0 0
Torun
Country [31] 0 0
Poland
State/province [31] 0 0
Warszawa
Country [32] 0 0
Poland
State/province [32] 0 0
Warszaw
Country [33] 0 0
Poland
State/province [33] 0 0
Wroclaw
Country [34] 0 0
Spain
State/province [34] 0 0
A Coruña
Country [35] 0 0
Spain
State/province [35] 0 0
Santiago De Compostela
Country [36] 0 0
Sweden
State/province [36] 0 0
Lund
Country [37] 0 0
Sweden
State/province [37] 0 0
Malmo
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Blackpool
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Cannock
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Mancheter
Country [41] 0 0
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
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02301234