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OsteoarthritisPhase 3NCT02336698

Study of Efficacy, Safety of Fulranumab Monotherapy for OA of Hip or Knee, PAI3002

A Phase 3 study testing Fulranumab 1 mg and Fulranumab 3 mg in people with Osteoarthritis and Pain, run by Janssen Research & Development, LLC at 32 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of fulranumab as Monotherapy 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Osteoarthritis, Pain
What is being tested?
Fulranumab 1 mg and Fulranumab 3 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
32 sitesin 4 countries
Study dates
13 Jul 2015to 15 Sep 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Must have an unsatisfactory response (inadequate efficacy or poor tolerability) that includes all 3 classes of analgesic medications (acetaminophen/paracetamol, NSAID, and an opioid); For participants in the USA and Canada: Must have 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)
  • 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

Who cannot join

  • Increased risk of osteonecrosis (ON) or rapidly progressive osteoarthritis (RPOA)
  • Unstable or progressive neurologic disorders

Trial locations and contacts

32 sites in 4 countries.

32 sites in 4 countries

United States26 sites

  • Study site

    Atlanta, Georgia

  • Study site

    Bay City, Michigan

  • Study site

    Bedford, Texas

  • Study site

    Boynton Beach, Florida

  • Study site

    Caro, Michigan

  • Study site

    Charleston, South Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Costa Mesa, California

  • Study site

    Cypress, Texas

  • Study site

    Grand Rapids, Michigan

  • Study site

    Greenville, North Carolina

  • Study site

    Houston, Texas

  • Study site

    Laguna Hills, California

  • Study site

    Lake Clarke Shores, Florida

  • Study site

    Lakewood, California

  • Study site

    Memphis, Tennessee

  • Study site

    Miami, Florida

  • Study site

    Norfolk, Virginia

  • Study site

    Northridge, California

  • Study site

    Phoenix, Arizona

  • Study site

    Riverton, Utah

  • Study site

    Santa Clarita, California

  • Study site

    Somerset, New Jersey

  • Study site

    Thousand Oaks, California

  • Study site

    Waxahachie, Texas

  • Study site

    Wichita, Kansas

Other trials in United States

Spain4 sites

  • Study site

    A Coruña

  • Study site

    Barcelona

  • Study site

    Mérida

  • Study site

    Santiago de Compostela

Other trials in Spain

Poland1 site

  • Study site

    Elblag

Other trials in Poland

United Kingdom1 site

  • Study site

    Stourton

Other trials in United Kingdom

About this study

Official title: Randomized, 16-Week, Multi-Phase, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fulranumab as Monotherapy in Subjects With Signs and Symptoms of Osteoarthritis of the Hip or Knee

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of fulranumab as Monotherapy 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.

Read the detailed description

This is a randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-controlled (an inactive substance is given to one group of participants while active drug is given to another group of participants to see if there is a difference in response), parallel-group (study drugs given to participants in all treatment groups during the same time period) to evaluate the efficacy (capacity of the investigational drug to produce an effect), safety, and tolerability of fulranumab administered as monotherapy (alone; not in combination with other drug therapy) to participants with chronic moderate to severe pain and functional impairment from knee or hip osteoarthritis (OA) that is not adequately controlled by current pain therapy. The duration of participation in the study for an individual participant will be up to 67 weeks (includes a screening period of 3 weeks, a double-blind treatment period of 16 weeks, and a post-treatment follow-up period of up to 48 weeks).). All participants will be randomly assigned in a 1:1:1 ratio to 1 of 3 treatments (placebo, fulranumab 1mg, fulranumab 3mg) and given a single injection subcutaneously (under the skin) once every 4 weeks for up to 16 weeks. Blood samples will be collected from each participant at time points during the study. Safety evaluations will include assessment of adverse events, physical examinations, laboratory tests and vital signs which will be monitored throughout the study.

Conditions
Osteoarthritis, Pain
Being tested
Placebo, Fulranumab 1 mg, Fulranumab 3 mg
Keywords
Osteoarthritis, Pain, Fulranumab, JNJ-42160443, Monotherapy, Hip, Knee, Joint replacement surgery
Medical subject headings
Osteoarthritis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

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

  • Fulranumab 1 mgDrug

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

  • Fulranumab 3 mgDrug

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

Study groups in NCT02336698
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks).
Receives: Drug: Placebo
Fulranumab 1 mgExperimentalParticipants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks).
Receives: Drug: Fulranumab 1 mg
Fulranumab 3 mgExperimentalParticipants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks).
Receives: Drug: Fulranumab 3 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline, Week 16

  2. 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.

    Measured: Baseline, Week 16

  3. 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").

    Measured: Baseline, Week 16

Secondary outcomes (9)

  1. Change from baseline to the end of Week 16 in Patient Global Assessment (PGA) score

    See PGA described above.

    Measured: Baseline, Week 16

  2. Change from baseline to the end of Week 16 in WOMAC Stiffness subscale score

    See WOMAC 3.1 described above.

    Measured: Baseline, Week 16

  3. 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).

    Measured: Baseline, Week 16

  4. 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.

    Measured: Baseline, Week 16

  5. 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.

    Measured: Baseline, Week 16

  6. 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.

    Measured: Baseline, Week 16

  7. 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.

    Measured: Baseline, Week 16

  8. 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.

    Measured: Baseline, Week 16

  9. 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.

    Measured: Baseline, Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2015 (estimated)
  2. Study start13 Jul 2015
  3. Primary completion15 Sep 2016
  4. Study completion15 Sep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02336698
Sponsor's protocol ID
CR100069
Other IDs
42160443PAI3002, 2014-003879-37, 2014
Status last verified
Sep 2017
First submitted
8 Jan 2015
Last updated
2 Oct 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Kelly KM, Sanga P, Zaki N, Wang S, Haeussler J, Louie J, Thipphawong J. Safety and efficacy of fulranumab in osteoarthritis of the hip and knee: results from four early terminated phase III randomized studies. Curr Med Res Opin. 2019 Dec;35(12):2117-2127. doi: 10.1080/03007995.2019.1653068. Epub 2019 Sep 13.

    PubMed 31387410

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fulranumab 1 mg and Fulranumab 3 mg in people with Osteoarthritis and Pain, run by Janssen Research & Development, LLC at 32 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Spain, Poland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) pain subscale score (time frame: Baseline, Week 16). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02336698, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.

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