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OsteoarthritisPhase 2NCT00399490

Open-label Extension Study Of RN624

A Phase 2 study testing RN624 (PF-04383119) in people with Osteoarthritis and OA Knee Pain, run by Pfizer at 36 sites in United States.

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

Study RN624-CL007 is planned to be an open-label protocol to enroll subjects who have previously participated in Study No. RN624-CL006. In this study, subjects will receive RN624 on an open-label basis. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Osteoarthritis, OA Knee Pain, Arthritis
What is being tested?
RN624 (PF-04383119)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
287 participants
Where
36 sitesUnited States
Study dates
15 Sep 2006to 11 Feb 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Enrolled in Study RN624-CL006

Who cannot join

  • The occurrence of any adverse event or condition during the controlled studies that, in the opinion of the Investigator, should exclude the subject from participating in the open-label extension
  • Pregnant or lactating female subjects or subjects who do not agree to use an appropriate form of birth control throughout the study and for 3 months after completing the study

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

United States36 sites

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico, 87102

  • Imaging Centers of Anaheim

    Anaheim, California, 92801

  • Orange County Clinical Research

    Anaheim, California, 92801

  • Office of Walter F. Chase, MD, PA

    Austin, Texas, 78705

  • BrookWood Internal Medicine

    Birmingham, Alabama, 35209

  • Radiant Research

    Birmingham, Alabama, 35209

  • Covance Boise

    Boise, Idaho, 83704

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • Covance Clinical Research Unit, Inc

    Daytona Beach, Florida, 32117

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Sports Medicine and Orthopaedics Center

    Greensboro, North Carolina, 27401

  • Pharmquest

    Greensboro, North Carolina, 27408

  • Covance Clinical Research Unit, Inc. Honolulu

    Honolulu, Hawaii, 96813

  • Center for Pharmaceutical Research, P.C.

    Kansas City, Missouri, 64114

  • New Orleans Center for Clinical Research

    Knoxville, Tennessee, 37920

  • Volunteer Research Group

    Knoxville, Tennessee, 37920

  • Office of David Neustadt, PSL

    Louisville, Kentucky, 40202

  • Northwest Indiana Center for Clinical Research

    Merrillville, Indiana, 46410

  • Pivotal Research

    Midvale, Utah, 84047

  • Synergy Clinical Research Center

    National City, California, 91950

  • Ocala Rheumatology Research Center

    Ocala, Florida, 34474-7455

  • Quality Clincal Research

    Omaha, Nebraska, 68114

  • Arizona Research Center, LLC

    Phoenix, Arizona, 85023

  • AAIR Research Center

    Rochester, New York, 14618

  • Radiant Research - San Antonio

    San Antonio, Texas, 78217

  • Radiant Research San Antonio Northeast

    San Antonio, Texas, 78217

  • Rheumatology Associates of South Texas

    San Antonio, Texas, 78217

  • South Texas Radiology Imaging Center

    San Antonio, Texas, 78217

  • David M. Radin, MD

    Stamford, Connecticut, 06905

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905

  • Tampa Medical Group, PA

    Tampa, Florida, 33614-7118

  • Habana Hospital Pharmacy

    Tampa, Florida, 33614

  • The Center for Rheumatology and Bone Research

    Wheaton, Maryland, 20902

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts, 01610

  • Clinical Trials Northwest

    Yakima, Washington, 98902

  • Pharmacotherapy Research Associates Incorporated

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: OPEN-LABEL, MULTIPLE-DOSE STUDY OF THE SAFETY AND EFFICACY OF RN624 IN ADULTS WITH PAIN DUE TO OSTEOARTHRITIS OF THE KNEE.

Study RN624-CL007 is planned to be an open-label protocol to enroll subjects who have previously participated in Study No. RN624-CL006. In this study, subjects will receive RN624 on an open-label basis.

Being tested
RN624 (PF-04383119)
Keywords
Monoclonal antibody
Medical subject headings
Osteoarthritis, Arthritis

What participants receive

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

  • RN624 (PF-04383119)Drug

    50 mcg/kg

Study groups in NCT00399490
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: RN624 (PF-04383119)

What is being measured

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

  1. Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 12 weeks after last dose that were absent before treatment in this study or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events.

    Measured: Baseline up to 12 weeks after last dose of study drug

Secondary outcomes (9)

  1. Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72

    The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from the five individual questions scored on a visual analog scale (VAS) of 0 to 100, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 100, where higher scores indicate higher pain.

    Measured: A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72

  2. Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72

    The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as mean of the scores from the 2 individual questions scored on VAS of 0 to 100, where higher scores indicate worse function. Total score range for WOMAC stiffness subscale score is 0 to 100, where higher scores indicate worse function. Stiffness is defined as a sensation of decreased ease in movement of knee.

    Measured: A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72

  3. Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72

    The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on VAS of 0 to 100, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 100, where higher scores indicate worse function.

    Measured: A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72

  4. Change From A4091008 (NCT00394563) Baseline Visual Analog Scale (VAS) for Pain Intensity in the Index Knee at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72

    Participants answered: "In the past 24 hours, how much pain have you had in your index knee caused by your osteoarthritis?" Participants responded by using a VAS of 0 to 100, where 0 = no pain and 100 = extreme pain, higher scores indicated more pain.

    Measured: A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72

  5. Change From A4091008 (NCT00394563) Baseline in Participant Global Assessment Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72

    Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a VAS of 0 to 100, where 0 = very poor and 100 = very good, where higher scores indicated better health condition.

    Measured: A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72

  6. Number of Participants With Response to Participant Satisfaction Questionnaire

    Participants answered: "Overall, how satisfied are you with the study drug treatment you received as part of this study?" Participants responded by selecting the most appropriate among the following responses: not at all satisfied, a little satisfied, somewhat satisfied, and very satisfied.

    Measured: A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72

  7. Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72

    SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (CS). The total score for each section and 2 component scores are an average of the individual question scores, which are scaled from 0 to 100, where 0=lowest level of functioning and 100=highest level of functioning, higher scores indicated better functioning .

    Measured: A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72

  8. Percentage of Participants Who Discontinued the Study

    Measured: A4091009: Baseline up to 12 weeks after last dose of study drug

  9. Median Time in Study A4091009

    Median time of participation in the study for all the participants was evaluated.

    Measured: A4091009: Baseline up to 12 weeks after last dose of study drug

Timeline

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

  1. First posted15 Nov 2006 (estimated)
  2. Study start15 Sep 2006
  3. Primary completion11 Feb 2008
  4. Study completion11 Feb 2008

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
287 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00399490
Sponsor's protocol ID
A4091009
Other IDs
RN624-CL007
Status last verified
Nov 2020
First submitted
14 Nov 2006
Last updated
2 Feb 2021
Data monitoring committee
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Schnitzer TJ, Lane NE, Birbara C, Smith MD, Simpson SL, Brown MT. Long-term open-label study of tanezumab for moderate to severe osteoarthritic knee pain. Osteoarthritis Cartilage. 2011 Jun;19(6):639-46. doi: 10.1016/j.joca.2011.01.009. Epub 2011 Jan 18.

    PubMed 21251985

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RN624 (PF-04383119) in people with Osteoarthritis and OA Knee Pain, run by Pfizer at 36 sites in United States.

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 1 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 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to 12 weeks after last dose of study drug). 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 NCT00399490, 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 Feb 2021.

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