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A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee (ITIC)

Primary Purpose

Osteoarthritis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

SD-6010

Placebo

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring knee Osteoarthritis Disease Modifying Osteoarthritis Drug

Eligibility Criteria

40 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects aged >= 40 years with a BMI >= 25 and <= 40 kg/m2
In the past, has been diagnosed with knee OA
Radiographic evidence of OA in the study knee

Exclusion Criteria:

A diagnosis of any other rheumatic disease
Current conditions in the study knee that would confound efficacy
Selected, traditional clinical safety and laboratory parameters

Sites / Locations

Brookwood Internists, P.C.
Greystone Medical Center
Pivotal Research Centers
Arizona Research Center
Pivotal Research Centers
University of Arizona
Martin Bowen Hefley Orthopedics
Teton Research, LLC
Med Center
College Hospital Costa Mesa
NeuroNetwork Trials
Med Investigations, Inc.
Sierra Clinical Research
University of California Davis Health System
University of California Davis
Scripps Clinic-Clinical Research
Plaza Medical Imaging
Denver Internal Medicine Group
Mountain View Clinical Research, Inc.
New West Physicians Clinical Research
Advanced Radiology Consultants
Advanced Radiology Consultants
Stamford Therapeutics Consortium
New England Research Associates, LLC
Southeastern Arthritis Center
Southeastern Imaging & Diagnostics
Southeastern Integrated Medical, PL, d/b/a Florida Medical Research Institute
Jacksonville Center for Clincal Research
Memorial Hospital Jacksonville
Gold Coast Research, LLC
Marin E. Hale, M.D., P.A.
Sabiha Khan, M.D.
Kanner, Mendelson, Shteinman, LLC
Radiant Research
Rheumatology and Endocrinology Specialists of the Palm Beaches, P.A.
North Georgia Clinical Research
North Georgia Clinical Research
East-West Medical Research Institute
Preventive Medicine
Rehabilitation Institue of Chicago
NorthShore University HealthSystem
NorthShore University HealthSystem
Clinical Investigation Specialists, Inc.
Illinois Bone and Joint Institute, LLC
The Arthritis Center
NorthShore University HealthSystem
Ronald Keith Stegemoller, American Health Network
Floyd Memorial Hospital
Heartland Research Associates, LLC
Family Medicine East, Chartered/Radiology
Heartland Research Associates, LLC
Office of Manoj Kohli, M.D.
L-MARC Research Center
Commonwealth Biomedical Research, LLC
TFD Research, LLC
Rheumatology Associates
The Center for Rheumatology and Bone Research
The Center for Rheumatology and Bone Research
Miray Medical Center
Phase III Clinical Research
Fall River Clinical Research
HCI Metromedic Walk-In
MedVadis Research Corporation
Fallon Clinic, Inc. (Drug Shipment)
Fallon Clinic, Inc.
Cadillac Clinical Research, LLC, located at Great Lakes Family Care
Arthritis and Osteoporosis Treatment and Research Center
Planters Clinic
North Mississippi Medical Center, Inc.
Mercy Medical Group/Woodlake Research
Dynamic Clinical Research, Inc.
Joan Prouty Moore, MD
Orthopaedic and Occupational Medicine
The Center for Pharmaceutical Research, P.C.
Affiliated Clinical Research, Inc.
Office of Michael Mall, M.D.
Nevada Imaging Centers
Nevada Imaging Centers
Office of Danka Michaels, MD
Office of Stephen H. Miller, MD
Regional Clinical Research, Inc.
NYU Hospital for Joint Diseases
VirtualScopics, Inc.
Crouse Medical Practice, PLLC d/b/a Internist Associates of Central New York
Kernodle Clinic Inc.
Southeastern Radiology
PharmQuest
Research Institute of the Carolinas, PLLC
PMG Research of Salisbury
Piedmont Healthcare/Research
Carolina Arthritis Associates, PA
PMG Research of Wilmington, LLC
Internal Medicine Associates
Lillestol Research, LLC
Advantage Diagnostics
Rapid Medical Research, Inc.
Columbus Clinical Research, Inc.
Optimed Research, LLC
Lake Health Lyndhurst Clinic
East Penn Rheumatology Associates, PC
Altoona Center for Clinical Research
BioImaging Technologies, Inc.
Memorial Hospital of Rhode Island
Rheumatology Associates
Radiant Research, Inc.
Parkway Medical Group
Holston Medical Group
D. Matthew Sellers MD PC
Southwind Medical Specialists
Baylor Research Institute
Metroplex Clinical Research Center
Radiant Research San Antonio Northeast
South Texas Radiology Imaging Center
Oakwell Clinical Research, LLC
Pivotal Research Centers
National Clinical Research - Norfolk, Inc.
National Clinical Research, Incorporated
Advanced Pain Management
Tacoma Center for Arthritis Research, PS
Clinical Investigation Specialists, Inc.
OMI - Organización Médica de Investigación
Saint Dennis Medical Group S.A.
Investigaciones Reumatológicas y Osteológicas S.R.L.
Instituto Médico Especializado (IME)
IMAI Research
Menzies Research Institute
Cliniques Universitaires St Luc
Universitair Ziekenhuis Gasthuisberg / Rheumatology
Rheumatology Research Associates Ltd.
Nexus Clinic Research
The Arthritis Program Research Group Inc.
Centre de Rhumatologie St-Louis
Revmacentrum MUDr. Mostera, s.r.o.
Fakultni nemocnice u sv. Anny v Brne
MEDIPONT Plus, s.r.o.
MEDIPONT, s.r.o.
ARTMEDI UPD s r.o.
DC Mediscan
MediCentrum Praha, a.s.
Nemocnice Na Frantisku s poliklinikou
Revmatologicky ustav
Centrum pro zdravotnicke zabezpeceni sportovni reprezentace
Ustredni vojenska nemocnice Praha
MSI - Muskuloskeletalni institut
Nemocnice Atlas, a.s.
PV-Medical s.r.o.
Praxis fuer Orthopaedie, Chirotherapie und Akupunktur
Praxis fuer Orthopaedie
Klinische Forschung Berlin-Buch
Praxis Dr. Thomas Jung
Klinische Forschung Schwerin
Orszagos Gerincgyogyaszati Kozpont
Synexus Magyarorszag Kft.
Heves Megyei Onkormanyzat Markhot Ferenc Korhaz
Bekes Megyei Kepviselo-testulet Pandy Kalman Korhaz, Reumatologia
Selye Janos Korhaz, Reumatologiai Szakrendelo
MAV Korhaz es Rendelointezet
Veszprem Megyei Onkormanyzat Csolnoky Ferenc Korhaz-Rendelointezet
Azienda Sanitaria Genovese, Ospedale La Colletta, Dipartimento Apparato Locomotore
Presidio Ospedaliero Augusto Murri, Reparto di Reumatologia
Ospedale Luigi Sacco, Azienda Ospedaliera Polo Universitario Unita' Operativa di Reumatologia
Centro Empresarial - Altavista Polo 4
Instituto de Ginecologia y Reproducción & Cirugia Minimamente Invasiva
Hospital Nacional "Alberto Sabogal Sologuren" - Essalud
Clínica San Felipe
Hospital Nacional "Edgardo Rebagliati Martins" - Essalud
Instituto Peruano del Hueso y la Articulación SAC.
Hospital Maria Auxiliadora
Centro Medico Corpac
NSZOZ "MEDICUS II" S.C. Irena Klimczak, Malgorzata Klimczak, Jerzy Klimczak
"SYNEXUS SCM" Sp. z o.o.
Katedra i Klinika Ortopedii i Traumatologii Narzadu Ruchu
Russian State Medical University, Moscow Faculty, City Clinical Hospital #4
Institute of Rheumatology
City Alexandrovskaya Hospital
L.G. Sokolov Clinical Hospital #122 of Federal Medical-Biology Agency of Russia, Central Polyclinic
Research Institute of Traumatology and Orthopedy Named After R. R. Vredena
V. Interna klinika FN a LF UK
Ivan Ujvari
Narodny ustav reumatickych chorob
Hospital Ntra. Sra. de La Esperanza
Hospital General Universitario de Guadalajara
Hospital Nuestra Señora de Valme

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

200 mg

50 mg

Placebo

Arm Description

High dose active comparator

Low dose active comparator

Placebo comparator to be used for control purposes

Outcomes

Primary Outcome Measures

Rate of Progression of Joint Space Narrowing

Rate of progression of joint space narrowing (JSN) was defined as narrowing in joint space width (JSW) over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in millimeter per year (mm/year) over a 2 year period was used to assess the rate of progression of JSN. Negative values indicating a worsening of osteoarthritis.

Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Less Than or Equal to (<=) 2

Rate of progression of JSN was defined as narrowing in joint space width over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in mm/year over a 2 year period was used to assess the rate of progression of JSN. KLG system was a method of classifying the severity of knee OA using five grades (0 [no severity] to 4 [maximum severity], higher grade indicating worse knee function). Negative values of slope indicating a worsening of osteoarthritis.

Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3

Secondary Outcome Measures

Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24

The WOMAC was a self-administered, disease-specific instrument which probed clinically important, participant relevant symptoms in the areas of pain, stiffness, and physical function in participants with OA of the knee. The WOMAC composite index was the sum of 24 individual questions regarding subscales of pain, stiffness and physical function (for each item score range: 0 [minimum] to 4 [maximum], higher score indicating worse knee condition). Total score was sum of the 3 subscale scores, giving a possible overall score range of 0 (minimum) to 96 (maximum). Higher score indicating the worse level of pain, stiffness and physical function.

Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24

The WOMAC pain subscale was comprised of 5 questions regarding the amount of pain experienced due to OA in the study knee. The WOMAC pain subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse pain. An overall subscale score range of 0 (minimum) to 20 (maximum), with higher scores indicating more pain.

Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24

Stiffness was defined as a sensation of decreased ease in which the participant moved the knee with OA. The WOMAC stiffness subscale was comprised of 2 questions regarding the degree of stiffness experienced in the study knee. The WOMAC stiffness subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse stiffness. An overall score range of 0 (minimum) to 8 (maximum), with higher scores indicating more stiffness.

Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24

The WOMAC physical function subscale referred to the participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was comprised of 17 questions regarding the degree of difficulty experienced due to OA in the study knee. The WOMAC physical function subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse physical function. An overall score range of 0 (minimum) to 68 (maximum), with higher scores indicating worse physical function.

Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24

Pain VAS was a self-administered instrument, a 100 millimeter (mm) line marked by participant. Intensity of pain range (over past week): 0 (mm) =no pain to 100 (mm) =worst possible pain. Higher score indicating severe pain.

Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24

Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using the scale ranging from 1 (minimum) to 5 (maximum), where 1 =very good, 2 =good, 3 =fair, 4 =poor and 5 =very poor. Higher scores indicating worse condition.

Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24

Physician assessed the overall impact of arthritis on the participant's daily life. Participant's condition was rated by the physician using the scale ranging from 1 (minimum) to 5 (maximum), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicating worse condition.

Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24

The pain VAS following a 50 foot walk was a single-item, self-administered instrument. Participants were asked to assess the pain due to OA in their study knee after a 50-foot walk. Participants responded on a VAS scale ranging from 0 (no pain) to 100 (severe pain). Higher scores indicating more pain.

Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24

The OA pain and assessment tool-knee joint is also known as the intermittent and constant osteoarthritis pain (ICOAP) scale. The OA pain assessment tool-knee joint was an 11-item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. The total score was calculated by adding the 11 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse health.

Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24

The OA pain assessment tool-knee joint constant pain subscale was a 5 item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Overall subscale score was calculated by adding the 5 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse constant pain.

Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24

The OA pain assessment tool-knee joint intermittent pain subscale score a 6 item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Overall subscale score was calculated by adding the 6 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse intermittent pain.

Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24

The OARSI knee function survey was an 11-item scale with each item scored 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. The total score was the sum of the 11 items and ranged from 0 (minimum) to 44 (maximum), where higher scores indicating worse health condition.

Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24

The KOOS-PS was used to rate participant's opinions about the difficulties they experienced with activity due to problems with their knee. It was a 7-item scale, each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Total score was calculated by adding the responses to 7 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse health condition.

Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 16.18 (minimum) to 57.11 (maximum), with higher scores indicating better physical functioning.

Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 18.45 (minimum) to 56.62 (maximum), with higher scores indicating better role-physical.

Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 19.23 (minimum) to 60.88 (maximum), with higher scores indicating lower bodily pain.

Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 16.75 (minimum) to 63.72 (maximum), with higher scores indicating better general health.

Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 22.02 (minimum) to 69.92 (maximum), with higher scores indicating better vitality.

Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 13.38 (minimum) to 56.40 (maximum), with higher scores indicating better social functioning.

Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 10.25 (minimum) to 55.68 (maximum), with higher scores indicating better role-emotional.

Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 8.02 (minimum) to 63.43 (maximum), with higher scores indicating better mental health.

Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 22.88 (minimum) to 58.69 (maximum), with higher scores indicating better physical health.

Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 11.11 (minimum) to 61.67 (maximum), with higher scores indicating better mental health.

Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score

EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D mobility domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problem), 2 =moderate health (some problems) and 3 =worst health (confined to bed). Higher scores indicating worse health condition. Participants with EQ-5D mobility domain score were reported in this measure.

Number of Participants With EuroQoL-5D Self-Care Domain Score

EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D self-care domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problems with self-care), 2 =moderate health (some problems) and 3 =worst health (unable to wash or dress). Higher scores indicating worse health condition. Participants with EQ-5D self-care domain score were reported in this measure.

Number of Participants With EuroQoL-5D Usual Activity Domain Score

EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D usual activity domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problems), 2 =moderate health (some problems) and 3 =worst health state (unable to perform usual activities). Higher scores indicating worse health condition. Participants with EQ-5D usual activity domain score were reported in this measure.

Number of Participants With EuroQo-5D Pain and Discomfort Domain Score

EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D pain and discomfort domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no pain and discomfort), 2 =moderate health (moderate pain and discomfort) and 3 =worst health state (extreme pain and discomfort). Higher scores indicated worse health condition. Participants with EQ-5D pain and discomfort domain score were reported in this measure.

Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score

EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. EQ-5D anxiety and depression domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (not anxious, depressed), 2 =moderate health (moderately anxious, depressed) and 3 =worst health (extremely anxious, depressed). Higher scores indicating worse health condition. Participants with EQ-5D anxiety and depression domain score were reported in this measure.

EuroQoL-5D Visual Analog Scale Score

The EQ-5D VAS score was a participant rated questionnaire to assess health-related quality of life in terms of a single index value. It was a visual analogue scale that ranged from 0 (minimum) to 100 (maximum), with higher scores indicating a better health condition.

Number of Participants With Increase in Total Analgesic Medication Use

Increase in total analgesic medication use for OA in the study knee was a comparison back to baseline of an increased and sustained use of standard background and/or rescue medication for more than 28 days as measured at the Month 12 and 24 visits. Only medications for OA knee pain were considered.

Number of Participants With Decrease in Total Analgesic Medication Use

Decrease in total analgesic medication use for OA in the study knee was a comparison back to baseline of a decreased and irregular use of standard background and/or rescue medication for more than 28 days as measured at the Month 12 and 24 visits. Only medications for OA knee pain were considered.

Patient Global Impression of Change Score

Patient global impression of change was a participant-rated instrument that measured change in participant's overall status on a 7-point scale ranging from: 1 =very much improved, 2 =much improved, 3 =minimally improved, 4 =no change, 5 =minimally worse, 6 =much worse and 7 =very much worse. Higher scores indicating worse condition.

Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index

The OMERACT-OARSI responder index was used to determine whether participants may be considered responders to treatment. An OMERACT-OARSI responder was a participant who had a better response on the WOMAC pain subscale score, a better response on the WOMAC physical function subscale score or improvement on at least two of the three domains: WOMAC pain subscale score (overall score range of 0 [minimum] to 20 [maximum], higher scores indicating more pain), WOMAC physical function subscale score (overall score range of 0 [minimum] to 68 [maximum], higher scores indicating worse physical function) and patient global assessment of arthritic condition score (overall score range of 1 [minimum] to 5 [maximum], higher scores indicating worse condition). Number of participants who were OMERACT-OARSI responder were reported in this measure.

Number of Participants With Joint Space Narrowing Progression

JSN progressor was defined as a participant with a decrease in joint space width that was greater in magnitude than the smallest detectable difference (0.199 mm).

Number of Participants Applicable for Virtual Joint Replacement

A virtual joint replacement candidate was defined as a participant whose last two WOMAC pain subscale scores (overall score range of 0 [minimum] to 20 [maximum], higher scores indicating more pain) were at least 8, last two WOMAC physical function subscale scores (overall score range of 0 [minimum] to 68 [maximum], higher scores indicating worse physical function) were at least 28 and was a joint space narrowing progressor (a participant with a decrease in JSW that was greater in magnitude than the smallest detectable difference =0.199 mm).

Full Information

NCT ID

NCT00565812

First Posted

November 29, 2007

Last Updated

November 1, 2016

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00565812

Brief Title

A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee

Acronym

ITIC

Official Title

A Long-Term, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Radiographic Study To Investigate The Safety And Efficacy Of Orally Administered SD-6010 In Subjects With Symptomatic Osteoarthritis Of The Knee

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The objective of this 2-year study is to evaluate the safety, tolerability and disease modifying efficacy of SD 6010, an inhibitor of inducible nitric oxide synthase (iNOS), in overweight and obese subjects with knee osteoarthritis. The efficacy of SD-6010 will be evaluated by radiography using joint space narrowing in the medial tibiofemoral compartment of the study knee as the primary endpoint.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

Keywords

knee Osteoarthritis Disease Modifying Osteoarthritis Drug

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1457 (Actual)

8. Arms, Groups, and Interventions

Arm Title

200 mg

Arm Type

Active Comparator

Arm Description

High dose active comparator

Arm Title

50 mg

Arm Type

Active Comparator

Arm Description

Low dose active comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo comparator to be used for control purposes

Intervention Type

Drug

Intervention Name(s)

SD-6010

Intervention Description

200 mg tablets once a day for 2 years

Intervention Type

Drug

Intervention Name(s)

SD-6010

Intervention Description

50 mg tablets once a day for 2 years

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo tablets once a day for 2 years

Primary Outcome Measure Information:

Title

Rate of Progression of Joint Space Narrowing

Description

Time Frame

Baseline up to Month 24

Title

Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Less Than or Equal to (<=) 2

Description

Time Frame

Baseline up to Month 24

Title

Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3

Description

Time Frame

Baseline up to Month 24

Secondary Outcome Measure Information:

Title

Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24

Description

Time Frame

Baseline, Month 3, 6, 12, 18, 24

Title

Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24

Description

Time Frame

Baseline, Month 3, 6, 12, 18, 24

Title

Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24

Description

Time Frame

Baseline, Month 3, 6, 12, 18, 24

Title

Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24

Description

Time Frame

Baseline, Month 3, 6, 12, 18, 24

Title

Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24

Description

Time Frame

Baseline, Month 3, 6, 12, 18, 24

Title

Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24

Description

Time Frame

Baseline, Month 3, 6, 12, 18, 24

Title

Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24

Description

Time Frame

Baseline, Month 3, 6, 12, 18, 24

Title

Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24

Description

Time Frame

Baseline, Month 3, 6, 12, 18, 24

Title

Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24

Description

Time Frame

Baseline, Month 3, 6, 12, 18, 24

Title

Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24

Description

Time Frame

Baseline, Month 3, 6, 12, 18, 24

Title

Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24

Description

Time Frame

Baseline, Month 3, 6, 12, 18, 24

Title

Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24

Description

Time Frame

Baseline, Month 3, 6, 12, 18, 24

Title

Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24

Description

Time Frame

Baseline, Month 3, 6, 12, 18, 24

Title

Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24

Description

Time Frame

Baseline, Month 12, 24

Title

Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24

Description

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 18.45 (minimum) to 56.62 (maximum), with higher scores indicating better role-physical.

Time Frame

Baseline, Month 12, 24

Title

Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24

Description

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 19.23 (minimum) to 60.88 (maximum), with higher scores indicating lower bodily pain.

Time Frame

Baseline, Month 12, 24

Title

Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24

Description

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 16.75 (minimum) to 63.72 (maximum), with higher scores indicating better general health.

Time Frame

Baseline, Month 12, 24

Title

Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24

Description

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 22.02 (minimum) to 69.92 (maximum), with higher scores indicating better vitality.

Time Frame

Baseline, Month 12, 24

Title

Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24

Description

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 13.38 (minimum) to 56.40 (maximum), with higher scores indicating better social functioning.

Time Frame

Baseline, Month 12, 24

Title

Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24

Description

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 10.25 (minimum) to 55.68 (maximum), with higher scores indicating better role-emotional.

Time Frame

Baseline, Month 12, 24

Title

Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24

Description

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 8.02 (minimum) to 63.43 (maximum), with higher scores indicating better mental health.

Time Frame

Baseline, Month 12, 24

Title

Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24

Description

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 22.88 (minimum) to 58.69 (maximum), with higher scores indicating better physical health.

Time Frame

Baseline, Month 12, 24

Title

Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24

Description

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 11.11 (minimum) to 61.67 (maximum), with higher scores indicating better mental health.

Time Frame

Baseline, Month 12, 24

Title

Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score

Description

Time Frame

Baseline, Month 12, 24

Title

Number of Participants With EuroQoL-5D Self-Care Domain Score

Description

EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D self-care domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problems with self-care), 2 =moderate health (some problems) and 3 =worst health (unable to wash or dress). Higher scores indicating worse health condition. Participants with EQ-5D self-care domain score were reported in this measure.

Time Frame

Baseline, Month 12, 24

Title

Number of Participants With EuroQoL-5D Usual Activity Domain Score

Description

EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D usual activity domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problems), 2 =moderate health (some problems) and 3 =worst health state (unable to perform usual activities). Higher scores indicating worse health condition. Participants with EQ-5D usual activity domain score were reported in this measure.

Time Frame

Baseline, Month 12, 24

Title

Number of Participants With EuroQo-5D Pain and Discomfort Domain Score

Description

EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D pain and discomfort domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no pain and discomfort), 2 =moderate health (moderate pain and discomfort) and 3 =worst health state (extreme pain and discomfort). Higher scores indicated worse health condition. Participants with EQ-5D pain and discomfort domain score were reported in this measure.

Time Frame

Baseline, Month 12, 24

Title

Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score

Description

EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. EQ-5D anxiety and depression domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (not anxious, depressed), 2 =moderate health (moderately anxious, depressed) and 3 =worst health (extremely anxious, depressed). Higher scores indicating worse health condition. Participants with EQ-5D anxiety and depression domain score were reported in this measure.

Time Frame

Baseline, Month 12, 24

Title

EuroQoL-5D Visual Analog Scale Score

Description

Time Frame

Baseline, Month 12, 24

Title

Number of Participants With Increase in Total Analgesic Medication Use

Description

Time Frame

Month 12, 24

Title

Number of Participants With Decrease in Total Analgesic Medication Use

Description

Time Frame

Month 12, 24

Title

Patient Global Impression of Change Score

Description

Time Frame

Month 24

Title

Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index

Description

Time Frame

Month 24

Title

Number of Participants With Joint Space Narrowing Progression

Description

JSN progressor was defined as a participant with a decrease in joint space width that was greater in magnitude than the smallest detectable difference (0.199 mm).

Time Frame

Month 24

Title

Number of Participants Applicable for Virtual Joint Replacement

Description

Time Frame

Month 24

Other Pre-specified Outcome Measures:

Title

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

Description

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the 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 were events between first dose of study drug and up to 7-10 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. Adverse events included both serious and non-serious adverse events.

Time Frame

Baseline up to 7-10 days after last dose of study drug (Week 111)

Title

Number of Participants With Electrocardiogram (ECG) Abnormalities

Description

Atrial (enlargement, fibrillation, premature beat), axis deviation, atrioventricular (accelerated conduction, first/second degree block), left anterior and posterior hemiblock, left atrial hypertrophy, left and right (complete/incomplete bundle branch block, ventricular hypertrophy), QRS (high/low voltage, nonspecific, prolongation greater than [>]140 milliseconds [msec]), junctional/paced rhythm, intraventricular conduction delay (>120 msec), early repolarization, ventricular premature contraction and beat, prolonged QTC, sinus (arrhythmia, bradycardia/tachycardia), supraventricular extra systole and premature beat, short PR syndrome. Abnormal Q-wave (>=30 msec), P-wave left/right atrial abnormality, T-wave flattened/inverted abnormality, U-wave abnormality, ST-T indeterminate abnormality, ST-T nonspecific changes, ST-T changes compatible with ischemia and pericarditis. ECG findings were judged by investigators for qualitative evaluation of abnormalities.

Time Frame

Baseline, Month 3, 6, 12, 18, 24

Title

Number of Participants With Laboratory Test Abnormalities

Description

Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit (hct), red blood cell(RBC) count: less than(<)0.8*lower limit of normal(LLN), platelet: <0.5*LLN or greater than (>)1.75*upper limit of normal (ULN), white blood cell (WBC): <0.6*LLN or >1.5*ULN, lymphocyte, neutrophil:<0.8*LLN or >1.2*ULN, basophil, eosinophil, monocyte:>1.2*ULN; total bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, gammaglutamyl transferase, alkaline phosphatase:> 3.0*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN; blood urea nitrogen, creatinine:>1.3*ULN, uric acid >1.2*ULN; sodium <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, magnesium, bicarbonate: <0.9*LLN or >1.1*ULN, phosphate <0.8*LLN or >1.2*ULN; glucose <0.6*LLN or >1.5*ULN, lipase >1.5*ULN; urine (specific gravity <1.003 or >1.030, pH <4.5 or >8, glucose, ketones, protein, blood/Hgb greater than or equal to [>=]1); pancreatic amylase >1.5*ULN.

Time Frame

Baseline up to Week 111

Title

Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96

Description

Blood pressure (BP) was measured by sphygmomanometer while participant was in supine position. Conditions were kept constant from visit to visit including observer, participant's same arm, cuff size, supine position, location, temperature, noise level. The same size BP cuff which was properly sized and calibrated, was used to measure BP each time.

Time Frame

Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96

Title

Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96

Description

BP was measured by sphygmomanometer while participant was in supine position. Conditions were kept constant from visit to visit including observer, participant's same arm, cuff size, supine position, location, temperature, noise level. The same size BP cuff which was properly sized and calibrated, was used to measure BP each time.

Time Frame

Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96

Title

Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96

Time Frame

Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects aged >= 40 years with a BMI >= 25 and <= 40 kg/m2 In the past, has been diagnosed with knee OA Radiographic evidence of OA in the study knee Exclusion Criteria: A diagnosis of any other rheumatic disease Current conditions in the study knee that would confound efficacy Selected, traditional clinical safety and laboratory parameters

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Brookwood Internists, P.C.

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Greystone Medical Center

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35242

Country

United States

Facility Name

Pivotal Research Centers

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

Arizona Research Center

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85023

Country

United States

Facility Name

Pivotal Research Centers

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85027

Country

United States

Facility Name

University of Arizona

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

Martin Bowen Hefley Orthopedics

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Teton Research, LLC

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Med Center

City

Carmichael

State/Province

California

ZIP/Postal Code

95608

Country

United States

Facility Name

College Hospital Costa Mesa

City

Costa Mesa

State/Province

California

ZIP/Postal Code

92627

Country

United States

Facility Name

NeuroNetwork Trials

City

Costa Mesa

State/Province

California

ZIP/Postal Code

92627

Country

United States

Facility Name

Med Investigations, Inc.

City

Fair Oaks

State/Province

California

ZIP/Postal Code

95628

Country

United States

Facility Name

Sierra Clinical Research

City

Roseville

State/Province

California

ZIP/Postal Code

95661

Country

United States

Facility Name

University of California Davis Health System

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

University of California Davis

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Scripps Clinic-Clinical Research

City

San Diego

State/Province

California

ZIP/Postal Code

92128

Country

United States

Facility Name

Plaza Medical Imaging

City

Santa Ana

State/Province

California

ZIP/Postal Code

92704

Country

United States

Facility Name

Denver Internal Medicine Group

City

Denver

State/Province

Colorado

ZIP/Postal Code

80209

Country

United States

Facility Name

Mountain View Clinical Research, Inc.

City

Denver

State/Province

Colorado

ZIP/Postal Code

80209

Country

United States

Facility Name

New West Physicians Clinical Research

City

Golden

State/Province

Colorado

ZIP/Postal Code

80401

Country

United States

Facility Name

Advanced Radiology Consultants

City

Fairfield

State/Province

Connecticut

ZIP/Postal Code

06824

Country

United States

Facility Name

Advanced Radiology Consultants

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06902

Country

United States

Facility Name

Stamford Therapeutics Consortium

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06905

Country

United States

Facility Name

New England Research Associates, LLC

City

Trumbull

State/Province

Connecticut

ZIP/Postal Code

06611

Country

United States

Facility Name

Southeastern Arthritis Center

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

Facility Name

Southeastern Imaging & Diagnostics

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

Facility Name

Southeastern Integrated Medical, PL, d/b/a Florida Medical Research Institute

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

Facility Name

Jacksonville Center for Clincal Research

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Memorial Hospital Jacksonville

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Gold Coast Research, LLC

City

Plantation

State/Province

Florida

ZIP/Postal Code

33317

Country

United States

Facility Name

Marin E. Hale, M.D., P.A.

City

Plantation

State/Province

Florida

ZIP/Postal Code

33317

Country

United States

Facility Name

Sabiha Khan, M.D.

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

Kanner, Mendelson, Shteinman, LLC

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Facility Name

Radiant Research

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Facility Name

Rheumatology and Endocrinology Specialists of the Palm Beaches, P.A.

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Facility Name

North Georgia Clinical Research

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

North Georgia Clinical Research

City

Woodstock

State/Province

Georgia

ZIP/Postal Code

30189

Country

United States

Facility Name

East-West Medical Research Institute

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96814

Country

United States

Facility Name

Preventive Medicine

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Rehabilitation Institue of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

NorthShore University HealthSystem

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

NorthShore University HealthSystem

City

Glenview

State/Province

Illinois

ZIP/Postal Code

60025

Country

United States

Facility Name

Clinical Investigation Specialists, Inc.

City

Gurnee

State/Province

Illinois

ZIP/Postal Code

60031

Country

United States

Facility Name

Illinois Bone and Joint Institute, LLC

City

Morton Grove

State/Province

Illinois

ZIP/Postal Code

60053

Country

United States

Facility Name

The Arthritis Center

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62704

Country

United States

Facility Name

NorthShore University HealthSystem

City

Vernon Hills

State/Province

Illinois

ZIP/Postal Code

60061

Country

United States

Facility Name

Ronald Keith Stegemoller, American Health Network

City

Avon

State/Province

Indiana

ZIP/Postal Code

46123

Country

United States

Facility Name

Floyd Memorial Hospital

City

New Albany

State/Province

Indiana

ZIP/Postal Code

47150

Country

United States

Facility Name

Heartland Research Associates, LLC

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67205

Country

United States

Facility Name

Family Medicine East, Chartered/Radiology

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67207

Country

United States

Facility Name

Heartland Research Associates, LLC

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67207

Country

United States

Facility Name

Office of Manoj Kohli, M.D.

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40517

Country

United States

Facility Name

L-MARC Research Center

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40213

Country

United States

Facility Name

Commonwealth Biomedical Research, LLC

City

Madisonville

State/Province

Kentucky

ZIP/Postal Code

42431

Country

United States

Facility Name

TFD Research, LLC

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71115

Country

United States

Facility Name

Rheumatology Associates

City

Portland

State/Province

Maine

ZIP/Postal Code

04102

Country

United States

Facility Name

The Center for Rheumatology and Bone Research

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

Facility Name

The Center for Rheumatology and Bone Research

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

Miray Medical Center

City

Brockton

State/Province

Massachusetts

ZIP/Postal Code

02301

Country

United States

Facility Name

Phase III Clinical Research

City

Fall River

State/Province

Massachusetts

ZIP/Postal Code

02720

Country

United States

Facility Name

Fall River Clinical Research

City

Fall River

State/Province

Massachusetts

ZIP/Postal Code

02721

Country

United States

Facility Name

HCI Metromedic Walk-In

City

New Bedford

State/Province

Massachusetts

ZIP/Postal Code

02740

Country

United States

Facility Name

MedVadis Research Corporation

City

Wellesley Hills

State/Province

Massachusetts

ZIP/Postal Code

02481-2106

Country

United States

Facility Name

Fallon Clinic, Inc. (Drug Shipment)

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01605

Country

United States

Facility Name

Fallon Clinic, Inc.

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01605

Country

United States

Facility Name

Cadillac Clinical Research, LLC, located at Great Lakes Family Care

City

Cadillac

State/Province

Michigan

ZIP/Postal Code

49601

Country

United States

Facility Name

Arthritis and Osteoporosis Treatment and Research Center

City

Flowood

State/Province

Mississippi

ZIP/Postal Code

39232

Country

United States

Facility Name

Planters Clinic

City

Port Gibson

State/Province

Mississippi

ZIP/Postal Code

39150

Country

United States

Facility Name

North Mississippi Medical Center, Inc.

City

Tupelo

State/Province

Mississippi

ZIP/Postal Code

38801

Country

United States

Facility Name

Mercy Medical Group/Woodlake Research

City

Clarkson Valley

State/Province

Missouri

ZIP/Postal Code

63011

Country

United States

Facility Name

Dynamic Clinical Research, Inc.

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64114

Country

United States

Facility Name

Joan Prouty Moore, MD

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64114

Country

United States

Facility Name

Orthopaedic and Occupational Medicine

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64114

Country

United States

Facility Name

The Center for Pharmaceutical Research, P.C.

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64114

Country

United States

Facility Name

Affiliated Clinical Research, Inc.

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

Office of Michael Mall, M.D.

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89109

Country

United States

Facility Name

Nevada Imaging Centers

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89117

Country

United States

Facility Name

Nevada Imaging Centers

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89118

Country

United States

Facility Name

Office of Danka Michaels, MD

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

Facility Name

Office of Stephen H. Miller, MD

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89144

Country

United States

Facility Name

Regional Clinical Research, Inc.

City

Endwell

State/Province

New York

ZIP/Postal Code

13760

Country

United States

Facility Name

NYU Hospital for Joint Diseases

City

New York

State/Province

New York

ZIP/Postal Code

10003

Country

United States

Facility Name

VirtualScopics, Inc.

City

Rochester

State/Province

New York

ZIP/Postal Code

14625

Country

United States

Facility Name

Crouse Medical Practice, PLLC d/b/a Internist Associates of Central New York

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

Kernodle Clinic Inc.

City

Burlington

State/Province

North Carolina

ZIP/Postal Code

27215

Country

United States

Facility Name

Southeastern Radiology

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27407

Country

United States

Facility Name

PharmQuest

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

Research Institute of the Carolinas, PLLC

City

Mooresville

State/Province

North Carolina

ZIP/Postal Code

28117

Country

United States

Facility Name

PMG Research of Salisbury

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

Piedmont Healthcare/Research

City

Statesville

State/Province

North Carolina

ZIP/Postal Code

28625

Country

United States

Facility Name

Carolina Arthritis Associates, PA

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

PMG Research of Wilmington, LLC

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Internal Medicine Associates

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58103

Country

United States

Facility Name

Lillestol Research, LLC

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58103

Country

United States

Facility Name

Advantage Diagnostics

City

Beachwood

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

Rapid Medical Research, Inc.

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

Columbus Clinical Research, Inc.

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43213

Country

United States

Facility Name

Optimed Research, LLC

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43235

Country

United States

Facility Name

Lake Health Lyndhurst Clinic

City

Lyndhurst

State/Province

Ohio

ZIP/Postal Code

44124

Country

United States

Facility Name

East Penn Rheumatology Associates, PC

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18015

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

BioImaging Technologies, Inc.

City

Newtown

State/Province

Pennsylvania

ZIP/Postal Code

18940

Country

United States

Facility Name

Memorial Hospital of Rhode Island

City

Pawtucket

State/Province

Rhode Island

ZIP/Postal Code

02860

Country

United States

Facility Name

Rheumatology Associates

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Radiant Research, Inc.

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

Parkway Medical Group

City

Fayetteville

State/Province

Tennessee

ZIP/Postal Code

37334

Country

United States

Facility Name

Holston Medical Group

City

Kingsport

State/Province

Tennessee

ZIP/Postal Code

37660

Country

United States

Facility Name

D. Matthew Sellers MD PC

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

Facility Name

Southwind Medical Specialists

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38125

Country

United States

Facility Name

Baylor Research Institute

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Metroplex Clinical Research Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Radiant Research San Antonio Northeast

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78217

Country

United States

Facility Name

South Texas Radiology Imaging Center

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78217

Country

United States

Facility Name

Oakwell Clinical Research, LLC

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78218

Country

United States

Facility Name

Pivotal Research Centers

City

Midvale

State/Province

Utah

ZIP/Postal Code

84047

Country

United States

Facility Name

National Clinical Research - Norfolk, Inc.

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

National Clinical Research, Incorporated

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

Advanced Pain Management

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23454

Country

United States

Facility Name

Tacoma Center for Arthritis Research, PS

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Clinical Investigation Specialists, Inc.

City

Kenosha

State/Province

Wisconsin

ZIP/Postal Code

53142

Country

United States

Facility Name

OMI - Organización Médica de Investigación

City

Buenos Aires

ZIP/Postal Code

C1013AAR

Country

Argentina

Facility Name

Saint Dennis Medical Group S.A.

City

Buenos Aires

ZIP/Postal Code

C1034ACO

Country

Argentina

Facility Name

Investigaciones Reumatológicas y Osteológicas S.R.L.

City

Buenos Aires

ZIP/Postal Code

C1114AAH

Country

Argentina

Facility Name

Instituto Médico Especializado (IME)

City

Buenos Aires

ZIP/Postal Code

C1405BCH

Country

Argentina

Facility Name

IMAI Research

City

Buenos Aires

ZIP/Postal Code

C1425AWC

Country

Argentina

Facility Name

Menzies Research Institute

City

Hobart

State/Province

Tasmania

ZIP/Postal Code

7000

Country

Australia

Facility Name

Cliniques Universitaires St Luc

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Universitair Ziekenhuis Gasthuisberg / Rheumatology

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Rheumatology Research Associates Ltd.

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5M 0H4

Country

Canada

Facility Name

Nexus Clinic Research

City

St. John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1A 5E8

Country

Canada

Facility Name

The Arthritis Program Research Group Inc.

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y 3R7

Country

Canada

Facility Name

Centre de Rhumatologie St-Louis

City

Sainte-Foy

State/Province

Quebec

ZIP/Postal Code

G1W 4R4

Country

Canada

Facility Name

Revmacentrum MUDr. Mostera, s.r.o.

City

Brno - Zidenice

ZIP/Postal Code

615 00

Country

Czech Republic

Facility Name

Fakultni nemocnice u sv. Anny v Brne

City

Brno

ZIP/Postal Code

656 91

Country

Czech Republic

Facility Name

MEDIPONT Plus, s.r.o.

City

Ceske Budejovice

ZIP/Postal Code

370 01

Country

Czech Republic

Facility Name

MEDIPONT, s.r.o.

City

Ceske Budejovice

ZIP/Postal Code

370 01

Country

Czech Republic

Facility Name

ARTMEDI UPD s r.o.

City

Hostivice

ZIP/Postal Code

253 01

Country

Czech Republic

Facility Name

DC Mediscan

City

Praha 11 - Chodov

ZIP/Postal Code

148 00

Country

Czech Republic

Facility Name

MediCentrum Praha, a.s.

City

Praha 11 - Chodov

ZIP/Postal Code

148 00

Country

Czech Republic

Facility Name

Nemocnice Na Frantisku s poliklinikou

City

Praha 1

ZIP/Postal Code

11000

Country

Czech Republic

Facility Name

Revmatologicky ustav

City

Praha 2

ZIP/Postal Code

128 50

Country

Czech Republic

Facility Name

Centrum pro zdravotnicke zabezpeceni sportovni reprezentace

City

Praha 6

ZIP/Postal Code

162 00

Country

Czech Republic

Facility Name

Ustredni vojenska nemocnice Praha

City

Praha 6

ZIP/Postal Code

162 00

Country

Czech Republic

Facility Name

MSI - Muskuloskeletalni institut

City

Praha 6

ZIP/Postal Code

169 00

Country

Czech Republic

Facility Name

Nemocnice Atlas, a.s.

City

Zlin

ZIP/Postal Code

760 01

Country

Czech Republic

Facility Name

PV-Medical s.r.o.

City

Zlin

ZIP/Postal Code

760 01

Country

Czech Republic

Facility Name

Praxis fuer Orthopaedie, Chirotherapie und Akupunktur

City

Bad Hersfeld

ZIP/Postal Code

36251

Country

Germany

Facility Name

Praxis fuer Orthopaedie

City

Berlin

ZIP/Postal Code

12247

Country

Germany

Facility Name

Klinische Forschung Berlin-Buch

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

Praxis Dr. Thomas Jung

City

Deggingen

ZIP/Postal Code

73326

Country

Germany

Facility Name

Klinische Forschung Schwerin

City

Schwerin

ZIP/Postal Code

19055

Country

Germany

Facility Name

Orszagos Gerincgyogyaszati Kozpont

City

Budapest

ZIP/Postal Code

1126

Country

Hungary

Facility Name

Synexus Magyarorszag Kft.

City

Budapest

ZIP/Postal Code

H-1036

Country

Hungary

Facility Name

Heves Megyei Onkormanyzat Markhot Ferenc Korhaz

City

Eger

ZIP/Postal Code

3300

Country

Hungary

Facility Name

Bekes Megyei Kepviselo-testulet Pandy Kalman Korhaz, Reumatologia

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

Selye Janos Korhaz, Reumatologiai Szakrendelo

City

Komarom

ZIP/Postal Code

2900

Country

Hungary

Facility Name

MAV Korhaz es Rendelointezet

City

Szolnok

ZIP/Postal Code

H-5000

Country

Hungary

Facility Name

Veszprem Megyei Onkormanyzat Csolnoky Ferenc Korhaz-Rendelointezet

City

Veszprem

ZIP/Postal Code

H-8200

Country

Hungary

Facility Name

Azienda Sanitaria Genovese, Ospedale La Colletta, Dipartimento Apparato Locomotore

City

Arenzano

ZIP/Postal Code

16011

Country

Italy

Facility Name

Presidio Ospedaliero Augusto Murri, Reparto di Reumatologia

City

Jesi (Ancona)

ZIP/Postal Code

60035

Country

Italy

Facility Name

Ospedale Luigi Sacco, Azienda Ospedaliera Polo Universitario Unita' Operativa di Reumatologia

City

Milano

ZIP/Postal Code

20157

Country

Italy

Facility Name

Centro Empresarial - Altavista Polo 4

City

Santiago de Surco

State/Province

Lima

ZIP/Postal Code

Lima 33

Country

Peru

Facility Name

Instituto de Ginecologia y Reproducción & Cirugia Minimamente Invasiva

City

Santiago de Surco

State/Province

Lima

ZIP/Postal Code

Lima 33

Country

Peru

Facility Name

Hospital Nacional "Alberto Sabogal Sologuren" - Essalud

City

Callao

ZIP/Postal Code

Callao-02

Country

Peru

Facility Name

Clínica San Felipe

City

Lima

ZIP/Postal Code

L-11

Country

Peru

Facility Name

Hospital Nacional "Edgardo Rebagliati Martins" - Essalud

City

Lima

ZIP/Postal Code

L-11

Country

Peru

Facility Name

Instituto Peruano del Hueso y la Articulación SAC.

City

Lima

ZIP/Postal Code

L-27

Country

Peru

Facility Name

Hospital Maria Auxiliadora

City

Lima

ZIP/Postal Code

L-29

Country

Peru

Facility Name

Centro Medico Corpac

City

Lima

ZIP/Postal Code

Lima-27

Country

Peru

Facility Name

NSZOZ "MEDICUS II" S.C. Irena Klimczak, Malgorzata Klimczak, Jerzy Klimczak

City

Cieszyn

ZIP/Postal Code

43-400

Country

Poland

Facility Name

"SYNEXUS SCM" Sp. z o.o.

City

Wroclaw

ZIP/Postal Code

50-088

Country

Poland

Facility Name

Katedra i Klinika Ortopedii i Traumatologii Narzadu Ruchu

City

Wroclaw

ZIP/Postal Code

50-556

Country

Poland

Facility Name

Russian State Medical University, Moscow Faculty, City Clinical Hospital #4

City

Moscow

ZIP/Postal Code

115093

Country

Russian Federation

Facility Name

Institute of Rheumatology

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

City Alexandrovskaya Hospital

City

St. Petersburg

ZIP/Postal Code

193312

Country

Russian Federation

Facility Name

L.G. Sokolov Clinical Hospital #122 of Federal Medical-Biology Agency of Russia, Central Polyclinic

City

St. Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

Research Institute of Traumatology and Orthopedy Named After R. R. Vredena

City

St. Petersburg

ZIP/Postal Code

195427

Country

Russian Federation

Facility Name

V. Interna klinika FN a LF UK

City

Bratislava

ZIP/Postal Code

826 06

Country

Slovakia

Facility Name

Ivan Ujvari

City

Bratislava

Country

Slovakia

Facility Name

Narodny ustav reumatickych chorob

City

Piestany

ZIP/Postal Code

921 12

Country

Slovakia

Facility Name

Hospital Ntra. Sra. de La Esperanza

City

Santiago de Compostela

State/Province

A Coruña

ZIP/Postal Code

15705

Country

Spain

Facility Name

Hospital General Universitario de Guadalajara

City

Guadalajara

ZIP/Postal Code

19002

Country

Spain

Facility Name

Hospital Nuestra Señora de Valme

City

Sevilla

ZIP/Postal Code

41014

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

23144445

Citation

Hellio le Graverand MP, Clemmer RS, Redifer P, Brunell RM, Hayes CW, Brandt KD, Abramson SB, Manning PT, Miller CG, Vignon E. A 2-year randomised, double-blind, placebo-controlled, multicentre study of oral selective iNOS inhibitor, cindunistat (SD-6010), in patients with symptomatic osteoarthritis of the knee. Ann Rheum Dis. 2013 Feb;72(2):187-95. doi: 10.1136/annrheumdis-2012-202239. Epub 2012 Nov 10.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6171016&StudyName=A%20Long-Term%2C%20Placebo-Controlled%20X-Ray%20Study%20Investigating%20the%20Safety%20and%20Efficacy%20of%20SD-6010%20in%20Subjects%20with%20Osteoarthritis%20of%20the%20Knee

Description

To obtain contact information for a study center near you, click here.

Learn more about this trial

A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee

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