Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00768053
Previous Study | Return to List | Next Study

Evaluation of EULAR-RAID Score in Rheumatoid Arthritis Patients (Rainbow)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00768053
Recruitment Status : Completed
First Posted : October 7, 2008
Results First Posted : April 21, 2011
Last Update Posted : July 29, 2011
Sponsor:
Collaborators:
Lincoln Medical and Mental Health Center
Umanis
SODIA
depolabo
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE October 3, 2008
First Posted Date  ICMJE October 7, 2008
Results First Submitted Date  ICMJE March 24, 2011
Results First Posted Date  ICMJE April 21, 2011
Last Update Posted Date July 29, 2011
Study Start Date  ICMJE October 2008
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2011)
  • Reliability of the European League Against Rheumatism - Rheumatism Arthritis Impact of Disease (EULAR-RAID) Score [ Time Frame: Screening, baseline ]
    EULAR-RAID score reliability assessed using an intraclass correlation coefficient (using a consistency definition where the between-measure variance is excluded from the denominator variance and its 95% confidence interval) and the standard error of measurement (SEM) and its 95% confidence interval (CI). A higher intraclass correlation coefficient (ICC) indicates greater score reliability (0.0 to 0.10=virtually none; 0.11 to 0.40=slight; 0.41 to 0.60=fair; 0.61 to 0.80=moderate; 0.81 to 1.00=substantial).
  • Simplicity: Time for Completion of the EULAR-RAID Questionnaire [ Time Frame: Baseline up to Week 12 ]
    EULAR-RAID is an assessment of patient reported outcomes for pain, functional disability, fatigue, sleep disturbance, coping, overall assessments of physical well-being and emotional well-being based on 7 numerical rating scales (NRS) questions. NRS individual questions with range of 0 (not affected, very good) to 10 (most affected) weighted and calculated with a total score range of 0 (not affected, very good) to 10 (most affected).
  • Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28) [ Time Frame: Baseline, Week 4 ]
    DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the DAS28. A higher correlation coefficient indicates greater EULAR-RAID score validity.
  • Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28): Week 12 [ Time Frame: Week 12 ]
    DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the DAS28. A higher correlation coefficient indicates greater EULAR-RAID score validity.
  • Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28): Time-normalized Average [ Time Frame: Baseline, Last observation up to Week 12 ]
    Time-normalized average is the area under the curve (AUC) / time between first and last observations. DAS28 calculated from number of swollen joints and painful joints using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID and DAS28 scores. A higher correlation coefficient indicates greater EULAR-RAID score validity.
  • Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status [ Time Frame: Baseline, Week 4 ]
    PGA of health status is a single-item participant rated response to the question "in general, how would you rate your health over the last 2 to 3 weeks"; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the PGA. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85).
  • Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status: Week 12 [ Time Frame: Week 12 ]
    PGA of health status is a single-item participant rated response to the question "in general, how would you rate your health over the last 2 to 3 weeks"; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and PGA health status score. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85).
  • Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status: Time-normalized Average [ Time Frame: Baseline, Last observation up to Week 12 ]
    Time-normalized average is the area under the curve (AUC) / time between first and last observations. PGA of health status is a single-item participant rated response to the question "in general, how would you rate your health over the last 2 to 3 weeks"; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and PGA health status score. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85).
  • Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 4 [ Time Frame: Baseline, Week 4 ]
    Sensitivity to change analyzed by testing if the difference of change from baseline of EULAR-RAID score minus the change from baseline of each component (pain, functional disability, fatigue, sleep disturbance, coping, overall physical and emotional well-being with score range 0 [not affected, very good] to 10 [most affected]) was different from 0 or not. Results expressed as standardized response mean (SRM) calculated as ratio of mean change over standard deviation of the change. A non significant test (p value ≥0.05) means the component had a significant influence to global EULAR RAID score.
  • Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 12 [ Time Frame: Baseline, Week 12 ]
    Sensitivity to change analyzed by testing if the difference of change from baseline of EULAR-RAID score minus the change from baseline of each component (pain, functional disability, fatigue, sleep disturbance, coping, overall physical and emotional well-being with score range 0 [not affected, very good] to 10 [most affected]) was different from 0 or not. Results expressed as standardized response mean (SRM) calculated as ratio of mean change over standard deviation of the change. A non significant test (p value ≥0.05) means the component had a significant influence to global EULAR RAID score.
Original Primary Outcome Measures  ICMJE
 (submitted: October 6, 2008)
To evaluate the simplicity, the reliability, the face validity and the sensitivity to change of the EULAR-RAID score. [ Time Frame: 18 weeks ]
Change History Complete list of historical versions of study NCT00768053 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2011)
  • Percentage of Participants Achieving a Moderate or Good EULAR Response Rate at Week 12 [ Time Frame: Week 12 ]
    EULAR response rate is based on DAS28. For DAS28 ≤3.2 at observation (low disease activity), change from baseline of <-1.2=good response or ≥-1.2 to <-0.6=moderate response; DAS28 >3.2 to 5.1 at observation (moderate or high disease activity), change from baseline of <-1.2 or ≥-1.2 to <-0.6=moderate response; DAS28 >5.1 (high disease activity) at observation, change from baseline of <-1.2=moderate response. DAS28 calculated using the 28 joints count, ESR mm/hour, and PGA of disease activity (participant rated arthritis activity measured on 11-point rating scale: 0 [none] to 10 [extreme]).
  • Minimal Clinically Important Improvement (MCII) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12 [ Time Frame: Week 4, Week 12 ]
    MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No Change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). The MCII score is defined as the 75th percentile of the change in EULAR-RAID score between baseline and observation among participants whose evaluation of the response therapy at observation was Moderately or Slightly important improvement.
  • Percentage of Participants Achieving a Minimal Clinically Important Improvement (MCII) Score at Week 4 Who Had Moderately or Slightly Important Improvement at Week 4, Week 12, or Last Observation (Last Obs) [ Time Frame: Week 4, Week 12, and Last observation up to Week 12 ]
    MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). MCII score at Week 4 calculated on participants with Moderately or Slightly important improvement (Mod/Slightly Imp Improvement) achieved at observation.
  • Percentage of Participants Achieving a Minimal Clinically Important Improvement Score at Week 12 Who Had Moderately or Slightly Important Improvement at Week 4, Week 12, or Last Observation (Last Obs) [ Time Frame: Week 4, Week 12, and Last observation up to Week 12 ]
    MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). MCII score at Week 12 calculated on participants with Moderately or Slightly important improvement (Mod/Slightly Imp Improvement) achieved at observation.
  • Patient Acceptable Symptom State (PASS) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12 [ Time Frame: Week 4, Week 12 ]
    PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be Acceptable or Unacceptable to you?). PASS score is defined as the 75th percentile of the change in EULAR-RAID score between baseline and observation among participants whose evaluation of their symptom state at observation was Acceptable.
  • Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS) Score at Week 4 Who Had an Acceptable Symptom State at Week 4, Week 12, or Last Observation (Last Obs) [ Time Frame: Week 4, Week 12, and Last observation up to Week 12 ]
    PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be acceptable or unacceptable to you?). PASS score at Week 4 calculated on participants with Acceptable symptom state achieved at observation.
  • Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS) Score at Week 12 Who Had an Acceptable Symptom State at Week 4, Week 12, or Last Observation (Last Obs) [ Time Frame: Week 4, Week 12, and Last observation up to Week 12 ]
    PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be acceptable or unacceptable to you?). PASS score at Week 12 calculated on participants with Acceptable symptom state achieved at observation.
  • Percentage of Participants Achieving > 1.2 Improvement in DAS28 at Week 12 [ Time Frame: Week 12 ]
    DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission. Achievement of >1.2 improvement defined as decrease in DAS28 >1.2 (i.e., change in DAS28 < -1.2).
  • Percentage of Participants Achieving Remission (DAS28 <2.6) at Week 12 [ Time Frame: Week 12 ]
    DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scalescored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission.
  • Percentage of Participants Achieving Low Disease Activity (DAS28 ≤3.2) at Week 12 [ Time Frame: Week 12 ]
    DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission.
  • Percentage of Participants Achieving > 0.6 DAS28 Response at Week 12 [ Time Frame: Week 12 ]
    DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission. Achievement of >0.6 DAS28 response defined as decrease in DAS28 > 0.6 (i.e. change in DAS28 < -0.6).
  • Time to Achievement of Sustained Low Disease Activity Score (LDAS): DAS28 ≤3.2 [ Time Frame: Baseline up to Week 12 ]
    Time to sustained LDAS measured as maintenance of low disease activity score beyond Week 12. DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission.
  • Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 12 [ Time Frame: Week 12 ]
    American College of Rheumatology 20% (ACR20) response: responder = ≥20% improvement in tender and swollen joint count and ≥20% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient's Global Assessment and Physician's Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.
  • Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12 [ Time Frame: Week 12 ]
    American College of Rheumatology 50% (ACR50) response: responder = ≥50% improvement in tender and swollen joint count and ≥50% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient's Global Assessment and Physician's Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.
  • Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 12 [ Time Frame: Week 12 ]
    American College of Rheumatology 70% (ACR70) response: responder = ≥70% improvement in tender and swollen joint count and ≥70% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient's Global Assessment and Physician's Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.
  • Percentage of Participants With American College of Rheumatology (ACR) 90 Response at Week 12 [ Time Frame: Week 12 ]
    American College of Rheumatology 90% (ACR90) response: responder = ≥90% improvement in tender and swollen joint count and ≥90% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient's Global Assessment and Physician's Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2008)
MCII of the EULAR-RAND. PASS of the EULAR-RAID score. Time to sustained LDAS/ The proportion of subjects achieving an improvement in DAS28, (remission, low disease activity), moderate or good EULAR response, DAS28 response, a MCII or PASS. ACRXX. [ Time Frame: 18 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of EULAR-RAID Score in Rheumatoid Arthritis Patients
Official Title  ICMJE Open-Label Study To Evaluate The EULAR-RAID Score, Rheumatoid Arthritis Impact Of Disease Score, In Rheumatoid Arthritis Patients Eligible To Etanercept And Who Will Receive Etanercept
Brief Summary The Disease Activity Score (DAS) is a system of measurement developed in the 1980s that uses certain criteria, including joint counts and patient perceived disease activity, to measure disease activity in people with Rheumatoid Arthritis . More recently, the European League against Rheumatism (EULAR) has developed a new system of measurement known as the Rheumatoid Arthritis Impact of Disease score, or EULAR-RAID score. The EULAR-RAID score is a composite score based on patient reported outcomes, and includes such criteria as pain, functional disability, fatigue, sleep disturbances, coping, overall assessment of physical well being and overall assessment of psychological well being. The objective of this study is to evaluate the practical modalities and performance of the EULAR- RAID score in patients with rheumatoid arthritis who have been prescribed etanercept as part of usual medical practice.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Drug: Etanercept
Etanercept 50 mg once a week
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Etanercept
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2011)
108
Original Estimated Enrollment  ICMJE
 (submitted: October 6, 2008)
107
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient aged up to or equal 18 years
  • Meet the 1987 ACR Revised Criteria for Rheumatoid Arthritis.
  • Active rheumatoid arthritis with a DAS greater than 3,2 and one of the two followings : Objective evidence of 4 clinical synovitis or CRP (plasma C-reactive protein) greater than 10 mg/l or ESR (erythrocyte sedimentation rate) greater than 28 mm/h
  • Failure of MTX, taken for at least 3 months and at least 15 mg/wk or maximal tolerated dosage . In patients with contraindications or intolerance to MTX, failure of another drug with structural efficacy (leflunomide or sulfasalazine), taken for at least 3 months at the optimal tolerated dosage Concomitant treatment for RA : DMARDs, corticosteroids, NSAIDs and analgesics are permitted. DMARDs and corticosteroids should be stable between screening and baseline visits.
  • Functional status Class I, II or III as defined by American College of Rheumatology (ACR) Revised Criteria.
  • Negative serum beta-human chorionic gonadotropin (beta-HCG) pregnancy test at screening for all women of childbearing potential. Sexually active women of childbearing potential must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Sexually active men must agree to use a medically accepted form of contraception during the study.
  • Able and willing to self-inject ETN or have a designee who can do so.
  • Able to store injectable test article at 2 Celcius degree to 8 Celcius degree

Exclusion Criteria:

  • Prior experience of biologic treatment for their RA including ETN.
  • Sepsis or risk of sepsis.
  • Current or recent infections, including chronic or localized.
  • Planned orthopedic surgery within 3 months (for RA disease)
  • History of orthopedic surgery 1 month before screening
  • Latex sensitivity.
  • Vaccination with live vaccine in the last 4 weeks, or expected to require such vaccination during the course of the study.
  • Previous clinical trial involvement in the last 3 months.
  • Patients with the following conditions or risk factors should only be entered into the study if the investigator has conducted and documented a full risk/benefit evaluation
  • History of recurring or chronic infection, or underlying condition which may predispose patients to infections e.g. tuberculosis (TB) infection (Note: follow SmPC and French guidelines for appropriate screening and treatment of TB in the setting of anti-tumor necrosis factor (anti-TNF) therapy. Patients with latent TB (contact with TB patients, history of primary TB, intradermal test with 5 IU of tuberculin greater than 5 mm, or radiographic lung density greater than 1 cm and consistent with TB) should receive appropriate prophylactic therapy as recommended by the French Agency for healthcare Product Safety (AFSSAPS, http//afassaps.sante.fr/), serious infection (infection associated with hospitalization and/or intravenous antibiotics) within 1 month of test article administration or active infection at screening, open cutaneous ulcers, known human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) positive.
  • Current or prior history of blood dyscrasias. Abnormal safety baseline blood test e.g. hemoglobin <= 85 g/L; hematocrit less than 27 %; platelet count less than 125 x 109/L; white blood cell count less than 3.5 x 109/L; serum creatinine greater than 175 µmol/L; aspartate aminotransferase (AST [SGOT]) and alanine aminotransferase (ALT [SGPT]) greater than 2 times the laboratory's upper limit of normal.
  • Pre-existing or recent onset central nervous system (CNS) demyelinating disease.
  • Cardiovascular conditions, e.g., myocardial infarction within 12 months of the screening visit, unstable angina pectoris, class III or IV congestive heart failure as defined by the New York Heart Association classification or decompensated congestive heart failure.
  • Uncontrolled conditions, e.g., diabetes mellitus, hypertension (defined as screening systolic blood pressure greater than 160 mm Hg or screening diastolic blood pressure greater than 100 mm Hg), severe pulmonary disease requiring hospitalization or supplemental oxygen.
  • At increased risk of malignancy.
  • Reasonable expectation that the subject will not be able to satisfactorily complete the study.
  • History of or current psychiatric illness, alcohol or drug abuse that would interfere with the subject's ability to comply with protocol requirements or give informed consent.
  • Employment by the investigator or reporting directly or indirectly to the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Monaco
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00768053
Other Study ID Numbers  ICMJE 0881X1-4508
B1801019
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE
  • Lincoln Medical and Mental Health Center
  • Umanis
  • SODIA
  • depolabo
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP