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Evaluation of EULAR-RAID Score in Rheumatoid Arthritis Patients

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Amiens, , 80054 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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 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.

NCT00768053
Pfizer
Completed
Evaluation of EULAR-RAID Score in Rheumatoid Arthritis Patients

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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 SummaryThe 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 DescriptionNot 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 DateMarch 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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, 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 CenterPfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateJuly 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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