Clinical trial NCT00768053: Evaluation of EULAR-RAID Score in Rheumatoid Arthritis Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: EULAR-RAID
active rheumatoid arthritis
etanercept
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Lincoln Medical and Mental Health Center
name: Umanis
name: SODIA
name: depolabo
First posted: 2008-10-07
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reliability of the European League Against Rheumatism - Rheumatism Arthritis Impact of Disease (EULAR-RAID) Score
timeFrame: Screening, baseline
measure: Simplicity: Time for Completion of the EULAR-RAID Questionnaire
timeFrame: Baseline up to Week 12
measure: Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28)
timeFrame: Baseline, Week 4
measure: Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28): Week 12
timeFrame: Week 12
measure: Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28): Time-normalized Average
timeFrame: Baseline, Last observation up to Week 12
measure: Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status
timeFrame: Baseline, Week 4
measure: Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status: Week 12
timeFrame: Week 12
measure: Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status: Time-normalized Average
timeFrame: Baseline, Last observation up to Week 12
measure: Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 4
timeFrame: Baseline, Week 4
measure: Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving a Moderate or Good EULAR Response Rate at Week 12
timeFrame: Week 12
measure: Minimal Clinically Important Improvement (MCII) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12
timeFrame: Week 4, Week 12
measure: 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)
timeFrame: Week 4, Week 12, and Last observation up to Week 12
measure: 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)
timeFrame: Week 4, Week 12, and Last observation up to Week 12
measure: Patient Acceptable Symptom State (PASS) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12
timeFrame: Week 4, Week 12
measure: 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)
timeFrame: Week 4, Week 12, and Last observation up to Week 12
measure: 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)
timeFrame: Week 4, Week 12, and Last observation up to Week 12
measure: Percentage of Participants Achieving > 1.2 Improvement in DAS28 at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving Remission (DAS28 <2.6) at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving Low Disease Activity (DAS28 ≤3.2) at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving > 0.6 DAS28 Response at Week 12
timeFrame: Week 12
measure: Time to Achievement of Sustained Low Disease Activity Score (LDAS): DAS28 ≤3.2
timeFrame: Baseline up to Week 12
measure: Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 12
timeFrame: Week 12
measure: Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12
timeFrame: Week 12
measure: Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 12
timeFrame: Week 12
measure: Percentage of Participants With American College of Rheumatology (ACR) 90 Response at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Amiens
country: France
facility: Pfizer Investigational Site
city: Amiens
country: France
facility: Pfizer Investigational Site
city: Belfort
country: France
facility: Pfizer Investigational Site
city: Berck sur Mer
country: France
facility: Pfizer Investigational Site
city: Bonneville Cedex
country: France
facility: Pfizer Investigational Site
city: Cahors
country: France
facility: Pfizer Investigational Site
city: Corbeil-Essonnes
country: France
facility: Pfizer Investigational Site
city: Créteil
country: France
facility: Pfizer Investigational Site
city: Dijon
country: France
facility: Pfizer Investigational Site
city: Lomme
country: France
facility: Pfizer Investigational Site
city: Montpellier
country: France
facility: Pfizer Investigational Site
city: Mulhouse
country: France
facility: Pfizer Investigational Site
city: PARIS Cedex 14
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Rodez Cedex 9
country: France
facility: Pfizer Investigational Site
city: Saint-priest En Jarez
country: France
facility: Pfizer Investigational Site
city: Valenciennes
country: France
facility: Pfizer Investigational Site
city: Monaco
country: Monaco
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Duarte C, Santos EJF, Ferreira RJO, Kvien TK, Dougados M, de Wit M, da Silva JAP, Gossec L. Validity and reliability of the EULAR instrument RAID.7 as a tool to assess individual domains of impact of disease in rheumatoid arthritis: a cross-sectional study of 671 patients. RMD Open. 2021 Feb;7(1):e001539. doi: 10.1136/rmdopen-2020-001539.
citation: Dougados M, Brault Y, Logeart I, van der Heijde D, Gossec L, Kvien T. Defining cut-off values for disease activity states and improvement scores for patient-reported outcomes: the example of the Rheumatoid Arthritis Impact of Disease (RAID). Arthritis Res Ther. 2012 May 30;14(3):R129. doi: 10.1186/ar3859.
citation: Dougados M, Ripert M, Hilliquin P, Brocq O, Brault Y, Logeart I. Onset of action of etanercept in rheumatoid arthritis based on patient-reported outcomes. Clin Exp Rheumatol. 2012 Mar-Apr;30(2):266-8. Epub 2012 Apr 13.