Evaluation of EULAR-RAID Score in Rheumatoid Arthritis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00768053
• Date of registration: 03/10/2008
• Prospective Registration: No
• Primary sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Public title: Evaluation of EULAR-RAID Score in Rheumatoid Arthritis Patients Rainbow
• Scientific 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
• Date of first enrolment: October 2008
• Target sample size: 108
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00768053
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

France, Monaco

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Etanercept

Primary Outcome(s)

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]

Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status: Week 12 [Time Frame: Week 12]

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]

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]

Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status [Time Frame: Baseline, Week 4]

Reliability of the European League Against Rheumatism - Rheumatism Arthritis Impact of Disease (EULAR-RAID) Score [Time Frame: Screening, baseline]

Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 12 [Time Frame: Baseline, Week 12]

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]

Simplicity: Time for Completion of the EULAR-RAID Questionnaire [Time Frame: Baseline up to Week 12]

Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 4 [Time Frame: Baseline, Week 4]

Secondary Outcome(s)

Time to Achievement of Sustained Low Disease Activity Score (LDAS): DAS28 =3.2 [Time Frame: Baseline up to Week 12]

Percentage of Participants Achieving a Moderate or Good EULAR Response Rate at Week 12 [Time Frame: Week 12]

Percentage of Participants Achieving Remission (DAS28 <2.6) at Week 12 [Time Frame: Week 12]

Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 12 [Time Frame: Week 12]

Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 12 [Time Frame: Week 12]

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]

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]

Percentage of Participants Achieving Low Disease Activity (DAS28 =3.2) at Week 12 [Time Frame: Week 12]

Percentage of Participants Achieving > 0.6 DAS28 Response at Week 12 [Time Frame: Week 12]

Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12 [Time Frame: Week 12]

Percentage of Participants Achieving > 1.2 Improvement in DAS28 at Week 12 [Time Frame: Week 12]

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]

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]

Percentage of Participants With American College of Rheumatology (ACR) 90 Response at Week 12 [Time Frame: Week 12]

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]

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]

Secondary ID(s)

B1801019

0881X1-4508

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Lincoln Medical and Mental Health Center

SODIA

Umanis

depolabo

Results

• Results available: Yes
• Date Posted: 21/04/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00768053